Digitalization of Clinical Development
臨床開発のデジタル化
Collect and Transform Raw Data into Actionable Insights to Accelerate and Improve Clinical Outcomes
生データを収集、実用的なインサイトに変換し、臨床転帰を加速かつ改善
2025年4月2日〜4日 米国東部標準時（EDT）
4月2日（水）
Registration Open8:00 am
Recommended Pre-Conference Workshops and Symposia*9:00 am
On Wednesday, April 2, 2025, Cambridge Healthtech Institute is pleased to offer five pre-conference Workshops scheduled across two time slots (9:00 am–12:00 pm and 1:15–4:15 pm) and three Symposia from 9:00 am–4:20 pm. All are designed to be instructional, interactive, and provide in-depth information on a specific topic. They allow for one-on-one interaction and provide a great way to explain more technical aspects that would otherwise not be covered during the main conference tracks that take place Thursday–Friday.
*Separate registration required. See details on the Symposia here and details on the Workshops here.
Talk Title to be AnnouncedFrom Bytes to Breakthroughs: Generative AI Driving the Future of Life Sciences and Healthcare
Subha Madhaven, Vice President and Head, AI/ML, Quantitative and Digital Sciences, Global Metrics and Data Management, Pfizer Inc.
Generative AI has the potential to transform life sciences and deliver unprecedented insights, automation, and efficiency. But is it? This keynote panel brings together leaders from biopharma, healthcare, and emerging tech who are leveraging AI to advance drug discovery, diagnostics, and patient care. Panelists will share their own case studies and real-world applications and discuss how they’ve tackled challenges—both technical and cultural. Look beyond the hype curve to see how this technology is really being used now and where the next opportunities lie.
Welcome Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)6:10 pm
The Bio-IT Kickoff Reception is a reunion—reconnect with friends, explore cutting-edge research, and celebrate innovation! Enjoy poster presentations, networking, and vote for the Best of Show and Poster awards.
Close of Day7:25 pm
4月3日（木）
Registration Open7:00 am
Talk Title to be AnnouncedAI-POWERED PLATFORMS IN DRUG DISCOVERY: TACKLING ANTIBIOTIC RESISTANCE AND AGING THERAPEUTICS
創薬におけるAI活用のプラットフォーム：抗生剤耐性と老化治療への取り組み
Deep Learning for Antibiotic Discovery
James J. Collins, PhD, Termeer Professor, Medical Engineering & Science, Massachusetts Institute of Technology
In this presentation, we highlight the Antibiotics-AI Project, which is a multi-disciplinary, innovative research program that is leveraging MIT's strengths in artificial intelligence, bioengineering, and the life sciences to discover and design novel classes of antibiotics. The Antibiotics-AI Project is focused on developing, integrating, and implementing deep learning models and chemogenomic screening approaches: (1) to predict novel antibiotics from expansive chemical libraries with diverse properties, (2) to design de novo novel antibiotics based on learned structural and functional properties of existing and newly discovered antibiotics, and (3) to identify, using explainable deep learning models, the chemical structures and molecular mechanisms underlying the newly discovered and/or designed antibiotics. With these deep learning approaches, we are utilizing multi-scale computation to embrace and harness the complexity of biology and chemistry, so as to discover, design, and develop new classes of antibiotics, up through preclinical studies. Our platform has been designed so that it can be utilized and applied in a rapid fashion to emerging and re-emerging bacterial pathogens, including multidrug-resistant (MDR) bacteria and extensively drug-resistant (XDR) bacteria.
Coffee Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)9:30 am
Start your morning with coffee, connections, and cutting-edge research! Enjoy poster presentations, network in the Exhibit Hall, vote for awards, and a chance at a fabulous raffle prize!
