2025年 講演者

Desiree Abu-Odeh is a Senior Scientist in Merck's Global Trial Optimization (GTO) department. She has 15 years of research experience in academic, government, and clinical research settings. Desiree was with GTO from 2020 to 2022, then had the opportunity to lead diversity, equity, and inclusion work for a department in the City of Chicago enterprise. She returned to GTO in 2023 and remains committed to DEI in her work at Merck. Desiree has a BS in Neuroscience and MA in Bioethics from the University of Minnesota and an MPH and PhD in Sociomedical Sciences from Columbia University.

• Feasibility & Study Start-Up

Rolando was born and raised in Puerto Rico. He holds a Bachelor of Science in Computational Mathematics from the University of Puerto Rico at Humacao and a PhD in Biostatistics from Harvard University. His PhD work focused on developing statistical methods to assess population mobility and mortality after natural disasters. Rolando joined the Biostatistical Engineering group at Regeneron in July 2022 where he works on analyzing data stemming from wearable devices, developing machine learning models for the creation of prognostic factors, disease progression modeling research, among other things. More broadly, he is interested in statistical methods and computational tools to elucidate problems in medicine.

• Digital Health Technologies

Monique Adams is Executive Director, Global Head Diversity & Inclusion in Clinical Trials She is a thought expert on identifying innovative ways to improve the clinical trial experience for patients, clinical sites and the clinical teams who design and run the studies. She also manages the innovation project leads. Monique has a broad understanding of clinical development, gained through years of experience across Medical Affairs and Global Clinical Operations in different market environments. Monique is also the Vice-President of Women of Color in Pharma (WOIP) a nonprofit professional society founded in March 2015. WOCIP is committed to providing an environment that nurtures and empowers Black and Latina women employed in the pharmaceutical industry to take charge of their professional and personal development.

• Patient-Centric Trial Design & Inclusive Research
• Recruitment & Engagement

Dr. Ryan Ahern is Co-founder and Chief Medical Officer of Truveta and has more than a decade of experience in healthcare data and clinical research. At Truveta, Ryan leads the Life Science Partner team which focuses on developing new partnerships and ensuring those partners are successful in their research. He is currently a Clinical Assistant Professor of Medicine at the University of Washington School of Medicine and practices at Harborview Medical Center, Seattle’s large county hospital. Prior to this, he trained in internal medicine at the Massachusetts General Hospital and has served as a Clinical Assistant Professor of Medicine at Weill Cornell Medical Center and New York Presbyterian; attending physician at Massachusetts General Hospital; and instructor at Harvard Medical School.

• Real World Evidence

No bio available.

• Clinical Trial Venture, Innovation & Partnering

Jodi is a healthcare executive, leader, innovator, advisor and serial entrepreneur. She has more than 20 years experience in clinical development, scientific and regulatory strategy, management and medtech market development from start-ups to S&P 500 companies. Prior to founding Hawthorne Effect, Inc., Jodi was Global VP Clinical Affairs at Edwards Lifesciences, LLC- where she led the seminal clinical trials and regulatory approvals for transcatheter heart valve therapy. Also a humanitarian, Jodi led international healthcare initiatives including Heart To Heart International Children's Medical Alliance, The Nahapetov Friendship Foundation and the China Heart Group, a joint venture with the United Nations Industrial Development Organization. She holds an undergraduate degree in Foreign Service from Georgetown University, Masters in Physiology and Nursing from Pace University, New York and 8 patents with a few more pending.

• Clinical Trial Venture, Innovation & Partnering

Damalie Akuamoah is a Clinical Trial Diversity Program Lead at Merck & Co., driving the global strategy to enhance diversity and inclusion across atherosclerosis, cardiovascular, infectious disease, and vaccine clinical trials. Her mission ensures participant populations reflect communities the organization serves. Akuamoah leads Merck's Diversity in Clinical Trials Global Perspective Working Group, facilitating international collaboration on best practices and localized solutions for inclusive trials. With over a decade at Merck, Damalie has held roles as an Epidemiology Scientist and Clinical Scientist, leading and supporting global observational and clinical studies in various therapeutic areas including cardiovascular, diabetes, women’s health, and oncology. Damalie earned a Bachelor of Science from City College of New York, CUNY, and a Master of Public Health in Epidemiology from Drexel University.

• Quality & Monitoring

Todd Albin launched Cedar Health Research following more than two decades of experience as an accomplished leader in the clinical research industry. He is an expert in the areas of clinical research site operations and patient recruitment. Cedar Health Research is a pioneer site and patient network in the development and utilization of AI/ML technology in support of expanding clinical research access to support accelerated recruitment of diverse populations. His past experience include executive roles with Synexus, PPD/Acurian, and Ora where he led global teams supporting operations, investigator site relations, and patient recruitment and retention. received is bachelors in business administration from the University of Miami and his MBA from Florida International University.

• Site Engagement & Enablement

Demissie Alemayehu is Vice President of Biostatistics at Pfizer. He has over 25 years of leadership experience in the pharmaceutical industry. He has been influential externally, with decades of research and teaching experience at major institutions. He has held important offices at key professional societies and has served on editorial boards of major journals. Demissie has published extensively in refereed journals and has co-authored or edited three monographs. He is a Fellow of the American Statistical Association and holds a Ph.D. degree in Statistics from the University of California at Berkeley.

• Real World Evidence

Adrelia Allen is a 24-year veteran of the pharmaceutical industry working in sales and clinical research at Merck. She has held positions of increasing experience as a Clinical Research Associate, Clinical Trial Project Manager, and Clinical Research Manager (CRM). She is currently the Director of Clinical Trial Patient Diversity, where she is responsible for the strategy and execution of activities for the diverse representation of patients in clinical trials. Adrelia has a Doctor of Pharmacy degree from Florida A&M University College of Pharmacy.

• Patient-Centric Trial Design & Inclusive Research

Dr. Jodie Allen leads Clinical Trial Diversity at AstraZeneca and is responsible for global strategy and capability building in clinical development and operations. A medical sociologist by training, Jodie has 15+ years experience working across academic public health, life science consulting, and in pharma (Commercial and R&D). The red thread in her work is delivering large scale organizational change to improve patient access, experience, and outcomes. Her background in human behaviour in clinical settings, experience in technology implementation, and impact measurement are currently being combined to ensure that clinical trial populations reflect disease state populations in AZ sponsored trials.

• Patient-Centric Trial Design & Inclusive Research

Sandra Amaro, MBA, is the Head of Clinical Trial Diversity at Pfizer, located in Groton CT. In this role, she leads a group of Clinical Trial Diversity Leads who are accountable for enabling Pfizer’s Clinical Study Teams in the effort to increase equity and inclusion in clinical trials. Within her role, Sandra is also responsible for helping elevate the topic of diversity both within Pfizer and externally. In 2021, Sandra was appointed as TransCelerate’s Workstream Lead for their Diversity of Participates in Clinical Trials initiative. Sandra has been with Pfizer since May 2004, where she has held different leadership positions within Clinical Development and Operations and Global Clinical Supply. Sandra received her Bachelor of Science in Business and Leadership from Albertus Magnus College and her Masters of Business Administration from the University of Rhode Island.

• Patient-Centric Trial Design & Inclusive Research

No bio available.

• Real World Evidence

Mike brings 23+ years of industry experience with 19 of those years focused on clinical trial recruitment and retention. He joined ICON in 2017, with a focus on digital recruitment and various strategic account leadership roles in the space. Mike’s experience includes global CROs as well as patient recruitment agencies covering rare disease, oncology, vaccines, pediatrics, dermatology, neurology and infectious diseases. In a previous role, Mike was one of the founding members of a Patient Experience team for a mid-size CRO eventually acquired by ICON. Mike holds degrees in Mechanical Engineering and a Masters in Business Administration with a concentration on international marketing.

• Recruitment & Engagement

No bio available.

• Clinical Trial Venture, Innovation & Partnering

Martha Azer is an Associate Director of Global Regulatory Policy and Intelligence within Global Regulatory Affairs at Johnson & Johnson. She leads the US policy work on Digital Health, Artificial Intelligence/Machine Learning, and Precision Medicine to help shape the regulatory policy landscape to advance innovation in product development to provide exceptional medicine to patients. Martha has more than 10 years of experience in the pharmaceutical industry and held various roles at both J&J and Pfizer, including a background in pharmacovigilance. Martha received her Doctor of Pharmacy from Ernest Mario School of Pharmacy - Rutgers University in New Brunswick, NJ. Upon graduating, she completed a managed care residency at Horizon Blue Cross Blue Shield of New Jersey and served her community as a retail pharmacist for over 6 years.

• Digital Health Technologies

Sol Babani is a seasoned biopharma executive with over 25 years industry experience. The last 10 years he has been on the CRO side of the business, while the 17 years before that he was on the “sponsor” side in a variety of roles including: bench scientist, finance, project management, outsourcing and alliance management. Sol has spent time in large pharma (Pfizer and Novartis), biotech (Regeneron), and virtual development organizations (Auven/Celtic Therapeutics) and has thus seen the industry from many viewpoints. Mr. Babani also has a passion for innovation and how to better apply technology to the clinical research space, and has spoken at industry conferences on the topic of, “The Role of the CRO in the Healthcare Model of the Future.” With this experience, Sol has established himself as an expert in building and maintaining strategic partnerships, alliances, and collaborations. In his current role as CEO at Crovelis, Sol is responsible for leading the clinical operations team that services the clinical development needs of the Insud Pharma portfolio companies.

• Budgeting & Resources
• Outsourcing

No bio available.

• AI for Clinical Trials

Sameer leads Enterprise Strategy, Digital and Experience functions for Fairview Health Services. He is responsible for shaping corporate strategies that drive our organization’s long-term growth. By aligning consumer experience and digital-enabled transformation with strategic objectives, he focuses on market differentiation for Fairview. Prior senior management roles were at Sutter Health, Intermountain Health and at the University of Chicago Medicine. As a nationally-renowned educator and board member, he advises on strategy, innovation, and transformation. Sameer received his medical degree from Delhi University, clinical training from University of Oklahoma and bio-medical informatics training from University of Utah. In 2022 he graduated from Harvard Business School in the flagship Advanced Management Program.

• Clinical Trial Venture, Innovation & Partnering

Innovative IT Professional with experience as a Program Manager, Business Analyst, Project Manager, Solution Architect, Account Manager, Principal Instructor, Systems Engineer, Team Leader, and Manager.

• Small Biopharma Strategies

Dr. Mohan Bangalore is currently the Group Director in R&D Procurement & Supplier Management team at Organon, a Women's Health biopharma company. His group supports the R&D outsourcing needs for Pre-Clinical studies, Early Clinical & Late Clinical trials, and also Outcomes Research. Dr. Bangalore has worked in the Pharma industry for over 20 years with companies such as GlaxoSmithKline, Bristol-Myers Squibb, and Wyeth/Pfizer. His expertise includes Strategic Sourcing, Vendor Management, Clinical Operations, Medical Affairs, Biomarkers/Labs, Biospecimen management, and Project/Change management. Dr. Bangalore is a scientist/virologist by training with a PhD in Molecular Biology from Iowa State University, Iowa. He later obtained an MBA from Temple University in Philadelphia, PA. Combining his scientific and technical expertise with business operations skills, Dr. Mohan Bangalore brings unique perspectives to this summit.

• Outsourcing

Dr. Matt Barfield has over 30 years of industry experience, managing global teams and overseeing both routine and novel modalities from internal and external perspectives. He earned his PhD in Chemistry from the University of Lincoln. Dr. Barfields career includes significant tenures at Upjohn, SmithKlineBeecham, and GSK, where he played a crucial role as a bioanalyst. Over his 24-year tenure at GSK, he ascended through increasingly senior scientific roles within DMPK, ultimately serving as a Director in The Bioanalysis and Biomarker Analysis group. In 2020, Dr. Barfield joined Roche, initially leading the Regulated Bioanalytical group. By 2022, he had advanced to the position of Chapter Lead for The Regulated Bioanalysis and Biosample Operations (RBBO) group. With over three decades of experience, Dr. Barfield has been pivotal in advancing numerous therapeutic agents to market, significantly enhancing patient lives.

• Biomarkers & Precision Medicine Trials
• Clinical Supply & Logistics
• Recruitment & Engagement

Shelly Barnes is the UCB Global Innovations Lead based in Raleigh, NC USA. She is accelerating innovative strategies and solutions driving the improvement of the patient experience within the conduct of their clinical trials. Shelly is delivering solutions using novel technologies, transforming from traditional clinical trials to sustainable human-centric clinical trials while maintaining quality, compliance and stakeholder commitments. Shelly actively represents UCB on several industry consortiums including DTRA, CTTI, TransCelerate and IHI.

• Decentralized & Hybrid
• Patient-Centric Trial Design & Inclusive Research
• Feasibility & Study Start-Up
• Site Engagement & Enablement

Tricia Barrett is the President of Praxis, leading the day-to-day management of the business. A member of the Praxis team since 2003, Tricia oversees all Praxis operations from proposal generation through completed, enrolled studies. Her experience encompasses a wide range of therapeutic areas and tactical strategies, which brings a unique approach to patient recruitment that focuses on both sound science and innovative execution.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Professor Dr. Dorothee B. Bartels is a trained epidemiologist (Harvard School of Public Health, PhD and Habilitation Hannover Medical School), senior thought leader in (pharmaco)epidemiology, Real World Data (RWD) strategies, and evidence generation, both, based on established methods and (gen)AI. After several senior global leadership roles in the pharmaceutical industry, she moved into the innovative-digital space, i.e. in the innovation hub of Boehringer Ingelheim as Chief Digital Science Officer, to X, Moonshot (Alphabet) as Clinical and Real World Strategy Lead, and to Aetion (a software company analyzing claims/EHR) as Chief Digital Officer. Dorothee is founder of HeDa (HealthData)-Advisors, providing strategic and execution advice for real world data insights and evidence generation. She holds several board positions and is teaching on a regular basis advanced pharmacoepidemiology in academia.

• Real World Evidence

Sophie Bartram is a fourth-year undergraduate student at The Ohio State University studying Health Sciences. During her undergraduate studies, she gained hands-on patient care experience through interning at a rehabilitation hospital and for a pediatric occupational therapy group. Over the summer, she worked as a Digital Health Sciences Intern for Takeda Pharmaceuticals. In this position, she focused on identifying and assessing the burden on patients and site personnel induced by digital health technologies in clinical trials.

• Decentralized & Hybrid

Tuba is a Senior Director at Clinical Center of Excellence (CCoE) team as Clinical Capabilities Lead, serving as Global Process Owner for Clinical Protocol Development Process. Some of the highlights from her work are leading cross-functional teams to success for process improvement activities and contributing to organizational excellence. Prior to her role at CCoE, Tuba was a Senior Clinical Development Scientist at BMS Melanoma Program providing scientific leadership and expertise to execute clinical trial activities. Before joining BMS Tuba served as Lead Clinical Scientist at Merck for the Keytruda Lung Program leading her teams to successful global approvals. She was also the Data Monitoring Committee (DMC) coordinator for the Oncology Lung Program. Before her career at Merck, Tuba served as a Postdoctoral Research Scientist at EMD Serono in Translational and Biomarker Research, and Research Fellow at two different academic institutions, the Albert Einstein College of Medicine Cancer Center and Biomedical Engineering Department at Worcester Polytechnic Institute. Tuba has a Bachelor’s degree in Chemistry and Master’s degree in Environmental Sciences from Bogazici University, and earned a PhD in Biomedical Sciences from the University of Massachusetts Medical School based on her work in the laboratory of Nobel Laureate, Craig C. Mello, identifying new components of the Wnt signaling pathway in C. elegans; and her work in Kobertz Lab on glycobiology that provided a new biogenic mechanism for channelopathies. In the course of her academic and pharmaceutical career, Tuba has published extensively over a variety of diverse topics including organic chemistry, intracellular signaling pathways, animal models, hematopoietic stem cell physiology, NSCLC, and melanoma. In her spare time, Tuba enjoys traveling, plenty of outdoor activities (hiking, swimming, playing tennis), gaming (computer and board), learning (clarinet, piano, new concepts/languages), reading Sci-Fi books, and socializing with friends and family. Tuba is a happy puppy mom; and she loves spending time with her pup, “Lucky.”

• Patient-Centric Trial Design & Inclusive Research

Deirdre currently serves as SVP, R&D Strategic Operations for CSL. In this role she leads a multi-functional “nerve center” for R&D designed to leverage and connect capabilities across the organization to integrate the business management of R&D; enable data driven insights & decisions; provide operational excellence; enable high performing teams and embed patient focus into the delivery of a diverse and innovative portfolio. Strategic Operations includes Clinical Development Operations, R&D Project & Portfolio Management, Integrated Business Operations, R&D Enabling Technology, R&D Patient Partnerships, and R&D Japan. Previously Deirdre has led Clinical Development Operations organizations at Nektar Therapeutics, Endo Pharmaceuticals, and Otsuka Pharmaceuticals. She also held significant leadership roles establishing innovative models dedicated to bringing clinical trials to community physicians and their patients. Additionally, her background includes working in a CRO and a start-up software company. This diversity of experience has given her a broad and global perspective of the clinical research industry. Deirdre strives to be a servant leader who operates with humble confidence and a healthy curiosity about people, projects, and process. Her leadership expertise is in creating inclusive teams and environments that allow for innovation, performance excellence, and personal development. She has been awarded an HBA Rising Star and PharmaVoice 100 of the Most Inspiring People for Change Agent category. Deirdre’s professional passion is in partnering with patients and their providers for increased and optimized opportunities for clinical trials. Personal passions include family, travelling, a well-crafted cocktail, a good book, and any reason to laugh!

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Liz Beatty is the Chief Strategy Officer at Inato, a clinical trials marketplace which flips the traditional model and allows sites to participate in the trials that are best aligned with their interests and that of their patients. She is focused on advancing Inato’s corporate strategy, developing partnerships and driving growth in North America. Previously, Liz was the Head of Digital Clinical Trials at Bristol-Myers Squibb where she led digital innovation efforts across Global Clinical Operations. Her team leveraged innovative approaches to increase clinical trial participation and enhance the clinical trial experience for sites, patients, and their care team. Liz previously held positions in clinical operations including managing a global patient recruitment team, and various positions in protocol management and site management.

• Clinical Trial Venture, Innovation & Partnering

Jimmy Bechtel is the Society for Clinical Research Sites' (SCRS) Vice President of Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter, and operations manager. On the pharma side where he worked in innovation project management, Jimmy utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Jimmy to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Jimmy is in charge of developing and executing the company's site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. Additionally, Jimmy drives the implementation the Membership department’s site-focused operations as well as design and marketing.

• Decentralized & Hybrid
• Budgeting & Resources
• Outsourcing

Becker has been a Principal Industry Consultant at SAS since 2013. Prior to joining SAS, he had been using SAS in the life sciences industry since 1988. He focused on clinical programming, data management and visualizations. Becker presented numerous papers and won best paper awards at DIA, PharmaSUG, SUGI and SAS® Global Forum, PHUSE, PharmaSUG China and numerous regional users group meetings.

• AI for Clinical Trials

Joanne Benedict is Head of Risk-Based Quality Management at Gilead. Joanne is a strategic leader in the pharmaceutical industry with a passion for industry collaboration and the tremendous value it offers. Joanne leads global cross-functional teams in designing and deploying innovative processes and technology to further transform clinical trial management and data surveillance.

• Quality & Monitoring

Assistant Director of research nursing and quality assurance and Nurse Practitioner with more than a decade clinical trial experience in all phases. Certified through American Academy of Nurse Practitioners (AANP), Oncology Nursing Society (AOCNP), and Society of Clinical Research Associates (CCRP). Experience overcoming barriers to access to care in underserved communities. Committed increasing to Diversity, Equity, and Inclusion in healthcare and clinical trials.

• Recruitment & Engagement

Stephanie Berger brings nearly two decades of clinical research experience to her role as Director of Clinical Research at Urology Clinics of North Texas and Cancer Clinics of North Texas. This care team features a multidisciplinary network of urologists, radiation oncologists, and medical oncologists, including 65 providers across 21 offices throughout North Texas. Stephanie's experience encompasses a wide range of clinical research environments, including large hospitals, academic institutions, consortiums, and community healthcare settings. Her work spans the continental US, Puerto Rico, the Dominican Republic, US Virgin Islands, India, and Eastern Europe. She enjoys optimizing operational workflows and enhancing site quality, transforming struggling sites into high-performing research centers.

• Site Engagement & Enablement

Director of Clinical Innovation & Strategic Partnerships at Pfizer's Global Product Development Operations Center of Excellence. With a Ph.D. in Analytical Chemistry from the University of Vermont and a BA/BS from St. Anslem College, I have been with Pfizer since 1994. In my current role I lead Pfizer's Clinical Trial Concierge as part of the Decentralized Clinical Trials Community of Practice, focusing on innovative ways to improve clinical studies. I have extensive experience in leading clinical study teams and BLA submissions for Global Product Development and Research & Development. I also served as a Clinical Supply Chain Lead for 10 years. My work has been instrumental in driving innovation and change within the biopharmaceutical industry, particularly in drug and clinical development. I am also a key contributor to Pfizer's Care Anywhere initiative, which aims to decrease patient burden and increase retention through the use of wearables, telehealth, at-home labs, home health, mobile clinics, and direct-to-patient drug delivery. Additionally, I lead the development and deployment of Mobile Units, which offer location flexibility and expand the reach of clinical trials to more diverse and underserved populations.

• Decentralized & Hybrid

Dr. Erwin Berthier is the Co-Founder and CTO of Tasso. An adept innovator, the technologies developed under his leadership at Tasso are empowering patients and clinicians to realize virtual care, perform frequent monitoring, and improve health outcomes. In addition to his role at Tasso, Erwin is also an Affiliate Assistant Professor in the Department of Chemistry at the University of Washington in Seattle. Erwin received a Diplome Ingenieur in Fluid Mechanics from ENSTA (Ecole Nationale Superieure des Technologies Avancees) in Paris, an MS in Electrical Engineering from the University of Canterbury in New Zealand, and a PhD in Biomedical Engineering from the University of Wisconsin-Madison. He is the author of over 50 publications in peer-reviewed scientific journals and a co-author of the book “Open Microfluidics”.

