Short Courses

Sunday, May 3 | 10:00 am - 1:00 pm | Morning Short Courses

SC1: Clinical Assessment of Immunogenicity of New Modalities: Focus on Bispecific Antibodies, Gene Therapy and Oligonucleotides

The course will discuss immunoassays and ELISPOT, binding antibody assays, neutralizing antibody assays, and best practices in assay development and validation, as well as reagent challenges.

Instructors: Darshana Jani, MS, Associate Director, Pfizer Inc.

Ramakrishna Boyanapalli, PhD, Associate Director, Bioanalytical and Biomarker Development, Wave Life Sciences

Magdalena Tary-Lehmann, MD, PhD, CSO, Cellular Technology Limited (CTL); Adjunct Associate Professor of Pathology, Case Western Reserve University (CWRU)

Seema Kumar, PhD, Associate Director, Quantitative Pharmacology & Drug Disposition (QPD), R&D Global Early Development (GED), EMD Serono

Linzhi Chen, Senior Research Fellow & Bioanalytical Group Leader, Boehringer Ingelheim Pharmaceuticals

SC2: Translational Biotherapeutic Development Strategies: Part I, Discovery, Molecular Assessment and Early-Stage Development

The rapid rise of antibody-based therapies is due to their desirable safety profile, target specificity, and efficacy. Sources for antibody leads include immunization of animal species, phage-displayed antibody libraries, and direct cloning of antibody encoding genes from plasma and memory B cells of animals and humans. Antibody therapies come in different forms and sizes, including naked IgGs, ADCs, bispecific antibodies, Fc-fusion proteins, radioimmunoglobulins, and antibody fragments. Each modality requires an array of complex engineering steps, such as humanization, affinity maturation, Fc engineering, and linker chemistry. Part 1 of the course will discuss the latest progress in antibody sources, protein engineering, and drug target selection.

Instructors: Zhiqiang An, PhD, Professor, Chemistry; Director, Texas Therapeutics Institute, University of Texas Health Science Center at Houston

Gadi Bornstein, PhD, Senior Director, Biologics Discovery, TESARO, Inc.

Juan Carlos Almagro, PhD, Founder and CEO, GlobalBio, Inc.

SC3: Understanding and Modulating Tumor Microenvironment for Immunotherapy

This interactive short course tackles our emerging understanding of the role of the tumor microenvironment (TME) in tumor immunotherapy. The TME can have a marked immunosuppressive effect leading to suboptimal responses of tumors to immunotherapies. Strategies to change the immunosuppressive nature of the TME to one that supports immune responses and enhances the impact of tumor immunotherapy will be discussed.

Instructors: Scott Gerber, PhD, Assistant Professor, Co-Director, Center for Tumor Immunology Research, Surgery, Microbiology, Immunology, Radiation Oncology, University of Rochester Medical Center

RJ Tesi, MD, CEO, CMO, INmune Bio

SC4: LC-MS Method Validation for Small Molecules in Biological Matrix

This short course will focus on practical LC-MS method validation for small molecules in biological matrix. It will help audiences to comply with the regulations for drug discovery and development. This course will benefit the analytical chemists, lab supervisors, QA/QC managers, regulators, and CRO consultants who work in the GLP-regulated labs and in the pharmaceutical industry. This course will also benefit all levels of management as a refresher course to stay current with the GLP regulations and guidance.

Instructor: Perry Wang, PhD, Research Chemist, US Food and Drug Administration (FDA)

Sunday, May 3 | 2:30 - 4:30 Pm | Afternoon Short Courses

SC7: Introduction to Bispecific Antibodies: Design, Formats and Applications

Bispecific antibodies are a rapidly growing therapeutic modality that allow simultaneous targeting of disease mediators. This course serves as an introduction to bispecific antibodies by highlighting the history, design of different bispecific formats, and therapeutic applications of multiple clinical-stage bispecific antibodies. The course will also contrast the development process of a bispecific program with that of a traditional monospecific antibody and underscore the critical attributes specific to bispecific antibody development.

