Peter Korytko, Ph.D.
Senior Associate, Toxicology
Expert in non-clinical study design and executionPharmaceutical industry experience with small molecules, monoclonal antibodies, and proteins. Has supported 29 clinical trials and regulatory filings including 18 INDs, numerous Phase 2 starts, bioequivalence trials and 1 supplemental NDA. Experience includes authoring regulatory documents including BLA, IND, IB, and briefing packages; designing ICH compliant toxicology programs and implementing over 171 GLP toxicology studies; conducting numerous PK/PD/ADME and pharmacology assessments; outsourcing and monitoring external studies; supporting clinical development and regulatory affairs; due diligence; leading teams; strategic publications; and communicating recommendations to management. Therapeutic areas include inflammation, oncology, bone growth, and pain.