• Decentralized & Hybrid

Aman Bhandari heads up the corporate data science division At Vertex Pharmaceuticals that integrates and scales advanced analytics and AI (e.g. machine learning, generative AI, data solutions) across disease areas and high priority business functions including clinical, commercial, manufacturing and HR. His role extends to engaging directly with executive management, the privacy office, IT and with the Board of Directors annually, delivering the vision and tangible impacts of data science and AI. Aman has assembled an elite technical team from the ground up that delivers novel insights, automation and enables operational excellence. Prior to joining Vertex in 2017, Aman held roles at Merck, Genentech, the White House, and the Centers for Medicare and Medicaid Services. In these roles he created the first formal data science team at Merck and while at the White House paved the wave for the first Chief Data Officers across the U.S. Government. Aman earned a PhD in health services research and a master's in epidemiology, with a focus on using large scale data to better understand healthcare. He has been an advisor to data/tech initiatives for the World Bank, USAID, Harvard, Cornell, Ashoka Foundation, Knight News Foundation, Boston Children's Hospital and others.

• AI for Clinical Trials

Sidd is a Partner in PwC's Healthcare Analytics and AI practice, serving as the Life Sciences Gen AI leader. With over 20 years of product engineering experience, Sidd has worked with market-leading organizations to launch innovative cross-industry solutions, specializing in Cloud Native & AI. He has dedicated over 10 years to serving the pharmaceutical, biotechnology, and medical device industries.

Relevant experience

• Sidd has cross-functional expertise focused on the intersection between R&D strategy, operations, and technology. He has diverse experience ranging from ERP system implementation, operating model design, M&A post-merger integration, innovation, and digital strategy.

• Sidd has conceptualized, designed, and built several industry first FDA validated Artificial Intelligence (AI)-enabled product enabling intelligent automation in the pharmaceutical R&D domain.

• Sidd is a thought leader at PwC's life sciences digital/AI transformation practice and a speaker at top-tier industry conferences. He serves as a lead advisor to senior leadership at Fortune 500 companies, providing guidance on AI strategy and implementation. Sidd has co-led programs to expand AI capabilities, collaborating with third-party research labs, startups, and other specialty sources to enhance knowledge domains.

• AI for Clinical Trials

Rebecca has over 25 years of pharmaceutical industry experience in varying roles. She has been a Study Coordinator, CRA, Clinical Trial Manager and Lead, Technical Writer, Trainer, Instructional Designer, and Quality Manager. She has led functional areas and departments at time managing up to 20 direct reports. She has successfully led company-wide initiatives including the implementation of a learning management system and establishing a new clinical study information repository usually meeting required deadlines. Rebecca attributes the majority of her success, including the recent implementation of her organization’s enhanced clinical study risk management process, to effective application of change management principles.

• Quality & Monitoring

Karina Bienfait, PhD is the Executive Director of Specimen Infrastructure and Informed Consent within Global Biospecimen and Imaging Management at Bristol Myers Squibb (BMS). In this role, Karina oversees a team of leaders with subject matter expertise in informed consent, biobanking, specimen logistics, and specimen data and analytics. Since joining BMS, she has strategically transformed end-to-end consent operations for specimens for both protocol-related and future-use testing. She has also overseen implementation of a state-of-the-art specimen management system, as well as implemented policies and processes to ensure specimen oversight. Most recently, Karina has assumed responsibility for informed consent management for all BMS-sponsored clinical trials as well as leadership of the R&D Data & Specimen Governance Council which oversees secondary use of clinical trial data and specimens. Prior to BMS, Karina was at Merck & Co. for 10 years, where she held positions of increasing responsibility within Clinical Pharmacogenomics and Clinical Specimen Management. Her last role was head of Global Genomic Policy, Process, and Compliance (GPPC), where was responsible for evaluating the impact of global genomic and biospecimen policies and laws/regulations on Merck’s research programs; developing Merck policies, processes, and consent related to genomics and biobanking; and ensuring the compliant use of biospecimens. In this role, Karina also implemented routine genotyping of patients participating in Merck’s clinical trials to identify genetic predictors of drug response. Karina is currently an Advisor to SCOPE for Biomarkers and Biospecimens and co-chair of the Industry Pharmacogenomics Working Group. She has also served as a member of the Genomics Roundtable of the National Academy of Sciences, Engineering, and Medicine. Karina completed an internship in Clinical Psychology at Nassau University Medical Center and a postdoctoral fellowship in Clinical Psychopharmacology in the Department of Psychiatry at Rutgers University - Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a B.A. in Psychology and French from New York University.

• Biomarkers & Precision Medicine Trials

Malachi Bierstein leads global sales and marketing and is responsible for driving the commercial growth of the company. Malachi brings 20 years of global sales management, major international account strategy, and customer centric product positioning expertise. Malachi has held senior leadership positions responsible for media technology licensing and distribution at Nokia Technologies, Rovi (now Tivo), and DivX (acquired by Rovi). Malachi is a pioneer of technology licensing models and digital video delivery solutions. He holds a B.S. in Industrial and Systems Engineering from the University of Florida.

• Patient-Centric Trial Design & Inclusive Research

No bio available.

• Site Engagement & Enablement

Julie Blasingim is a seasoned IRB executive with 20 years of extensive regulatory, operational, and compliance experience in human research protection and site operations of clinical research. She has served in a dozen senior leadership roles across multiple central IRBs including Independent IRB, Schulman, and Advarra. Routinely consulted for her extensive human research protection regulatory expertise, she has hosted countless FDA inspections at both the IRB and under site operations and has managed multiple accreditations and certifications through AAHRPP and ISO. Julie holds a master’s degree in business administration specializing in leadership.

• Outsourcing

Lukasz received his PhD in biochemistry from Nencki Institute of Polish Academy of Sciences and after enjoying a career in academia he joined pharma industry in 2009. Initially, he was involved in preclinical development programs at Celon Pharma SA, where he led several drug discovery projects in psychiatric and metabolic diseases. Some of these projects are now continued in clinical development phase. Later on, Lukasz transitioned to clinical monitoring roles at Quintiles Inc. (now IQVIA) and then at Covance to eventually join Centralized Monitoring Team at AstraZeneca in 2016. Now Lukasz is leading the Centralized Monitoring group, which guides study teams through study de-risking exercise and identification of areas that are critical to study quality. In the study execution phase the team led by Lukasz performs continuous central monitoring of study data in search of risk signals at study, country, and site levels.

• Quality & Monitoring

Lynette Bojko is an Executive Director working in Clinical Development & Operations at Pfizer. During her 27 year career at Pfizer, Lynette held roles in Data Management, Study Management, Project Management and Vendor Management. She is currently the Head of Sourcing Compliance Management, where she leads a team that is responsible for the design and monitoring of vendor engagement processes, sourcing strategy and governance framework.

• Outsourcing

I am a seasoned professional in the field of clinical operations feasibility with over 12 years of experience. As Director of Strategic Feasibility and Analytics at AstraZeneca, I have been instrumental in driving the success of numerous clinical trials across biopharmaceuticals respiratory, inflammation, and autoimmunity. My expertise lies in feasibility analysis, site selection, and operational strategy, ensuring that trials are conducted efficiently and effectively. Throughout my career, I have demonstrated a deep understanding of the complexities of clinical trial operations, leveraging data-driven insights to optimize site performance and patient recruitment. I have a proven track record of collaborating with cross functional teams, regulatory bodies and key stakeholders to navigate the challenges of clinical research and bring innovative therapies to market. I hold a master's degree in developmental kinesiology from Bowling Green State University, a bachelor's degree in clinical psychology, and a bachelor's degree in kinesiology from Michigan State University. I am excited to share my knowledge and experiences on best practices in clinical trial feasibility and operations and am passionate about advancing clinical research and improving patient outcomes through meticulous planning and execution.

• Feasibility & Study Start-Up
• Site Engagement & Enablement

Emily is a Senior Research Analyst at the Tufts Center for the Study of Drug Development where she works on a variety of studies focusing on clinical trial execution strategies and practices, diversity and inclusion, and patient experience and perspectives. Emily Botto has been published in peer-reviewed journals including Therapeutic Innovation & Regulatory Science, Nature Biotechnology, and JAMA Network Open and in trade journals including Applied Clinical Trials. She has given presentations at major industry conferences including Contracting and Outsourcing Conference, DIA Global Annual Meeting, Festival of Biologics, and the ACRP Annual Conference. Emily graduated from Brandeis University with BAs in Business and Communication and completed her MPH from Tufts University.

• Patient-Centric Trial Design & Inclusive Research

Dr. Ariel Bourla serves as Senior Director on Johnson & Johnson R&D's Data Science and Digital Health team, where she leads efforts to apply real-world data and other innovative technology solutions to advance and accelerate Oncology clinical programs. Dr. Bourla holds a strong background in Medical Oncology, Immunology, and Data Science. She spent 6 years at Flatiron Health as a Medical Director and Clinical Trials Lead. In this role, she led research teams executing prospective real-world studies, methodologic and observational research projects, and development of new technologies for sites and sponsors participating in clinical trials. Dr. Bourla received her MD/PhD training from the Mount Sinai School of Medicine, with a subsequent internship and residency at New York Presbyterian-Columbia University Medical Center, and a Medical Oncology fellowship at Memorial Sloan Kettering Cancer Center. She earned a BA in English Language and Literature from Yale University.

• Data

Danilo Branco, Director of Central Monitoring at Fortrea, is a passionate, optimistic, tech-savvy clinical trials Risk Based Quality Management, Central Monitoring, Project Management, and Clinical Operations professional with 21 years of experience managing complex studies in both big Pharma and CRO settings. He co-leads a team of 50+ employees globally in the mission of improving data quality while bringing efficiencies to Clinical Trials conduct. The last 10 years were dedicated to leading and encouraging process creation, continuous assessment, and enhancements to maximize the positive impact of the RBQM adoption in full alignment with regulatory expectations.

• Quality & Monitoring

Mary Brantner is Senior Director, Head of Clinical Program Optimization and Innovation at Insmed Inc. In her role, she identifies opportunities to standardize processes and leverage technology to streamline and optimize conduct of clinical trials. She also leads creation of Patient Diversity Action Plans at Insmed. Mary has 35 years of experience in the Pharmaceutical and Device Industry, having worked at Daiichi Sankyo and Becton Dickinson along with other pharma companies before joining Insmed. Her recent roles have been in the Global Development Operations and Process and Systems areas where she has overseen Global Development Operations functions that include Clinical Operations, TMF Operations, Process Excellence and Training, Clinical Trial Disclosure and Transparency, Clinical Systems, and Medical Writing. Ms. Brantner holds an MS in Clinical Research Administration from New York Medical College and a BS in Biology from Ramapo College. She also holds certifications with ACRP as a CCRA and Prosci for Change Management.

• Site Engagement & Enablement

Dan is the Founder & CEO of 1nHealth. Prior to starting 1nHealth, Dan led client and portfolio development at SPRIM and SPRIM Ventures, leading all online initiatives for SPRIM and its venture companies. Dan blended his perspective in clinical and consumer to launch 1nHealth. Prior to SPRIM, Dan was the CEO of several e-commerce ventures. In these roles, Dan was involved in launching hundreds of new products and direct marketing to a wide range of consumers and use cases. With a previous background in Life Sciences Consulting at SPRIM, Dan has blended his perspective in clinical and consumer to launch 1nHealth.

Dan’s prior start up experience included the launching of TriNova and leading the brand to acquisition by Gold Eagle Company in 2016, joining the acquiring Company’s board in 2017. As a passionate alumnus, Dan would like to note he earned his M.B.A. from UCF before their football team was good.

• Small Biopharma Strategies

Katherine Broecker is Senior Director, Design Hub Data Insights, Clinical Innovation & Optimization with Eli Lilly. With a background in both business management and biostatistics, her passion is using data and analytics to make the next business decision to drive clinical trial success and provide medicines to patients. Her current role is focused on global clinical trial allocation and novel ways to identify and reach target patients, including diverse populations.

• Site Engagement & Enablement

Denise N Bronner, PhD, has roughly 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global therapy program strategy development, pitch and storytelling refinement, and identifying business opportunities within pharma. Beyond her professional endeavors, she's passionate about enhancing diversity in STEM fields, serving on advisory boards, participating as a judge in pitch/business competitions, and mentoring young professionals. She holds a bachelor’s degree in Biological Sciences from Wayne State University, a Ph.D. in Microbiology & Immunology from the University of Michigan-Ann Arbor, and certification from the Venture Capital Executive Program from UC Berkeley Haas School of Business. She is the founder of Empactful Ventures which currently consults healthcare-focused startups and venture funds, and she is a member of the Clinical Leader editorial board.

• Clinical Trial Venture, Innovation & Partnering

Wout Brusselaers is the founder and CEO of Deep 6 AI, a precision research company that empowers healthcare organizations and life sciences companies to de-risk and accelerate clinical research. Wout founded Deep 6 AI in 2016 to improve clinical trial outcomes through AI-driven software that mines electronic medical record (EMR) data to precision match patients to trials. Wout leverages his entrepreneurial experience and deep operational expertise to help address the industry’s patient recruitment and retention challenges. Wout holds a Masters in International Economics from the University College Dublin, and a Licentiate degree in Economics from Vrije Universiteit Brussel.

• Digital Health Technologies

Dawn Buchanan is a seasoned Clinical Operations executive with over 25 years of experience at both small/large pharma and a CRO, and now is the Head of Clinical Development Operations at AffyImmune, a small start-up biotech developing autologous CAR T cell therapy for solid tumors. Dawn started at AffyImmune as the first Clin Ops hire and has built the function and her team from the ground up. She is passionate about cell therapy, with a unique CV having also been on the External Manufacturing side of cell therapy as an Operations Lead for establishing a CDMO in the EU while at Celgene/BMS. Her small biotech experience has allowed her to lean into a leadership role in new ways that she finds fulfilling, including building a high-performing team and working closely with other functions including QA, CMC, Clinical Development as part of senior leadership in establishing strategy for the first clinical program.

• Budgeting & Resources
• Small Biopharma Strategies
• Outsourcing

Tricia Buchheit has over 25 years of Patient Recruitment, Retention, and Project Management industry experience through her work at agencies, CROs, core labs, and biotechnology companies. This vast experience provides a 360-degree perspective of the challenges key stakeholders encounter with recruitment and retaining patients into clinical trials. Currently, Tricia focuses on the development and implementation of thoughtful recruitment and retention strategies and solutions to bring much needed RNAi therapeutics to market.

• Patient-Centric Trial Design & Inclusive Research

Lee is an experienced senior executive and corporate director with deep commercial expertise in the biotechnology sector. His management experience includes as CEO and VP of public and private biotech companies, as well as providing management and strategic consulting services to public and private bio-pharma companies in Canada, the United States, Middle East, Japan, and Europe. Lee’s deepest expertise is in the cell therapy and regenerative medicine sector having lead several transformative transactions including multinational investment and licensing deals involving companies in North America, Europe, and Asia. Lee has particular experience in Canada, the United States, and Japan. Lee holds a Bachelors of Education and a JD from the University of British Columbia.

• Clinical Supply & Logistics

Christine P. Bump, Principal and founder of Penn Avenue Law & Policy, is an insightful regulatory attorney with two decades of experience developing and implementing FDA strategies for devices, diagnostics, digital health platforms, and genetic and genomic tests. She advises laboratories, large corporations, and emerging companies with an awareness and understanding of their business and strategic goals. Christine has served as regulatory counsel for a national diagnostic coalition, written several articles, and presented at numerous industry conferences. Before starting her firm, she practiced at Hyman, Phelps, & McNamara, P.C. and in the Life Sciences group at Goodwin. Christine earned a B.A. from Sweet Briar College, an M.P.H. from Emory University’s Rollins School of Public Health, and a J.D. from Emory University School of Law.

• Biomarkers & Precision Medicine Trials

Wes is a retired film art director who spent most of his career at Dreamworks Animation. He has participated worldwide in his field from industry to academia and has recently taken a more active role in legislative and health-care advocacy due to his own rare diease, Fabry. Wes lives near Portland, Oregon where he is currently participating in a gene therapy clinical trial in a mostly remote capacity.

• Decentralized & Hybrid
• Quality & Monitoring
• Digital Health Technologies

Brian Burkhardt is the Executive Director and Co-Founder of the Oliver Patch Project (OPP). His journey to OPP has been marked by a diverse array of creative experiences, all culminating in his current role. In 2020, Brian's son, Oliver, was diagnosed with Leukemia during the peak of the pandemic. Faced with the fear of Oliver's prognosis, Brian and his wife, Trisha, approached the diagnosis with positivity and love. Early in Oliver’s treatment, Brian initiated a simple request on Facebook for friends and family to "Send a Patch," encouraging Oliver to walk to the mailbox daily. This call to action garnered over 2,000 patches within the first month alone. Brian began sewing these patches onto Oliver’s jacket, transforming it into a symbolic suit of armor for his journey. As Oliver opened patches and sent thank-you videos, he suggested, "Mom, Dad, we should do this for other kids." This heartfelt moment sparked the beginning of their mission. The Oliver Patch Project collaborates with artists globally to create a fun, free, and engaging platform that aims to empower children battling cancer through the power of patches. Currently operational in over 260 hospitals across all 50 states, OPP has reached thousands of children, teenagers, and families. Oliver’s dream of extending this support to other children has become a reality and remains Brian’s driving passion. Driven by the vision to extend love and support to every child, teenager, and family participating in clinical trials, the Oliver Patch Project recently launched its Global Clinical Patch Support (Retention) Program. This initiative aims to unite participants in clinical trials, creating a cohesive community irrespective of trial specifics or organizers. OPP endeavors to build a comprehensive network that reassures every pediatric participant that they are not alone on their journey.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

John Cai, MD, PhD, FAMIA, is Executive Director, Real-world Data Analytics and Innovation, in the Merck Center for Observational and Real-World Evidence. He is leading a team of data scientists and outcomes researchers to generate real-world evidence and insights through innovative and advanced analytics. John has more than 20 years of experience in biomedical and clinical research across academic, biotech, and pharmaceutical settings. John received his medical training from China Medical University and his Medical Informatics training from Harvard Medical School. Pursuing a passion for both medicine and computing, John has co-authored peer-reviewed publications in the areas of medical informatics, machine learning, clinical trials, and cancer genomics. John is a Fellow of the American Medical Informatics Association (AMIA), and also serves in the AMIA Industry Advisory Council.

• Real World Evidence

Mr. Callow is the Managing Partner of Boston Millennia Partners. Prior to founding Boston Millennia Partners, Mr. Callow co-founded the predecessor fund of BMP in 1982. Before that, he worked as a Senior Consultant at Braxton Associates, an international strategic planning firm that was formed by professionals from Bain & Co. and Boston Consulting Group. He worked with Fortune 100 companies in strategic planning and implementing merger and acquisition strategies. Prior to working in the management consulting business, Mr. Callow worked in sales and marketing for Tymshare, Inc. (McDonnell-Douglas). He was formerly Lead Director and Chair of the governance committee of PAREXEL International Corporation (Formerly NasdaqGS:PRXL), a $2.5 billion revenue clinical trials management company sold on September 29,2017 for $5 billion. He is a lead investor in, or has served as, a Director of a number of other public and private companies, including ILEX Oncology, Inc. (Nasdaq: ILXO), a cancer pharmaceutical company acquired by Genzyme for $1 billion; MedAptus, Inc., a mobile computing provider of clinical, financial and administrative software solutions to the medical community; and COTA Healthcare, Inc., a precision medicine company that stores, tracks and analyzes longitudinal clinical and billing data of oncology patients with the goal of improving outcomes and reducing costs. Other investment responsibilities included Glycofi Inc., (acquired by Merck, NYSE: MRK); HotJobs, Inc. (acquired by Yahoo, NasdaqGS: YHOO); iVillage, Inc. (acquired by NBC Universal, a subsidiary of General Electric, NYSE: GE); and Tektagen, Inc. (acquired by Charles River Laboratories, NYSE: CRL) Mr. Callow is a member of the Advisory Board of the Dartmouth/Tuck Center for Private Equity and Entrepreneurship. He is also a member of the Board of Trustees and member and past Chairman of the Investment Committee at Tufts University and on the Board of Overseers at Tufts University Medical School. Mr. Callow is a National Board member for the Leukemia & Lymphoma Society where he chaired its Therapy Acceleration Program committee. Mr. Callow is a graduate of Tufts University and holds an MBA from the Amos Tuck School at Dartmouth

• Clinical Trial Venture, Innovation & Partnering

Andrea Carney is a subject matter expert in cellular therapy specializing in TCR based and CAR-T immunotherapy techniques. Andrea has brought her expertise from the clinical setting into industry to support the collection of T cells and supply chain logistics for immunotherapy manufacturing. Having worked in both the commercial setting at Novartis supporting Kymriah, and now in Phase I/II clinical trials with Immatics, Andrea has a broad range of experience in clinical supply chain management.

• Clinical Supply & Logistics

Jim Carroll currently serves as the Head of Real-World Evidence for the Walgreens Clinical Trials business. Over the course of two years, Jim has led the build out of an integrated business unit that provides novel Real-World Evidence and Patient Recruitment solutions to sponsors. Underlying this build out is a core mission of improving patient access to clinical research. Jim brings more than twenty-five years of hands-on business unit management and functional leadership experience to the life sciences industry. He has managed numerous P&Ls aligned to the creation of novel services, digital platforms, and business entities while bringing unique value to biopharmaceutical sponsors across the product lifecycle. Jim has previously served in several executive and strategic advisory roles, including as Vice President of Life Science Solutions at OM1. He has also served as VP and Global Business Unit Leader for ICON Plc’s Real-World Evidence Strategy & Analytics unit where he was responsible for strategic direction, staffing and the establishment of ICON’s broader market positioning for their Real-World Evidence services. Prior to ICON, he was VP of Product Management and Marketing at Syneos Health. He has also held leadership roles at IQVIA, PharMetrics, Muro Pharmaceuticals and Cambridge Isotope Labs, a unit of Otsuka Holdings. Jim received an MBA from the Questrom School of Business at Boston University and a BS in Chemistry from the University of Massachusetts at Amherst.

• Decentralized & Hybrid

Mia is a Senior Manager of Product Delivery at ICON, where she leads the development and implementation of ICON’s RTSM, Flex Advantage. With expertise in integrating Flex Advantage with ICON’s proprietary clinical supplies management module and third-party systems, Mia brings valuable insights from both an IRT/RTSM and clinical trial logistics perspective. As a member of ICON’s IRT and CSM team, her comprehensive knowledge helps drive successful solutions for complex and simple clinical trials.

