トレーニングセミナー | 21st Annual PEGS Boston Summit 2025 公式サイト

Cambridge Healthtech Instituteのトレーニングセミナーでは、学術的な理論や背景を幅広くカバーするとともに、実際のケーススタディ、遭遇した問題、適用されたソリューションを提供します。各トレーニングセミナーでは、正式な講義とインタラクティブディスカッションやアクティビティを組み合わせて、学習経験を最大限に高めることができます。経験豊富な講師が、現在の研究に適用可能なコンテンツに焦点を当て、この分野に不慣れな人にも重要なガイダンスを提供します。

トレーニングセミナーは、対面のみで提供
一貫性と集中できる学習環境を確保するため、
会議セッションとトレーニングセミナー間の移動は禁止されています。

Monday, May 12, 2025 8:30 am - 6:05 pm | Tuesday, May 13, 2025 8:30 am - 12:45 pm

TS3A: Introduction to Multispecific Antibodies: History, Engineering, and Application

Introduction to Multispecific Antibodies is an informative and practical guide to getting up to speed on critical aspects of multispecific antibody therapeutics. Topics will include historical successes, failures, and lessons learned. Specific practical instruction will span mechanisms of action, engineering, developability, regulatory considerations, and translational guidelines. Perspectives on ideal implementation of multispecifics as targeted and immunomodulatory approaches will be discussed.

Topics to be Covered:

A brief history of bispecific antibodies: 60 years of progress with critical advances and key pioneers
Bispecific applications and powerful mechanisms-of-action
Engineering bispecific antibodies:100 formats and counting
Bispecific-specific considerations in preclinical development and regulatory landscape
Developability, manufacturing, and analytical considerations
Clinical experience, translation, and regulatory approval
Current trends and future opportunities in regulating immune checkpoints, cell-based therapies, and personalized approaches

INSTRUCTOR BIOGRAPHIES:

G. Jonah Rainey, PhD, Associate Vice President, Eli Lilly and Company

Jonah Rainey holds a PhD in Biochemistry from Tufts University and completed postdoctoral training at the University of Wisconsin and the Salk Institute. He has engaged in discovery, research, and development of bispecific antibodies for more than 15 years. He is an inventor on several patents describing novel bispecific platforms and current clinical candidates that exploit these platforms as well as an author on almost 30 publications. Jonah contributed to research and early development leading to multiple clinical candidates from Phase I and through approved products and led many advanced preclinical programs in oncology, infectious disease, autoimmunity, and other therapeutic areas. Previous industry experience includes MacroGenics, MedImmune/AZ, Oriole Biotech, Gritstone Oncology, and Alivamab Discovery Services. Currently, Jonah is a Senior Director in Protein Science at Eli Lilly & Co.

TS7A: Introduction to Immunogenicity

This 1.5-day training seminar provides a practical, comprehensive overview of immunogenicity-the causes, how to assess, predict, and prevent, and what to do if you observe immunogenicity during preclinical, clinical, and post-market approval. The seminar begins by detailing the science behind immunogenicity, the latest international guidance, followed by assay and bioanalytical assessment strategies for traditional and emerging biologics. Other topics include predictive models, the role of AI/ML, and reporting immunogenicity.

TOPICS TO BE COVERED INCLUDE:

Part 1: Introduction to Immunology and Immunogenicity

What is immunogenicity?
Immunology and major mechanisms affecting immunogenicity
B cell development
Clinical consequences of ADA
Risk-based approach
Immunogenicity in the clinic Regulations and guidance governing immunogenicity

Part 2: Predictive Immunogenicity and Role of AI/ ML

Part 3: Clinical Considerations of Immunogenicity and Regulatory Expectations

Part 4: Assay Methodology and Approaches for Describing Immunogenicity in the Clinic

Assay methodologies
Comparison of different methods
Screening, confirmation
Characterization of anti-drug-antibodies
Cut-points Immunogenicity of complex biologics (e.g. multi-domain, biosimilars)
PK/PD and safety and efficacy-- as a measure
Immunogenicity in the clinic - how to report

