Session 6 – Protein Drugs and Combination Products
Date: 25 July (Thursday) 14:00 – 17:30 Venue: 3F, Bldg. A, CTBC Financial Park, Ballroom B
Sr. Director, R&D
Currently, Larry serves as a Sr. Director R&D at Corvidia Therapeutics where he is a strategic leader for translational sciences and oversees activities to support all pipelines’ clinical and nonclinical studies for therapeutic antibody and peptide program. Prior to Corvidia, Larry served as a Director of Global Biomarker Discovery and Development at Biogen to focus on how to design and execute a biomarker strategy in early clinical development stages. During his 11-year tenant at HGS, his work covered from therapeutic antibody generation, lead discovery and early clinical development. Larry’s work contributed to first FDA approval for Benlysta in Lupus and raxibacumab for anthrax treatment. Larry obtained his Ph.D. in Macromolecular, Cellular Structure and Chemistry from The Scripps Research Institute. Following his Ph.D., Larry continued his work at Scripps in capacity of Research Scientist and then Assistant Professor in Chemistry Department. During his career at Scripps, his works focused in to develop human antibody for catalysis and cancer therapeutic from human antibody phage libraries. Session Speech Title & Synopsis: Current Thoughts on Therapeutic Antibody Discovery & Development
During the past over three decades, over 75 therapeutic antibodies have been approved for many indications, such as in cancer and autoimmune diseases. The landscape for therapeutic antibody of discovery and development has been evolved dramatically since the first one was approved in 1986. Thanks for significant progress made in platform/technology and novel discovery in disease biology, generation of fully human or humanized antibody to a specific target with desired property and potency was much less a challenge nor a hurdle compared to the time decades ago. However, due to the increasing cost of drug development; the promotion in collaborations between early discovery research and clinical scientists to identify and answer critical proof-of-biology (POB) and proof-of-concept (POC) questions became more important.
In this presentation, we will focus on how to align the translational research data from clinical or nonclinical into a strategy at early stage of program. In addition, options to mitigate the potential risks prior to CMC and clinical development will be discussed.