TS6A: Intro to Bispecifics: History, Engineering, and Application

Day 1: 13:30 - 19:30 | Day 2: 08:30 - 18:30

Room 5B


G. Jonah Rainey, PhD, CEO, Oriole Biotech

Training Seminar Description:
Intro to Bispecifics 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. 

Topics to be Covered:

  • A brief history of bispecific antibodies: 57 years of progress with critical advances and key pioneers
  • Bispecific applications and powerful mechanisms of action
  • Engineering bispecific antibodies: 80 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 Biography:

Dr. Jonah Rainey is currently the CEO of Oriole, a consulting and research organization focused on discovery through early development of biologic in San Diego. He holds a PhD in Biochemistry from Tufts University and completed postdoctoral training at the University of Wisconsin and the Salk Institute. He has been actively engaged in discovery, research, and development of bispecific antibodies in a biotech setting for 12 years. He is an inventor on several patents and applications describing novel bispecific platforms as well as current clinical candidates that exploit these platforms. Dr. Rainey led or had major contributions to research and early development of at least three current clinical candidates in phase 1 and 2, and led many additional advanced preclinical programs in oncology, infectious disease, autoimmunity, and other therapeutic areas. Industry experience spans small biotech (MacroGenics, MabVax) and large pharma settings (MedImmune/Astrazeneca).