Tuesday, May 11, 2021 3:30 - 6:00 PM |
SC1: CAR T Cell Therapy from A-Z
Detailed AgendaThis 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.
Tara Arvedson, PhD, Executive Director, Oncology Research, Amgen, Inc.
INSTRUCTOR BIOGRAPHY:
Tara Arvedson, PhD, Executive Director, Oncology Research, Amgen, Inc.
Tara Arvedson, Executive Director in Oncology Research at Amgen, has led multiple T cell therapeutic programs and is currently responsible for a large portfolio of T cell therapeutic assets and platform strategy. She received her Ph.D. at Caltech and was later a Damon Runyon Cancer Research Fellow at UC San Diego.
SC2: Introduction to Gene Therapy Products Manufacturing and Analytics
Detailed AgendaThis 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.
Claire Davies, PhD, Associate Vice President, Bioanalytics, Sanofi
Scott Dooley, Scientist, Analytical Development, Sanofi
INSTRUCTOR BIOGRAPHIES:
Claire Davies, PhD, Associate Vice President, Bioanalytics, Sanofi
After obtaining her PhD from the University of London in 2001, Claire Davies performed her postdoctoral work at the William Harvey Research Institute (WHRI) at Bart’s and The London, Queen Mary's School of Medicine and Dentistry and Joslin Diabetes Center, Harvard Medical School, Boston. Over the last 18 years, Dr Davies has led analytical and CMC teams in product development and analytical method development and validation. Currently, Dr Davies leads Bioanalytics, a group responsible for developing methods and strategies to support process development, product characterization and release and stability testing for therapeutic proteins and gene therapy products in preclinical and clinical development.
Scott Dooley, Scientist, Analytical Development, Sanofi
After obtaining his master’s degree from the University of Massachusetts Amherst in 2013, Scott Dooley began working for the Analytical Development department at Sanofi. Over the past 7 years, Mr. Dooley has supported analytical method development and validation for enzyme-replacement therapies, antibodies, and gene therapy products. Currently, Mr. Dooley acts as the analytical team leader within CMC for two products in clinical development.
Wednesday, May 12, 2021 3:30 - 6:00 PM |
SC3: Developability of Bispecific Antibodies: Formats and Applications
Detailed AgendaBispecific antibodies are a rapidly growing and clinically validated class of antibodies with 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 highlights the rapid growth in the field, therapeutic applications and focuses on challenges with discovery and development of bispecific antibodies. We will use an approved bispecific antibody as a case study to understand the varied aspects of discovery and development of bispecific antibody programs.
Nimish Gera, PhD, Head, Biologics, Mythic Therapeutics
INSTRUCTOR BIOGRAPHY:
Nimish Gera, PhD, Head, Biologics, Mythic Therapeutics
Nimish Gera is the Head of Biologics at Mythic Therapeutics leading multiple projects to engineer and develop novel antibody and antibody-based drugs in oncology and immuno-oncology. Prior to Mythic, Nimish has over ten years of experience in antibody and protein engineering with five years leading bispecific antibody programs in several disease areas such as rare diseases, oncology and immunology at Alexion Pharmaceuticals and Oncobiologics. Nimish received his PhD degree in Chemical and Biomolecular Engineering from North Carolina State University and a B.Tech degree in Chemical Engineering from Indian Institute of Technology, Guwahati.
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