Webinar: Becoming the early bird - Establishing a dialogue with the FDA around accelerating preclinical research

Despite technology advances that have improved the ability of bench scientists to rapidly identify new drug targets, translating laboratory discoveries into marketable products remains a frustratingly slow process that often leads to dead ends. But by establishing an early dialogue with the FDA—when potential products are still in preclinical testing—companies can gain valuable insights that could boost their chances of success.

In 2019, the FDA announced a new effort to modernize drug development, which included helping companies to streamline the preclinical phase of the process. The agency expressed an interest in working with companies to identify technology tools that can be used instead of animal trials to test toxicity, for example, and to improve the detection of biomarkers that might enhance patient selection for clinical trials.

This webinar will bring together experts in preclinical trial design, R&D efficiency and regulatory affairs to offer advice on how companies can best engage the FDA early in the research process.

Topics include:

  • Strategies for determining the best timeline for approaching the FDA with a new drug candidate
  • A review of new technologies designed to speed up preclinical testing
  • How fast is too fast? Ensuring the proper balance between streamlining preclinical research and gathering enough data to satisfy regulators

Stacie Shepherd, M.D., Ph.D.

Chief Medical Officer

Fore Biotherapeutics

Dr. Shepherd served as SVP of Clinical Development at QED Therapeutics before joining Fore, leading oncology program clinical development, operations and translational science. Prior, she served as VP, Oncology at Corcept Therapeutics and Senior Medical Director at AbbVie where she led clinical development of PARP inhibitor programs in ovarian and BRCA-mutated breast cancer. Dr. Shepherd received her M.D./Ph.D. in Medicine and Neuroscience from the University of Illinois (Urbana-Champaign) and trained in Pediatrics at St. Louis Children’s Hospital and Pediatric Endocrinology.

Judy Chou, Ph.D.

President and Chief Executive Officer

AltruBio Inc.

Dr. Judy Chou has 25 years of experience in drug development and biomanufacturing. Before joining AltruBio, she headed the global biotech organization at Bayer Pharmaceuticals overseeing the manufacturing and distribution of Bayer’s $3+ billion per year biotechnology product portfolio & 2000+ employees and leading the drug development activities for Biologics pipeline. Prior to Bayer she has held leadership and drug development roles at Pfizer, Genentech, Wyeth and Abbott and was integral in the successful launch of Humira.


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