INSTRUCTOR BIOGRAPHIES:

Chloé Ackaert, PhD, Senior Scientist, Immunogenicity, ImmunXperts, a Q2 Solutions Company

Chloé Ackaert is a pharmacist by training (Catholic University of Leuven 2009) and obtained her PhD at the University of Salzburg (Austria) for the research on the impact of nitration on the immunogenicity of birch pollen allergens in 2013. She first joined ImmunXperts in the start-up phase and continued academic research at the Free University of Brussels (2015-2018) working on the immunogenicity of Nanobodies. Afterwards, she joined ImmunXperts again where she is a senior scientist in the immunogenicity team, collaborating both on the client-based projects as well as on the continuous basic research projects to elucidate immunogenicity-related questions.

Sofie Pattijn, Founder & CTO, ImmunXperts, a Q2 Solutions Company

Sofie Pattijn, CTO and founder of ImmunXperts, has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development with a focus on functional assays for immunogenicity, immune oncology, and cell and gene therapy products. She has extensive hands-on lab experience and has managed and coached several in vitro teams over the last decade. From 2008 until 2013, she was Head of the in vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics in Belgium for over 15 years.

Bonnie Rup, PhD, Biotechnology Consultant, Bonnie Rup Consulting

Bonita Rup is a biopharmaceutical development consultant, providing expert advice on bioanalysis, immunogenicity risk assessment, and related regulatory strategy aspects of biopharmaceutical development. Previously she was Research Fellow and lead for the Immunogenicity Discipline at Pfizer, Assistant Vice President of Protein Bioanalytics in Wyeth, and held various positions directing development and application of immuno-ligand binding assay technologies for PK, immunogenicity and protein impurity analysis, and other aspects of biopharmaceutical development. During her career, she has been involved in multiple regulatory filings during preclinical, clinical development and marketing approval of biopharmaceutical products. She has been a member of AAPS, EIP, European IMI ABIRISK consortium, and Biosafe; with these organizations, she has been a co-author for multiple publications related to monitoring immunogenicity and bioanalysis of therapeutic proteins. Bonnie received her B.S. from University of Massachusetts, Amherst, Ph.D. from University of Texas, Austin, and conducted postdoctoral research at Duke University and University of Rochester, NY.

TS9A: Introduction to Protein Engineering

This course presents a comprehensive tutorial in the concepts, strategies, and latest tools of protein engineering applied to biotherapeutic research and development, particularly antibody-related products. The class is for scientists new to industry or working in support roles, academics, and protein scientists wanting a detailed update on the current state of the field.

What is protein engineering?
Tools and techniques
Engineering-by-design
Designed libraries, display technologies
Production and manufacturing
Improving manufacturing by protein engineering methods
Other protein modifications
Expression of antibodies and fragments for discovery and testing
Emerging molecule and product formats
Antibody-drug conjugates (ADCs)
AI/ML applications and limitations
Other emerging approaches

INSTRUCTOR BIOGRAPHIES:

David Bramhill, PhD, Founder, Bramhill Biological Consulting LLC

Dr. Bramhill has over 20 years’ experience in biologics, both in large biopharma and startup biotech companies. He has expertise in isolating and improving antibodies using phage display and other display systems and is an inventor on library design for small scaffolds and bi-specific formats. He also has experience in diverse expression systems for producing antibodies, antibody fragments and scaffolds. Additionally, Dr. Bramhill has extensive experience in ADC development including diverse chemical and biochemical conjugation methods. He has taught numerous technical courses for over 15 years at international conferences and served as a Key Opinion Leader for major BioPharma companies.

TS10A: Antibody Drug Discovery: From Target to Lead

At least 100 antibody therapies have been approved for the treatment of cancer, immune disorders, metabolic, cardiovascular, and infectious diseases, and among the top 20 bestselling prescription medicines in 2020, 14 are antibody-based. This trend will continue as about 50% of the new drugs in various stages of clinical development are antibodies. This course will review state-of-the-art concepts, methodologies, and current trends in therapeutic antibody discovery and development.

