TS6A: Intro to Bispecifics: History, Engineering, and Application
MONDAY 12 NOVEMBER AND TUESDAY 13 NOVEMBER
Day 1: 13:30 - 19:30 | Day 2: 08:30 - 18:30
Room 5B
Instructor:
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).