9776 NE Radio School Rd
Suite 100 Bainbridge Island, WA 98110
USA
Contact Information:
Telephone:
(206) 842-1004
Mobile Number:
(206) 473-2913
Email Address:
Peter.Korytko@gmail.com
Specialties
Develop and implement preclinical strategies to support small and large molecule pharmaceuticals including antibodies, antibody-drug conjugates, peptides, and RNA-based drugs.Regulatory writing (IND, IB, BLA, CTA).Study support: design, implement, monitor, and interpret, toxicology studies. Study types include genetic toxicity, safety pharmacology, general toxicology, and reproductive toxicology.
Experience
My background includes 12 years of pharmaceutical industry experience with small molecules, monoclonal antibodies, proteins and RNA preceded by a PhD (Cornell University) and MBA (DePaul University). In those 12 years, I supported 29 clinical trials and regulatory filings including 18 INDs, numerous Phase 2 starts, bioequivalence trials and 1 supplemental NDA. I am currently authoring the preclinical section of a Biologics Licensing Agreement. My experience includes designing ICH compliant programs and implementing over 170 GLP toxicology studies; conducting numerous PK/PD/ADME and pharmacology assessments; outsourcing and monitoring external studies; supporting clinical development and regulatory affairs; leading teams; strategic publications; and communicating recommendations to management. Therapeutic areas include inflammation, oncology, bone growth, and pain.