Topics to be covered include:

Different Sources of Antibodies

- Animals: mouse, rat, rabbit, chicken, llama, etc.

- Libraries: immune, synthetic, native, fully human, etc.

- B cells: memory B cells, plasma B cells, human, and animals

Antibody-Based Drug Modalities

- IgGs, IgA, IgM, Bites, nanobody, antibody fragments, etc.

- Naked antibody

- ADC

- Bispecific/multispecific

- CAR T

Antibody Engineering

- Affinity maturation

- Humanization

- Fc-engineering: half-life, immune effector function, etc.

Target Selection and Validation

Antibodies Targeting Complex Membrane Proteins

- GPCRs

- Ion channels

- Transporters and membrane-bound enzymes

Delivery of Antibodies

Crossing the Brain-Blood Barrier (BBB)

Case Studies

AI-based Protein and Antibody Design

INSTRUCTOR BIOGRAPHIES:

Zhiqiang An, PhD, Professor, Robert A. Welch Distinguished University Chair in Chemistry; Director, Texas Therapeutics Institute; Director, CPRIT Core for Antibody Drug Discovery; Vice President, Drug Discovery, University of Texas Health Science Center at Houston

Dr. Zhiqiang An is Professor of Molecular Medicine, the Robert A. Welch Distinguished University Chair in Chemistry, Director of the Texas Therapeutics Institute, and Vice President of Drug Discovery at the University of Texas Health Science Center at Houston. His laboratory focuses on antibody drug resistance mechanisms, biomarkers for therapeutic antibodies, and antibody drug discovery targeting human diseases. During the last five years, more than 12 novel antibody drug leads discovered in his laboratory were licensed to eight biotechnology companies, and six (6) have advanced to clinical trials for diseases ranging from acute myeloid leukemia (IO-202), breast cancer bone metastasis (ALMB-0168), solid tumor (IO-108), spinal cord injury (ALMB-0166), COVID-19 (IGM6268), and solid tumor (PRTH-101). Previously, he served as Chief Scientific Officer at Epitomics, Inc. and was Director of Biologics Research at Merck Research Laboratories. He has authored over 200 journal articles including more than 30 papers in Nature, Science, and Cell journal series; and two books including the award-winning “Therapeutic Monoclonal Antibodies: from Bench to Clinic.” He is an elected fellow of Society for Industrial Microbiology and Biotechnology (SIMB), the American Academy of Microbiology (ASM), American Association for the Advancement of Science (AAAS), and the National Academy of Inventors (NAI). Dr. An received his PhD from the University of Kentucky and his postdoctoral training at the University of Wisconsin-Madison.

Tuesday, May 13, 2025 2:20 - 6:10 pm | Wednesday, May 14, 2025 10:20 am - 6:40 pm

TS9B: Introduction to Machine Learning for Biologics Design

This course offers an introduction to concepts, strategies, and machine learning methods used for biologics design. It includes presentations and demonstrations of the methods used in the field, covering techniques such as triaging sequences, modulating affinity, and designing antibody libraries, along with increasing manufacturability. The course is directed at scientists new to the field and protein engineers wanting an introduction to how machine learning can aid in guiding biologics design.

Basics of machine learning and where does it fit into drug discovery
Modern homology modeling and structure prediction
Predicting antibody affinity and specificity modulation
Generative design in biologics: Library design and language models
Machine learning applications of T cell and B cell immunogenicity
Methods and application of ML for chemical, folding, solution stabilities

INSTRUCTOR BIOGRAPHIES:

Christopher R. Corbeil, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada

Dr. Christopher Corbeil is a research officer at the National Research Council Canada (NRC) who specializes in the development and application of computational tools for biotherapeutic design and optimization. He is also an associate member of the McGill Biochemistry Department and teaches classes in Structure-Based Drug Design at McGill University. After receiving his PhD from McGill University, he joined the NRC as a Research Associate investigating the basics of protein-binding affinity. Following his time at the NRC he joined Chemical Computing Group as a research scientist developing tools for protein design, structure prediction, and binding affinity prediction. He then decided to leave private industry and rejoin NRC with a focus on antibody engineering. Dr. Corbeil has authored over 30 scientific articles and is the main developer of multiple software programs.

