Preclinical Development Discussion: The "Black Box" between Med Chem and Clinical
Peter Korytko
CEO, Preclinical GPS
A discussion with pharma leaders on the roadmap for early development with Tox, ADME, CMC and Phase 1 clinical design. Topics include Toxicity program for peptides, how to pick clinical dose, and preclinical to clinical translation. Panelists brought their experiences and discussed lessons learned in short presentations and a moderated roundtable.
Peter Korytko has 25 years of pharmaceutical/biotech industry experience (Pfizer, Amgen, and Preclinical GPS) with preclinical development of peptides, small molecules, monoclonal antibodies, proteins, and oligonucleotides preceded by a PhD (Cornell University) and MBA (DePaul University). Peter was lead toxicologist or nonclinical scientist for 47 Phase 1 starts, >30 Phase 2 clinical studies, and 2 NDAs, as well as >1400 nonclinical studies.
Preclinical GPS is a consulting company that helps biotech companies with successfull nonclinical programs.