• Clinical Supply & Logistics

Joan led the non-profit organization, Greater Gift, as CEO. The mission focuses on raising awareness of clinical research, fostering trust through celebrating and expressing gratitude for all participants, and contributing to the well-being of vulnerable children by paying forward the gift of health. A results-driven executive in health life sciences, known for implementing innovative strategies across diverse industries and demonstrating expertise in marketing and operations.

• Recruitment & Engagement
• Feasibility & Study Start-Up

Janice Chang is the Chief Operating Officer at TransCelerate BioPharma Inc. Ms. Chang has been involved with the organization since its inception. In her current position, Ms. Chang works closely with the CEO and the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives. Ms. Chang defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries. She has accountability overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio. Ms. Chang also actively participates in various cross-stakeholder global discussions to help evolve our R&D paradigm. Most recently she joined the Advisory Council for HL7 International’s Vulcan Accelerator. Vulcan, which is a global strategic effort to bring together stakeholders across the translational and clinical research community to align on data exchange standards to bridge existing gaps between clinical care and clinical research, enabling more effective acquisition, exchange, and use of healthcare data in translational and clinical research. With a background of 20+ years of experience leading initiatives in large pharma and biotech companies, Ms. Chang has experience spanning across regulatory, clinical, and manufacturing. Ms. Chang is passionate in driving meaningful change across our ecosystem and not settling for the status quo. She believes in reimagining the way we advance innovative medicine and advocates for the power of open collaboration across stakeholder groups.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Rachel is the Associate Director of Digital Science Strategy at AbbVie. She integrates digital health technologies into evidence-generation strategies within AbbVie's neuroscience portfolio. Prior, she was the founding Director of Innovation at the Digital Medicine Society (DiMe) and worked on Pfizer's Digital Medicine team, digital health start-ups, consulted for pharma, and supported various other clinical teams for over a dozen years.

• Digital Health Technologies

Senior Director with a demonstrated history of working in academia, hospital, and healthcare industry settings and over 27 years’ experience. Skilled in Pharmacoepidemiology, Oncology, Infectious Diseases, Immunology, Vaccines, Global Public Health, Clinical Trials, and Regulatory disciplines. Strong professional with a Ph.D. in Epidemiology from the University of Alabama at Birmingham (2003). Currently leads Walgreens Boots Alliance Pharmacoepidemiology, Real-World Evidence-Clinical Trials across all therapeutic areas.

• Real World Evidence

Lauren Chazal, MBA, is an expert in the clinical trials industry, with extensive experience in site operations, business development, and financial management. She spent the first five years of her career with traditional financial organizations and then pivoted to clinical research with a privately held multi-site clinical research organization. She has been instrumental in business development, mergers and acquisitions, and relationship management for global clinical research sites since 2012. This includes but not limited to Headlands Research where she holds the current title Chief Business Development Officer. Lauren joined Headlands Research, a KKR portfolio company, in October of 2018 as the first employee under the then CEO. She has been integral in building the business from concept to 18 research centers across the US/Canada and 550+ employees to date. In addition to KKR, Lauren has reporting experience with several mid/large sized private equity groups. Lauren's deep understanding of the dynamics between clinical research centers, CROs, and sponsors is complemented by her expertise in securing high-quality trial sites and patient recruitment solutions. Lauren earned a dual degree in Finance and Marketing from Lehigh University and an MBA from the University of Florida (UF). She is actively involved in the Healthcare Businesswomen’s Association (HBA) and serves on the board of the International Women’s Forum (IWF) Arizona Chapter. She has been a regular speaker at multiple industry conferences. Outside of her professional achievements, Lauren spends time with her two beautiful children, is an avid reader and is also a dedicated four-time marathon runner.

• Site Engagement & Enablement

Dr. Chelico is a board-certified internal medicine and clinical informatics physician. His expertise is in the use of electronic health record systems for the improvement of clinical care, quality, research and financial strength. He is currently the System Vice President and Chief Medical Information Officer at CommonSpirit Health. Formed in 2019 through the alignment of Catholic Health Initiatives (CHI) and Dignity Health, CommonSpirit is the largest nonprofit health systems in the United States, with more than 1,200 care sites in 24 states, serving 25 million patients across America. Dr. Chelico is also currently an Assistant Professor of Medicine at the Zucker School of Medicine at Hofstra / Northwell and continues his clinical practice as an internal medicine hospitalist where he is a ward attending to house staff and medical students. Additionally, he is an Adjunct Assistant Professor of Population Health Sciences at Weill Cornell Medical School where he teaches a course focused on Clinical Informatics and Healthcare Quality since 2016. Dr. Chelico is a graduate of New York University, where he studied Computer Science at the Courant Institute of Mathematical Sciences. He completed his medical education at the State University of New York Downstate Medical Center, and finished residency training in Internal Medicine at North Shore University Hospital in Long Island, New York. Dr. Chelico went on to complete a National Institutes of Health (NIH) funded Post-Doctoral Fellowship and Masters Degree in Biomedical Informatics at the Columbia University Medical Center. During his fellowship, he became intricately involved with the strategy and re-architecture of the clinical data warehouse for the New York Presbyterian Healthcare System of Columbia University Medical Center and Weill Cornell Medical Center. Following his fellowship, Dr. Chelico joined the New York City Health and Hospitals Corporation as the Assistant Chief Medical Information Officer of Bellevue Hospital Center and the South Manhattan Healthcare Network. In the following years, he assumed the position as both the Director of Clinical Informatics at NYU Langone Medical Center and the Director of Data Warehouse Research at NYU Center for Health Informatics and Bioinformatics. At NYU Langone Medical Center he was a physician lead overseeing the Data Warehouse, Business Intelligence, and Epic Electronic Health Record System implementation across the enterprise. In 2011, he joined Northwell Health as the Chief Medical Information Officer at both cornerstone tertiary medical centers of North Shore University Hospital and Long Island Jewish Medical Center to oversee the electronic health information systems implementation and optimization. Starting in 2016 he took on a new role for Northwell Health, as the Vice President and Chief Information Officer of the Feinstein Institutes for Medical Research, where he is responsible for the Information Technology & Informatics that supports clinical research across the entire health system. In 2018 he was named the Vice President and Chief Informatics and Innovation Officer for the health system and founded the Northwell Health Center for Research Informatics and Innovation. This center concentrated on working with commercial partners looking to bring new technology into the health system and capitalize on the data assets that a large health system can provide to industry. Dr. Chelico is regularly invited to participate as a clinical informatics expert and health information technology consultant for industry and health care systems internationally.

• Real World Evidence

Clinical executive with more than 20 years’ experience transforming clinical teams to clinical operations excellence in both industry and study sites. Developer of innovative study designs that successfully gathers data for both regulatory and commercial success. Strong clinical expertise in electrophysiology, pulmonology, surgery, oncology, and orthodontics that increases KOL engagement and participation. Negotiator of clinical regulatory strategies with US, EU, Canada, China and Japanese regulatory bodies. Expert in revamping and revitalizing clinical operations and execution of failing studies.

• Site Engagement & Enablement

30 year industry experience across CROs & Pharma working in Clinical Operations, Business Development & Procurement. Following a Biology Degree I started my career as CRA working for Icon before moving into Business Development at Covance and subsequently Kendle (now Syneos). I joined Bayer in 2003 heading up a European Clinical Outsourcing function. As the outsourcing function developed and ultimately moved into the Global Procurement function at Bayer I assumed greater responsibility. Responsibilities have included leading regional teams across Europe & Asia for Pharma Development sourcing activities and Global teams responsible for Pharma Development Category strategy. During this time I was also heavily involved in the management of key supplier partnerships. I moved back into Bayer R&D to take a role leading an agile team to identify and manage a portfolio of future solutions supporting new approaches to clinical trial Planning and conduct to deliver faster, better, cheaper trials. Subsequently moving to the Alliance Management function in my current role as Strategic Alliances Lead, leading the Bayer's key strategic projects with external suppliers to enable the organizations ongoing transformation.

• Outsourcing

Committed, strongly clinical and technical research executive with proven experience in developing innovative solutions to complex medical problems. Experience spanning private startups, hospitals, university research labs, venture capital and patient advocacy groups. Established strength in forging partnerships between leading academic medical centers, community clinics, advocacy groups and government organizations to solve complex clinical syndromes. Strong technical skills in large complex data sets, electromagnetics and human disease.

• Clinical Trial Venture, Innovation & Partnering

Dr. Ciaccio uses Artificial Intelligence and Machine Learning to help accelerate Pharmaceutical Development at AbbVie Biopharmaceutical company. He is a member of the AbbVie RAIDERS (Rapid A.I. Developers) that are dedicated to the implementation of A.I. throughout the company. Mark specifically focuses on Clinical studies, currently working to simulate clinical trial enrollment, write chatbots to help answer regulatory questions, and design machine learning models to implement wearable devices in the clinic.

• AI for Clinical Trials

Chris Cirillo is a Clinical Operations Professional with 25+ years of progressive experience from Clinical Research Associate to Senior Director, Clinical Operations. He's made a career in small/midsize pharma serving as an advisor and leader in design, implementation, and closure of large-scale programs, specifically clinical trials in all phases of development. While thriving in small organizations, it's provided the opportunity to work closely with others in Regulatory, CMC, Clinical Supply, Medical Writing, Research, and Medical Affairs to understand the cross-functional aspects of Drug and Device Development.

• Recruitment & Engagement

No bio available.

• Patient-Centric Trial Design & Inclusive Research
• Feasibility & Study Start-Up

Michael J. Cohen, MSc, MBA is the Senior Director, Environmental Sustainability and Innovation at PPD. In this role, Michael leads PPD’s efforts to decarbonize clinical research at the study level through innovative solutions focused on key areas of carbon emissions. Prior to joining PPD in 2022, Michael helped start the CVS Health Clinical Trial Services business, developed pharmaceutical commercialization data programs at AETNA, worked in Medical Affairs at Johnson & Johnson and led a medical device startup. Michael is a bioengineer and materials scientist by training, with degrees from both University of California, Berkeley and Northwestern University, as well as an MBA in finance from Louisiana State University, Shreveport. Michael has published in both Science and Nature, presented medical videos at the Cannes Film Festival, previously served on the Dean’s Advisory Board at Harvard School of Dental Medicine and currently serves on the Northwestern University Alumni Admissions Council.

• Budgeting & Resources

Cal co-founded OpenClinica with colleague Ben Baumann in 2006. OpenClinica provides a comprehensive, best-in-class suite of data management and workflow solutions for clinical trials. Cal co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on an eSource initiative integrating EHR and EDC systems. He has been active in standards development work for many years, including as a member of CDISC’s Operational Data Model V2 feature team, the HL7 Vulcan Advisory Council and Steering Committee and the SCDM eSource Consortium.

• Data

Gina Conenello, PhD, is a virologist who received her PhD from Mount Sinai School of Medicine. She joined BARDA/DRIVe in 2022 as a Program Manager to focus on de-risking cutting edge technologies, developing novel regulatory strategies, and facilitating decentralized care modalities for pandemic response. She currently leads the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program in BARDA DRIVe (Division of Research Innovation and Ventures), aiming to catalyze decentralized clinical studies and healthcare delivery at real world locations where patients are seeking care today. Prior to BARDA, she spent over 10 years at FDA as a lead reviewer and subject matter expert in point of care and home use diagnostics with a focus on microbiology diagnostics. During the pandemic she was instrumental in the EUA authorizations for the first home use tests for SARS-COV-2.

• Decentralized & Hybrid

Anca Copaescu, CEO, is the powerhouse behind Strategikon's success and the driving force behind the company's revolutionary Clinical Maestro® platform. With over 15 years of experience in the clinical research industry, Anca's expertise in clinical outsourcing and analytics is second to none. As Head of Clinical Outsourcing and Analytics at BioMarin Pharmaceuticals, she managed and advanced the company's global outsourcing, vendor management and clinical analytics functions. Her passion for efficiency and innovation led her to relentlessly pursue improvements in clinical study planning, outsourcing, and financial management. And when she couldn't find a technology solution that met her standards, she decided to build a better one - the game-changing Clinical Maestro platform.

• Budgeting & Resources

With 20 years of experience and industry roles spanning across small to large CRO and Sponsor organizations, Jodi attributes developing budgets and proposals in her early CRO days to deepening her understanding of the critical relationship between CROs and Sponsors. As she progressed in her career, she transitioned to supporting Sponsor organizations in Outsourcing Management, developing processes and negotiating CRO budgets and contracts for Phase I-IV clinical trials. Her passion for developing effective communication and governance structures expanded as she discovered a gap in “true strategic partnerships” between cross-functional trial teams. With the addition of ICH E6 R2, Jodi found her niche as she began to lead and develop strategic and innovative vendor management and performance management oversight solutions between Sponsor and CRO matrix organizations. She is highly passionate about establishing internal and external cross-functional communication processes, effective issue escalation pathways and finds joy in building positive strategic partnerships that drive quality performance in support of clinical trial development.

• Outsourcing

Amy Elizabeth Cramer draws on her experience as a cardiac critical care nurse, clinical research coordinator, certified healthcare quality professional, and clinical research informaticist. Amy has worked in a community hospital, an independent academic medical center, and a world-class, academic medical institution. She is currently a Director of Data Acquisition-eSource for Johnson and Jonson Innovative Medicine. Amy is the founder of Vulcan, HL7 FHIR Accelerator dedicated to Translational and Clinical Research. She holds several previous leadership roles such as the Vice Chair for the Society for Clinical Data Management (SCDM) eSource Consortium, Co-Chair HL7 Clinical Interoperability Council and Board for the North Carolina Healthcare Quality. Throughout her career, Amy’s focus has been to determine improvements that provide better patient-centric care, whether that is in developing a visualization for a complex hypoglycemia protocol, developing a transplant quality program, or optimizing the use of the electronic health records for clinical research. Currently, Amy has been engaged in discussions about clinical trials solutions, which includes eSource; specifically, the secondary use of EHR data for clinical research. She is a TransCelerate member and reviewer for many professional journals. Amy received a Master in Management of Clinical Informatics from Duke University School of Medicine.

• AI for Clinical Trials
• Data
• Real World Evidence

Building on a strong academic research background in pre-clinical molecular oncology at Oxford and MIT, I have also developed significant industry experience combining medical affairs, clinical development and trial design, health economics and health outcomes research. My industry experience spans UK and Europe, supporting pipeline, pre-launch and marketed products. I have been commended for my innovative and collaborative contributions for evidence generation to support products.

• Real World Evidence

Roger Craveiro is a Specimen Lifecycle Management, Associate Director with over two decades of experience in the pharmaceutical industry. Roger's career began at the bench in a molecular biology lab, screening human genomic libraries. Over the years, Roger transitioned into clinical operations and specimen management, applying his expertise supporting clinical trials and pharmaceutical drug development. Residing on the East Coast, Roger enjoys spending time outdoors where he finds balance and inspiration and an occasional round of discgolf with his family and friends.

• Biomarkers & Precision Medicine Trials

Janeen Crawford brings over 30 years of experience in the healthcare industry, with a solid background in the pharmaceutical sector for over 22 years. Throughout her career, she has gained a diverse range of healthcare experiences, including Clinical Research, Sales, Medical Education, Expert Engagement, Operations, and Procurement. Currently, Janeen holds a crucial role as a manager for the Imaging services category in Merck's clinical research portfolio. Alongside her professional endeavors, Janeen actively serves her community in various capacities as a non-profit board member, Deacon, community advocate, and as a proud member of Delta Sigma Theta Sorority, Inc.

• Outsourcing

Michelle Crouthamel is an “intrapreneur” and a pioneer of mobile technologies in pharmaceutical development. As the Head of Digital Science at AbbVie, Michelle leads a team of digital health strategists and signal processing scientists to modernize outcome assessments and advance drug development programs. Prior to joining AbbVie, Michelle led many successful innovation programs in R&D at Merck and GSK and received numerous awards. She is a scientific advisor to many tech companies, an inventor who holds multiple patents, and an author who published extensively in Neuroscience, Oncology, and Digital Health. Michelle also collaborates broadly with academics, tech, consortia, and health authorities to drive progress and realize the value of digital health.

• Digital Health Technologies

Strategic Visionary in Digital Transformation & Analytics Leadership with Proven Analytics Portfolio Management Expertise With a keen eye for Strategic Vision, I've been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. My prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies. My role extends beyond mere strategy. I've championed an analytical development portfolio including in-house data & analytics transaction platform serving >1400 users, generative AI, and advanced modeling for business intel, ensuring robust analytical methodologies are in place, which has been pivotal for leadership and governance decisions. My expertise in Business Analytics and Product Analytics has been the backbone of this success, coupled with a budget management responsibility of >$5M. Building and nurturing relationships is at the core of my approach. I've continuously influenced key organizational stakeholders, ensuring the seamless adaptation and implementation of analytics and intelligence strategies. My proficiency in Engagement Management and Data Governance has been crucial in maintaining positive vendor partnerships, emphasizing quality delivery and continuous improvement. As a people leader, I've instilled a performance-centric culture, emphasizing Business Planning and actionable metrics. My commitment to Data Strategies and analytical thinking has ensured project and portfolio deliveries are not just timely but also rooted in process improvement. I've coordinated work with an agile mindset, ensuring products are delivered with consistency and precision. My technical acumen extends to Natural Language Processing (NLP), Business Intelligence (BI), data visualization, and cloud platforms including AWS, positioning me at the intersection of strategy and technology.

• AI for Clinical Trials

No bio available.

• Quality & Monitoring

Business-minded researcher and team leader with strong clinical background, graduate training in epidemiology and health economics, and over 15 years of experience designing, conducting, and communicating scientific research to healthcare providers, hospital administrators, health plan executives, policymakers, and others. Extensive hands-on experience with study design, execution, data analysis, and scientific writing, as demonstrated by track record of publications and presentations. Skilled in development and synthesis of evidence in acute and chronic pain, spinal disorders, musculoskeletal conditions, neurologic disorders, rare genetic diseases, and other therapeutic areas.

• Real World Evidence

Caroline Davis is a Senior Program Associate in the Public and Patient Engagement team at the Patient-Centered Outcomes Research Institute (PCORI). In her role, Caroline assists in the management and planning for PCORI’s Science of Engagement funding initiative, and in other project management activities related to supporting Engagement in research in PCORI’s funded research portfolio, including the update of PCORI’s engagement guidance and release of the Foundational Expectations for Partnerships in Research. Before joining PCORI in 2021, Caroline worked in diversity, equity and inclusion training and tool development for a medical professional association. She received her master’s in public policy from George Washington University in 2019, where she focused on health economic policy.

• Feasibility & Study Start-Up
• Site Engagement & Enablement

20+ years in the industry including positions in central lab supplier, EDC and sponsor roles. Currently, leading a new organization that has grown out of the goal for end to end management of biospecimens from collection to destruction.

• Biomarkers & Precision Medicine Trials

Angela DeLuca is the Vice President, Head of Oncology and Cell Therapy, Clinical Operations at Takeda. Angela is responsible for leading the clinical operations group to drive the clinical development operational strategy and execution of clinical trials. During more than 18 years in the biopharmaceutical industry, Angela has extensive oncology experience and has lived and worked in the US and Japan. Angela has been recognized for her ability to lead the progress of global clinical development excellence through the creation of innovative operational strategies and the early adoption of digital health initiatives, to optimize the R&D landscape to accelerate products to the global market. Before joining Takeda, Angela was Head of Global Site Management, Clinical Development Operations at AbbVie where she spearheaded the transformation of the clinical development operations enterprise, developing a knowledge center of excellence to create an industry-leading clinical development function. During her years at AbbVie and Abbott, Angela held other leadership roles such as Head of Strategy and Operations for Portfolio Program Management serving as consulting arm to R&D Leadership team, assessing & executing innovative improvement opportunities across the R&D enterprise. Angela also served as Head of Innovation where she managed the Japan Design Lab’s team and ensured digital technologies, health technologies, big data and predicative analytics were used to support enhanced clinical trial design and business decision making. Angela holds an MBA in Innovation from the University of North Carolina Chapel Hill, Kenan Flagler Business School, and a Bachelor’s in Chemistry from The Ohio State University. She is also a certified PMP.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Vivian is currently the Chief Strategy Officer at Faro Health, a healthcare technology company dedicated to driving innovation in Clinical Development. At Faro, she leads marketing and professional services, and works to maintain strategic alignment across the organization as the company scales. Previously, she was Chief Commercial Officer at NeuraLight, a digital biomarker and diagnostics company focused on neurodegenerative diseases. Prior to her role at NeuraLight, she was the VP of Strategy at Komodo Health, where she led a cross-functional team of market strategists to set corporate and segment-level revenue goals, direct product development strategy, and lead GTM operations for Komodo’s software and data products for Life Sciences and Healthcare customers. Before her roles in sales and segment leadership at Komodo, Vivian spent nearly a decade in life sciences strategy consulting at Trinity Life Sciences, supporting both small biotech and large pharma clients on everything from early commercial planning and portfolio strategy, to L&A opportunity assessments, to new product launch planning. Vivian holds a BA from Princeton University, where she studied cognitive and computational neuroscience, and an MBA from Berkeley-Haas.

• AI for Clinical Trials

Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development, clinical research, and consulting and his 20-year engagement with CDISC includes roles as a volunteer, implementer, and board member. Chris is passionate about leading CDISC towards a technology-based standards future and expanding the organization's global impact in clinical research standards.

• AI for Clinical Trials
• Data
• Real World Evidence

Years with Takeda: 4 Years in the PR&R Industry: 16 Amanda joined the Takeda Patient Recruitment & Retention team in August 2019. Prior to her tenure with Takeda, she worked for several patient recruitment and retention agencies where she partnered with sponsors, CROs, and sites to design and implement multi-channel PR&R campaigns to meet the specialized needs of individual protocols. Amanda has experience across a broad range of therapeutic areas with a forward-looking approach to maintain a strong pulse on the industry’s latest advancements in delivering patient-centric research. She earned a BA and MA from Villanova University in suburban Philadelphia and resides in Conshohocken, PA.

• Recruitment & Engagement

Dr. Charmaine Demanuele is an Executive Director in the AI/ML Quantitative and Digital Sciences group within Global Biometrics and Data Management, Pfizer Research & Development. She leads a team of statisticians and data scientists that bring end-to-end clinical trial innovation with digital health technologies, imaging and statistical, AI/ML methodologies. Her group works across Pfizer's portfolio to develop novel digital endpoints, and leverages models such as Bring-Your-Own-Device and Decentralized Clinical Trials to enable efficient, patient-centric trials and faster breakthroughs for patients. Prior to joining Pfizer, Charmaine was as a neuroscience research fellow at Harvard Medical School and Massachusetts General Hospital in Boston.