Francis Gaudreault, PhD, Associate Research Officer, Human Health Therapeutics, National Research Council Canada

Francis obtained his PhD in Biochemistry from University of Sherbrooke in 2015, during which he developed a molecular docking program for docking small molecules to flexible protein or RNA targets. While doing his PhD studies, Francis co-founded a successful IT company for automating the management of scientific conferences. Francis joined the National Research Council (NRC) of Canada in 2016, where he has taken part in and led various efforts in the discovery and engineering of antibodies or other biologics. In such efforts are included the structure prediction of antibodies alone or in complex, the affinity assessment of antibody-antigen complexes, and the detection of antibody developability issues. Francis is leading the technical efforts in using artificial intelligence for antibody discovery.

TS10B: Introduction to Antibody-Drug Conjugate Design: Targets, Payloads, and Linkers

In this training seminar, your instructors will take you on a journey through the history of ADC technology, the current status of the ADC field, and the most promising up-and-coming technologies that will shape the ADCs of tomorrow. We will place particular emphasis on design principles that can be applied to next generation ADC programs, whether in oncology applications or in a myriad of other therapeutic applications. We will introduce various assay strategies, experimental approaches, and technical insights that will enable participants to have both a practical and a theoretical understanding of the inner-workings of a successful ADC program. Your instructors are seasoned ADC experts that have been involved in numerous ADC programs in academia, in big pharma, and in biotechnology companies.

Topic areas to be covered include:

An overview of the history of ADCs, emphasizing key developments and discoveries that shape the current therapeutic landscape
Principles and lessons in target selection
Antibody engineering: considerations and current trends
Conjugation and linker chemistry, past and present payload design and selection
Designing effective lead identification and screening strategies
Next-generation ADC technology:
What does the future hold?
ADCs beyond oncology

Who should attend?

Seasoned scientists who are moving into the ADC field
Early career scientists in the ADC field who want a solid grasp of the “big picture” of ADC
Executives and project managers who want a solid grasp of the challenges and opportunities of ADC technology

INSTRUCTOR BIOGRAPHIES:

Robert J. Lutz, PhD, CSO, Iksuda Therapeutics

Bob has been an independent consultant in the biotech/pharma industry since 2015 and has worked with multiple clients providing strategic, tactical and operational input for their research and development efforts. Prior to initiating his consulting practice, Bob held various R&D roles over a 23 year span at ImmunoGen, Inc. In his most recent position at ImmunoGen, Bob was Vice President of Translational Research and Development with responsibility for all early stage antibody drug conjugate (ADC) development programs from lead identification through phase 2. He also served as ImmunoGen’s research lead on Genentech’s FDA-approved trastuzumab emtansine (T-DM1) program. Before the ADC research position, Bob was part of ImmunoGen’s Apoptosis Technology Inc subsidiary where he led the research collaboration leading to the discovery of the BH3 domain of the BCl-2 family of death regulatory proteins. Before ImmunoGen, Bob was a research and postdoctoral fellow at the Eleanor Roosevelt Institute in Colorado. He earned his doctoral degree in Biochemistry at Brandeis University.

Nathan L. Tumey, PhD, Associate Professor, Pharmaceutical Sciences, SUNY Binghamton

L. Nathan Tumey is joined Binghamton University in 2017, following 15 years of medicinal chemistry experience in the pharmaceutical and biotechnology industry. His research focuses on the design of antibody-drug-conjugates (ADCs) for the treatment of cancer, auto-immune disorders, and rare diseases. Specific research projects include immune-stimulating antibody conjugates, glucocorticoid-antibody conjugates, legumain-cleavable linkers, and site-specific conjugation technology. He is a frequent consultant at various biotechnology and pharmaceutical companies, and serves on the scientific advisory board of multiple ADC-related organizations. Dr. Tumey received his PhD in chemistry from Duke University in 2001, under the supervision of Michael Pirrung. During his years in the pharmaceutical industry, Tumey was a key leader in multiple drug-discovery programs including the development of 5HT2c agonists for obesity, PKC-theta inhibitors for asthma, IRAK4 inhibitors for rheumatoid arthritis and antibody-drug-conjugates (ADCs) for the treatment of cancer.

