Training Seminars - 2023 Archive

2023 ARCHIVES

Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.

Training Seminars Will Be Offered In Person Only

Monday, May 15, 2023 8:30 am - 3:20 pm | Tuesday, May 16, 2023 8:30 am - 1:10 pm

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

Detailed Agenda

Introduction to Bispecific Antibodies will be organized as an informative and practical guide to get 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 ideal implementation of bispecifics as targeted and immunomodulatory approaches will be discussed.

G. Jonah Rainey, PhD, Senior Director, Protein Engineering, Eli Lilly and Company

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 Immunogenicity

Detailed Agenda

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 and reporting immunogenicity.

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

Bonnie Rup, PhD, Biotechnology Consultant, Bonnie Rup Consulting

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

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 ADARisk-based approach
Immunogenicity 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 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:

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.

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.

TS9A: Introduction to Protein Engineering

Detailed Agenda

CHI’s Introduction to Protein Engineering training seminar offers a comprehensive tutorial in the concepts, strategies and tools of protein engineering – and explains the role of this discipline in the progression of biotherapeutic research and development. The class is directed at scientists new to the industry or working in support roles, academic scientists and career protein scientists wanting a detailed update on the current state of the field. Today’s wealth of knowledge of protein structures is reviewed, along with the genetics of diversity generation of antibodies, to give insights into the best strategies for improving protein function. There is particular emphasis on the selection of functional assays to monitor effectively the changes in desired properties. Display technologies such as phage display and yeast display are described and the advantages and disadvantages of each compared. Design strategies are presented for constructing libraries of variant proteins for display, and panning strategies for enriching proteins with the desired properties considered. The course details the engineering and enhancement of traditional antibodies and also cytokines, antibody fragments and emerging antibody-like scaffolds. Also included is a discussion of the roles of protein engineering in the discovery, design and development of new therapeutic modalities including antibody-drug conjugates (ADCs), bispecific antibodies and Chimeric Antigen Receptor (CAR) constructs. This class will discuss the expression platforms used for producing proteins for testing and for manufacture, along with the rapidly emerging role of protein engineering in optimizing antibody and other protein therapeutics. A background in biochemistry and molecular biology is useful, as the course is designed to progress rapidly from simple to advanced concepts. Links and references will be provided with the course materials to provide a glossary and other useful resources.

David Bramhill, PhD, Founder, Bramhill Biological Consulting LLC

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

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.

Tuesday, May 16, 2023 2:30 - 6:00 pm | Wednesday, May 17, 2023 8:30 am - 6:40 pm

TS9B: Introduction to Machine Learning for Biologics Design

Detailed Agenda

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.

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

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.

TS10B: Analysis and Interpretation of Antibody Deep Sequencing and Single Cell Analysis Data

Detailed Agenda

In this training seminar, participants will learn about recently developed methods for Next-Generation Sequencing (NGS) and single-cell analysis of antibody repertoires. The course will be interactive with case studies, participants will be able to download data and examples. Please bring your computer.

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 University

Matias Gutierrez-Gonzalez, PhD, Research Fellow, The Ragon Institute of MGH, MIT, and Harvard

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:

Dr. Brandon DeKosky is an Assistant Professor in the Department of Chemical Engineering at MIT and a Core Member of the Ragon Institute of MGH, Harvard, and MIT. Research efforts at the DeKosky lab have developed a suite of high-throughput single-cell platforms for comprehensive analyses of adaptive immunity. These efforts are advancing new approaches in biologic drug discovery, and for the comprehensive analyses of genetic and functional diversity in adaptive immune cells. The group seeks to reveal the quantitative principles that govern effective adaptive immunity and provide molecular design strategies for vaccines and biologics to combat global infectious agents including HIV-1, malaria, and SARS-CoV-2. The DeKosky lab is also investigating quantitative principles of immune regulation and establishing new approaches for targeted and personalized cancer therapies. Dr. DeKosky has been awarded several honors for his research program. His PhD research was supported by a Hertz Foundation Graduate Fellowship, an NSF Graduate Fellowship, and a Donald. D. Harrington Graduate Fellowship. In 2016, DeKosky was awarded a K99 Pathway to Independence Award and an NIH Early Independence Award and began a joint faculty appointment at the University of Kansas Departments of Chemical Engineering and Pharmaceutical Chemistry. He has also received the Department of Defense Career Development Award, the Biomedical Engineering Society Rising Star Award, and the AIChE Young Faculty Futures award. In 2021, Dr. DeKosky began as an Assistant Professor in a joint appointment at MIT Chemical Engineering and The Ragon Institute.

Matias Gutierrez-Gonzalez, PhD, Research Fellow, The Ragon Institute of MGH, MIT, and Harvard

Dr. Matias Gutierrez is a Postdoctoral Researcher in the lab of Dr. Brandon DeKosky at the University of Kansas. Dr. Gutierrez’s graduate research studied the development and characterization of biopharmaceuticals, with a focus on monoclonal antibodies. Currently, Dr. Gutierrez works to develop new tools for bioinformatic analysis of single-cell antibody repertoire data, and to establish new techniques for high-throughput B cell sequencing.

Thursday, May 18, 2023 8:30 am - 4:20 pm | Friday, May 19, 2023 8:30 am - 12:30 pm

TS7C: Introduction to Bioassay Design, Development, Analysis, Validation, and Monitoring

Detailed Agenda

This course will build from an introduction to the statistical concepts needed for bioassays (all illustrated with useful and relevant examples) and some review of the properties of bioassays. These inform the choices we make in applying DOE to bioassay development, validation, and monitoring. We will cover ways that strategic assay design considerations support good assay monitoring with graphical and quantitative tools as part of a lifecycle approach.

David Lansky, PhD, President, Precision Bioassay, Inc.

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.

David Lansky has been practicing statistics on bioassays (and other non-clinical applications in Pharma) for 30 years. This includes Searle/Monsanto/Pharmacia (10 years) and as the owner of Precision Bioassay, Inc. (since 2002). David has been and is still an active participant in the work to revise the USP bioassay chapters. His education includes a year of Electrical and Computer Engineering (University of Michigan), a BS in Botany (San Francisco State), an MS in Entomology (Cornell) and finally both an MS and Ph.D. in Biometry (both Cornell).