Cambridge Healthtech Instituteのトレーニングセミナーでは、実際のケーススタディ、遭遇した問題、適用された解決策、学術的な理論や背景の広範な説明が提供されます。各トレーニングセミナーでは、学習体験を最大限に高めるために、正式な講義とインタラクティブなディスカッションやアクティビティが組み合わされています。これらのトレーニングセミナーは、経験豊富な講師陣が担当し、現在の研究に応用できる内容に焦点を当てるとともに、各分野の初心者には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、対面式でのみ開催予定
一貫性のある集中的な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。
2025年1月14日（火） 8:30 am - 6:30 pm | 2025年1月15日（水） 8:30 - 11:00 am
TS5B: 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, MD, PhD, CSO, Specifica, an IQVIA business
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.
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.
TS6B: 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.
TS7B: Bridging the Gap from R&D to Bioprocessing
Do you seek to better understand end-to-end operations in drug development; gain clarity of biotech-pharma functions, cross-functional teams, and phase-appropriate analytics; and improve quantitative go/no-go decisions in order to accelerate therapies to patients?
This 1.5 day course will focus on discovery & drug development processes and operations-providing an overview of the drug pipeline and key milestones towards IND filings, detailed assessments of cross-functional strategies, and in-depth learnings in R&D spanning therapeutic candidate selection, developability assessments, risks & mitigations, and analytical & process development considerations for regulatory submissions.
This interactive course is designed for scientists and engineers in discovery, nonclinical development, and CMC, with a desire to increase the probability of success of therapeutic candidates across multiple modalities (biologics, small molecules, cell and gene therapies). Instructors will share best practices, key pitfalls, translational guidelines, data-driven strategies, and regulatory considerations through case studies, course materials, and supplemental information.
Topics to be covered:
- Drug pipeline overview and key milestones towards IND filings
- Key elements of therapeutic candidate selection
- Developability assessments
- Process and analytical and development considerations for regulatory submissions
- Regulatory considerations, Quality-by-Design (QbD)
- Cross-functional strategies: drug discovery & development data integration, mathematical models, & utility
Who should attend:
Scientists and engineers in discovery, nonclinical development, and CMC, with a desire to facilitate and accelerate successful development of clinical therapeutic candidates across multiple modalities (biologics, small molecules, cell and gene therapies).
INSTRUCTOR BIOGRAPHIES:
Carissa L. Young, PhD, Senior Director, Development Asset Lead, Biogen
Carissa has 18+ years in pharma-biotech spanning nonclinical, CMC, and clinical development across multiple modalities (cell therapies, biologics, small molecules) and disease indications. She has built and managed cross-functional teams in Drug Development and Data Sciences to maximize the value of therapeutic pipelines, portfolio, and platforms. Her versatility enables her to engage across the diversity of translational sciences, process-product development life cycle, clinical/nonclinical study designs to regulatory filings, data quality oversight and compliance. Previous industry experience includes Intellia Therapeutics, Takeda, Applied Biomath, and Johnson & Johnson. Teaching experience as Instructor at Harvard Medical School and the University of Delaware. Carissa received her Chemical Engineer degrees at Georgia Tech (BS) and the University of Delaware (PhD), completing her post-doctoral training in Biological Engineering at MIT.
Marieke Koedood Zhao, PhD, Independent Consultant, Bioprocess Development
Marieke has 20+ years experience in bio-therapeutic development, facilitating collaboration of research, preclinical, CMC, and clinical development teams and had a track record of ushering novel Biologics from pre-development to first-in-human clinical trials with aggressive timelines. She has hands-on experience in drug substance process development, technology transfer, process scale-up, selection and management of Contract Manufacturing Organizations (CMOs), CMC strategy, and regulatory filings for antibody-drug conjugates and mRNA products entering the clinic. Previous industry experience includes Kudo Biotechnology, GreenLight Biosciences, Mersana Therapeutics, ImmunoGen and Wyeth Biopharma. Marieke received her PhD from the University of Zurich in Switzerland and completed post-doctoral training at Boston University.
