About Shawn Heidel, D.V.M., Ph.D.

Shawn Heidel, DVM, Ph.D. is the Executive Director, Lead Optimization Pharmacology & Toxicology at Covance Inc. Shawn Heidel has extensive experience in small and large molecule drug development, from early discovery to post-marketing. He spent 13 years with Eli Lilly and Company in various roles including eight years as a Director of Toxicology and lead of the Toxicology Project Leader and Study Monitor groups. Shawn has been a member of the BioSafe Leadership Committee for the last eight years and was elected as chair two years ago. He has been active in the ICH process as a member and signatory of ICHS6(R1) and as a current member of the ICHS1 Expert Working Group. His current role at Covance includes setting the strategic direction for the Lead Optimization Toxicology, Pathology, and Molecular and Anatomic Imaging groups.

“Fail Fast” Using Toxicology Endpoints in Pharmacology Studies

“Fail Fast” Using Toxicology Endpoints in Pharmacology StudiesSuccessful drug development is increasingly dependent on a robust “fail fast” strategy that includes incorporation of safety / toxicology endpoints into lead optimization pharmacology studies. This early marriage of pharmacology and toxicology will provide insight into the margin of safety that is critical for advancing the molecule, the design of the GLP studies and the clinical plan. Biopharmaceutical companies that employ a “fail fast” strategy can make safety decisions from the integration of toxicology into pharmacology studies, which markedly reduces lead optimization cycle times and overall spend during this phase. Continue reading