Training Seminars - 2025 Archive

2025 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
To ensure a cohesive and focused learning environment, moving
between conference sessions and the training seminars is not allowed.

Monday, 10 November 2025 08:30 - 17:00

TS1: AI-Driven Design of Biologics: A Hands-on Guide to Using State-of-the-Art ML Protein Models

Detailed Agenda

Since 2021, artificial intelligence models have revolutionized AI-driven biologics development, enabling breakthroughs in structure prediction, sequence design, and protein engineering. This course equips researchers and professionals with the expertise to leverage cutting-edge tools for structure prediction (AlphaFold, ImmuneBuilder), protein engineering with protein language models (ESM, AntiBERTy) and structure-based design (ProteinMPNN and RFDiffusion). Through a blend of lectures and hands-on exercises, participants will learn best practices for tool selection, method optimization, and design selection. By exploring real-world applications and emerging techniques, such as BindCraft and RFAntibody, attendees will gain a practical understanding of performance capabilities, limitations, and effective workflows.

David P. Nannemann, PhD, Vice President, Rosetta Commons Foundation

Participants are expected to have some prior exposure to computational modelling tools (e.g. Python, R, COOT, Rosetta, AutoDock Vina, etc.) but limited experience applying them to their projects. They should be comfortable using Jupyter notebooks and prepared to explore topics such as evaluating metrics, determining appropriate sampling sizes, and selecting key adjustable parameters. While this course does not cover ligand docking or protein-protein docking, it is well-suited for those interested in antibody modeling and, potentially, enzyme design language models.

Topics to be covered:

Building practical experience with AI-based modelling of proteins
A breakdown of input formats, command lines, and analysis of output
Hands-on exercises using real-world scenarios in antibody structure prediction, developability pre-screening, immunogen solubilization, and de novo binder design
Discussion of and guidance on questions like how many models, in silico selection metrics and ranking, and how many to test in the lab
Pipelining of protein design software and the critical use of an “oracle”?

INSTRUCTOR BIOGRAPHIES:

David P. Nannemann, PhD, Vice President, Rosetta Commons Foundation

David is an expert in protein engineering and computational design, with extensive experience applying AI-driven modeling tools in an industry setting. He serves as Vice President of the Rosetta Commons Foundation and Industry Chair on the Rosetta Commons board, helping bridge academic advancements with industry applications. As Managing Member of Rosetta Design Group, he collaborates with companies of all sizes to tackle complex challenges in biologics design. David's deep expertise in leveraging cutting-edge tools like Rosetta, AlphaFold, and diffusion-based models for protein design make him an invaluable guide for participants looking to apply AI-driven biologics design in real-world settings.

TS2: Introduction to Multispecific Antibodies: History, Engineering, and Application

Detailed Agenda

Introduction to Multispecific Antibodies is an informative and practical guide to getting up to speed on critical aspects of multispecific 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 multispecifics as targeted and immunomodulatory approaches will be discussed.

G. Jonah Rainey, PhD, Associate Vice President, 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 personalised approaches

INSTRUCTOR BIOGRAPHIES:

G. Jonah Rainey, PhD, Associate Vice President, 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.

Tuesday, 11 November 2025 08:30 - 18:35

TS7A: 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.

Francis Gaudreault, PhD, Associate Research Officer, Human Health Therapeutics, National Research Council Canada

Basics of machine learning and where does it fit into drug discovery
Modern homology modelling and structure prediction
Predicting antibody affinity and specificity modulation
Generative design in biologics: Library design and language models
Machine learning applications of T cell and B cell immunogenicity
Methods and application of ML for chemical, folding, solution stabilities

INSTRUCTOR BIOGRAPHIES:

Francis Gaudreault, PhD, Associate 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.

TS8A: Introduction to Analytical Characterisation and Quality Control for Biological Products

Detailed Agenda

This training seminar provides a practical and comprehensive overview of analytical procedures, quality control, and characterisation methods for R&D scientists as well as CMC staffs. Attendees will learn the analytical procedures of product identity, strength, potency (ELISA, CBA, SPR), product-related impurity (HPLC, CE), process-related impurities (residual HCP, DNA, ProA), and contaminants. Case studies will be presented to demonstrate method development, robustness, validation, and specifications for QC batch analysis and stability. The instructor will elaborate extended characterisation and CMC comparability by HRMS, MAM, PTM, glycan profiling, higher order structure, aggregation (by SVP analysis), charge variant analysis, HCP (by MS), and discuss polysorbate degradation control strategy. Join this interactive training course to learn the best practices of analytical development, characterisation and QC.

Kevin Zen, PhD, Principal Consultant, Biologics CMC Consulting

Topics to be covered (what you will learn)

The evolving modality of therapeutic biological products
QbD and DoE: Analytical development, qualification, validation, and post-validation for quality control
Biologics instability: developability, forced degradation, and formulation development
Product strength methods: protein concentration, DNA concentration and viable cell density
Product purity/impurities methods: HPLC and CE (charge variant analysis)
Product potency methods: bioassays, ELISA, SPR, and CBA
Product identity methods: peptide mapping, sequencing, icIEF, binding ELISA, FCM
Product safety: methods of process impurities (residual HCP by ELISA and MS, polysorbate degradation) and contaminants (microbiological attributes, adventitious agents)
Characterisation of aggregates and SVP analysis
Extended characterisation: LC-MS, MAM, PTM, charge variant analysis, and HOS analysis
CMC analytical comparability exercise

Who should attend? (Who will benefit from this training)

The class is for academics, scientists new to industry, and veterans wanting an update on the current state of biologics analytical field. It is beneficial to the individuals involved in biologics drug discovery, developability assessment, analytical development, formulation development, process development, biologics manufacturing, quality control, quality assurance, clinical supply, regulatory affairs, project management, or related functional areas.

INSTRUCTOR BIOGRAPHIES:

Kevin Zen, PhD, Principal Consultant, Biologics CMC Consulting

Kevin is a passionate, committed CMC subject matter expert, developing biologics to help patients and serving biotech community by teaching CMC-related training courses. Kevin has served leadership positions developing therapeutic biological products at AbbVie, AnaptysBio, Catalent Biopharma Solutions (CDMO), IGM Biosciences and Opthea. Kevin not only has in-depth expertise in Analytical Development but also has broad experience in Biologics CMC operation. In the past decades, he has successfully managed many biological drug candidates from early development to commercial. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external CDMO and 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 validation, reference standard qualification, extended characterization, and CMC analytical comparability.

TS9A: Everything You Ever Wanted to Know about Immunogenicity

Detailed Agenda

Chloé Ackaert, PhD, Senior Scientist, Immunogenicity, IQVIA Laboratories

Timothy Hickling, PhD, Investigative and Immunosafety Chapter, Roche

Sofie Pattijn, Founder & CTO, IQVIA Laboratories

This 1-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, the role of AI/ML, and reporting immunogenicity.

INSTRUCTOR BIOGRAPHIES:

Chloé Ackaert, PhD, Senior Scientist, Immunogenicity, IQVIA Laboratories

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.

Timothy Hickling, PhD, Investigative and Immunosafety Chapter, Roche

Tim currently contributes to immunogenicity risk and mitigation strategies for large molecules at Roche, from early discovery projects to those in clinical development and post-marketing. During the last ten years he has contributed immunology expertise to the development of an in silico immunogenicity model, with the purpose of improving predictions of clinical immunogenicity for drug candidates. Tim previously worked on vaccine development and holds a PhD in Immunology from the University of Oxford.

Sofie Pattijn, Founder & CTO, IQVIA Laboratories

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.