Provide preclinical consulting services to biotech and pharmaceutical companies. Specialities include toxicology, pharmacology, PK/PD, and TK..

SUMMARY: Offer preclinical solutions in discovery and development of pharmaceuticals. Eleven years of industry experience with small molecules, monoclonal antibodies, and proteins. Supported over 30 clinical trials and regulatory filings including 21 INDs, 11 Phase 2 starts, bioequivalence trials, supplemental NDA, and BLA. Experience includes designing ICH compliant programs and implementing over 196 GLP toxicology studies; conducting numerous PK/PD/ADME and pharmacology assessments; outsourcin...

SUMMARY: Offer preclinical solutions in discovery and development of pharmaceuticals. Eleven years of industry experience with small molecules, monoclonal antibodies, and proteins. Supported over 30 clinical trials and regulatory filings including 21 INDs, 11 Phase 2 starts, bioequivalence trials, supplemental NDA, and BLA. Experience includes designing ICH compliant programs and implementing over 196 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. Led by Peter Korytko, PhD, MBA.