2025年1月15日（水） 3:15 - 5:50 pm | 2025年1月16日（木） 8:15 am - 4:15 pm
TS5C: 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
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.
TS6C: Label-Free Binding Kinetics, Epitope Binning & Solution Affinities in Therapeutic Antibody Discovery
This training seminar will cover the main applications and guidelines for best practices of commonly used commercial label-free biosensors in the interaction analysis of therapeutic antibodies. We will primarily focus on Surface Plasmon Resonance (SPR) and Kinetic Exclusion Assay (KinExA) technologies but will also address other surface (BLI) and solution (MSD and Gyrolab) methods. We will first cover the fundamental concepts used to design a binding kinetic experiment for affinity determination, then do a ‘deep dive’ into epitope binning and explore solution affinity methods with an emphasis on expanding throughput. In addition, we will showcase the complementary use of surface and solution approaches for determining affinities across a broad range of values to highlight their unique strengths and limitations.
BINDING KINETICS
- Introducing binding kinetics and rate constants
- Working principle of SPR
- SPR best practices for generating high-quality kinetic data
EPITOPE BINNING
- Assay formats (tandem, premix and classical sandwich)
- Bin definition
- Throughput
- Nuanced binning (antigen heterogeneity, asymmetry, and displacement)
SOLUTION AFFINITY (KinExA, MSD, and Gyrolab)
- Introducing the solution affinity method and its need
- KinExA method and best practices
- Data analysis and interpretation
- Advanced applications (on-cell and ultra-high affinities)
- Expanding throughput using plate-based methods (MSD and Gyrolab)
COMPLEMENTARY USE OF SURFACE & SOLUTION METHODS FOR AFFINITY DETERMINATIONS
- Case study from the literature
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.
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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.
TS7C: Data Skills for Scientists
In today's data-driven research landscape, effective data management practices are crucial for enabling reproducibility, collaboration, and driving new discoveries. This course equips scientists with essential skills to harness the power of relational databases and laboratory information management systems (LIMS) for streamlining their data workflows. Participants will gain a solid understanding of database fundamentals, learn how to design robust schemas tailored to their research needs, and master data wrangling techniques using open-source tools. The course also delves into best practices for LIMS implementation, addressing common challenges and providing strategies for successful rollout, training, and long-term maintenance. Whether you're exploring a new LIMS solution or optimizing an existing system, this course offers a unique blend of conceptual knowledge and hands-on activities to empower you to effectively organize, store, query, and integrate your valuable scientific data.
Topics to be covered:
- Overview of laboratory information management systems (LIMS) and their benefits in scientific research data management
- Introduction to relational database concepts
- How to design a fit-for-purpose relational database for your team’s and organization’s needs
- Data wrangling techniques to transform plate-based experiments for database ingestion including hands-on activities with open source web apps that let you design rectangular plate maps and combine them with your linear-formatted results files.
- Best practices for LIMS rollout and training
- Challenges in LIMS implementation
Who should attend this course?
This course provides a blend of conceptual knowledge about databases/LIMS and hand-on skills beneficial for those interested in how to effectively organize, store, query, and integrate their data. It would benefit anyone interested in leveraging databases and LIMS for efficient data organization and integration. No knowledge of SQL is necessary, as a basic overview of SQL will be provided.
INSTRUCTOR BIOGRAPHIES:
Emma Altman, Senior Research Associate, Protein Sciences, Kite, A Gilead Company
Emma is currently a senior research associate at Kite Pharma, where she is a member of a team focused on the design, production, and characterization of critical protein reagents to support CAR T cell discovery and drug development efforts. She has a wide-ranging background in academic and industry settings, working on characterizing metal-containing enzymes, understanding viral evolution through a bacteriophage model system, and supporting protein reagent development at 10X Genomics. She also recently earned an master's degree in anthropology with research focusing on intersection of historical archaeology and science.
Nicole Cannon, Protein Sciences, Kite Pharma
I manage research data storage, processing and analysis systems to make quality data easier and more valuable in a discovery research setting. I am to teach, train and create automated integrations to aid bench scientists in generating data in formats ideal for data scientists and machine learning algorithms.
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