トレーニングセミナー | 23rd Annual PEP TALK 2024 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、実際の事例研究や遭遇した問題、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、正式な講義と双方向の討論・行動を組み合わせて、学習体験を最大化することができます。トレーニングセミナーは、経験豊富なインストラクターが担当し、現在の研究に応用可能な内容に焦点を当てると共に、この分野に不慣れな方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形式でのみ開催されます。

2024年1月16日（火）午前9:00～午後5:45｜2024年1月17日（水）午前11:05～午後2:00

TS6A: Introduction to Multispecific Antibodies

Introduction to Multispecific Antibodies will be organized as an informative and practical guide to getting up to speed on critical aspects of bispecific 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 the 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, Senior Director, Protein Engineering, 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 Antibody Engineering

In this training seminar, students will learn about antibody basics, including structure, genetics, and the generation of diversity, as well as the generation of potential therapeutic antibodies. This latter part will include antibody humanization, affinity and specificity maturation, display technologies, creation of naive libraries, and antibody characterization. The seminar will be fully interactive with students providing ample opportunities to discuss technology with instructors.

Antibody Background

Structure
Genes
Generation of Diversity (recombination, somatic hypermutations)

Antibody Humanization

Closest human gene approach
Minimal modification approach
Veneering

Display Technologies Overview

Phage
Yeast
Combining phage and yeast display
Ribosome
Others

Generation of Naive Antibody Libraries

Natural libraries (methods, quality control)
Synthetic libraries (including strategies for generation diversity)

Affinity Maturation

Error-prone PCR
Chain shuffling
CDR-targeted mutations

Next-Generation Sequencing in Antibody Engineering

Platforms: advantages and disadvantages
Error rates and why they are important
Naive library diversity analysis
Selection analysis

Antibody Characterization and Developability

Expression
Specificity
Aggregation
Solubility

INSTRUCTOR BIOGRAPHIES:

Andrew R.M. Bradbury, PhD, CSO, Specifica, Inc.

Andrew Bradbury is Chief Scientific Officer of Specifica. He trained in medicine at the universities of Oxford and London and received his PhD from the university of Cambridge at the MRC Laboratory of Molecular Biology under the guidance of Nobel Laureate, Cesar Milstein. He has worked in the fields of phage and yeast display, library generation, antibody engineering and Next Generation Sequencing for over thirty years. He was a Group Leader at Los Alamos National Laboratory before founding Specifica. Specifica's mission is to enable companies developing therapeutic antibodies with the world’s best antibody discovery platform.

James D. Marks, MD, PhD, Professor and Vice Chairman, Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF); Chief of Performance Excellence, Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG)

Dr. Marks is Professor and Vice-Chairman of the Department of Anesthesia and Perioperative Care at the University of California, San Francisco (UCSF) and Chief of Performance Excellence at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG). Dr. Marks received his medical degree from UCSF where he also completed residencies in Internal Medicine and Anesthesia and a fellowship in Critical Care Medicine. He received his Ph.D. in molecular biology from the Medical Research Council Laboratory of Molecular Biology in Cambridge, England. Dr. Marks is an internationally recognized pioneer in the field of antibody engineering, has had constant federal funding for 27 years and has authored more than 200 publications and 100 patents. In recognition of these scholarly achievements, he was elected to the National Academy of Medicine. As an entrepreneur, he has co-founded four biotechnology companies and currently serves on three biotechnology corporate boards.

TS8A: 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.

Seminar Highlights:

Basics of machine learning and where it fits into drug discovery
Machine learning: a historical view of its application in the field of drug discovery
How machine learning revolutionized homology modeling
Applying machine learning to structure-based biologics design
Guiding the design of display libraries using machine learning

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, 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.

TS9A: Advanced Purification of Engineered Biologics and Research Protein Tools

Nominating engineered biologics lead drug candidates for treating diseases with complex metabolic pathways is a challenging endeavor. This is attributable to a plethora of Achilles heels along the production process for these molecules. The production pitfalls of engineered biologics include immunogenicity, toxicity, poor manufacturability, low potency, long production cycle-time, the high cost of production, and labor intensity. Screening out these detrimental attributes requires production, purification, and characterizing thousands of molecules through a battery of robust low protein consumptive HT-assays. This course presents two high-throughput (HT) “plug-and-play” single-cycle protein purification strategies. From crude cell cultures with cells, the first strategy delivers ample high-quality proteins at low cycle time, cost, and labor intensity for lead nomination. Parallel to the above strategy is a second high-HT pneumatic purification strategy for biologics or tagged protein panels from filtered cell cultures.