• Decentralized & Hybrid
• Quality & Monitoring
• Digital Health Technologies

As Vice President of Portfolio Management at TransCelerate, Rob's current role includes oversight of a portfolio of projects that include digital transformation, pragmatic trials, and real-world data. He is a member of the Vulcan Advisory Committee. From 2018-2021, Rob was the Deputy Chief Health Officer at IBM Watson Health, where he led external collaborations to implement digital COVID Trial screening tools and leveraged his industry experience to guide software developers working on life sciences offerings. He joined IBM after a long career in Pharmaceutical R&D spanning nearly 30 years; 25 with GlaxoSmithKline where he served in a variety of leadership positions. While at GSK, Rob was the Vice President of Clinical Pharmacology Sciences and Study Operations with a global footprint that included the US, UK, Australia, and China. Rob’s team designed clinical trials aimed at profiling new medicines, establishing proof of concept, and delivering critical data for product labeling. He also led the development of a number of late-phase oncology projects leading to successful product approvals. In 2015, Rob launched a Clinical Innovation and Digital Platforms Team at GSK where he focused on identifying, evaluating, and piloting emerging technical solutions to automate different areas of clinical trial design and implementation. Under his leadership, Rob’s team launched the first industry-sponsored Apple Research Kit Study to assess disease burden in rheumatoid arthritis patients in a real-world setting. He also led the Common Protocol Template and Digital Data Flow work streams sponsored by TransCelerate. He was also one of the team leads for the Clinical Trials Transformation Initiative (CTTI) sponsored Mobile Clinical Trials Novel Endpoints project. Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality, and ethics in research.

• AI for Clinical Trials
• Data
• Real World Evidence

Lindsay is a seasoned healthcare leader, and proud mom of three, with over 20 years experience working for Johnson & Johnson and Everyday Health Group. She founded the BabyCenter patient recruitment business in 2016 and expanded it to include What to Expect, when the brands came together under Everyday Health Group in 2019. She currently leads all aspects of the growing business and is passionate about delivering best-in-class experiences for patients and clients. She lives in Houston and loves to explore the outdoors with her family.

• Patient-Centric Trial Design & Inclusive Research

Sina Djali has over 25 years of experience in drug and clinical development in various companies and academia. Currently he is the head of Integrated Clinical and Operations Analytics at Jansen Pharmaceuticals. In this role Sina is responsible for incorporating Risk Management principles through applied analytics in the day to day R&D clinical operations. This includes managing both data engineering and analytics/data science teams to provide sustainable solutions in support of R&D clinical operations. Prior to this role, Sina was the head of Risk Management - Central Monitoring at Janssen R&D. Previously he has been responsible for Clinical Process and System Department at Tibotec Pharmaceuticals, where he developed and implemented a data driven Quality Risk Management System. He has also held several positions in research, regulatory affairs and R&D Quality Assurance departments at Wyeth and Aventis Pharmaceuticals.

• AI for Clinical Trials
• Data
• Real World Evidence

Marissa Dockendorf, PhD, is the Executive Director and Head of the Digital Clinical Measures group at Merck. She has 18 years of experience in the pharmaceutical industry and has made significant contributions to the research and development of several pharmaceutical products. In her current role, she leads a team of scientists in identifying, developing, and implementing novel digital clinical measures in clinical trials across Merck's portfolio to enable more efficient and patient-centric drug development. She has played critical roles in driving innovation projects focused on modernizing clinical trials and has been instrumental in inclusion of blood micro- and outpatient sampling, digital medication adherence monitoring technologies, and wearable devices in clinical trials. Prior to her current position, Marissa spent 10 years in Merck's Quantitative Pharmacology & Pharmacometrics organization providing pharmacokinetic and pharmacometric expertise and scientific oversight for numerous programs across the drug discovery-development continuum, covering diverse therapeutic areas including cardiovascular, neuroscience, and ophthalmics. Marissa also worked at Johnson & Johnson Vision Care for 3 1/2 yrs, where she contributed to the research & development of ocular drug-device combination products. Marissa has co-authored over 30 peer-reviewed manuscripts. She has a PhD in chemical engineering and a master’s degree in biomedical engineering from the University of Florida and an undergraduate degree from the Illinois Institute of Technology.

• Digital Health Technologies

Experienced Director in clinical operations management with a demonstrated history of creating and building global teams. Enthusiastic about 20+ years in the pharmaceutical industry skillfully managing stakeholders, leading projects/management of projects, and line management. Passion: Patients and strengthening their awareness and involvement in clinical research; being part of the solution for companies and communities to increase participation and diversification in clinical trials leading to better medications for everyone.

• Patient-Centric Trial Design & Inclusive Research

No bio available.

• Outsourcing

Donna Dorozinsky, President & CEO Just in Time GCP As the Founder and CEO of Just in Time GCP, Donna Dorozinsky leads a highly respected organization dedicated to supporting life sciences companies in maintaining Good Clinical Practice (GCP) compliance and optimizing clinical trial operations. Her company provides specialized clinical compliance and inspection readiness consulting and Trial Master File (TMF) management services. With over 30 years of experience in study operations, Donna possesses in-depth knowledge across a broad spectrum of functions, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her extensive experience working with a diverse range of stakeholders-from small biotech startups to large pharmaceutical companies, academic institutions, regulatory agencies, CROs, and investigator sites-enables her to effectively guide organizations toward achieving and sustaining GCP compliance. Donna’s career began at GlaxoSmithKline, where she spent 15 years focusing on Phase I Clinical Research Operations. In 2005, she founded Just in Time GCP, which has since evolved into an industry recognized leader in clinical compliance and operational optimization. Throughout her career, Donna has successfully led complex, large-scale projects, conducting operational gap analyses and driving process improvements for sponsors, CROs, and clinical sites. Her expertise in inspection readiness has helped numerous organizations successfully navigate regulatory inspections and implement remediation strategies for eClinical systems, quality management systems, and TMF services. A well-known speaker and dynamic educator, Donna has delivered numerous training programs on topics such as GCP compliance, Quality Management Systems (QMS), Inspection Readiness, and TMF Management. She is the Lead Editor of the 2024/2025 edition of Good Clinical Practice: A Question and Answer Guide and serves as a member of the TMF Reference Model Steering Committee. Donna’s leadership and entrepreneurial accomplishments have been recognized by Ernst & Young, which named her an Entrepreneur of the Year. Under her direction, Just in Time GCP has been included on the INC5000 list for four consecutive years. Donna holds a BSN from Gwynedd Mercy University, where she also serves on the Board of Trustees, and an MSN from Widener University.

• Small Biopharma Strategies

Tom Dougherty is currently the Data Science & AI Innovative Partnership Lead at Novo Nordisk. He is responsible for developing external partnerships to accelerate the development of new assets across the portfolio. Prior to Novo Nordisk, Tom was the Director of RWE Partnerships & Innovation at Pfizer where he launched therapeutic area external data partnerships and novel technologies. Tom has over 18 years of experience in healthcare with Merck, GE Healthcare, Boston Scientific, and Premier. He received a bachelor’s degree in chemistry and an MBA from Villanova University.

• Real World Evidence

No bio available.

• Clinical Trial Venture, Innovation & Partnering

Sara Edwards is the Senior Director for Decentralized Design and Delivery Integration at Eli Lilly and Company where she is responsible for integration of decentralized solutions into clinical trial design and implementation of Organizational Change Management strategies to accelerate adoption of Community-based research. Sara is an advocate for process improvement efforts that will enhance the investigator and patient experience and increase accessibility, diversity and inclusion in clinical trials.

• Decentralized & Hybrid

Kevin co-founded Contraline and has been CEO since its inception. Contraline is a biotechnology company developing paradigm-shifting innovations in reproductive health, starting with the world's first long-lasting, reversible male contraceptive known as ADAM. Kevin has led Contraline from an idea to clinical-stage company, built a world-class team, and has brought in >$30M in funding. Prior to Contraline, Kevin was involved in drug development in immuno-oncology and non-hormonal female contraception. He is an inventor on over 50 patents relating to novel contraceptive drugs, medical devices, and biomaterials. He has a degree in Nanomedicine Engineering from the University of Virginia, and in 2017, was named on the Forbes 30 Under 30 in Healthcare. Kevin is also an active angel investor and startup advisor, with a focus on biotech, deep tech, and women's health companies.

• Small Biopharma Strategies

No bio available.

• Decentralized & Hybrid

A leader in Clinical Research with more than 30 years' experience in Corporate R&D pharma organizations, Thierry has been promoting patient engagement strategy across the Industry. Thierry is now acting as an independent consultant providing strategic consulting and is very much convinced that digital innovation and patient engagement are the key success factors in the drug development phase and will impact positively the medicinal product lifecycle. Thierry acts as a Portfolio Lead for the Pistoia Alliance, a global, not-for-profit members’ organization collaborating to lower barriers to innovation in life science and healthcare R&D.

• Feasibility & Study Start-Up

No bio available.

• Budgeting & Resources

Cheryle is a senior-level executive with extensive, progressive clinical research experience and is responsible for the strategic planning and tactile operations in project management, clinical monitoring, site activation, safety and document management. She has led global teams across multiple disciplines, successfully utilizing automation to improve quality and streamline operations. Prior to joining Advanced Clinical in 2013, Cheryle was the VP of Clinical Monitoring, NA, with inVentiv Health Clinical, where she led the optimization of three global strategic units: Global Study Start-Up, Expedited Safety Reporting and Document Management and Publishing. Prior to her tenure with inVentiv Health Clinical, Cheryle was part of a strategic team with Essential CRO, where she supported the transition and growth from a site management organization to a top-five, global, full-service CRO. Cheryle has therapeutic expertise in cardiovascular, urologic, dermatologic and women’s/men’s health clinical trials. A life-long Chicagoan, Cheryle is a registered nurse in the state of Illinois, with a specialty in critical care nursing, and she attended the University of Illinois at Chicago. She is a published thought leader on implementing risk-based monitoring for midsize pharma, biotech and device companies and a frequent speaker at industry conferences.

• Small Biopharma Strategies

Michelle Everill is a pioneer in the field of clinical trial optimization that includes the intersection of data science, technology, innovation, and process simplification and flexibility. She has worked in clinical research since 2000 in a variety of roles at sponsors, CROs, and sites, and has participated in trials as a patient. She strives to drive more effective trials in terms of scientific advancement, patient, site, and operational burden, and the time and cost trade off. Michelle has led feasibility, data science, and business operations organizations at three of the top-ten pharma companies, consulted for and advised many organizations, and recently joined Alnylam as VP, Global Trial Optimization to further strategic approaches to innovative and curative medicines research.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Matthew Failor is the Director and Head of Clinical Operations for MAIA Biotechnology. Currently he is responsible for the delivery and oversite of global Phase II/III multi-national clinical trials. Over his 13-year career, he worked and led key clinical trials that contributed to the FDA approval of several new therapies such as VEKLURY (Remdesivir), KEYTRUDA (Pembrolizumab), and ENTYVIO (Vedolizamab).

• Outsourcing

Alyssa Farrell leads industry marketing for the SAS Global Health and Life Sciences Practice. In this role, she focuses on the SAS solutions that help optimize health outcomes for individuals and their communities. Alyssa is actively engaged in analyst relations, market research and influencer marketing to stay on top of industry trends and align SAS capabilities to customer needs. She has also supported the global energy and public sector teams during her career at SAS. Prior to joining SAS in 2004, Alyssa was a senior consultant in the Deloitte Public Sector practice. She earned her MBA degree with a concentration in Management Information Systems from the University of Arizona. She also holds a Bachelor of Arts degree with honors from Duke University.

• AI for Clinical Trials

Jessica Federer is a recognized leader in the global life sciences industry. She was the first Chief Digital Officer for the Bayer AG group, as well as the first woman to hold that role in the industry. She led Bayer’s digital transformation across the pharmaceutical, consumer care, crop science, material science and animal health businesses during record setting years for both sales and EBITDA. Reporting into the Bayer AG Group Management Board, Federer united the company’s digital strategy and investments across divisions to accelerate growth across the 118,00 employees. During her tenure, the company acquired and integrated Merck’s consumer care business and Monsanto, becoming, respectively, the second largest consumer health and the leading agriculture businesses on the planet, and floated their material science division into Covestro. With a focus on scalable digital enablers to business integrations and success, Federer streamlined investments, modernized capabilities, and upskilled the workforce. Prior to leading digital for the group business, Federer established a track record inside Bayer for delivery across regulatory affairs, market access, product launches, and business turnarounds. This includes the launch team for the record holding biologic EYLEA ®, an overhaul in the animal health business, and establishing the market access function globally. Federer regularly contributes to publications and events for the FT, Reuters Health, Bloomberg, and leading consultancies. Ms. Federer joined BMP as a Venture Affiliate in 2018, and is a Partner for the Opportunity Fund. She is a graduate of George Washington University and received an MPH from the Yale School of Public Health.

• Clinical Trial Venture, Innovation & Partnering

Olivia began her career as a clinical research associate at a contract research organization prior to becoming a lead clinical research associate and then a project manager, overseeing the operations of clinical trials in multiple therapeutic areas. After several years in project management, Olivia transitioned to the risk-based monitoring space. She supported the start-up of RBM within the CRO, including process design, procedural document development, RBM platform support and performing central monitoring activities. In 2019, Olivia joined CSL Behring to lead the central monitoring group and the implementation of Risk Based Quality Management practices.

• Quality & Monitoring

Christine Fernandez is an advanced practice nurse leader with over 30+ years of experience across a variety of cell and gene platforms. She has extensive experience creating treatment plans, developing protocols, and establishing collection requirements and cell processing center networks for both clinical and commercial programs. She is currently providing consulting services assisting with Strategic Planning, Resource Development and Patient Care Protocols to several start-up biotech companies globally. Christine serves on the Executive Board of the World Apheresis Association, is a member of the Qualification in Apheresis Exam Committee and is a Past President of the American Society for Apheresis. She is dedicated to ensuring patients and families have access to cutting-edge care while reducing disparities.

• Clinical Supply & Logistics

Maca Fernandez holds a Bachelor’s degree in Veterinary Medicine and Surgery and brings over 17 years of diverse experience in the clinical research sector. With a robust background that spans site-facing roles to feasibility assessments, Maca has recently transitioned into strategic program-level initiatives. Passionate about integrating real-world evidence (RWE) into healthcare practices, Maca focuses on enhancing the patient journey and ensuring the patient perspective is at the forefront of decision-making. Her special blend of clinical and strategic expertise positions her as a key advocate for innovative approaches in improving patient outcomes.

• AI for Clinical Trials

Always striving for excellence, Jay heads up Clario’s development, information technology and strategic sourcing initiatives. With over 25 years of experience of working as a global technology leader, Jay has a wealth of knowledge which helps drive changes that are critical to managing data protection. An expert in improving and implementing data policies, Jay is well placed to ensure the complete privacy and protection of data belonging to Clario’s customers and patients.

• Data

I am a passionate real-world-data & evidence enthusiast with 12 years of experience in the biotech industry. Most recently, I worked in the early days (employee #10) at ConcertAI in NYC. During my career at J&J, I have focused on the external innovation space (primarily oncology) for data science and digital health initiatives (primarily Phase II+). During this time, I have connected with small and mid-size companies (but mostly start-ups) all over the globe, and am super passionate making connections and creating opportunities in the industry.

• Data

For 25 years, Rosalie “Rosie” Filling has developed clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence-transforming R&D operations for pharmaceutical companies. As a member of the global R&D leadership team at Endo, she oversees the coordination and implementation of the company’s clinical development strategies, including clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness, and business operations. Endo’s active research programs span men’s health, orthopedics, and endocrinology, as well as focused development in the areas of sterile injectables and complex generic products. Rosie’s main focus at all times is on the end users-the patients. Bringing new life-enhancing and, at times, life-saving medications to patients drives Rosie’s sense of purpose. As a breast cancer clinical trial participant herself, she knows firsthand that her work and commitment can make a positive impact and improve patients’ lives. Guided by that tireless dedication, Rosie has earned a reputation as a powerful thought leader and mentor. She has participated as a keynote speaker at industry conferences, sharing her vision of how companies can shape the future of clinical trials; she regularly presents to Johns Hopkins University Ph.D. candidates about potential career paths; and within Endo, she supports team members both formally and informally, particularly as an executive champion for the company’s employee resource group for women, AWE (Alliance for Women at Endo). In previous roles, Rosie built teams and capabilities at Lupin Pharmaceuticals, Teva, and other respected life sciences companies. She earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

• Budgeting & Resources
• Outsourcing

In her current role as Co-Founder and Senior Vice President of Strategy and Product Development at ClinEco, Inc., Marina Filshtinsky is leading platform development and working closely with an offshore team of engineers. She is also leading and coordinating the work with advisors and investors on go-to-market strategy, business model, and positioning the platform within the clinical trials industry. At her "day job" Marina is working as executive conference director for several CHI’s events including SCOPE and SCOPE Europe.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Barbara Fink, MS, CCRP, EMR, is Associate Director of Clinical Affairs for Philips Emergency Care. She has over 15 years of clinical evidence generation experience in varying roles. She has been a Study Coordinator and Clinical Trial Safety Specialist in the hospital setting. In the medical device industry she has been a CRA, senior CRA, Clinical Study Manager, Clinical Operations Manager, and a Senior Manager prior to transitioning into her current role. She has successfully led initiatives implementing paperless systems, including an electronic Institutional Review Board submission system, an electronic patient recruitment database, and e-consent.

• Real World Evidence

Wes Fishburne is a Zelta Senior Product Manager who brings over 20 years of expertise supporting software solutions for the clinical trial industry. With extensive experience supporting clinical sites with a clinical trial management system (CTMS) and now working with the Zelta team, he has been instrumental in the development of Zelta’s eConsent and eCOA modules, as well other core areas of the Zelta Clinical Data Management System (CDMS) and EDC platform.

• Decentralized & Hybrid

Nasha Fitter is a leader in the rare disease space through her work on utilizing patient data to accelerate treatments. She is also the mother of a child with the rare neurological condition, FOXG1 Syndrome, and co-founded and leads the FOXG1 Research Foundation.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

No bio available.

• Outsourcing

Mette Flindt Heisterberg, Competency Development Specialist, Novo Nordisk. Mette has a background in academic research and has a PhD degree from Basic and Clinical Research in Musculoskeletal Sciences, Faculty of Health and Science, University of Copenhagen. Since 2017 Mette has worked at Novo Nordisk within Clinical Operations as trial manager and within the latest years as project manager on different innovative improvement projects.

• Site Engagement & Enablement

Patrick has over 27 years’ experience in new drug development. He joined Regeneron in March 2020. His current role is the Head of the Global Clinical Trial Services group, responsible for global site management, central monitoring, study feasibility and site selection, study/site start up, eCOA and patient technology initiatives. Prior to this, Patrick spent 25 years at Pfizer, with most of his time spent in clinical program operations but also includes GCP Quality (level 1) and Analytics. Patrick has extensive international experience in drug development. He helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. Subsequently, Patrick spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups. Patrick is a former officer in the U.S. Army and is a veteran of the Gulf War.

• Data

Maria Florez is a research consultant affiliated with the Tufts Center for the Study of Drug Development. Her research looks at the impact of digital transformation in clinical research; practices, strategies, and incentives driving improvements in the pharmaceutical R&D process; and the economics of new drug development. Maria has been a researcher and strategist in the healthcare sector for more than a decade. She has held positions at Cleveland Clinic, New York-Presbyterian Hospital of Columbia, and Cornell Universities. Maria holds a bachelor’s degree in quantitative economics and master’s degree from The Fletcher School of Law and Diplomacy at Tufts University.

• AI for Clinical Trials

With over two decades of experience in strategic leadership roles at Takeda, Astellas, and AI/ML life science startups, Tim is a seasoned industry veteran with a wealth of knowledge and expertise. His strong track record of successfully leading strategic initiatives and dedication to biomarker-driven drug development make him the perfect choice to drive Scailyte's growth strategy. As a result-driven executive with a background in business development, he specializes in creating value, providing guidance, resolving complex problems, and leading new technologies and product strategies. With a track record of executing transactions worthover $16B, Tim has a focus on helping novel life science startups secure funding and navigate the partnering paradigm to bring innovative solutions to the market. His strategic vision and hands-on approach are crucial in taking Scailyte to new heights.

• Small Biopharma Strategies

As the Corporate Global Head of Accessibility at Merck & Co., Inc., Dr. Stephen Framil has been an ardent advocate and practitioner of equitable access across the range of human experience: including the built environment, food sustainability, education, performing arts, and the digital landscape. With over 30 years of executive leadership in business strategy and innovation, policy and governance, procedure and operations, and portfolio management expertise, Steve continues to lead and champion accessibility in multinational corporations, non-profit education, and the performing arts. Steve resides in the Greater Philadelphia area with his wife Natalia, children Aren and Sasha, cats Mila and Jana, and dogs Benji and Joey. Steve maintains an active music career as the founding Executive & Music Director of Camerata Philadelphia and the Port City Music Festival (Wilmington NC), as well as Director of Orchestra & Strings at Eastern University PA. To make this all happen as a CRC Survivor (2024 NED), Steve energizes through marathons and triathlons, and is a 4X Ironman (2021-2024)-why be bad at one sport, when you can be bad at three!

• Digital Health Technologies

As the Vice President, Head of Clinical Operations North America - ClinChoice, Antoinette leads and manages the delivery of high-quality clinical trials for biotech, pharma, and medical device clients in the US and Canada. She has over 30 years of experience in the clinical research industry, with a proven track record of operational excellence, strategic planning, and team development.

Antoinette is passionate about improving the lives of patients through science and innovation. She has extensive therapeutic expertise in rare diseases, oncology, respiratory, cardiovascular, diabetes, and women's health, among others. She is also a member of the Association of Clinical Research Professionals, and a graduate of the UCLA Anderson School of Management Executive Program. Antoinette's mission is to foster efficiency and effectiveness throughout the clinical research processes and systems, and to build high-performing teams that deliver value to the clients and the industry.

