Who We Are
Peter Korytko has over 15 years of pharmaceutical/biotech industry experience (Pfizer, Amgen, and Preclinical GPS) with preclinical development of small molecules, monoclonal antibodies, proteins, and oligonucleotides preceded by a PhD (Cornell University) and MBA (DePaul University). In those 15 years, Peter supported 36 clinical trials and regulatory filings including 21 INDs, numerous Phase 2 starts, bioequivalence trials and supplemental NDA. Peter’s experience includes designing ICH compliant programs; implementing over 196 GLP toxicology studies and over 800 total preclinical studies; conducting numerous PK/PD/ADME and pharmacology assessments; outsourcing and monitoring external studies; supporting clinical development and regulatory affairs; leading teams; strategic publications; communicating recommendations to management; and interacting with regulatory agencies (FDA, Health Canada, and EMA).
Preclinical GPS LLC was originally formed as Preclinical Safety Consulting. The name of the company was changed to Preclinical GPS – Global Preclinical Services LLC with the expansion of services beyond preclinical safety and the opening of company offices and affiliates in the US, Canada, and India.