ABCs of the FDA: How to Set Up a Preclinical Road Map
Moving a program from Discovery through Development is an arduous task. Key among these challenges is designing a safe and druggable molecule that can withstand the rigors of preclinical testing in support of First in Human (FIH) trials, human Proof of Concept (POC), and ultimately global drug registration. This session will highlight design considerations to optimize drug disposition and safety characteristics in the Discovery phase, so that the preclinical road in Development will be a smooth one. In addition, you will learn what startups need to know about preclinical requirements and resources to support early clinical trials through Human POC. This “how to” workshop is geared towards pharmaceutical and biotech startups.
Topics will include:
–Key drug metabolism, pharmacokinetic and toxicology characteristics that should be considered in molecule design
–Preclinical requirements to support FIH and POC
–Evaluating preclinical resources (consultants and CROs) to support your program
–Hiring your first Preclinical FTE
The workshop will feature Michael Kelley, VMD, Ph.D., DABT, Senior Scientific Director with Janssen Research & Development. Mike has over 25 years of industry experience and has held leadership positions in both small and large biopharmaceutical companies.
The “How to…Workshop” series is dedicated to giving you the keys to a successful business, from creation to exit. As with all our events, the “How to…Workshop” is interactive and informal so bring your questions with you!
Michael Kelley, VMD, Ph.D., DABT | Senior Scientific Director, Janssen Research & Development read bio»
4:00 PM | Registration and Networking
4:30 PM | Presentation
5:30 PM | Networking Reception
6:30 PM | Program Close
$35 General Public