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、適用された解決策を提供しています。各トレーニングセミナーでは、学習体験を最大化するために、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正式な講義に交えて提供しています。これらのトレーニングセミナーでは、現在の研究に応用可能なコンテンツに焦点を当て、経験豊富なインストラクターが、この分野に不慣れな方への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の提供です
2023年5月15日(月) 8:30 - 3:20 pm | 2023年5月16日(火) 8:30 - 1:10 pm
TS3A: Introduction to Bispecific Antibodies: History, Engineering, and Application
TS3A:二重特異性抗体入門 - 歴史、エンジニアリング、および応用
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
TS7A:免疫原生入門
- What is immunogenicity?
- Immunology and major mechanisms affecting immunogenicity
- B cell development
- Clinical consequences of ADARisk-based approach
- Immunogenicity in the clinic
- Regulations and guidance governing immunogenicity
- 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:
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
TS9A:タンパク質エンジニアリング入門
Topics to be covered include:
What is Protein Engineering?
- Functions amenable to engineering: affinity, specificity, catalysis, stability, solubility, immunogenicity, serum half-life
Tools and Techniques
- The measure of success: functional assays
- Engineering by design
- Engineering by random mutation
- Designed libraries display technologies
- Deep sequencing applications in analyzing libraries and repertoires
Production and Manufacturing
- Evaluating biotherapeutic developability
- Improving manufacturing by protein engineering methods
- Glycosylation engineering - function and homogeneity
- Other protein modifications
- Immunogenicity engineering and humanization
- Expression of antibodies and fragments for discovery and testing
- Manufacturing platforms for antibodies and fragments
Emerging Molecule and Product Formats
- Bispecific antibodies/binders
- Antibody-drug conjugates (ADCs)
- CAR T strategies
- Other emerging constructs
The Future of Protein Engineering
INSTRUCTOR BIOGRAPHIES:
David Bramhill, PhD, Founder, Bramhill Biological Consulting LLC
2023年5月16日(火) 2:30 - 6:00 pm | 2023年5月17日(水) 8:30 - 6:40 pm
TS9B: Introduction to Machine Learning for Biologics Design
TS9B:バイオロジクス設計のための機械学習入門
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
Francis Gaudreault, PhD, Research Officer, Human Health Therapeutics, National Research Council Canada
TS10B: Analysis and Interpretation of Antibody Deep Sequencing and Single Cell Analysis Data
TS10B:抗体ディープシーケンシングと単細胞分析データの分析と解明
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 Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard
Matias Gutierrez-Gonzalez, PhD, Research Fellow, The Ragon Institute of MGH, MIT, and Harvard
2023年5月18日(木) 8:30 - 4:20 pm | 2023年5月19日(金) 8:30 - 12:30 pm
TS7C: Introduction to Bioassay Design, Development, Analysis, Validation, and Monitoring
TS7C:バイオアッセイの設計、開発、分析、バリデーション、モニタリング入門
Topics to be Covered Include:
1. Statistical concepts
2. Biological Assays
- Fundamental concepts
- Types of bioassays
- Similarity: what, why, and how
- Properties of bioassays
3. Introduction to "Classical" Design of Experiments
- Factorials: why and how
- Blocking and other designs
- Sequences of experiments
4. Using DOE with bioassays
5. Bioassay analysis
- Challenges: non-constant variance, non-normality, outliers
- Modeling methods: non-parametric, linear, nonlinear
- Mixed models: what, why, and how
- Similarity and Potency
6. Considerations when setting product specifications
- Clinical experience
- Manufacturing experience
- Assay and process capability
7. Setting assay and sample acceptance limits in bioassays
8. Modular assay designs ease development, robustness, qualification, and validation
9. Qualification and validation design and analysis
10. Assay monitoring
11. Managing changes in assays
12. Assay transfers
13. Assay updates
WHO SHOULD ATTEND: Those who are involved with the design, development, analysis, validation, monitoring, transfer, and updating of biological assays will benefit from this course. This includes bench scientists, assay managers, those responsible for planning and analyzing bioassay validation experiments, statisticians who are new to bioassay, as well as managers who have responsibility for bioassay development and validation. The course focuses on key concepts, properties of bioassays, with enough details to understand how medical needs drive product specifications, which drive the requirements for assay capabilities. We will not focus on formulae or calculations. We will discuss the strengths and weaknesses of various big picture approaches to bioassay development and validation.
INSTRUCTOR BIOGRAPHIES:
David Lansky, PhD, President, Precision Bioassay, Inc.
* 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。
2023年 プログラム
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