• Small Biopharma Strategies

Cristin Freeman is the Head of Informed Consent at Bristol Myers Squibb, where she is focused on the ethical use of clinical trial samples and data, adherence to global genomic and data policies, and informed consent process and technology. Cristin is approaching 20 years of experience in research, ethics, project management and trial operations in academia and industry, holding various positions managing large scale pharmacoepidemiologic studies, leading cross-functional teams to execute global studies, and managing and executing global processes regarding consent including global and country consent templates. Additionally, Cristin holds a Master of Public Health from the Medical College of Virginia and a Master of Bioethics from the University of Pennsylvania.

• Biomarkers & Precision Medicine Trials

Jason has more than 25 years of experience in healthcare operations, medical informatics, clinical research, and organizational strategic planning. Jason has held various leadership roles over the years and was awarded top honors from US Healthcare News twice while at Intermountain Healthcare, where he oversaw business operations and strategy for the Homer Warner Center of Informatics Research. He was the former Senior Director at Parexel where he implemented new data solutions and operational strategies that transformed how data is being used to support all phases of clinical trial work across all therapeutic areas.

• Real World Evidence

Silvio Galea is the Chief Data & Analytics Officer of WCG, where he leads the overall data and analytics strategies to create competitive differentiation, improve business agility, and create operational efficiency across the enterprise. Silvio has over two decades of experience leading and managing software, data, & AI organizations across a range of industries including Healthcare, Finance and Publishing.

• Data

James brings over two decades of distinguished leadership in the Life Sciences industry, demonstrating expertise in managing budgets exceeding $200 million and leading diverse teams of up to 700+ professionals. Renowned for building high-performance teams and navigating complex business transformations, James has dedicated his career to Biometrics and, more recently, immersed himself in clinical innovation and technology.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Laura has a unique role which blends internal and external components. Laura is Merck’s assigned leadership to the Oversight Committee of TransCelerate BioPharma, Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics, and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck's objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.

• Patient-Centric Trial Design & Inclusive Research

No bio available.

• Site Engagement & Enablement

Genoa Garcia, Senior Business Development Manager at Avantor Sciences, specializes in supporting diagnostic labs and bio pharma companies from R&D to commercialization. Leveraging her expertise to support customers with end to end solutions, she specializes in implementing protocol solutions that help create, advance, and result in the adoption and accuracy needed for formal submission to governing bodies. She has a focus in early-stage diagnostic labs from conception through commercialization. She received her MBA from the University of California Davis and went on to support many successful clinical trials.

• Clinical Supply & Logistics

Drew’s career in pharmaceutical technology spans over 25 years and includes significant experience in eClinical system architecture, design, and development, as well as process design, solution validation, and international implementation and support. In his role as CTO, Drew collaborates with customers, partners, and the industry to set vision and direction of Veeva Clinical Data products.

• Decentralized & Hybrid

With 16 years in the CRO space and a deep expertise in clinical technology across various platforms, I have specialized in RBQM technology training, adoption, and implementation since 2018. Currently, I’m the Director of Customer Success at CluePoints, where I leverage my extensive background to drive impactful outcomes and enhance client experiences.

• Quality & Monitoring

Lisamarie is entering her 24th year working in the pharmaceutical industry, focusing on Clinical Operations and Clinical Supplies. She has held many different roles within her career, including various positions of increasing responsibilities at BioMerieux, Hospira, and Thermofisher. Lisamarie is currently the Senior Director of Clinical Supplies at MacroGenics. She was sought out to form the company's first Clinical Supply Department. Lisamarie is known for her mentoring of colleagues and direct reports. With her extensive technical skills and mentoring mentality, Lisamarie has successfully created a robust and dynamic clinical supply department and team contributing to the success MacroGenics.

• Clinical Supply & Logistics

Brittany brings over 16 years of global clinical operations experience working at various pharmaceutical companies and CROs and 7 years of entrepreneurial experience. Her expertise includes global study management, global site management, monitoring, and clinical trial diversity and inclusion. In her current role, she leads the strategy for implementing inclusive clinical trials, leads the cross-functional Clinical Trial Health Equity Working Group, and represents her organization on clinical trial diversity matters internally and externally. With a passion for clinical trial diversity and inclusion, she is eager to apply successful solutions to advance clinical trial diversity globally and address health disparities. She has a special interest in digital health solutions for underrepresentation populations in clinical trials and maternal and infant health.

• Patient-Centric Trial Design & Inclusive Research

Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.

• Decentralized & Hybrid

Mr. Goldberg is an Operating Partner of Arsenal where he focuses on networking and sourcing transactions for the healthcare team. Prior to joining Arsenal in 2014, Mr. Goldberg was a Managing Director, Corporate Development of Endo Pharmaceuticals. Previously, he was a founding Partner of ProQuest Investments and the founding CEO or founder of three biotechnology companies that were acquired or taken public. In addition, he also held executive positions at Becton Dickinson and at GSK. He serves on Dana Farber Cancer Institute Visiting Committee and board of NIH/Cambridge/Oxford Scholars program.

• Clinical Trial Venture, Innovation & Partnering

Norman M. Goldfarb is Executive Director of the Site Council and the Clinical Research Interoperability Standards Initiative (CRISI). He is also Managing Director of Elimar Systems, which is developing a technology platform to transform clinical research into a collaborative, learning enterprise. Previously, he was Chief Collaboration Officer of WCG Clinical, founded and led the MAGI conferences, and published the Journal of Clinical Research Best Practices.

• Site Engagement & Enablement

As the Head of Clinical Operations, I oversee, manage, and analyze the project performance of all global clinical trials, ensuring they are executed as per scope, timeline, budget, and quality standards. With over 15 years of clinical research experience at the site/CRO/Sponsor level, I have acquired extensive therapeutic knowledge and skills in various areas, such as analgesia, GI, pulmonary, hepatology, cardiovascular, dermatology, endocrinology, rare disease, oncology, women's health, men's health, infectious disease and CNS disorders.

• Small Biopharma Strategies

Gretchen Goller leads the Patient Recruitment and Retention Solutions group at Seagen with a focus on oncology-specific solutions resulting in a holistic, patient centered approach ensuring that patients and their families have the most positive experience. Ms. Goller has over 20 years’ experience gained in pharma and CRO industries. Prior to Seagen, she was the Global Head of the Patient Recruitment and Retention team at ICON. Previously, Ms. Goller was the Patient Recruitment and Retention leader at sanofi-aventis. Other roles included Clinical Trial Manager, Medical Affairs at Wyeth and Study Manager at Astra Zeneca. She has held positions at the University of Pennsylvania including Study Coordinator and Site Director working on a range of therapeutic areas including vaccines, cardiovascular, cardiology, ophthalmology, women's health, HIV, and endocrinology. Ms. Goller has a BA from the University of Massachusetts and an MSW from the University of Pennsylvania and is located outside of Philadelphia, PA.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Melanie has been part of the clinical trial industry for 20+ years focusing on trial enrollment and supplier relationships in a variety of therapeutic areas. Her most recent role is with Immunocore supporting Relationship Management across all Clinical Operations suppliers.

• Small Biopharma Strategies

Dr. Goss joined the Digital Health strategy team at AbbVie in 2020, focusing on the development of more objective and sensitive efficacy measures in support of Immunology pipeline development. After completing her PhD at the University of Connecticut and Post-doctoral fellowship at the University of North Carolina, Sandy joined the Abbott/Abbvie clinical pharmacology department in 2008. She supported clinical pharmacology activities for all phases of development across multiple therapeutic areas and has been an advocate for novel analysis and clinical innovation. She joined the AbbVie Development Design Center in 2017 that fostered a collaborative environment to help clinical teams optimize the design and execution of their trials. She also led the exploration of decentralized trials and home health care to decrease the patient burden and helped integrate the use of real-world data in clinical decision-making.

• Digital Health Technologies

Vaishali Goyal is a dynamic IT leader with extensive experience in the pharmaceutical industry, known for her transformative impact since joining AstraZeneca R&D IT in November 2018. She has driven significant advancements across multiple domains, including medical evidence, real-world evidence, digital health, software as a medical device, R&D transformation programs, and AI initiatives. Vaishali's proactive leadership has been instrumental in spearheading transformative change, and her collaborative efforts with cross-functional IT business teams have propelled AstraZeneca's digital transformation to new heights. In addition to her industry role, Vaishali is an Adjunct Professor at George Mason University, where she passionately teaches graduate-level courses on Big Data, demonstrating her commitment to continuous learning and education.

• AI for Clinical Trials
• Data

Professor Bola Grace has decades of leadership experience across multiple sectors across pharma, biotech, and academia. She enjoys collaborative research and development as well as the application of data science in women's health, digital health, inclusive innovation, and health inequalities. She is a Royal Academy of Engineering Visiting Professor of Healthcare Engineering and Inclusive Innovation, an Honorary Professor of Practice at UCL, and MD at Cambridge Matrix. She has a PhD from University College London and an Executive MBA from the University of Cambridge Judge Business School.

• Digital Health Technologies

Catherine Gregor is an expert in clinical research operations and e-clinical solutions. With nearly two decades of clinical research experience, she has honed a deep understanding of clinical trial design, conduct, and patient outcomes. As the Chief Clinical Trial Officer for Florence Healthcare, she is at the forefront of designing and implementing technology solutions to support the mission of faster cures for everyone.

• Site Engagement & Enablement

Senior Vice President of Product & Chief Architect, QuartzBio A translational informatics visionary and creator of SaaS solutions supporting clinical sample inventory and biomarker data management, Tobi drives technology innovation across data-centric spaces from complex biomarker signatures for patient selection to enterprise software solutions for pharmaceutical and biotechnology companies. At QuartzBio, Tobi leads innovation for product management, product development, software engineering, product support, technical professional services, and solutions engineering.

• Biomarkers & Precision Medicine Trials

Sofia is an investor in the Cambridge office, where she focuses on healthcare and biotech. Sofia began her career as a consultant at Bain and Company, where she worked on strategy, operations, and due diligence projects across healthcare and technology. Prior to joining Bessemer, she was an investor at BoxGroup Ventures and the co-founder and President of Nucleate Bio, a national life sciences entrepreneurship program helping PhDs, Post-docs, and students commercialize scientific projects. Sofia earned her MBA from Harvard Business School and her BA with high honors in Chemistry from Harvard University. While in school, she conducted research alongside Bob Langer, a serial entrepreneur and one of 12 Institute professors at MIT widely recognized for his contributions to drug delivery and tissue engineering fields.

• Clinical Trial Venture, Innovation & Partnering

Maria Gujral is the Head of Biospecimen & Imaging Management at Bristol Myers Squibb (BMS), bringing over 20 years of experience in biospecimen and vendor management. In her current role, she supports biospecimen and imaging management for hematology, oncology, and cell therapy trials. Her team ensures the timely and efficient delivery of all biospecimen and imaging operational aspects across all stages of dynamic clinical studies, from start-up to conduct and close-out. Maria has led and participated in several continuous improvement initiatives aimed at enhancing end-to-end specimen tracking oversight. She has also overseen multiple strategic BMS vendor partnerships with Central and Specialty labs. Maria holds a BS from The College of New Jersey (NJ, USA) and an MS in Quality Assurance and Regulatory Affairs from Temple University (PA, USA).

• Biomarkers & Precision Medicine Trials

Dr. Arkady Gusev is the Executive Director of Laboratory Excellence and Operations in Biomarker Development/Translational Medicine at Novartis Institute for Biomedical Research. In his current role, he is responsible for the scientific and operational leadership of clinical biomarkers, assay outsourcing, sample operations, central laboratory setup, and vendor management. Previously, Arkady Gusev led the Business and Technology Operations units in the Department of Pharmacokinetics, Dynamics, and Metabolism in Pfizer Global Research Division. Arkady Gusev received his PhD (1992) in mass spectrometry from the Institute of Space Research, Russian Academy of Sciences. Following his PhD, he joined the Department of Chemistry, University of Pittsburgh as a postdoc and held a Research Assistant Professor position in the Department of Chemistry at Vanderbilt University before joining the industry in 1997. Arkady Gusev is the author and co-author of 60+ peer-reviewed publications in different areas of bioanalytical technologies, bioanalysis, biomarkers, and clinical operations. Arkady Gusev’s recent research interests include patient-centric technologies, bioanalytical and biomarker assay outsourcing, vendor management, clinical operations, and the art of operational excellence and portfolio management.

• Biomarkers & Precision Medicine Trials
• Clinical Supply & Logistics

Over the past two decades, Allison Guy has established a strong track record of following the science to develop and deliver life-changing medicines with a focus on patient-centricity and use of innovative tools to expedite patient access to safe and effective treatments. She has led regulatory strategies for biologics and small molecules in different therapeutic areas at various stages of their life cycles and has published on multiple regulatory topics. Allison is currently a Regulatory Affairs Director in the Oncology Regulatory Science, Strategy and Excellence group at AstraZeneca and a recurring guest lecturer at the Leslie Dan Faculty of Pharmacy.

• Patient-Centric Trial Design & Inclusive Research

With over 25 years of expertise in the life sciences, Sheila serves as a senior leader and trusted advisor to organizations in regulated industries. As Vice President and Head of Consulting at Halloran Consulting Group, she leads a dynamic team of experts dedicated to designing and implementing innovative solutions that drive impactful business results and create a competitive edge for our clients.

Her expertise spans management consulting, quality and compliance, business process optimization, risk management, and organizational transformation. She is passionate about fostering a culture of quality, continuous improvement, and innovation within life sciences organizations, empowering them to achieve their strategic objectives. Sheila has a proven track record of spearheading initiatives that enhance organizational performance, elevate client satisfaction, and ensure regulatory excellence.

• Small Biopharma Strategies

Syed Haider is a Leader in AI and Data Sciences driving digital innovations at Merck. He leads and supports global AI solutions and automation with human-in-the-loop in clinical trials. Syed is responsible for AI strategy, successful adoption, and change management in global operations. He is passionate about sharing his knowledge and experience with the new talent; Syed is an Adjunct Associate Professor at Columbia University where he teaches graduate courses in AI, and mentors graduate students at the Data Science Institute. Syed led AI and Data Science in Life Sciences and Healthcare for over 17 years.

• AI for Clinical Trials
• Data

I am a board-certified Neurologist with fellowship training in neurodegenerative diseases and postgraduate training in medical informatics. In my current role at Lilly, I am a clinical research physician in the Digital Health Research and Development group, as well as the Vice Chair of the Lilly Bioethics Advisory Committee. Previously at Lilly I have led late- and early-phase clinical trials and have provided medical leadership in Medical Affairs in neurodegeneration and in migraine. Prior to joining Lilly, I was an Associate Professor of Clinical Neurology at the Indiana University School of Medicine, where I now continue to hold an adjunct faculty position, serve on the Institutional Review Board, and see neurology outpatients twice monthly.

• Digital Health Technologies

Duncan has over 20 years of experience in the life sciences technology sector. Duncan started TRI in 2013 with the specific aim of making Risk-Based Quality Management (RBQM) simple and accessible for all clinical trials. He has overseen the development of OPRA, an industry leading RBQM platform that integrates risk assessment, risk management and central monitoring. Duncan’s extensive knowledge of RBQM in clinical trials means he’s a sought-after expert speaker at industry events.

• Quality & Monitoring

Seth Halvorson is the General Manager of WCG’s Site Solutions business unit that includes WCG’s study start up teams, site network, CTMS, recruitment and retention services, study acceleration, and site augmentation solutions. Seth started at WCG in 2018 as the General Manager of WCG ThreeWire. Prior to joining WCG he was Vice President and Assistant General Counsel at Syneos Health. Seth worked at Syneos Health for 9 years through the i3/PharmaNet merger that created inVentiv Health and the INC Research Merger that created Syneos Health. During that time, Seth was responsible for leading the clinical division’s global contracting teams and providing legal counsel for the clinical division. Seth was a member of the inVentiv Health Patient Centricity task force.

Seth devotes his energy to developing and deploying realistic and effective solutions that connect the keys clinical trial stakeholders of sponsor, site, and participant.

• Recruitment & Engagement

Troy Hamilton serves as the Director of Operations at CaRe Clinic, bringing a wealth of experience from medical research roles at the University of Calgary and senior management positions in private clinics. Renowned for his ability to transform significant initiatives into measurable outcomes, Troy leverages his background in biological sciences and project management, along with his CCRP designation from SoCRA. He excels in business operations, quality control, process optimization, stakeholder engagement, financial forecasting, resource allocation, and KPI development within the clinical research sector. As a recognized expert, Troy is frequently invited to speak at provincial, national and international conferences and events. He is also a co-author of the ACRC Research Glossary. Outside of his professional life, Troy enjoys hiking, gardening, and exploring culinary arts.

• Site Engagement & Enablement

Donna Hanson, Vice President, Strategy & Optimization, has over 20 years of experience in the clinical research industry spanning site management and contract research organizations (CROs), patient recruitment, and functional service provider offerings. Seasoned in clinical development strategy, Donna’s focus has been in executing and leading teams in patient recruitment, feasibility, site identification/engagement, and proposals. Her therapeutic expertise spans most major areas, including oncology, and includes all Phases; her passion is in rare disease and pediatrics, and she continually looks for ways to support Sponsors in ensuring patient and site centricity. Donna is located in Wisconsin, US.

• Small Biopharma Strategies

Meghan serves as the Vice President, Clinical Trial Financial Management at Medidata, driving roadmap and strategy across our Grants Manager and Payments products. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first-hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. Meghan joined a CNS-focused start up in RTP and has spent the last 20 years working in the life science technology industry. The last decade of this time has been solely focused on the clinical trial financial domain driving product strategy and leading teams responsible for complex system implementations.

• Budgeting & Resources

Melissa has 23 years of industry experience dedicated to accelerating patient recruitment from all possible feeds including site EHRs, AI and data enabled recruitment channels, digital and online media and community engagement programs. Melissa works to harness the benefits of applying innovative solutions toward successful patient recruitment and retention campaigns while driving health literacy, diversity and inclusion and patient access equity to reduce study burden and facilitate enrollment into everyday life. Melissa heads up Fortrea’s Voice of Patient program to drive patient insights into every step of the drug development paradigm and is a Co-Lead of Fortrea’s Site Advisory Board.

• Patient-Centric Trial Design & Inclusive Research

Suzanne Harris serves as the Senior Vice President of Marketing at SubjectWell, provider of the most accurate, diverse, predictable, and patient-centric platform that connects patients and caregivers to breakthrough healthcare opportunities. Suzanne’s personal involvement in clinical trials and patient advocacy drives her passion for advancing clinical technology and improving the patient experience.

• Recruitment & Engagement

Chris Hart is a litigation partner and co-chair of the Privacy and Data Security group at Foley Hoag LLP, a leading law firm with a global reach and a reputation for excellence. With nearly two decades of civil litigation and human rights experience, Chris helps clients navigate complex and evolving data privacy and cybersecurity challenges, from compliance and incident response to government investigations and litigation. As a certified privacy professional and a recognized leader in the field, Chris advises clients across various industries and geographies on their data management and governance practices, including their obligations under comprehensive data protection laws (such as CCPA, GDPR, PIPEDA), and other domestic and international frameworks (such as the TCPA). Chris has extensive teaching experience as a part-time lecturer at Northeastern University School of Law, where he designed and taught courses on data privacy regulation and compliance. Chris has a vibrant pro bono practice, for which he has received significant recognition. Chris is a passionate advocate for diversity, equity, and inclusion, and leads the firm's practice in counseling clients on their DE&I practices and managing investigations relating to DE&I.

• Small Biopharma Strategies

Michelle Hartmann, CCRP, is the Director/Owner of South Broward Research which is located in SE Florida. She started with South Broward Research in 2006. South Broward Research is a community based, independent site. She is dedicated to the pursuit of advancing healthcare by ensuring integrity and quality in the work performed at South Broward Research. She feels fortunate to be a part of an incredible team. She attended The Florida State University where she received both her Bachelor of Science and Master of Science. She has continued her education in the field of research by attending research seminars and conferences, participating in panels with sponsors and industry organizations, and becoming a Certified Clinical Research Professional. She enjoys spending time with her family, traveling, and can often be found reading a good book.

• Site Engagement & Enablement

As the Vice President of Research Technology at Mass General Brigham, Chris leads a team of over 60 professionals who provide cutting-edge informatics and analytics solutions to support the research mission of one of the largest and most prestigious healthcare systems in the world. With over 20 years of experience in the hospital and healthcare industry, he has a proven track record of delivering value to stakeholders, partners, and customers through strategic vision, operational excellence, and business development. He has been involved from the start in the development of the Mass General Brigham Research Patient Data Registry (RPDR) as well as i2b2 (Informatics for Integrating Biology and the Bedside), an open-source informatics platform used at over 300 academic institutions worldwide. He is passionate about advancing biomedical research and innovation through the use of data and technology with a goal of empowering researchers to discover new insights, improve patient outcomes, and transform health care.

• Feasibility & Study Start-Up
• Site Engagement & Enablement

No bio available.

• Biomarkers & Precision Medicine Trials

Josh Hershelman has 18 years of experience in the pharmaceuticals industry. He started in field sales and worked with multiple large sponsor organizations before joining AstraZeneca. After a few years in field sales with AZ he decided to transition to the R&D side of the business. His unique industry experience over the past 18 years in global patient insights, clinical operations analytics, sales, monitoring, and feasibility provides a wholistic view of the drug development process. Today he leads the US Site Engagement Partners in Care Network team supporting the growth of AZ's strategic footprint across the US.

• Site Engagement & Enablement

Alyson Higgins is Director of Study Feasibility and has been with Abbott/AbbVie more than 25 years holding various roles in Pharma R&D and Diagnostics. Experience includes clinical trial design and execution, country and site optimization, project management, change management, operations management, quality assurance and manufacturing operations. Alyson is passionate about leveraging technology to work smarter and drive efficiency for development operations through interdisciplinary collaboration. The Study Feasibility team supports clinical teams with insights to inform strategic decisions from early concept through enrollment.

• Feasibility & Study Start-Up

I am passionate about creating new paradigms that create meaningful change through innovation in healthcare and clinical research through investing, strategy, M&A and partnerships. I have held a variety of roles in my ~17 years in healthcare technology (EHR and clinical trial tech) in leadership roles spanning corporate strategy, product strategy, product management, and partnerships across stages from company start-up to scale. Through that time I launched six technology products, driving M&A strategic evaluation and processes including completing six strategic acquisitions, developing corporate strategy, and developing and launching partner programs. I have been on the sell side of company exits twice, helping develop a strategic thesis for growth that has continued to be the path the company follows. I have a Bachelor’s in Molecular / Cell Biology from Vanderbilt University, am a mentor to start-up entrepreneurs in Madison, active in helping improve healthcare in Africa, and spend my free time negotiating with my young daughter or outdoors hiking or kayaking.