Learning points:

Surface chemistry of proteins and their behaviors in aqueous buffers

Protein-monodispersing elements for “sticky” proteins and clearance of low abundance product degrading and destabilizing impurities

Protein aggregates and aggregate clearance strategies

Old semi-automated robots for 24/96-format HT-panel protein purification

A novel hybrid HT-magnetic bead/resin-based purification robot for 6(x50ml), 24(x4ml), and 96(x1ml) formats

Side products clearance from biologics using purification promoting mutations

Protein purification tags and traceless engineering/purification tags for generating mutation-free bispecific molecules

High-speed HT-low protein consumptive analytics for protein panels

Who should attend?

Although this course is directed towards protein purification experts in the fields of biologics and proteomics, biologics engineers and experienced scientists in general protein purification will find it very useful.

INSTRUCTOR BIOGRAPHIES:

John K. Kawooya, PhD, Private Consultant of Robotics-Plate-Based-Ultra-HT Biologics Purification

Director, Biologics Optimization, Discovery Research, Amgen, Inc.; PhD, University of Illinois at Urbana-Champaign; Postdoctoral at the University of Chicago and University of Arizona, Tucson; Visiting Scientist, University of Rio de Janeiro; over 20 years of industrial experience in column protein purification and high-throughput magnetic protein purification technologies.

2024年1月18日（木）午前8:30～午後4:45｜2024年1月19日（金）午前9:00～午後1:00

TS6B: Biomanufacturing 101: An Overview on Animal Cell Culture Technology from Cell Line Development to Scale-Up Strategies

During this one and a half day of presentations and discussions, we will take an in-depth look at the modern cell culture techniques from a frozen stock to bioreactor design and operations. After the completion of this seminar, the participants will have a clear understanding of the principles and techniques utilized in culturing animal cells for production of biologics, quality control of a cell culture laboratory and avoiding batch failure, cell line development and clone selection with optimized nutrients for increased productivity and the scale-up strategies for both suspension and anchorage dependent cells. utilizing stirred tank bioreactors, hollowfiber bioreactors and microcarrier cell culture technology.

Training Seminar Outline:

Historical development and progress of animal cell culture technology

Animal cells as factories for production of biopharmaceutical products

Understanding the cell cycle at the molecular level and how it will impact cell productivity

Expression systems and transfection assays

Cell Line development, clone selection, cell line characterization and cell line banking.

The importance of nutrients and media design for specific cells and clones

Understanding scale-up issues in bioprocessing and how to scale-up your process with detailed description of hollow fiber, microcarrier and stirred-tank bioreactor systems

Case studies

Who Should Attend: This training seminar is very useful for life scientists and engineers who are either new graduates looking for employment in the biomanufacturing industry or employees of the industry who want to expand their knowledge of cell culture technology and bioprocessing. Graduate students who are utilizing animal cell systems will especially benefit from the detailed description of handling cells in culture and quality control of the laboratory.

INSTRUCTOR BIOGRAPHIES:

Kamal A. Rashid, PhD, President, International Biotechnology Associates

Dr. Kamal Rashid has over forty years of academic experience in research, teaching, and workforce development efforts. During his career he has developed, directed, and implemented biotechnology/biomanufacturing training programs at Albany College of Pharmacy and Health Sciences, Worcester Polytechnic Institute, Utah State University, Penn State University and internationally. He is an expert in animal cell culture technology as has developed and taught graduate courses in cell culture techniques and scale-up strategies for more than thirty-five years. He developed, in collaboration with Penn State faculty and staff the first hands-on animal cell culture training course for the bio-based industry employees in 1989 as part of a comprehensive bioprocessing training program at Penn State University. While a faculty at Penn State, Dr. Rashid established the international biotechnology associates (IBA) in 1977 as a strategic consulting partner for companies, institutions and government agencies, helping them bring life-changing bio-based products to people around the world. Operating on a model of collaboration, Dr. Rashid assembles and leads multidisciplinary teams to support specific client initiatives. Dr. Rashid received his Ph.D. from Penn State University with superior ranking.

