Connect with our monoclonal antibody (mAb) development experts at the upcoming PBSS workshop in Burlingame, CA, on June 11th at the Hilton San Francisco Airport Bayfront.

Workshop Title: Antibody Preclinical Development & IND Filing: Nuts, Bolts, Best Practices and Regulatory Strategies (In Collaboration with The Antibody Society)

Event Summary
The IND application is a critical step in a drug development program, and understanding the requirements for a successful IND filing is essential to ensure fast, efficient development. While the principles and basics are similar across different modalities for an IND filing such as safety studies, there are important aspects that need to be considered for antibody-based therapeutics (antibodies, antibody-drug conjugates and multispecific antibodies). In this workshop, our highly experienced speakers from industry and the FDA will discuss the necessary preclinical studies for an antibody candidate and the best practices and regulatory strategies for a successful IND package of an antibody candidate.

Key Topics Covered:
-Overview of antibody-based therapeutics: structure, generation, design, and optimization
-Overview of preclinical development and IND filing requirements for antibody-based therapeutics
-Non-clinical pharmacology considerations, antibodies and in vivo disease modeling
-Pharmacokinetic/Pharmacodynamic and bioanalytical considerations for successful IND filings
-Human dose projection through clinpharm quantitative modeling
-Preclinical toxicology studies
-IND-enabling CMC activities
-Clinical Development Plan
-Regulatory strategies and interactions with FDA: Industry perspective & how to prepare for FDA meetings
-The regulatory perspective: the do’s and don’ts and avoiding a clinical hold

Speakers:

Laurence Fayadat-Dilman, PhD, Merck; Ayse Meric Ovacik, PhD, Genentech; Stephanie Casey Parks, PhD, Amgen; Jay Tibbitts, PhD, Lycia; Saroja Ramanujan, PhD, Independent; Smita Salian-Mehta, PhD, Gilead; Lilia Koriazova, PhD, Erasca; Sara Glickstein Bar-Zeev, PhD, Genentech; Lauren Dam, Genentech; Leah Rosenfeld, PhD, FDA

Schedule a Meeting with our Experts