Greater certainity to your drug development lifecyle

May 14-16, 2024

Location

Convene CityView
30 S 17th St
Philadelphia, PA 19103

Certainty is an innovation showcase of the latest capabilities products and services available across the Certara platform and ecosystem.

Vice President in Toxicology  

Derek Leishman, PhD, Eli Lilly and Company

personal info

Derek Leishman is Vice President in Toxicology at Eli Lilly and Company with 34 years of industry experience spanning Marion Merrell Dow, Pfizer, and Lilly. His career has been anchored in cardiovascular safety pharmacology, with modeling and simulation as a consistent methodological thread from his earliest work at Pfizer through to his current research program.

 

A deliberate five-year move to lead Lilly’s Diabetes PKPD group (2013–2018) deepened his quantitative pharmacology fluency, which he subsequently brought back to safety — integrating PKPD thinking into cardiac risk assessment frameworks that now underpin his Bayesian weight-of-evidence work.

 

Derek is Rapporteur of the ICH E14/S7B Implementation Working Group and has been central to establishing the integrated nonclinical/clinical QTc assessment paradigm that replaced the mandatory thorough QT study. He is currently co-leading the revision of ICH S7A, the foundational safety pharmacology guidance last updated in 2000. He is co-chair of Lilly’s Cardiovascular Safety Advisory Committee and a past president of the Safety Pharmacology Society.

 

His collaborative safety modelling work includes participation in the TIPharma project and the TransQST EU IMI2 program, where he served as EFPIA co-chair. He holds a first-class honors degree and PhD in pharmacology from the University of Aberdeen.

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