TS7B: Introduction to CMC for Biotech, Cell & Gene Therapy Products

This interactive course will provide a comprehensive CMC overview of therapeutic biological products. It introduces a variety of therapeutic modalities including recombinant proteins, Mab and cell and gene therapy in the context of IMPD and IND regulatory filing. You will learn scientific, technical, and operational aspects of overall biologics CMC activities as well as quality compliance and regulatory requirements. The instructor will present common pitfalls and share the best industry practices.

The chemistry manufacturing and controls (CMC) of biologics is a multidiscipline technical operation of bioprocess, analytics, dosage formulation, and cGMP manufacturing/testing for DS/DP release and stability to treat human diseases. This interactive training course will provide a comprehensive CMC overview of therapeutic biological products. It introduces a variety of therapeutic modalities including recombinant proteins, monoclonal antibodies (Mab), and cell and gene therapy (CGT) in the context of IMPD and IND regulatory filing. Attendees will learn scientific, technical, and operational aspects of overall biologics CMC activities as well as quality compliance and regulatory requirements. The instructor will present common pitfalls and share the best industry practices. Numerous real-world regulatory queries/comments from health authorities worldwide will be exemplified as case studies during the training course.

TOPICS TO BE COVERED:

1. Diverse modality of therapeutic biological products

2. Biologics CMC activities for regulatory filing (IMPD/IND)

3. Quality by design (QbD) concept, quality target product profile (QTPP), and critical quality attributes (CQA)

4. Cell line development, process development, and manufacture of biologics, CGT DS and DP

5. Current analytical technologies to characterize product variants/impurities, process impurities (e.g., HCP), and contaminants

6. Formulation development and compatibility with container closures and injection devices

7. Reference material characterization/qualification and justification of specifications for DS/DP release and ICH stability for product expiry

8. Process validation, analytical validation, and control strategy of cGMP manufacturing

9. Manufacturing process changes during product development lifecycle: CMC comparability exercise

WHO SHOULD ATTEND: The course is beneficial to individuals involved in biologics drug research/development, bioprocess development, analytical development, formulation development, quality control, quality assurance, 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.

TS8B: Label-Free Biosensor Tools in Biotherapeutic Discovery: SPR, BLI & KinExA

This training seminar will cover the main applications of commonly used commercial label-free biosensors in the interaction analysis of biologics and guidelines for best practices to generate reliable and reproducible data. We will primarily focus on Surface Plasmon Resonance (SPR), Biolayer Interferometry (BLI), and Kinetic Exclusion Assay (KinExA) technologies and their application in drug discovery (binding kinetics and affinity, blocking and epitope binning).

Day 1: How, What & Why-Choosing the Best Tool for the Job

1. What is biomolecular interaction analysis and why is it important?

Non-covalent reversible interactions

Limitations of endpoint assays

Introduction to binding kinetic parameters

Clinical relevance

2. Working principles of label-free biosensor platforms: SPR, BLI & beyond

Surface-based methods and introducing the concept of ligand and analyte

Solution-phase methods and introducing the concept of constant binding partner (CBP) and titrant

Advantages and limitations of each platform

3. Best practices in SPR & BLI

Factors affecting binding assays

Minimizing artifacts

Qualitative vs. quantitative assays

Data analysis and interpretation

4. Best practices in KinExA

Sample requirements

Assay orientation

Dynamic range

Time to equilibrium

Data analysis and interpretation

5. Case Study: Measuring femtomolar affinity interactions and on-cell affinities using KinExA

Rationale for using KinExA

Optimal experimental design for studying ultra-high affinities

Optimal reagent requirements for on-cell measurements

6. Designing blocking assays to elucidate mechanism of action

Rationale for performing blocking assays

Designing blocking assays

Case studies

7. Epitope binning

Pairwise antibody competition assays

Bin definition

Throughput

Impact of antigen heterogeneity

Asymmetric binnings

Antibody displacement

Day 2: Good, Bad & Ugly

8. Case Study: Characterizing the FcRn/IgG interaction

Analyzing a pH-sensitive interaction

Use of complementary biosensor assay formats

Avidity matters in extending serum half life

9. Group Exercise: SPR, BLI & KinExA

Evaluating Good, Bad & Ugly in the published literature

10. Group Exercise: Complementary use of surface and solution methods in affinity determinations

Literature review

INSTRUCTOR BIOGRAPHIES:

Yasmina Abdiche, PhD, Vice President, Exploratory Research, OmniAb Inc.