• Clinical Trial Venture, Innovation & Partnering

With over 20 years of experience in the clinical research industry, Jesse has held significant site and CRO roles, including 12 years at Syneos Health, a global Contract Research Organization (CRO), and 4 years at Advanced Clinical Research, with 2 sites in Utah and Idaho. Since 2019, Jesse has been the Chief Business Officer at AMR, a prominent clinical research site company with over 30 locations across the United States.

• Site Engagement & Enablement

Dr. Faith Holmes brings over 30 years of patient care experience and 11 years in medical practice management to her role as Elligo’s Chief Medical Officer. Her background in Family Medicine, and Hospice and Palliative Medicine across various practice settings enhances her ability to build Elligo’s network of Research Ready physician practices. Dr. Holmes has served as Principal Investigator on 15 optimized trials in the virtual and hybrid models, in addition to trials at the local site, Elligo Clinical Research Center, in Austin.

• Decentralized & Hybrid

Jen Horonjeff, PhD, is the Founder & CEO of Savvy Cooperative, and was named one of the 50 Most Daring Entrepreneurs by Entrepreneur Magazine for her work at Savvy, the first patient-owned co-op that helps companies get input and insights from diverse patients. Jen grew up with juvenile idiopathic arthritis, survived a brain tumor, holds a PhD in Environmental Medicine, and previously worked as a health outcomes researcher, human factors engineer, and FDA advisor. Jen serves on the Board of Directors for The Sequoia Project, the Advisory Board of Trialbee, and numerous other committees to ensure the patient voice is included.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Daoying Hu has 17 years experience in pharmaceutical and CRO industry. She developed her career through several functional roles including biomedical research, project management, site network management, and clinical data solutions. She focuses on clinical planning and analytics in the recent years. Currently she leads Strategic Feasibility group at UCB, which support clinical operational teams to plan and start up clinical trials using big data/predictive analytics and innovative strategies. Daoying received her PhD from Baylor College of Medicine, and MBA from Duke University.

• Decentralized & Hybrid
• Quality & Monitoring
• Digital Health Technologies

A globally recognized advocate within the patient community, Stacy champions Parexel’s patients-first culture. She ensures that patients and caregivers have a seat at the table to translate their lived experience and recommendations into improvements in the drug development process at its earliest stages. Stacy champions accessibility to clinical research by expanding the definition of diversity to ensure that people with disabilities have an equitable chance at better treatments, improved outcomes, and cures. Stacy is an award-winning 25-year pharma executive with experience in functional areas such as sales, marketing, training, operations, and physician practice management. She is a frequent conference speaker and industry influencer, always championing patient involvement in clinical research, for example, as a member of the Global Annual Meeting Program Committee for Drug Information Association (DIA). Stacy is also co-chair of the board of the American Cancer Society Northeast Region (Pittsburgh market).  Stacy holds a bachelor’s degree in labor and industrial relations from Penn State University and master’s degrees in health administration and business administration from the University of Pittsburgh.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Dr. Brigham Hyde is CEO and co-founder of Atropos Health since August 2022. He provided funding and support for Atropos Health’s official launch in late 2020. Hyde has a significant track record of building businesses in the health tech and real-world data (RWD) space and most recently served as President of Data & Analytics at Eversana. Prior to that role, Mr. Hyde served as a healthcare partner at the AI venture fund Symphony AI, where he led the investment in, co-founded, and operated Concert AI, an oncology RWD company - most recently valued at $1.9B. Hyde held previous roles as Chief Data Officer at Decision Resources Group, which was acquired by Clarivate for $900M in 2020. He has also served on the Global Data Science Advisory Board for Janssen, as a research faculty at MIT Media Lab, and served as adjunct faculty at Tufts Medical School.

• Clinical Trial Venture, Innovation & Partnering

No bio available.

• Quality & Monitoring

Anne Marie Inglis has over 25 years of experience in clinical research, spanning all phases and therapeutic areas, but specializes primarily in Clinical Operations. She spent most of her career at GSK, and up until 2020 represented GSK on TransCelerate Biopharma workstreams, leading both the Site Qualification and Training team as well as the Patient Experience Team. She is passionate about improving the patient experience in clinical research and in particular, increasing the diversity of participants in clinical trials. She left GSK in 2020 to move into smaller biotech and at Mallinckrodt Pharmaceuticals developed a Risk Management framework that ensured compliance to ICH E6(R2). She moved to Affinivax and was responsible for developing the innovative operational strategy for an early-phase vaccine asset. In 2022, Affinivax was acquired by GSK, and Anne Marie is back as a Clinical Operations Asset Lead. She remains committed to employing innovative strategies to ensure clinical trials are available to all patients who could benefit, while improving quality and speeding delivery of new medicines to the marketplace.

• Budgeting & Resources
• Small Biopharma Strategies
• Outsourcing

No bio available.

• Feasibility & Study Start-Up

Venky Iyer is Director of Data Strategy & Automations within Information Management Group at Pfizer. He has over three decades of experience in the pharmaceutical sector delivering key enablers for multiple clients to drive business value. Currently, he is actively involved in several AI/ML strategic initiatives partnering with key stakeholders and driving key concepts for enablement. He holds a master’s degree in Mathematics and has been with Pfizer since 2019.

• AI for Clinical Trials
• Data

Paul Jacobs is Associate Director of Global Development Innovation at Regeneron. He is part of a function responsible for enabling clinical trials innovation by bringing innovative thinking, tools and techniques to the table through an innovation pipeline process. Before joining Regeneron in 2021, Paul worked in innovation roles at LEO Pharma as Head of Innovation, helping to establish and grow the R&D Data and Analytics function and, before that, as a founding member of the LEO Pharma Innovation Lab. Paul has also held roles in consultancy with Frog (Capgemini Invent) as Head of the UK Life Science Practice and various Medical Editing, Digital Strategy and Client Service roles at Publicis Healthcare, Sonic Boom and Nucleus Group companies. Paul received his Masters Degree in Biomedical Sciences from King’s College, London and his Bachelor’s degree in Biological Sciences from The University of Salford.

• Data

With experience of 22+years, Nitin Jain has worked extensively in Business Development, General Management, Strategic Alliances and Operations in the Drug Development, Pharmaceuticals & Central Laboratory industries in Asia Pacific, US, EU and the Indian Sub-Continent. Nitin has worked with organizations such as; Covance & INC Research as Head Business Development. At Theorem Clinical Research, as Vice President & General Manager, Nitin has effectively managed all activities of the company in Asia Pacific region including, Operations, General Management, Global Staffing business and Business Development. Nitin Jain completed his Higher Secondary education from David Game College, London, UK. He obtained his Bachelor in Administration degree from AMLA, LA, USA and Master of Business Administration degree from ACL, London, UK. An effective problem solver and decisive leader, Nitin Jain wishes to continue pursuing his career in the Drug Development industry.

• Clinical Supply & Logistics

Kelsey Jakee, managing consultant with PA Consulting, has an established track record of leading and managing transformation in pharmaceutical R&D. Over the past 14 years, she has advised Top 20 BioPharma and industry consortia on clinical innovation, new service and business model development, R&D technology strategy, digital transformation, improving the patient experience, and leveraging novel data sources across preclinical, clinical, and drug safety. Her mission is to drive high-impact and lasting change in clinical research to help us all live our best lives

• Site Engagement & Enablement

Usama is a dedicated pharmacist with a Master's in Health Informatics, blending clinical expertise with a passion for digital innovation in healthcare. With a career spanning from frontline patient care in retail pharmacy to shaping regulatory strategies in digital health at Merck, Usama leverages unique insights to drive impactful change. His diverse background fuels his commitment to improving patient outcomes through technology, making him an engaging thought leader at the intersection of pharmaceuticals, health technology, and regulatory innovation.

• Data

Don Jennings currently serves as a Senior Architect in Eli Lilly’s technical organization where he is responsible for defining, evolving and driving innovation in Lilly’s Clinical Trial Design & Operations capabilities. Don also participates in the Transcelerate Digital Data Flow (DDF) workstream as Vendor Engagement subteam lead where he advocates for industry-scale data system interoperability using USDM and its associated APIs. Previously, Don was a Lilly Digital Health technology advisor leading engineers in developing SaMD solutions to improve delivery of therapy for complex disease states (2018-2023). Don also led Lilly teams in development of eSource technologies, automated clinical information exchange, PK/PD simulation and genomic analytics (2007-2018). Prior to his roles at Lilly, Don participated in the original sequencing of the human and rat genomes at Celera Genomics (2000-2007) and delivered science ground segments for several NASA and ESA high energy astrophysics missions (1989-2000). Don holds an MBA from Butler University, an MS in Physics from Iowa State University, and bachelor’s degrees in Physics and Computer Science from the University of Missouri.

• Patient-Centric Trial Design & Inclusive Research

Dr. Otis Johnson is the Founder of Trial Equity, whose purpose is to ensure that medicines are safe and effective for all people by providing solutions for diverse patient recruitment in clinical trials. Recognized for his leadership by Pharmavoice, Informa Connect and Mogul, he has served on the diversity advisory boards of the Association of Clinical Research Organizations (ACRO) and the Association of Clinical Research Professionals (ACRP). He is also on the advisory board of Wake Forest University’s Master’s Degree Program in Clinical Research Management and a Global Advisory Board Member of the Healthcare Businesswomen's Association (HBA).

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

No bio available.

• Patient-Centric Trial Design & Inclusive Research

No bio available.

• Quality & Monitoring

Tom Johnson is a seasoned professional who has devoted the last decade to optimizing the clinical study process for life sciences companies, focusing on reducing technical burdens and enhancing efficiency in study start-up and application access management.  Exostar's expansive community includes half of the world’s largest pharmaceutical companies, over 30,000 organizations, 100+ connected applications, and over 700,000+ individuals working in thousands of sponsors, CRO and site locations worldwide. With a Bachelor of Science in Industrial Engineering from The Georgia Institute of Technology, Tom brings a unique blend of academic expertise and practical experience to his role, driving impactful solutions within the life sciences industry.

• Feasibility & Study Start-Up

Jill Johnston is the Chief Innovation Officer at WCG Clinical, where she drives cutting-edge innovation and integration initiatives across the organization. Focusing on business transformation and strategic exploration of new technologies, processes, and solutions, Jill ensures that WCG Clinical remains at the forefront of the industry. Bringing extensive experience from the Clinical Trial sector, Jill has previously served as President of WCG’s Study Planning and Site Solutions. Her professional journey includes significant roles such as Vice President of Clinical Strategy at Veeva Systems and Global Vice President of Business Transformation at Covance, where she spent more than 20 years leading pivotal clinical trials in oncology, cardiovascular, metabolic, and neurology. Jill’s remarkable contributions to the industry have been recognized through several prestigious awards, including the Excellence in Process Award and the Chairman’s Award-received twice during her tenure at Covance. She holds certifications as a Six Sigma Black Belt, certified Project Management Professional, and a certified Clinical Research Associate from ACRP. Jill earned a BSc in Biology from SUNY College of Environmental Science and Forestry. An active contributor to the academic community, she taught clinical monitoring and coordination to support Drexel University’s Clinical Development Master’s program. Jill was also a founding member and former Chapter President of the Association for Clinical Research Professionals (ACRP) in Greater Philadelphia.

• Site Engagement & Enablement
• Clinical Trial Venture, Innovation & Partnering

I am a Program Management leader with over 20 years' experience in overseeing projects and programs for CMC, preclinical, and clinical research. My expertise is in developing program management tools, processes, and teams for small pharma and biotech companies.

• Small Biopharma Strategies

In my role, I am skilled in collaborating with diverse stakeholders to enhance operational efficiency and propel clinical development programs forward. Excel in implementing best practices and ensuring the quality and integrity of clinical trial data. I oversee all aspects of clinical data management, from protocol development to study design and data collection, analysis, and reporting. By leveraging my expertise in regulatory requirements and industry standards, I ensure compliance with applicable guidelines and drive efficient and effective data management processes. My leadership style is characterized by collaboration, innovation, and a commitment to excellence. I foster a culture of teamwork and continuous learning, empowering my team to achieve their full potential and deliver high-quality results that meet or exceed stakeholder expectations. As a strategic thinker and results-oriented leader, I thrive in dynamic environments where adaptability and agility are essential. I am dedicated to delivering measurable outcomes and exceeding business objectives while maintaining a focus on patient safety and regulatory compliance. Let's collaborate to advance clinical data management practices, drive innovation in healthcare, and improve patient outcomes, while connecting and exploring opportunities to make a meaningful impact together.

• Small Biopharma Strategies

Dr. Naveen KK has worked in Healthcare, CRO & ITES industry for 18+ years, he has experience working across Pharmacovigilance, Risk-Based Monitoring, Cardiac Safety Services and Connected Devices. Physician with Master's in Business Administration degree & Lean Six Sigma Black Belt Certification. He is currently working as Executive Director & Global Head, Central Monitoring, Medical Data Review, and Clinical Trial Safety in Labcorp.

• Quality & Monitoring

As a seasoned professional in the pharmaceutical industry, I have amassed a wealth of experience as a Local Study Associate Director, overseeing the operational intricacies of clinical trials at AstraZeneca. In this pivotal role, I successfully managed the execution of clinical studies, ensuring adherence to regulatory standards, maintaining study timelines, and fostering collaboration with diverse stakeholders to achieve study objectives. Building on this foundation, I made a strategic transition into the realm of Feasibility, where I harnessed my operational expertise to evaluate the viability and practicality of conducting clinical trials on a broader scale. This shift empowered me to assess potential sites, forecast patient recruitment capabilities, and provide valuable input into study design by leveraging my comprehensive understanding of operational considerations. My journey from Local Study Associate Director to a Strategic Feasibility professional has equipped me with a holistic perspective on clinical trial management, blending operational acumen with strategic foresight to contribute meaningfully to the planning and execution of clinical studies at AstraZeneca.

• Feasibility & Study Start-Up
• Site Engagement & Enablement

Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical trials, and drug development activities, including pharmacoepidemiology, outcomes research, protocol design, site identification, data-driven patient recruitment, and the use of RWD to support evidence generation & submission to regulatory agencies (e.g., FDA). He has this experience across the spectrum of pharmaceutical/biotech, entrepreneurship, and large CRO businesses.

• Real World Evidence

Numan Karim is an Associate Director of Data Science & Analytics at AbbVie. He has 8 years of experience in the pharmaceutical industry, with a focus on enabling analytics capabilities across Clinical Development. Numan's current work involves developing fit-for-purpose analytics and data science capabilities for healthcare professionals and scientists in Clinical Operations and Patient Safety. Combining visual analytics, statistics, and modern data engineering tactics, he has deployed multiple data science products at scale. Numan is passionate about data science leadership and the intersection of analytics, technology, and medicine. Numan received a BS in Statistics & Integrative Biology from the University of Illinois at Urbana Champaign in 2016, and received an MS in Applied Data Science from the University of Chicago in 2020.

• Quality & Monitoring

Asma Kasuba is Senior Director, Global Development Data and Science and Digital Health at Johnson and Johnson Innovative Medicine. Her career in the pharmaceutical industry spans across all phases of clinical development and multiple therapeutic areas, enabling a diverse and broad lens to drug development. Asma has held roles in increasing responsibility across Regulatory Affairs, Program Management, Strategy, and Operations and Data Science in R&D, Medical Affairs and Commercial. In her current role, Asma is leading a team of Data Science PMs to build and utilize RWD, RCT, and AI/ML modeling capabilities to optimize clinical trial design, site selection and accelerate trial execution, and scaling these capabilities for greater impact across the portfolio. Asma has a Bachelor's Degree in Biochemistry from Rutgers University and an MBA in International Business. She is a PMP Certificated and a Stanford University Certified PM. Prior to joining Johnson and Johnson, Asma has prior experience at Pfizer and Biomatrix.

• Feasibility & Study Start-Up

Nechama Katan, is a Wicked Problem Wizard working at Pfizer as a Director of Data Science. She helps organizations understand technical processes and problems and then works to build trust and innovative solutions. Nechama has been supporting Pfizer’s Risk Based Monitoring team for over 6 years. Nechama has worked in multiple industries and organizations of all sizes, including high and low tech, finance, and pharmaceuticals. Nechama’s education includes an MSc from NYU/Courant Institute in Mathematics and an MA from Columbia University in Statistics.

• Quality & Monitoring

Dr. Kaye is the Layton Professor of Neurology and Biomedical Engineering at Oregon Health and Science University (OHSU). He directs the Layton Aging and Alzheimer’s Disease Center, ORCATECH (the Oregon Center for Aging and Technology), and ORCASTRAIT (the Oregon Roybal Center for Care Support Translational Research Advantaged by Integrating Technology). His long-standing research focus has been to advance methods to sustain healthy aging and treat conditions associated with aging. This work has been facilitated by a remarkable cadre of interdisciplinary colleagues and collaborators within OHSU, as well as many others at research centers around the world. Through these many associations, He has enjoyed extensive experience in team-building, designing, conducting and analyzing studies of aging and diseases of aging across a wide spectrum of environments (e.g., clinics, community residences, assisted living and nursing facilities, "smart" homes), designs (e.g., program projects, longitudinal natural history studies, proof-of-concept studies, randomized controlled trials, online surveys), and approaches (e.g., cognitive and behavioral testing, genetics, neuroimaging, biomarkers, in-home continuous assessment technologies). He leads or has led several longitudinal studies on aging and clinical trials including: The Oregon Brain Aging Study (OBAS), Intelligent Systems for Detection of Aging Changes (ISAAC), Ambient Independence Measures for Guiding Care Transitions, EVALUATE-AD (Ecologically Valid, Ambient, Longitudinal and Unbiased Assessment of Treatment Efficacy in Alzheimer’s Disease), DETECT-AD (Digital Evaluations and Technologies Enabling Clinical Translation for Alzheimer’s Disease), and the Collaborative Aging Research using Technology (CART) Initiative studies, all using pervasive computing and sensing technologies for assessment and interventions. He serves on many national and international panels and boards in the fields of geriatrics, neurology and technology. He is listed in Best Doctors in America. He has authored over 450 scientific publications and holds several major grant awards from federal agencies, national foundations and industrial sponsors.

• Digital Health Technologies

Lindsay Kehoe manages the development and implementation of projects at the Clinical Trials Transformation Initiative (CTTI). Lindsay has 10 years of experience coordinating clinical research. Prior to joining CTTI, she served as a clinical trial lead at Children’s National Medical Center in Washington, DC, coordinating both physician-driven and industry-sponsored trials. She also served on the hospital's Institutional Review Board. Lindsay is a certified genetic counselor with extensive experience in both pediatric and adult genetic counseling. Early in her career, Lindsay worked in the pharmaceutical sector, first in early-phase drug development at Millennium Pharmaceuticals (now Takeda Oncology) and then in post-marketing laboratory surveillance at Sanofi Genzyme. Lindsay is a proud alumnus of the University of Virginia and master’s graduate alumnus of Boston University School of Medicine.

• Decentralized & Hybrid
• Quality & Monitoring
• Digital Health Technologies

Jean is the Head of Clinical Operations and a Sub-Investigator at Rochester Clinical Research in Rochester, NY. She is a Physician Assistant by training and has several years of both outpatient and inpatient site research experience. Jean has a passion for site operations and the patient experience, because they are the core of what makes clinical research possible!

• Feasibility & Study Start-Up

Tom is an accomplished leader with over 20 years of progressive experience in healthcare, pharmaceutical R&D operations, and strategy leadership. He currently serves as the Program Director for both the Clinical Data Sharing and BioCelerate programs. In this role, Tom oversees strategic execution of portfolio plans, employs a rigorous risk management approach, and identifies and designs continuous improvement considerations and focuses on stakeholder management with member companies. Prior to TransCelerate, he was the Director of Operations for the Immunology Therapeutic Area Leadership Team at CSL Behring where he was responsible for collaboratively building the foundational TA strategy. Also, at CSL, Tom led a Clinical Trial Process Improvement and Innovation team within the Clinical Development Operations organization that was responsible for business process design enhancement, clinical trial software application implementation, change management and training. In addition, Tom was a Manager in Accenture’s R&D management consulting practice, a Clinical Data Manager at Covance and a Medical Technologist at both AstraZeneca’s Safety Assessment/Preclinical Toxicology group and the Alfred I. DuPont Hospital for Children. Tom earned an Executive MBA from Villanova University, a Master of Science in Microbiology from Thomas Jefferson University, and a Bachelor of Science in Medical Technology from the University of Delaware.

• Data

Pharmacist by profession but became a Clinical Project Manager to drive innovation in the pharmaceutical industry. With several years of on-site monitoring and clinical project management experience, I gained in depth knowledge about the full lifecycle of the clinical drug development process from Phase I to phase III on a wide range of therapeutic areas and different study designs. Involved in the set-up, monitoring and management of several hybrid clinical trials in the past 10 years.

• Decentralized & Hybrid

Mr. Kern is a patient-based clinical technology expert with over 25 years of clinical research experience and serves as the Executive Director of the eCOA Consortium at C-Path. Beginning his career in clinical data management roles at several CROs and pharmaceutical companies, Scottie was first exposed to Electronic Patient Reported Outcome (ePRO) technology back in 2003. Enthused by the potential of this technology and its direct interaction with patients, Scottie took a role as the functional lead for ePRO at Wyeth’s Vaccine Research Unit in 2004, one of the earliest dedicated enterprise-level ePRO ownership roles in the industry. Establishing himself as an industry SME and thought leader on ePRO and Electronic Clinical Outcome Assessments (eCOA), he went on to serve as the Head of Patient Technologies and Global Head of ePRO at Pfizer. Scottie launched his own consulting company in 2013, via which he supported a range of pharmaceutical companies with eCOA strategy and implementation. Scottie joined C-Path in 2021.

• Digital Health Technologies

Dr. Irfan Khan is the founder and CEO of Circuit Clinical. Dr. Khan is a cardiologist who served as a principal investigator on both therapeutic and device clinical trials for more than a decade and is passionate about improving access and equity in clinical trials, community engagement, and patient education and empowerment. Over the last six years, he has overseen Circuit Clinical’s growth to more than 2.5 million patients, involving 30+ partner locations including multi-specialty physician practices, Accountable Care Organizations, and Federally Qualified Health Centers. His work at Circuit Clinical has also included the creation of TrialJourney™, the first-ever ratings and reviews platform for clinical trial participants and people seeking clinical research as a care option. Under Dr. Khan's leadership, Circuit Clinical was awarded a "World Changing Ideas" recognition from Fast Company™, as well as being named an Inc. Magazine™ Best Workplace 2021, and a Fast Company™ Best Workplaces for Innovators 2021.