TS11B: Introduction to Analytical Characterization and Method Validation for Biological Products

This interactive training seminar introduces a full spectrum of analytical procedures and characterization methods in biologics development. The instructor will describe how to apply QbD/DoE to develop, qualify and validate analytical procedures with case study based on the newer ICH guidelines. The curriculum is meticulously designed to cover the practical aspects of the commonly used analytical procedures to address product identity, purity and impurity, strength and potency, process-related impurities, and contaminants. The extended characterization and analytical comparability will elaborate structure elucidation by HRMS, MAM, primary and secondary structure, PTM, glycan profiling, charge variant analysis, biophysical characterization of HOS and aggregation. The class is for academics, newcomers in industry, and veterans wanting an update on new analytical technologies.

Topics to be covered:

The evolving modality of therapeutic biological products
QbD and DoE: Analytical development (ICH Q14), qualification and validation (ICH Q2(R2))
Biologics instability: developability, forced degradation, and formulation development
Product strength methods: protein concentration, DNA concentration and viable cell density
Product purity/impurities methods: CE-SDS (NR/R), icIEF and HPLC
Product potency methods: bioassays, binding ELISA and CBA
Product identity methods: peptide mapping, sequencing, icIEF, binding ELISA, FCM
Product safety: methods of process impurities (residual HCP by ELISA and MS) and contaminants
Characterization of aggregates and SVP analysis
Extended characterization: LC-MS, MAM, PTM, charge variant analysis, and HOS analysis
CMC analytical comparability

Who should attend?

The curriculum provides a broad overview of biologics analytical and characterization strategies. It is beneficial to individuals involved in biologics drug discovery, developability assessment, analytical development, formulation development, process development, DS/DP manufacturing, quality control, quality assurance, clinical supply, regulatory affairs, project management, or related functional areas.

INSTRUCTOR BIOGRAPHIES:

Kevin Zen, PhD, Senior Director, IGM Biosciences

Kevin has over 20 years of broad experience in Biologics CMC, and Strategic and Technical Operations. Prior to joining IGM Biosciences, he held various positions in biologics CMC disciplines at Allergan, AnaptysBio, AstraZeneca, Becton Dickinson, and Catalent Biopharma Solutions. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external contract manufacturing organizations (CMO) and contract research organizations (CRO), including production cell line development, bioprocess development, DS/DP cGMP manufacturing, process characterization, process performance qualification (PPQ), formulation development by DoE, analytical procedure development and method validation, reference standard qualification, extended characterization, and CMC analytical comparability.

Thursday, May 15, 2025 8:30 am - 5:30 pm | Friday, May 16, 2025 8:30 am - 12:30 pm

TS7C: Bioassay Development and Analysis

This course will focus on factors to be considered in the design, development, and validation of bioassays. The course introduces terminology and important statistical tools and best practices. Examples and case studies will be provided to help solidify understanding on the topics of design and development, robustness, validation, and post-validation. Relevant pharmacopeial and EUA regulations will be highlighted.

Key Topics:

Introduction to Bioassays
Guidance Documents on Bioassays
Design & Development
RobustnessValidation & Post Validation
Statistical Analysis Models
Examples / Case Studies

INSTRUCTOR BIOGRAPHIES:

Steven Walfish, Owner, Statistical Outsourcing Services

Mr. Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee. Prior to this role Mr. Walfish was Principal Statistician at Becton Dickinson in Franklin Lakes, NJ responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish has held roles at GE Healthcare, Human Genome Sciences and Chiron. Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

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