Yasmina is an internationally recognized and innovative scientific leader in the field of antibody discovery and biosensors with twenty years of experience in protein engineering and biopharma. To date, she has authored over 45 peer-reviewed publications, had 25 patents granted in the therapeutic antibody space including a market-approved drug (Ajovy), presented over 50 times as an invited speaker globally, and has been involved in numerous industry-wide collaborations and scientific advisory groups. After a twelve-year career at Pfizer where she held positions of increasing responsibility from Principal Scientist to Research Fellow, more recently, Yasmina has held senior management roles at biotechnology companies and contract research organizations including Carterra (CSO), ImmunoPrecise Antibodies (CSO), ALX Oncology (Vice President Protein Science), Revelar (CSO and Co-Founder), and FairJourney Biologics (CTO). During her time as CSO at Carterra, she co-founded its antibody screening biosensor platform (the LSA) which has helped transform label-free interaction analysis in early-stage drug discovery. Yasmina has a Master's degree in Chemistry and a PhD in Biological Chemistry from Oxford University and did post-doctoral studies in biophysical interaction analysis at the University of Utah.

Vishal Kamat, PhD, Senior Director, Protein Sciences, Ampersand Biomedicines

Vishal (Vish) Kamat is an innovative and collaborative leader with 17 years of experience in the field of biotherapeutics and biophysical characterization of antibodies and proteins. He has supported the discovery and development of antibodies for 150+ targets which yielded 20 clinical drug candidates and 3 market-approved drugs - DUPIXENT, LIBTAYO, and EVKEEZA. He also has extensive experience in high throughput screening of antibodies using diverse platforms such as SPR, BLI, KinExA, Gyrolab, MSD and Luminex. His scientific excellence is evident by multiple peer-reviewed publications in high impact journals, patent approvals and IND reports. After a 12-year career at Regeneron Pharmaceuticals where he held positions of increasing responsibility from postdoctoral candidate to Sr. Staff Scientist, he worked as a Director of Antibody Characterization at Twist Biopharma and is currently working as a Senior Director of Protein Sciences at Ampersand Biomedicine. Vishal holds a PhD in Biomedical Engineering from Drexel University and BS in Electronics Engineering from University of Mumbai.

Palaniswami (Swami) Rathanaswami, PhD, CEO, PRSwami AbDev Inc.

World’s leading expert Scientist in Antibody affinity and kinetic characterization, especially for measuring femto molar affinities of antibodies for soluble and on-cell targets. World expert in solution binding measurements and using KinExA technology. Extensive user of SPR and BLI technologies. Experienced SME as Functional Lead for human therapeutic antibody programs and drug product development. Dedicated career to advancing medical research to alleviate disease and make individuals lives better. Consultant for leading biotech organizations on high throughput screening, affinity measurements and antibody drug product development. Did extensive research, over 40 years in the fields of Endocrine Biochemistry, Molecular Endocrinology, Inflammation Immunology-Rheumatology, Human therapeutic antibody generation, engineering and characterization (including immunization, high throughput binding and functional screening and very high affinity kinetic measurements). A key member of a team of 5 Scientists who developed SLAM technology for human therapeutic antibody generation and spun to a Canadian Biotech company - Immgenics Inc., and later acquired by Amgen. First Scientist to generate human antibodies by Single Cell RT-PCR amplification of V genes from antibody producing single B Cells, molecular cloning and express as full antibody. Published over 40 articles in very high impact Scientific Journals and inventor of over 20 scientific patents. Worked for Amgen 25+ years and generated over 100 human therapeutic antibodies of which about 5 are already used as pharmaceutical drugs in market. Invited speaker in national and international conferences, Universities and Research institutes across the globe. Chaired sessions in international conferences and seminars. Dr. Palaniswami Rathanaswami graduated in MSc (Biochemistry, Faculty of Medicine) and a PhD (Biochemistry), University of Madras, India.

TS9B: 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, with an emphasis on translational/development steps and overcoming the challenges of novel modalities and difficult targets using real-life examples.

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

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.

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