• Site Engagement & Enablement

With over two decades of experience leading the development and deployment of digital solutions in the pharmaceutical industry, I have spearheaded data science initiatives that optimize every stage of the clinical trial lifecycle. My expertise includes leading teams to harness machine learning for improved patient recruitment, integrating novel digital endpoints for deeper insights into drug efficacy, employing ML techniques for risk-based data monitoring, and automating regulatory document authoring using generative AI. At Biogen and through my consultancy, I have integrated digital technologies into clinical trials to streamline processes and enhance outcomes. At Harvard and MIT, I developed open-source Python tools for digital health and fostered industry-academia collaborations. I have published over 60 high-impact papers with over 2,000 citations and hold two patents in digital health technologies. Adept at leading cross-functional teams, I seamlessly merge technology and healthcare to accelerate clinical trials and drive strategic objectives.

• AI for Clinical Trials
• Data

Garo Kiledjian is the Founder, President, and CEO of SGM Alliance, a 501c3 nonprofit that focuses on educating and advocating for inclusive Sexual and Gender Minority (SGM) participation in clinical trials, life sciences, and the evolution of healthcare. Garo also serves as the Chief Operating Officer for Trialogic, a Site Network for one of the largest global LGBTQIA+ healthcare providers. Having served in multilevel roles within administration, research, pharmacy, operations, and finance, Garo brings a versatile skill set to his leadership role. He also serves on the Membership Planning Committee for Society for Clinical Research Sites (SCRS) and is on the Executive Committee for the National LGBTQ Task Force-one of the oldest social advocacy groups that focuses on legislative and policy changes at the grassroots level in Washington, DC. He is passionate about DEI and offers a unique perspective on how the intersectionality of race and ethnicity overlap with gender and sexuality. Garo earned his Bachelor’s from UCLA and studied Leadership and Global Strategy at Woodbury’s Graduate School of Business.

• Recruitment & Engagement

Tamy Kim is the Director for Regulatory Affairs and Policy in the Oncology Center of Excellence (OCE) at the FDA. She also has a dual role as the Associate Director for Regulatory Affairs within the Office of Oncologic Diseases within CDER. Dr. Kim is responsible for developing policies and procedures affecting the review of products under the OCE across CDER, CBER and CDRH. She is also responsible for providing guidance to oncology review divisions and sponsor for complex regulatory issues. During her time with FDA Oncology, Dr. Kim helped established the OCE and formed policy and procedures for Breakthrough Therapy, Accelerated approval, Real-Time Oncology Review (RTOR), expanded access, master protocols, seamless trials designs and more.

• Patient-Centric Trial Design & Inclusive Research

Brett Kleger is a nationally recognized executive leader with deep strengths in sales, marketing, corporate development, and product management. He has extensive experience building healthcare technology and services companies and divisions, and bringing new offerings and capabilities to market. He is particularly interested in data-driven digital solutions. Prior to Inspire, Brett was CEO of Datacubed Health, where he transitioned the company during the pandemic from early-stage concepts to a major contender in the eCOA and decentralized clinical trial platform categories. Prior to Datacubed, Kleger was Chief Commercial Officer and Chief Operating Officer at DrugDev, where he led the company’s market success to become the leading provider of site-facing technologies, resulting in an acquisition by IQVIA. He remained at IQVIA for several years post-acquisition to consolidate and lead the commercialization for all of IQVIA’s clinical trial technologies. Brett holds a business degree from the University of Maryland and a juris doctorate from the Villanova School of Law. In 2018, he was named to the PharmaVoice 100 in recognition of his considerable career achievements.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Olgica Klindworth is a Vice President, Medidata R&D spearheading development of data quality and risk management capabilities/Clinical Data Studio. Prior to joining Medidata, Olgica spent 17 years at PPD, 10 years in data management leading Data Management teams, building Data Management capabilities and overseeing execution of a number of clinical trials across various therapeutic areas. Olgica has also spearheaded development of Data Analytics and Centralized Monitoring processes and capabilities at PPD. She has participated in or led a number of data management, innovation and RBQM initiatives and served as a subject matter expert or speaker in a number of industry conferences. Olgica received her Bachelor of Science in Microbiology from University of Texas at Austin and Master of Science in Analytics from Texas A&M University.

• Quality & Monitoring

Sven Knapinski leads the newly established Site Partnerships Team at CSL. He and his team are excited to make a difference by deepening the relationship with key clinical research sites and institutions, expanding CSL’s site network, centralizing internal knowledge, and fostering streamlined internal and external information exchange. Sven has 18 years of Clinical Development experience most of it linked to Clinical Trial Management. After his PhD in Biology, he stared his career in a CRO and gained some experience in the medical device industry before he joined CSL (Vifor) 10+ years ago.

• Site Engagement & Enablement

Michael J. Koren, MD, practices cardiology and serves as the Chief Executive Officer at ENCORE Research Group. He founded ENCORE which has conducted over 2500 clinical trials at 8 locations in Florida since 1997. He received his medical degree cum laude at Harvard Medical School, and completed residency in internal medicine, chief residency and fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center. Dr. Koren is a fellow of the American College of Cardiology. He is a fellow and two-time past president of the Academy of Physicians in Clinical Research and past president of the regional chapter of the American Heart Association. As an ACRP Certified Principal Investigator, Dr. Koren has led more than 500 clinical trials on hypercholesterolemia, cardiovascular disease, and heart failure. He participates in the Cholesterol Treatment Trialist Collaboration based in Oxford. Dr. Koren’s research has been published in peer-reviewed journals including Nature, Journal of the American College of Cardiology, Circulation, New England Journal of Medicine, and The Lancet. He has lectured nationally and internationally on topics such as lipid-lowering therapy and preventive cardiology.

• Site Engagement & Enablement

Anna Kosenko currently holds the role of Associate Director, Biomarker Operations within iVAC Platform Team at BioNTech US Inc. Anna joined BioNTech US Inc. in July 2024. Anna previously worked at Takeda between 2022 and 2024 as Team Lead, Sample Management and Data Operations, playing a critical role in building a biomarker operations team with clinical sample and data operations capability to support Takeda’s oncology and cell therapy portfolio of Phase I through III global studies. Before joining Takeda, Anna worked in Oncology Biomarker Sample and Data Management role at Seagen (formerly Seattle Genetics). Anna spent 7 years at Parexel International, where she gathered a wealth of experience in clinical operations across therapeutic areas by supporting clinical trials for 20+ pharmaceutical and biotechnology companies. Anna holds an MS in Bioinformatics from Freie University of Berlin (Germany).

• Biomarkers & Precision Medicine Trials

Bridget is a senior conference director with over 20 years of experience in development, production and marketing of educational networking conferences across multiple industries, geographies, and cultures. Currently, she focuses on connecting biopharma leaders to advance pharmaceutical R&D in clinical trial operations, alliance management, data science and informatics, and program, portfolio and resource management.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Jennifer Krohn, MS, has over 17 years of experience in the pharmaceutical industry across a range of functions, with the last decade dedicated to risk-based quality management (RBQM) and a special focus on centralized monitoring (CM). She has extensive experience in developing and implementing CM tools and processes as well as leading data analyst teams at a large CRO. Recently, Jennifer transitioned to the pharmaceutical side at Gilead, where she serves as a Risk Advisor, helping to build RBQM capabilities and advising study teams on the development of strategic monitoring approaches. She also serves as a PHUSE RBQM Working Group lead for Central Monitoring and as a contributor to the QTL project. Jennifer holds a Master of Science degree in Biochemistry and Physiology. She resides in Wilmington, NC, with her husband of 16 years and their 10-year-old daughter.

• Quality & Monitoring

Marie is a Registered Nurse with over 25 years of clinical research experience. She began her passion for clinical research at academic centers, working with pediatric and adult oncology patients on Phase 1-3 research studies. Then transitioned to the pharmaceutical industry to better understand and influence the clinical protocol development before it reaches the patients. At Bristol Myers Squibb, she has held several roles within drug development spanning across all phases of drug development and always striving to improve and streamline processes. She is involved in leveraging new innovative technology to improve our ways of working.

• AI for Clinical Trials
• Data

Dr. Tobias Kruse is the Managing Director of Europe at SubjectWell. He is the founder and former CEO of Trials24, a company that supports biotech and pharmaceutical companies, as well as CROs, in accelerating patient recruitment. Trials24 was acquired by SubjectWell in September 2024. Before founding Trials24, Tobias co-founded ImevaX, a biotech company focused on vaccine development, where he developed and executed the out-of-site databases patient recruitment strategy. Tobias earned his PhD in Molecular Biotechnology from the Technical University of Munich, where he developed a vaccine against Helicobacter pylori. He holds numerous patents and has published papers in journals such as Nature and EMBO.

• Recruitment & Engagement

Sylvie Kruyner serves as Director, DCT Operations at Bayer Pharmaceuticals. Her primary focus is to support clinical and operational teams to evaluate the implementation of Decentralized Clinical Trial elements and to support with operationalization of these elements. Up until today, Bayer has implemented DCT in multiple global clinical trials, inclusive of hybrid and fully remote designs. Ms. Kruyner joined Bayer in 2014. She has more than 10 years of operational and trial management expertise within CRO and sponsor organizations, holding different roles on both local and global levels in Europe and the US. Next to this, Ms. Kruyner has also been involved in creating and providing intra-company trainings, several taskforce initiatives (related to customer-centricity, change management, monitoring, resourcing) and end-user-insight activities. She holds a Masters in Health Care Management and Policy from Ghent University, Belgium. She currently lives in Kansas, US.

• Decentralized & Hybrid

Sunny Kumar is a Partner at GSR Ventures, where he primarily invests in early-stage companies deploying emerging technologies to transform healthcare delivery, including lead investments in Medable, Deep 6 AI, and Osso VR. Sunny is a physician as well as a published medical researcher with a focus on applying informatics and artificial intelligence to translational medicine in the fields of neurosurgery and gene therapy. He is a serial entrepreneur and most recently founded a company to reduce readmissions for high-risk patients with chronic diseases using voice-enabled natural language processing technology. Sunny received a BS in Molecular Biology from Yale University, an MD from Stanford University School of Medicine, and an MBA from Stanford University Graduate School of Business.

• Clinical Trial Venture, Innovation & Partnering

As the Head of Diversity Strategy at Bristol Myers Squibb, Lorena has been leading the diversity in clinical trials efforts for the past two years, with the objective of recruiting a patient population that reflect both the demographics of the real world and represent the epidemiology of the disease being studied. Prior to working at BMS, she spent several years in the Latin America and Canada Region in Novartis, where she started her career in Pharma back in Mexico over 15 years ago. As a strong inclusion advocate, she leverages her experience, intersectionality, and personal purpose, as well as the roles she holds the WOCIP Board of Directors, the RedShoeMovement, and her hometown Diversity Committee to build an inclusive culture that values differences and serves ALL populations. Lorena was awarded the 2020 PEOPLE EN ESPANOL MAGAZINE Recognition: “Las 25 mujeres mas poderosas” celebrating women who have made a difference empowering others.

• Patient-Centric Trial Design & Inclusive Research
• Recruitment & Engagement

Dr. Mary Jo Lamberti manages multi-sponsored and grant-funded research projects at Tufts CSDD. She has extensive experience conducting market research on pharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts CSDD, Dr. Lamberti was Director of Market Research at CenterWatch. She has also worked on federally funded research studies in science education reform. Dr. Lamberti holds a B.A. from Wellesley College and a Ph.D. in Psychology from Boston University.

• AI for Clinical Trials

Rogier Landman is Associate Director Data Science at Pfizer and is based in Cambridge, MA. He has worked on a wide variety of data science projects. His latest work is on using large language models for facilitate clinical trial documentation, including strategies for evaluation of model output.

• AI for Clinical Trials

Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal decentralized clinical trial platform. In 2019 Kai co-founded the DEEP initiative to co-create a novel integrated ecosystem for the development, validation and acceptance of digital measures. Kai continues to contribute in an advisory role with DEEP, which is now an independent company. Through his involvement in technical, operational and scientific roles, he has gained deep and holistic understanding of the clinical trial process and the key mechanisms of our ecosystem. Kai brings his entrepreneurial spirit and creative mindset to support Janssen’s global regulatory policy work across a range of topics. Kai has a passion for broad pre-competitive collaboration and is motivated to modernize the ways our broader ecosystem works together to advance the adoption of novel tools and methods to support efficient and patient-centric pharmaceutical R&D.

• Digital Health Technologies

Dr. Lank is an emergency physician with additional specializations in medical toxicology and addiction medicine. As a faculty member at Northwestern University's Department of Emergency Medicine for more than a decade, Dr. Lank focused his research and teaching on the care of patients who had overdosed and those with substance use disorders. In 2022, Patrick joined AbbVie to take on two major roles -- both as a medical director in clinical development (Specialty Medicine focusing on infectious diseases) and as the medical director for the AbbVie Research Collaborative. The AbbVie Research Collaborative is an innovative program and platform to build cohorts of people with disease who are interested in engaging directly with AbbVie to share their health journey and insights -- elevating the patient voice in scientific research to shape the medicines of the future.

• Recruitment & Engagement

No bio available.

• Site Engagement & Enablement

Nicole Latimer is Medrio's Chief Executive Officer. As CEO, Nicole carves out her time in three equally and critically important areas: studying the life sciences industry, making decisions about how Medrio can have a greater impact on that industry, and then focusing on the best way to communicate those decisions to staff and customers. She brings 25 years of impressive and broad-based healthcare experience, including stints at The Advisory Board Company (now part of Optum) and Deloitte Consulting, where she focused on population health management, health system growth strategies, patient and employee education, and SaaS development and delivery. Most recently, in her role as CEO of Staywell, she drove the company’s mission to be the premier provider of lifestyle risk management programs for the entire healthcare ecosystem leveraging behavioral science as the foundation for improving health outcomes. She shines at redesigning processes, increasing efficiency, and reducing costs.

• AI for Clinical Trials

Dr. Ade Lawrence is a Physician Investigator and the Founder/Chief Executive of Bioluminux Clinical Research, where he leads initiatives to support clinical trial studies for Pharmaceutical companies and CROs. He also provides clinical development consulting and contracting services to small pharmaceutical companies and start-up biotech. He earned a Doctor of Medicine degree at the Universitatea de Medicina si Farmacie "Grigore T. Popa” din Iasi, Romania, and a Master's degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices at the Northeastern University, Boston. Dr. Lawrence has a special interest in promoting diversity in clinical research with a strong cultural and patient-centred approach.

• Feasibility & Study Start-Up
• Site Engagement & Enablement

Manny has held the position of Vice President, Head of Clinical Operations at Jounce Therapeutics since July 2016, where he is responsible for clinical strategy, planning and execution. Jounce Therapeutics is a clinical stage immuno-oncology company in Cambridge, MA dedicated to transforming the treatment of cancer. Manny started his industrial career 28+ years ago with positions of increasing responsibility beginning at Genetics Institute, Anika Therapeutics, Cubist Pharmaceuticals, Johnson and Johnson, Vertex Pharmaceuticals and Forum Pharmaceuticals. Manny holds a Master’s of Science in Drug Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and a Bachelor’s of Science in Biology from the University of Massachusetts at Boston. Before working in the device and biopharmaceutical industry, Manny served in the United States Air Force for 6 years as a Staff Sergeant.

• Small Biopharma Strategies
• Site Engagement & Enablement

Andrew (Andy) Lee is Senior Vice President and Head, Global Clinical Trial Operations (GCTO) at Merck. In this role, Andy leads and manages all operations related to the conduct of Merck clinical trials, with particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed, and quality standards. Andy is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems, and processes used in clinical trial executions. Andy joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO), and Head of the CSO Clinical Operations Cluster. In addition to directing the CSO, Andy led the integration of Sanofi with Genzyme, where he had been Senior Vice President, Global Clinical Operations. Earlier in his career, he spent more than 16 years in a range of positions of increasing responsibility at Pfizer. Andy holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc., a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies. He received his M.S. in Bioenergetics and Physiology from Ball State University in Indiana, and two undergraduate degrees from Rhodes University in South Africa.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Arlene Lee is a Director of Product Management for Data Quality and Risk Management solutions at Medidata, where she leverages her in-depth industry experience to advance innovative data quality and centralized monitoring systems. Prior to joining Medidata, Arlene brought over 23 years of experience in the pharmaceutical industry, with more than 17 years in Clinical Data Management and Centralized Monitoring across CRO, pharmaceutical, and biotech sectors. She has led the execution of Phase I-IV clinical trials across multiple therapeutic areas, with particular expertise in oncology and vaccines. Arlene has also been instrumental in establishing data management practices and advancing data quality solutions for global studies. She holds a Bachelor of Science degree in Chemistry from the University of Missouri - Columbia.

• Quality & Monitoring

Disa has 15+ years of experience working in technology and innovation, especially in the pharmaceutical industry. She is the Head of Integrated Clinical and Operational Analytics at Johnson & Johnson. She was previously at UCB as the Head of Innovation and held other leadership roles. Prior to joining the pharma, she was a co-founder of an IT company. She has an EMBA and B.S. in Pharmaceutical Chemistry. In 2017, Disa started a consortium, a cross-industry collaboration on blockchain via PhUSE. She was awarded Top 100 Women in Technology, Financial Times' top 100 most influential BAME Leader, and featured on the cover of CIO Look celebrating Women in Tech 2019. Recently, she co-authored a book titled 'Digital Health and Patient Data, Empowering Patients in the Healthcare Ecosystem'. Her passion is closing the gap for patients with unmet needs and exploring the right digital capabilities to accelerate the implementation of end-to-end patient solution.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Dr. Susan M. Leister serves as the Vice President of Quality and Compliance at Technical Resources International Inc. and Senior Trainer at Barnett International with over 25 years of experience in the pharmaceutical, biotech, and medical device industry. She has a Bachelor’s Degree in Biochemistry and Molecular Biology, an MBA, a Doctorate in Organization and Management with a focus in Leadership, and holds certifications from ASQ as a Certified Quality Auditor and a Six Sigma Black Belt. Dr. Leister has broad experience in GCP, GLP, and cGMP. She has led numerous regulatory inspections and built several quality management systems from the ground up. In addition, she has led and supported numerous sponsor and site regulatory agency inspections including FDA, EMA, Health Canada, MHRA, PMDA, and MFDS. She has obtained CE marking for medical devices and achieved both ISO 9001 and ISO 13485 certification for various organizations. She previously served her local ASQ Section 509 as the Section Chair. Dr. Leister has received several Merit Awards from the National Institute of Allergy and Infectious Disease Institute as well as the National Cancer Institute. Dr. Leister is a seasoned speaker covering global platforms on a variety of topics from quality risk management, quality tools, and inspection readiness.

• Risk-Based Quality Management for Clinical Trials: Implementing ICH E6 R3 Requirements

Dr. Steve Lesser, PhD, serves as the Vice President of Growth for Clinical Trial Solutions at Optum Life Sciences. With a robust career spanning over two decades, Steve has dedicated himself to the advancement of the clinical trial industry through application of innovative eClinical and data solutions. His extensive experience includes pivotal leadership roles at innovative, notable organizations such as Pluto Health, Medable, Medidata, INC Research (now Syneos), and IBM Life Sciences. In each position, Steve's primary focus has been collaborating with customers and partners to fundamentally enhance clinical trial processes and outcomes.

Holding an MS and PhD in Neurobiology from Duke University, Steve's academic background equips him with a deep understanding of the scientific and technical complexities inherent in clinical trials.

• Data

No bio available.

• Outsourcing

Patrick is the Chief Technology Officer at Faro Health, applying large language models and other forms of AI to optimize clinical trial development. Previously he was co-founder of Earthshot Labs, an NSF-funded deep tech company applying geospatial AI to predicting tropical ecosystem growth and carbon financing. Previously Patrick was CTO of Two Sigma's $4B AUM Private Investments division, pioneering the application of AI, data science, and alternative data to private equity and venture investing. Earlier Patrick spent 11 years at Google in engineering leadership positions including the Google Duplex conversational AI system. Patrick was also a founding employee and SVP Engineering at an early E-Commerce platform that IPOed in 1999.

• AI for Clinical Trials

Carrie Lewis is the Executive Director of Clinical Program Optimization at Endo, since June 2020. Carrie manages multiple teams of people to implement industry standard processes and practices across the organization to prepare Endo for advancement and expansion in both domestic and global clinical programs. Prior to Endo, Carrie was the Director of Project Delivery at PRA Health Sciences overseeing global clinical studies and operational strategy of new bids. Carrie has over 20 years of industry experience, holding various high level roles in clinical operations across both Branded and Generic programs and has experience working with academia, clinical sites, CROs and Pharmaceutical companies. Carrie has a BA in Psychology from West Virginia University and a MS in Clinical Research Administration from George Washington University.

• Budgeting & Resources
• Small Biopharma Strategies
• Outsourcing

April brings 25 years of experience in clinical R&D, demonstrating a proven track record of leading global teams to innovate and disrupt clinical trial operations. She has played a pivotal role in major transformational initiatives, including the Quintiles/IMS merger and GSK’s “Future Ready” initiative. Currently, April is the Senior Director of Innovative Health at Johnson & Johnson Innovative Medicine. In this role, she oversees the introduction, testing, development, and scaled delivery of novel capabilities, processes, and solutions aimed at enhancing patient and site experiences, increasing operational efficiencies, and setting new standards of excellence.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Micah has 20 years of experience in the biopharma industry. He is an Executive Director at Cambridge Healthtech Institute (CHI) where he is a producer, content developer, and facilitator of the Summit for Clinical Ops Executives (SCOPE), the leading event in the US and Europe for biopharmaceutical industry executives focused on driving innovation in clinical trials and digital health. On a daily basis, he builds a broad community of clinical research stakeholders and industry thought leaders, performs market research, and ascertains ever-changing industry trends in clinical trial optimization, clinical innovation, patient recruitment, digital health, drug development, clinical trial technology, and population health. He is also the Co-founder and Vice President of Community and Business Development of ClinEco. ClinEco unites sponsors, CROs, service providers, and sites on the world's first B2B global clinical trial marketplace so each can expand clinical partnerships. SCOPE and ClinEco are owned by Cambridge Healthtech Institute (CHI). Please join our SCOPE and ClinEco communities! https://clineco.io/; www.SCOPEsummit.com; www.SCOPEsummiteurope.com

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Holger Liebig is an Executive Director, Partnership Center of Excellence at Parexel. In his role, Holger creates infrastructure and intellectual property to support Parexel’s Strategic Partnerships. He is an active member of the core partnership teams including involvement in both internal and external governance, KPI definition, change management and process alignment. Holger is a certified Lean Six Sigma Black Belt with 33 years of industry experience. He worked on Phase I-III clinical research in various positions. This included line-management of geographically disparate project management groups and various roles with accountability for operational processes and systems. Holger is also responsible for the general management of Belgium as a country within Parexel.

