Cambridge Healthtech Institute的培訓研討會涵蓋了廣泛的學術理論及其背景,以及現實生活中的案例研究和所面臨的挑戰及適用的解決方案資訊。每個培訓研討會都結合了正式講座與互動討論和活動,以讓學習成果最大化。以熟練的講師來主持培訓研討會,以適用於目前研究的內容為焦點,提供針對在該領域的初學者重要的指南。
培訓研討會將僅以面對面型式進行。
2024年5月13日(一) 8:30 am - 6:05 pm | 2024年5月14日(二) 8:00 am - 1:30 pm
TS3A: Introduction to Multispecific Antibodies: History, Engineering, and Application
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
TS7A: Introduction to 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 approachImmunogenicity in the clinic
- Regulations and guidance governing immunogenicity
Part 2: Predictive Immunogenicity
Part 3: Clinical Considerations of Immunogenicity and Regulatory Expectations
Part 4: Assay Methodology and Approaches for Describing Immunogenicity in the Clinic
- Assay methodologiesComparison 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:
Chloe Ackaert, PhD, Senior Scientist, Immunogenicity, ImmunXperts, a Q2 Solutions Company
Sofie Pattijn, Founder & CTO, ImmunXperts, a Q2 Solutions Company
Bonnie Rup, PhD, Biotechnology Consultant, Bonnie Rup Consulting
TS9A: Introduction to Protein Engineering
Course Outline:
- 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)
- Other emerging approaches
INSTRUCTOR BIOGRAPHIES:
David Bramhill, PhD, Founder, Bramhill Biological Consulting LLC
TS10A: Antibody Drug Discovery: From Target to Lead
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
2024年5月14日(二) 3:00 - 6:10 pm | 2024年5月15日(三) 8:30 am - 6:10 pm
TS9B: Introduction to Machine Learning for Biologics Design
INSTRUCTOR BIOGRAPHIES:
Christopher R. Corbeil, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada
Francis Gaudreault, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada
TS10B: Introduction to Antibody-Drug Conjugate Design: Targets, Payloads, and Linkers
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
Nathan L. Tumey, PhD, Associate Professor, Pharmaceutical Sciences, SUNY Binghamton
TS11B: Label-Free Biosensor Tools in Biotherapeutic Discovery: SPR, BLI & KinExA
BINDING AFFINITY and KINETICS- Taught byVishal Kamat
- Concept of real-time binding kinetic assays and binding kinetic parameters - ka, kd, KD
- Working principle of SPR and BLI biosensors
- Designing binding kinetic assays on SPR & BLI biosensors
- Best practices to generate reliable binding kinetic data with minimal experimental artifacts on SPR & BLI biosensors
- Introducing the solution affinity method and its need
- KinExA method and best practices
- Data analysis and interpretation
- Advanced applications of KinExA
- Assay formats
- Bin definition
- Throughput
- Antigen heterogeneity
- Asymmetric binnings
- Antibody displacement
INSTRUCTOR BIOGRAPHIES:
Yasmina Abdiche, PhD, Vice President, Exploratory Research, OmniAb Inc. (Moderator)
Vishal Kamat, PhD, Senior Director, Protein Sciences, Ampersand Biomedicines
Palaniswami (Swami) Rathanaswami, PhD, CEO, PRSwami AbDev Inc.
2024年5月16日(四) 8:45 am - 6:00 pm | 2024年5月17日(五) 8:30 am - 12:30 pm
TS7C: Introduction to Bioassay Design, Development, Analysis, Validation, and Monitoring
- Statistical concepts
- Biological assay: fundamentals, types, properties, and similarity
- Intro to ‘classical’ design of experiments: factorials, response surface designs, blocking
- Using DOE with bioassays
- Bioassay analysis: addressing violations of assumptions, modeling, why mixed models, similarity
- Considerations when setting product specifications
- Setting assay and sample acceptance limits in bioassays
- Modular assay designs ease development, robustness, qualification, and validation
- Qualification and validation design and analysis
- Assay monitoring
- Managing changes in assays
- Assay transfers
INSTRUCTOR BIOGRAPHIES:
David Lansky, PhD, President, Precision Bioassay, Inc.
TS8C: 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 and cross-functional teams, phase-appropriate analytics, and improve quantitative Go/No Go decisions in order to accelerate therapies to patients?
- Drug pipeline overview and key milestones towards IND filings
- Key Elements of therapeutic candidate selection
- Developability assessments
- Analytical and process development considerations for regulatory submissions
- Risks and mitigations
- Cross-functional strategies and integrated timelines
INSTRUCTOR BIOGRAPHIES:
Carissa L. Young, PhD, Independent Consultant
Marieke Koedood Zhao, PhD, Vice President, Process Sciences, Kudo Biotechnology
TS9C: Analysis and Interpretation of Antibody Deep Sequencing and Single Cell Analysis Data
PART I:
- Introduction to NGS of antibody repertoires and bioinformatics tools
- Introduction to antibody repertoire analysis
- Experimental design and considerations
- Data analysis overview
- Hands-on session: introduction of common computational tools for NGS
PART II:
- Preprocessing and analysis of antibody repertoire
- NGS data hands-on session: preprocessing data hands-on session
- Antibody immune repertoire analysis
- Advanced methods for NGS data analysis
PART III:
- NGS sequencing of single B cell populations
- NGS for analysis of library screening results
- Single-B cell functional analyses via NGS
WHO SHOULD ATTEND: This course is designed for individuals in industry and/or academia who are establishing or learning high-throughput NGS-based technologies for antibody repertoire analysis and antibody discovery. Prior knowledge in the areas of antibody biology and command-line programming is very helpful, but not required. By the end of the workshop, course participants should have the ability to understand and evaluate experimental options for antibody NGS data acquisition, perform analysis and visualization of antibody sequencing data, identify related antibody variants from NGS information, and possess a general understanding of the current scope of NGS-enabled antibody discovery techniques.
INSTRUCTOR BIOGRAPHIES:
Brandon DeKosky, PhD, Phillip and Susan Ragon Career Development Professor of Chemical Engineering, MIT Core Member, The Ragon Institute of MGH, MIT, and Harvard University
Matias Gutierrez-Gonzalez, PhD, Research Fellow, The Ragon Institute of MGH, MIT, and Harvard
* 活動內容有可能不事先告知作更動及調整。
2024年 方案
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![Engineering](./images/stream1-engineering.png?sfvrsn=c7097d95_1)
![Oncology](./images/stream2-oncology.png?sfvrsn=36bf54d2_1)
![Bispecific Antibodies](./images/stream3-multispecifics.png?sfvrsn=97c5a57c_2)
![Immunotherpary](./images/stream4-immunotherapy.png?sfvrsn=c1343ec8_1)
![Expression](./images/stream5-expression.png?sfvrsn=8fd2293e_1)
![Analytical](./images/stream6-analytical.png?sfvrsn=6052a65a_1)
![Immunogenicity](./images/stream7-immunigenicity.png?sfvrsn=c7a722e4_1)
![Emerging Modalities](./images/stream8-therapies.png?sfvrsn=1fb8fb9e_1)