Organizer's Welcome Remarks10:15 am
HARNESSING THE POWER OF DATA AND AI FOR CLINICAL DEVELOPMENT
臨床開発向けデータとAIの活用
Chairperson's Remarks (Sponsorship Opportunity Available)10:20 am
Data—Your Second Language
Frank Dullweber, PhD, Digitalization Professional, Center of Excellence for Digital Transformation, Boehringer Ingelheim Pharma GmbH & Co. KG
Victoria A. Gamerman, PhD, Global Head of Data Governance, Boehringer Ingelheim Pharmaceuticals, Inc.
The digital transformation of Clinical Development goes beyond simple digital optimization and combines people, processes, and technology with the following core tasks: Treating data as an asset, fostering a data-driven mindset, and driving digital innovation. Artificial intelligence (AI) will not replace people, but will support them by combining human creativity with the data processing power of AI to create innovative solutions. The future of clinical development lies in our ability to harness the power of data and AI while maintaining our human-centered approach. This requires an organizational enablement through data-driven stories, trainings, and coaching.
Structured Content Authoring of Clinical Documents Using GenAI
Mark F. Ciaccio, PhD, Senior Biology Data Scientist, Platform Informatics & Knowledge Management, AbbVie, Inc.
Rapid progress in genAI has enabled advanced structured content authoring of diverse clinical, regulatory, and safety documents. We created an enterprise-wide web application to autogenerate whole documents such as
the Clinical Study Report, Informed Consent Form, and Product Safety Update Report using an extensible content template. The application can create whole documents in minutes by synthesizing and adding each section
according to the template including AI-generated text, tables, images, and diagrams.
Optimizing Trial Study Design: GenAI-Enhanced Protocol Intelligence Tool
Ophelia Mok, Senior Manager, Business Analytics and Insights, Global Development Organization, Takeda Pharmaceuticals, Inc.
We used a semi-automated, GenAI-powered Protocol Schedule of Activities (SOA) table analyzer to evaluate clinical trial study burden. This tool provides study teams with competitor intelligence and promotes early discussions.
It delivers actionable insights on patient burden related to protocol design, with the goal of minimizing protocol complexity and reducing the need for amendments.
The Adoption and Implementation of AI and ML across Biopharmaceutical Companies
Mary Jo Lamberti, PhD, Director and Research Associate Professor, Tufts Center for the Study of Drug Development (CSDD)
The presentation will review where sponsors and CROs are deploying AI (artificial intelligence) and machine learning (ML) in clinical development based on a collaborative industry study. The presentation will examine
the challenges of implementation as well as those methods that can increase trust in AI/ML across organizations.
Presentation to be Announced (Sponsorship Opportunity Available)11:55 am
Session Break and Transition to Lunch12:55 pm
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own1:05 pm
Refreshment Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)1:35 pm
Bio-IT's hall is bigger than ever—one break won’t cut it! Enjoy dessert and coffee after lunch, explore booths and posters, vote for awards, and participate in our raffle for a chance to win a prize!
DIGITIZING CLINICAL RESEARCH
臨床研究のデジタル化
Chairperson's Remarks (Sponsorship Opportunity Available)2:25 pm
Enabling Digital Data Flow via Digitalized Protocol
Sriram Krishnamurthy, Associate Director, Global Development Solutions, Regeneron Pharmaceuticals, Inc.
In our presentation, we will discuss Regeneron’s approach towards digitalization of the study protocol and the schedule of events. We will explore the different strategies for protocol digitization and discuss how Regeneron
is piloting an approach that leverages assisted authoring capabilities for protocol digitization. We will delve into the business processes and technologies that drive the digitization and highlight the value proposition
of this approach.
Digitizing Clinical Research: IEEE-SA CTTMN's Technical Standards Framework
Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, CEO, 4Biosolutions Consulting (Sci/Clin/Reg Affairs) & Co-Chair, EEE-SA, Clinical Trial Technology Modernization Network (CTTMN)
The IEEE-SA CTTMN will discuss its work on five crucial technical standards to digitize clinical research: AI/ML, Risk-Based Assessment, Telehealth, Cybersecurity, and Hospitals at Home. These standards ensure consistency,
reliability, and interoperability, enhancing patient safety, data quality, and security. By addressing key areas, they pave the way for efficient, secure, and patient-centric trials. Join this talk to discover how these
groundbreaking standards will reshape clinical research and elevate your trials.