Instructor: Nimish Gera, PhD, Director, Research and Development, Mythic Therapeutics

Sunday, May 3 | 2:30 - 5:30 pm | Afternoon Short Courses

SC5: In silico and in vitro Immunogenicity Risk Assessment: Overview and Real-Life Examples

Computational immunogenicity predictions for antibodies, as well as pathogens, help in the rational design and re-engineering. This facilitates to minimize anti-drug antibodies (ADA), as well as better vaccine design. Latest in silico tools can shorten the process from design to preclinical validations.

Instructors: Daron Forman, PhD, Principal Scientist, Molecular Discovery Technologies, Bristol-Myers Squibb

Jad Maamary, PhD, Associate Principal Scientist, Predictive and Clinical Immunogenicity, PPDM, Merck & Co. Inc.

SC6: Translational Biotherapeutic Development Strategies: Part II, Analytical and Clinical Considerations

Unlike small molecule drugs, therapeutic antibodies are large, complex molecules that are not easily formulated or delivered, and they are produced as heterogeneous mixtures of molecules, including different glycoforms that can vary greatly in molecular structure. In designing antibody therapeutics, it is sometimes desirable to diminish or abolish the ADCC and CDC functions while retaining its pharmacokinetic profile, in the case of a “benign blocker” antibody. As a result, complex analytical tools have been developed and optimized for the molecular and functional characterization of antibody therapeutics. Part 2 of the course will discuss the protocols for antibody affinity and biophysical characterization, assessment of Fc-immune effector function, and pharmacokinetics of mAbs and Fc-fusion proteins.

Instructors: Tony Christopeit, PhD, Research Scientist, Roche

An Song, PhD, Senior Vice President, Development Sciences, Immune-Onc Therapeutics, Inc.

Liming Liu, PhD, Senior Vice President, Curon Biopharmaceuticals, China

SC8: Engineering Better Antibody Therapeutics Using Computational Approaches

The Oxford Protein Informatics Group tools for therapeutic antibody research includes our structural antibody databases (SAbDab, Thera-SAbDab), our antibody structure prediction suite (SAbPred), and our antibody next-generation sequencing database (OAS). We will also show how the vast numbers of antibody sequences in databases like OAS can be structurally annotated (SAAB+) or modelled (ABodyBuilder). The applications will also cover repertoire mapping, developability issue prediction (TAP), and in silico high-throughput screening.

Instructors: Aleksandr Kovaltsuk, MSc (Glas.), DPhil Student, Oxford Protein Informatics Group, Department of Statistics, University of Oxford

Matthew Raybould, MChem (Oxon.), DPhil Student, Oxford Protein Informatics Group, Department of Statistics, University of Oxford

Tuesday, May 5 | 6:00 - 8:30pm | Dinner Short Courses

SC9: Introduction to Biophysical Analysis for Biotherapeutics: Development Applications

Biotherapeutics are challenging to develop due to complexity of the molecular structure, as well as the manufacturing process. Biophysical methods are crucial tools for analytical characterization of biotherapeutics and are routinely used in all stages of the product lifecycle, including: the initial screening of candidates for potential development liabilities; further characterization of the higher order structure (HOS); identifying optimal conditions to assure stability; and demonstrating HOS preservation during manufacturing, storage, and administration. This short course provides an overview of the common biophysical techniques used for HOS characterization in biologics development and their application considerations.

Instructor: Christine Chan, PhD, Director, Global Manufacturing Science & Technology, Sanofi

SC10: CAR T Cell Therapy from A-Z

This course will provide an overview of the history of the CAR T cell platform including early successes and failures. It will review learnings from the non-clinical and clinical evaluation of CAR T cells in hematologic malignancies and solid tumors. It will discuss challenges encountered with the current CAR T cell formats and approaches to address these challenges followed by discussion of the next generation CAR T cells including technical improvements and therapeutic opportunities.