• Outsourcing

Stacey Limauro, Executive Director of Clinical Operations at Deciphera Pharmaceuticals, has over 25 years of industry experience across all Phases of clinical development in both small and large Pharma organizations. In her current role, she provides leadership and oversight for the entire clinical development operations team and portfolio at Deciphera, including contributing to the operational strategy and implementation of process development and improvement within the department. One of Stacey’s most influential accomplishments was leading the successful approval of Deciphera’s first drug, QUINLOCK in 2020 for the treatment of GIST. She enjoys working with high-performing cross-functional teams to bring therapeutic treatments to patients in need. She received her BS in Chemistry from Trinity College in CT, and an MS in Biochemistry from Boston College in MA.

• Outsourcing

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is the founder of Clinical Innovation Partners, working as an advisor and board member with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig is also the Co-Chair for the Decentralized Trials & Research Alliance, the leading non-profit collaboration focused exclusively on improving access for research participation. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Previously Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures. He has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Robert Loll is SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies. Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.

• Recruitment & Engagement

Rana Lonnen is a healthcare technology investor, entrepreneur, and molecular biologist. At Novartis, she leads strategic investments in technology companies, on a mission to transform the healthcare ecosystem and make positive impact on people’s lives. Previously, Rana was Head of Preclinical Development at a UK biotech, Auspherix; investment consultant to IP Group in London; Founder and CSO of a UK-based Biotech, Axendos therapeutics. Prior to this, she was a Wellcome Trust-backed principal investigator in drug discovery in the field of Infection, Immunity, and Inflammation, author and inventor on high impact peer-reviewed publications and patents; before this, Rana worked at Bristol-Myers Squibb, in sales and marketing. Rana holds a PhD in molecular biology and an MBA from Imperial College London. She personally cares about equitable healthcare, social justice, sustainability, and the future of antimicrobial resistance. In her downtime, Rana likes to make culinary experiments, be in nature, and read. Rana is a board observer at Aktana, Cota Healthcare, H1 Insights, Koneksa, Mekonos, NuvoAir, and Dopavision. She is based out of Basel, Switzerland.

• Clinical Trial Venture, Innovation & Partnering

Gary is a recognized industry expert with a long record of achieving success. Gary has a long track record of successful launching, and running new businesses, managing a venture capital fund, leading transformative initiatives at Fortune 50 companies. He is a CPA, CGMA, CITP, and earned a BS from Washington University in St. Louis and an MBA from the Harvard Business School.

• AI for Clinical Trials

As the leader of Avoca’s integrated consulting and research solutions, Cristin MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has over 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management.

• Feasibility & Study Start-Up

With 20 years of experience in managing clinical trials at large Pharma, Biotech and CRO companies, Andrew Mackinnon, Executive GM, Customer Value at Medable, leverages his broad operational expertise to improve how the deployment of modern, digitally enabled clinical trials are utilized. From his involvement in one of the earliest deployments of decentralized methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on both sites and patients.

• Decentralized & Hybrid

Dr. Subha Madhavan is a dynamic and results-driven leader with a strong track record of excellence in organizations that operate in the nexus of science, technology and business. She is a world-class leader in Ai/ML, Drug R&D, Precision Medicine, Digital Health, Data Science & Analytics, Bioinformatics, Product development, Clinical informatics and Health IT. She and her team were responsible for initiation, design and execution of several large national and international clinical research programs including Cancer Moonshot, TCGA, CPTAC and Human Cell Atlas. In her role as the Founding Director of the Innovation Center for Biomedical Informatics at Georgetown, she developed a workforce of over 25 employees, to include staff scientists, health IT, and operations personnel with full P&L responsibility for the business center and its R&D team. She has initiated and successfully directed several productive research and development programs at the Lombardi Comprehensive Cancer Center, MedStar hospital network, FDA, NCI and industry. She was co-leader of the FDA Center for Excellence in Regulatory Science at Georgetown and worked with the Oncology Center for Excellence, Vaccines and related biological products, and Office of the Chief Scientist. As an industry advisor, she advices biopharma, federal, academic clients develop organization-wide R&D, data science and digital health strategy.

• AI for Clinical Trials
• Data

Courtney Maguire is a clinical research professional with more than 17 years of experience. She has worked in various pharmaceutical and medical device companies ranging from small start-ups to global 30,000+ employee organizations with roles including Clinical Project Manager, Clinical/Regulatory Affairs Manager, and to most recently the Head of Clinical Project Management. In her current role, she is responsible for all Clinical Project Managers and their associated teams in China, Europe, and the US. She oversees management of all Phase I to Phase IV studies in Aesthetic and Dermatological indications.

• Small Biopharma Strategies

Marcin Makowski is the Head of Centralized Monitoring and Data Analytics at GSK. Previously Marcin held similar positions at AstraZeneca and UCB. Last 10 years of Marcin’s career was revolving around establishing and improving Risk Based Monitoring models including centralized monitoring and quality tolerance limits. Marcin holds MD and PhD degrees from the Warsaw Medical University.

• Quality & Monitoring

Dr. Malikova is an Assistant Professor of Surgery at Boston University, School of Medicine, and an Executive Director of Research at the Department of Surgery at Boston Medical Center. Dr. Malikova has PhD in Biochemistry with strong background in biomedical sciences. She also holds a Master’s Degree in Clinical Investigation and Master’s of Business Administration in Health Sector Management from Boston University. She has over 18 years of experience in the biomedical product R&D, clinical development, operations and regulatory compliance fields; with the past 11 years on executive level. In her current role as Executive Director, Dr. Malikova macro-manages research programs in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations and compliance, strategic planning and execution oversight of clinical trials; safety and risk management. She is a member of International Society of Pharmacovigilance (ISoP), and currently serves as the Vice-President of NASoP.

• Budgeting & Resources

Dr. Paul Mancinelli is the Chief Technology Officer of WCG where he leads technology overall, including infrastructure, software engineering, and application development across the organization to support WCG’s strategy and enhance productivity, efficiency, and synergy throughout the enterprise. Paul previously served as Cigna's Chief Data and Analytics Engineering Officer where he was responsible for Cigna's enterprise authoritative data assets as well as the advanced analytics ecosystem and reporting solutions. Under Paul’s leadership, the Data & Analytics Engineering team was a catalyst for the use of Big Data, Machine Learning and Open Source technologies in support of Cigna’s Personalization and Affordability strategies. Paul also served as Vice President of IT Data and Analytics leading Cigna’s Data and Analytics software engineering team and was Informatics Senior Director leading Information Management in IT since starting at Cigna in 2014. He also served as a board member of the Gartner Data & Analytics Research Board. Prior to joining Cigna, Paul served as Chief Technology Officer at CoreOne Technologies in New York, where he was responsible for enterprise software development, technical support, operations, corporate IT, and information security. Prior to that, Paul served as Global Head, Research and Development Data/Systems/Tradebook at Bloomberg L.P where he worked for more than 16 years. Paul holds a BS in Physics from Rensselaer Polytechnic Institute and a PhD in Astrophysics from the State University of New York Stony Brook.

• Data

Data management professional with over 25 years' experience managing oncology clinical trials from ph1 to phIV as well as registrational clinical research collaboration studies.

• Data

Jean-Claude Marshall, MSc., PhD, currently serves as the Head of Clinical Biomarkers at Moderna. His group has responsibilities for all the strategy and implementation surrounding clinical biomarker assays to support programs across all therapeutic areas at Moderna. Previously he served as the head of the regulated Clinical Biomarker Laboratories in Early Clinical Development (ECD), at Pfizer. Before that he led the Clinical Genetics and Biospecimens group for Pfizer, and prior to that headed the CLIA certified Pharmacogenomics lab. Prior to joining Pfizer he served as the laboratory manager for a CLIA certified sequencing laboratory in Baltimore. Jean-Claude’s academic research was in pre-clinical drug and biomarker discovery in metastatic breast cancer at the NCI and uveal melanoma during his PhD at McGill University.

• Biomarkers & Precision Medicine Trials
• Clinical Supply & Logistics

Brian joined AbbVie in 2018 as the head of the newly formed RAIDERS team within Research & Development’s Information Research division, focused on accelerating, scaling, and amplifying the work of AbbVie’s R&D community using Artificial Intelligence technologies like machine learning, deep learning, graph computation, and cognitive computing. Brian is a part of the leadership team building and directing the AbbVie R&D Convergence Hub (ARCH) as part of the R&D Convergence initiative and a member of the ACOS Scientific Innovation Council. Brian came to AbbVie after spending five years in technology consulting across many industries, and over a decade of additional experience before that working in trading and financial markets technology. During his consulting time, Brian was the architect of the United States’ Common Securitization Platform and the technology founder of Publicis.Sapient’s AI practice. While his primary focus is AI technologies, he was also a co-founder of the QuPharm quantum computing community and the Pistoia/QED-C Quantum Community of Interest. He is a frequent presenter at conferences on topics as diverse as optical networking, quantum computing, blockchain, cognitive architecture, and other emerging technologies that are all part of digital transformation. Brian holds a B.S. degree in Computer and Cognitive Science from Alma College and a M.S in Computer Science from the University of Chicago. He is a board member for the Chicago Innovative Executives League and for the Mundelein High School Business Incubator program. He has been involved with the Creative Destruction Lab at the University of Toronto’s Rotman School and as a panelist/reviewer for the National Science Foundation Secure and Trusted Cyberspace grant division. Brian lives in Lake Bluff, Illinois with his wife and four children.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Craig is a deeply experienced executive, founder, board director, and advisor to biotech, pharma, health tech, and healthcare organizations. He has worked extensively with companies advancing novel technologies and treatment modalities including genomic sequencing, mRNA, gene editing, and the first approved gene therapy. Craig’s focus in emerging innovations and desire to make an impact in areas of high unmet need led to a particular emphasis in rare disease-including serving as CEO of Global Genes, a leading non-profit that brings together patient groups, research institutions, and industry to drive innovation across rare diseases. He was previously a Global Principal with Ogilvy Consulting and, prior to that, CEO of Ogilvy’s Feinstein Kean Healthcare. He’s held leadership positions with firms based in Cambridge, MA, Washington, D.C., New York, and Brussels, Belgium. Craig is a frequent commentator and panelist on key issues affecting patients and influencing health innovation.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Steven Martin is the Vice President of Product Management and Strategy at WCG. In this role, he leads the development of the product portfolio, identifies market opportunities, defines product-level strategies, and introduces modern product development processes across the organization. Steven brings over 20 years of experience in medical device and MedTech product management, marketing, and sales, spanning clinical trials, healthcare, and medical devices. Prior to joining WCG, he held positions of increasing responsibility at Medable, ZS Consulting, and Philips.

• Feasibility & Study Start-Up

Brian is an experienced life sciences investor who focuses on early to mid-stage companies. Prior to joining Norwest, Brian worked at Blackstone Life Sciences, where he helped lead over $1.5B of investments across biotech, medical devices, and diagnostics. He was a Board Observer or Alliance Committee Member at 5 companies, working closely with management teams on clinical trials, FDA approval process, and commercial strategy. Brian was previously an Engagement Manager at McKinsey & Company, where he advised companies across the healthcare industry. Brian has a medical degree from Stanford and MBA from Harvard. His research on prostate cancer, diabetic macular edema, and patient safety has been published in multiple peer-review journals.

• Clinical Trial Venture, Innovation & Partnering

Lydia Matombo is a Director, Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role, she establishes technical and cross-functional business needs, aligns with stakeholders, and oversees data integration activities between Merck and Suppliers resulting in the build-out, testing, implementation, and maintenance of business-critical Key Risk Indicators (KRI)s in support of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) risk-based initiative to further the organization’s risk-based quality management (RBQM) approach through advanced analytics. She ensures that supplier systems are ready and maintained throughout the study life cycle to enable the execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis, and Central Statistical Analytics. This enables each Clinical Trial Team to support the effective identification of important study issues that require monitoring, management, and adaptation of study plans. Lydia collaborates with other functions, Quality Assurance, Ethics’, and compliance, to ensure that systems and any outlined processes are compliant and Inspection ready. BACKGROUND Lydia has more than 20 years of clinical database management expertise, leading end-to-end clinical trial conduct and execution, strategic implementation of quality-by-design data collection systems, building and leading high-performing teams across many therapeutic areas, and is now in the role of Risk Systems Data Integration Lead. Lydia is committed to creating a diverse and inclusive work environment. She is a member of the GCTO’s Diversity, Equality, and Inclusion Ambassadors and Merck’s League of Employees of African Descent (LEAD). Lydia holds a BSN (Honors) from Fairleigh Dickinson University in New Jersey, is a Registered Nurse, and is Project Management Professional (PMP) certified.

• Quality & Monitoring

Marland May is the Associate Director of Clinical Trial Diversity & Patient Inclusion at AbbVie. He specializes in supporting territory development and new clinical investigator acquisition strategies. Through his efforts, AbbVie has established a streamlined process for identifying, training, and onboarding new investigators across the globe. Marland has over a decade of experience in the pharmaceutical industry, with leadership roles in global site management, clinical study leadership, and diversity and patient inclusion. He is committed to paving the way for a more equitable healthcare ecosystem for all. Marland first started his career in the mental health field as a clinical therapist and has worked at all levels of education, from elementary to college. He is an advocate for ensuring diverse perspectives are reflected in drug development and promoting inclusivity in clinical research.

• Feasibility & Study Start-Up

No bio available.

• AI for Clinical Trials

Mark McClellan, PhD, is Director and Robert J. Margolis, MD, Professor of Business, Medicine and Policy at the Duke-Margolis Institute for Health Policy at Duke University. He is a physician-economist who focuses on quality and value in health care, including payment reform, real-world evidence and more effective drug and device innovation. At the center of the nation’s efforts to combat the COVID-19 pandemic, the author of COVID-19 response roadmap, and co-author of a comprehensive set health policy strategies for COVID vaccines, testing, and treatments, Dr. McClellan and his Duke-Margolis colleagues are now focused on health policy strategies and solutions to advance the resilience and interconnectedness of 21st Century public health and health care. Mark is a former administrator of the Centers for Medicare & Medicaid Services and former commissioner of the US Food and Drug Administration, where he developed and implemented major reforms in health policy. Dr. McClellan is an independent board member on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and serves as an advisor for Arsenal Capital Group, Blackstone Life Sciences.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

In the digital world with shortened attention spans and demand for feel-good content, I have an empathetic approach to creating swipe-stopping collateral to cut through the clutter. During my 12+ year career in social media, spanning positions at the Cystic Fibrosis Foundation, Memorial Sloan Kettering Cancer Center, and New York Blood Center Enterprises, I find the opportunity to connect with patients in the online community a privilege. The patient voice and reported outcomes are vital to improving healthcare across the board, and meeting those patients where they are, often in the social space, is essential to all improvements and innovation.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Amy McCormick is a Senior Manager, Global Trial Optimization - Patient Engagement at Regeneron. In her role, Amy leads the development of patient engagement strategies for clinical trials ensuring the patient voice is considered in strategic study planning and execution. She has more than 12 years of experience in the pharmaceutical industry. Prior to her work in pharmaceuticals, Amy worked in various capacities as a Registered Nurse. While working as a Pediatric Bone Marrow Transplant Nurse, she cared for many patients who participated in clinical trials. This opened her eyes to a whole new career path outside of bedside nursing. Shortly thereafter, she began working as a Clinical Research Nurse at a US Oncology site in Arizona. Amy’s passion for oncology clinical trials and patient engagement grew rapidly with a goal to ensure all patients understood their treatment options, including investigational treatments. In pursuit of this passion, Amy eventually transitioned from working directly with patients to working "behind the scenes" at Eli Lilly, first as an Oncology Pharmaceutical Project Manager and later as an Associate Director - Patient & Site Experience before eventually joining Regeneron in 2022. Her work in Patient Engagement at Regeneron supports multiple therapeutic areas including oncology, with a special focus on diversity, equity, and inclusion (DEI).

• Feasibility & Study Start-Up
• Site Engagement & Enablement

Tom has over 20 years of industry experience in various roles within clinical trial supply and execution. Nearly half of this time has focused on the clinical supply chain-including raw materials, investigational supplies, lab kits, and biospecimens. When not concentrating on optimizing global logistics, Tom enjoys spending time with his family, boating and music.

• Biomarkers & Precision Medicine Trials
• Clinical Supply & Logistics

Kelly McKee serves as vice president of Decentralized Clinical Trials (DCTs) in Patient Cloud at Medidata. She is responsible for creating new solutions to engage clinical trial patients pre-trial, in-trial, and post-trial, as well as developing patient and product communications around all Patient Cloud Products for decentralized and hybrid clinical trials. Kelly is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions across organizations including innovations in clinical trial awareness, access, and improvements in patient experiences. Prior to Medidata, she spent over 20 years within clinical operations and patient recruitment at top-tier pharmaceutical companies including Sanofi, Merck, Eli Lilly and Co., and Vertex Pharmaceuticals. Kelly is passionate about celebrating the role that clinical trial participants bring in making new medicines and vaccines possible and was named one of Life Sci Voice’s Top Industry Leaders in 2022, PharmaVoice’s 100 Most Inspiring Leaders in 2020, Centerwatch’s Top 20 Innovators of 2018, and PharmaTimes’ Clinical Researcher of the Year, Clinical Research Teams, in 2012.

• AI for Clinical Trials
• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply & Logistics
• Budgeting & Resources
• Data
• Small Biopharma Strategies
• Outsourcing
• Patient-Centric Trial Design & Inclusive Research
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Site Engagement & Enablement
• Digital Health Technologies

Ms. McNeil is a Director, Regulatory Policy and Intelligence, at AbbVie. She has more than 25 years of Regulatory Affairs experience gained from a variety of roles in both the pharmaceutical industry and at the United States Food and Drug Administration. Currently, Ms. McNeil supports regulatory activities for AbbVie by identifying, analyzing, and commenting on proposed regulatory policies, and ensuring that appropriate AbbVie personnel are aware of emerging and final regulatory policies; in addition, she provides regulatory advice and strategic support to global project teams. Melodi has a Bachelor’s degree in Pharmacy and a Master’s degree in Management, with an emphasis in health care administration.

• Real World Evidence

Proven C-level leader with deep experience running global Fortune 500, start-up, and emerging pharmaceutical businesses, possessing the unique ability to blend, build, and strengthen performance from the ground up. Broad understanding of market strategy development within clinically diverse programs that achieve meaningful product differentiation. Significant accomplishments creating profitable business development and investment community partnerships within the C-suite. Strategy/Vision: Deep start-up, transaction and capital raising success through the establishment and guidance of Adiso, Adastra, and Churchill; creation and execution of clinical development and business strategy to lead the companies from formation; with the identification and advancement of multiple first-in-class drug product assets; negotiated and managed lucrative business development partnerships; business development and licensing with Baxalta, transaction to Cothera Bioscience and Sun Pharma FZE. Change Leadership: Adaptable and insightful leader instrumental in the cultural and team transformation of Onconova from a private 16-person medicinal chemistry company into a commercially prepared 67-employee Nasdaq listed company executing a successful Initial Public Offering (IPO). Commercial Innovation: Directly involved in numerous successful product development/co-development programs and commercial launches within oncology and specialty therapeutics. Demonstrated ability to employ unique approaches to value pricing and contracting within competitive markets. Execution/Implementation: Ability to visualize and articulate both long-term and near-term goals while promoting excellence through organization design, leverage of key functional areas, with clear decision making and process application. Global M&A: Marshalled Churchill Pharma through nine-month transaction process and successful sale of assets prior to product approval by FDA, while simultaneously preparing for a Churchill launch. While at Onconova, initiated and negotiated two separate license agreements for Japan/Korea and Europe

• Budgeting & Resources
• Small Biopharma Strategies
• Outsourcing

Michael works in the Cell and Gene Therapy Group at ZS focusing on designing a seamless C> treatment experience in order to define and shape the future commercialization of products. Working cross-functionally across site operations, supply chain, clinical and commercial operations, Michael leads the process of streamlining C> product delivery to provide a best-in-class customer and patient experience. By facilitating, supporting, and simplifying the end-to-end operations of C> products in a clinical trial setting, Michael prepares customers for commercial planning and launch when bringing transformative cell and gene therapies to market. Michael has spent 10+ years in the cell and gene therapy industry helping C> organizations operationalize products, build global site footprints, develop supply chain strategies, lead patient and customer engagement, and prepare for commercialization and product launch. Working for cell therapy biotech startups as well as global pharmaceutical companies such as Adaptimmune, Immatics and GSK, Michael has unique hands-on experience helping companies shape the clinical trial experience with C> products. With his rare and versatile experience, Michael has pioneered innovative C>-specific roles, such as the Cell Therapy Patient & Site Operations Lead, serving as a cross-functional C> subject matter expert.

• Clinical Supply & Logistics

No bio available.

• Biomarkers & Precision Medicine Trials

Mary Lynn Mercado is the Global Head of Protocol Delivery and US Site Head for Regulatory Writing and Submissions at Novartis. She has 12 years of research experience in academic and pharmaceutical settings and 15 years of experience in the Regulatory Writing and Clinical Operations spaces. For TransCelerate BioPharma, she is the co-workstream lead for the TransCelerate Clinical Content & Reuse initiative and supports Protocol Digitization efforts across initiatives. She is also the Deputy Topic Lead for PhRMA on the ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) Expert Working Group. Mary Lynn received her Bachelor of Science from Brown University and her PhD from Rutgers University.

• AI for Clinical Trials
• Data
• Real World Evidence

Over 24 years of leadership experience in clinical operations, project management and medical affairs which includes clinical development strategy, protocol design, training and development, vendor management, and stakeholder relationships. Therapeutic experience includes pulmonary, rare disease, central nervous system, dermatology, gastrointestinal, nephrology and oncology.

• Budgeting & Resources
• Small Biopharma Strategies
• Outsourcing