Med.ai HealthLink – a Multi-Tenant Data Solution to Enable Clinical Trial Tokenization
Med.ai HealthLink is a GxP-compliant, innovative multi-tenant data platform developed in-house by JnJ, which has facilitated over 10 tokenized trials for the company.
Presentation to be Announced (Sponsorship Opportunity Available)4:00 pm
Best of Show Awards Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)4:30 pm
Unwind with colleagues at our lively reception! Explore posters, vote for the best, network with exhibitors, enjoy a drink, and try to win a raffle prize. Celebrate Best of Show winners!
Close of Day5:45 pm
4月4日（金）
Registration Open7:00 am
Quick Bytes & Networking Breakfast—Lifted Rooftop Restaurant & Bar (Sponsorship Opportunity Available)7:00 am
Start your morning with ‘Quick Bytes & Networking’! Enjoy a cozy restaurant-style setting, quick bites, and speed networking. Connect, converse, and energize your Bio-IT experience before the plenary keynote!
Innovative Practices Awards: Excellence in Technological Innovation
Allison Proffitt, Editorial Director, Bio-IT World and Clinical Research News
The Innovative Practices Awards recognizes and celebrates technology innovation in the life sciences. Bio-IT World is currently accepting entries for the 2025 Innovative Practices Awards, a competition designed to recognize
partnerships and projects pushing our industry forward. Winners will be announced in mid-March 2025, recognized during the Friday, April 4 Plenary Keynote Program, and scheduled to give a podium presentation about
their project during the conference. For more details about the Awards and to submit an application, visit www.bioitworldexpo.com/innovativepractices.
Talk Title to be AnnouncedADVANCING DRUG DISCOVERY AND HEALTHCARE THROUGH DATA-DRIVEN INNOVATION: FROM GENOMICS TO THERAPEUTICS
ータドリブンのイノベーションによる創薬とヘルスケアの進歩：ゲノミクスから治療まで
Scaling Genomic Medicine: Transforming Newborn Screening through Informatics and Innovation
Robert C. Green, MD, MPH, Professor and Director of Genomes2People Research, Mass General Brigham, Broad Institute, Ariadne Labs and Harvard Medical School
The BabySeq Project has pioneered the integration of genomic sequencing into newborn and childhood screening, uncovering unexpected risk variants and transforming healthcare delivery. This keynote explores the groundbreaking
progress in genomic medicine, featuring real-world stories of families impacted by these discoveries. Learn about the informatics challenges and innovative solutions required to scale genomic screening for national
and global implementation, reshaping the future of precision medicine.
Unlocking the Power of Machine Learning and Data-at-Scale to Deliver with Speed the Best Therapeutic Candidates
Justin M. Scheer, PhD, Vice President In Silico Discovery & Head, Molecular Computational Team, Johnson & Johnson Innovative Medicine
The challenges of high costs, lengthy timelines, and significant attrition have prompted our industry to integrate AI/ML into all aspects of the business. This presentation highlights J&J's strategic investments
in AI/ML technologies to enhance the drug discovery processes, including molecule design and optimization. By investing in these technologies with a modality agnostic approach, J&J aims to tackle the hardest targets
in drug discovery, ultimately increasing the success rate of delivering better molecules faster.
Coffee Break in the Exhibit Hall with Poster Competition Winners Announced (Sponsorship Opportunity Available)9:45 am
Bio-IT is all about connections! Explore booths, award-winning posters, and network with clients, colleagues, and exhibitors. Grab coffee, build relationships, and stay for a chance to win a raffle prize!