Instructor: Tara Arvedson, PhD, Director, Oncology Research, Amgen

SC11: Developability of Bispecific Antibodies: Assays and Case Studies

Bispecific antibodies are a rapidly growing and clinically validated class of antibodies with three marketed drugs and multiple candidates in clinical trials. Targeting multiple antigens in a synergistic manner can confer enhanced therapeutic benefit and potentially uncover novel biological mechanisms. However, multiple formats and a tedious candidate selection process to select functional and developable bispecific antibodies makes such programs cumbersome. This short course focuses on challenges with discovery and development of bispecific antibodies. We will review in detail the various assays that could be utilized to assess developability of bispecific antibodies. In addition, we will use an approved bispecific antibody as a case study to understand the varied aspects of discovery and development of bispecific antibody programs.

Instructor: Nimish Gera, PhD, Director, Research and Development, Mythic Therapeutics

SC12: Emerging Applications for Gene Editing, Base Editing and RNA Editing

Gene- and cell-based therapies are yielding promising clinical benefits for treating many diseases and innovations in editing; particularly using the CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)/Cas9 system has been crucial for engineering targeted therapies. This course will highlight some of the new methods and strategies for efficient gene editing, base editing, and RNA editing for targeted in vivo and ex vivo delivery and engineering cells for therapeutic use. Clinical translation and safety concerns surrounding engineered therapies will also be discussed. The instructors will give short talks followed by open discussion with attendees, where they can elaborate on their experiences and expertise.

Instructors: Clifford Steer, MD, Professor of Medicine and Genetics, Cell Biology, and Development; Director, Molecular Gastroenterology Program, University of Minnesota Medical School

Khalid Shah, MS, PhD, Director, Center for Stem Cell Therapies and Imaging, Harvard Medical School; Vice Chair of Research, Brigham and Women’s Hospital

Jonathan Gootenberg, PhD, Fellow, McGovern Institute, MIT

Omar Abudayyeh, PhD, McGovern Fellow, McGovern Institute for Brain Research, MIT

Thursday, May 7 | 5:45 - 8:15 pm | Dinner Short Courses

SC13: Design Strategies and Development of ADCs

Recent innovations in ADC technologies provide new opportunities for successful drug development. What are the critical design factors? What are the considerations for successful ADC development? This short course will review ADC design concepts and strategies for ADC development, including biomarker and patient selection strategies.

Instructor: Robert Lutz, PhD, CSO, Iksuda Therapeutics

SC14: USP Standards to Support Quality of Potency Measurements

USP’s innovative public standards for bioassays have supported potency measurements for decades. Standards range from best practices for development, validation, and analysis of bioassays in general to more specific issues, such as Fc-receptor assay function or new in vitro assays to replace in vivo assays. This course will delve into the current state of documentary standards, as well as new biologics reference standards that support product quality and consistency over time.

Instructors: Steven Walfish, MBA, Principal Scientific Liaison, USP

Maura Kibbey, PhD, Senior Scientific Fellow, Education & Training, Global Biologics, USP

SC15: Introduction to Gene Therapy Products Manufacturing and Analytics

This short course introduces concepts that can be used to facilitate CMC development for gene therapy products. The instructors will review regulatory guidance and present phase-appropriate control strategies. Several CMC challenges unique to this modality will also be discussed, along with different manufacturing platforms. The workshop will include an interactive session on developing an integrated control strategy.

Instructors: Francis Poulin, PhD, Director, Analytical Development, Sanofi

Claire Davies, PhD, Associate Vice President, Bioanalytics, Sanofi

SC16: Assembling an Effective Toolbox of Expression Systems to Support your Research Efforts

This course will discuss the systems necessary to support the expression of both traditional (mAbs) and next-generation formats of proteins to support all aspects of drug discovery. This includes therapeutic candidates, assay reagents, immunogens, and proteins for structural studies.

Instructors: Richard Altman, Field Application Scientist, Protein Expression, Biosciences Division, Life Sciences Solutions Group, Thermo Fisher Scientific

Additional Instructors to be Announced

* The program is subject to change without notice, due to unforeseen reason.

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