Organizer's Remarks10:30 am
LEVERAGING TECHNOLOGIES TO DRIVE CLINICAL RESEARCH INNOVATION FORWARD
テクノロジーを活用し、臨床研究のイノベーションを推進
Chairperson's Remarks (Sponsorship Opportunity Available)10:35 am
Advanced Therapies Site Coordination and Logistics: Capabilities to Facilitate Patient Scheduling, Slot Management, and Logistics for Personalized Therapies Such as CAR T
CAR T therapies are the ultimate form of personalized medicine. This presentation will cover the unique challenges of running clinical trials, managing investigational supply, and the need for close coordination with
clinical trial sites from patient selection, slot reservation, and chain of identity/custody tracking. We'll review the technology components of a vein-to-vein capability, including a trial site front-end portal, slot
management capability, planning, and supply chain integration. We'll conclude by discussing opportunities for a broader set of advanced therapies.
The Future of Clinical Trials: Data-Driven Insights into Decentralized Solutions
Joan Chambers, Senior Consultant, Tufts Center for the Study of Drug Development
As clinical trials increasingly adopt decentralized clinical trial (DCT) solutions to improve patient accessibility, the Tufts CSDD-PACT Consortium has collected and analyzed data from 69 trials to assess the effectiveness
of various DCT methodologies. This presentation reveals key insights into the most frequently used DCT solutions and their impact on recruitment, retention, and cycle times, emphasizing the need for ongoing data collection
to optimize DCT implementation.
Patient Identification for Clinical Trials in Electronic Health Record Systems
Laszlo Vasko, Senior Director, Clinical Innovation R&D IT, Janssen Pharmaceuticals, Inc.
Patient recruitment into clinical trials continues to be the largest and costliest stumbling block in drug development. Certain therapies could significantly benefit from ways to flag patients in clinical care systems,
notifying site staff of opportunities to match patients to trials. This panel will discuss sponsor and healthcare institution perspectives on the opportunities and challenges of trying to tap into EHRs for patient
recruitment, as well as ideas for industry collaboration.
Presentation to be Announced (Sponsorship Opportunity Available)12:10 pm
Session Break and Transition to Lunch1:10 pm
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own1:20 pm
Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing (Sponsorship Opportunity Available)1:50 pm
Feeling tired? Recharge during the final Networking Exhibit Hall break! Visit booths, explore posters, connect with peers, and turn in your Game Cards for a chance to win a raffle prize.
DRIVING AI INNOVATION: BEST PRACTICES FOR IMPLEMENTATION IN BIOPHARMA
AIイノベーションの推進：バイオファーマにおける導入のベストプラクティス
Chairperson's Remarks (Sponsorship Opportunity Available)2:30 pm
Unlocking AI Potential: Best Practices for Implementation and Management
Petrina Kamya, PhD, Global Head of AI Platforms & Vice President, Insilico Medicine; President, Insilico Medicine Canada
As AI transforms drug discovery, development, and precision medicine, understanding the business operations behind these advancements is essential. This session will cover critical aspects such as AI tool selection, project
scoping, budget management, and prioritization amid evolving regulations. Gain insights from real-world case studies on successful AI deployment, with strategies to navigate regulatory risks while ensuring cost-effectiveness.
Join us for a dynamic discussion to harness AI’s full potential in life sciences innovation.
Close of Conference4:05 pm
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
データプラットフォーム・ストレージインフラ
データ管理
データサイエンス・アナリティクステクノロジー
ソフトウェアアプリケーション・サービス
AI/ML・モダンデータサイエンス向けクラウド
生成AI
創薬・医薬品開発向けAI
オンコロジー・精密医療・プレシジョンヘルス向けAI 
バイオインフォマティクス
製薬R&Dインフォマティクス
臨床開発のデジタル化
生成AIツール
デジタルバイオファーマ
ナレッジグラフ
