The Key Pillars for Drug Discovery and Development Programs

This seminar will provide a high-level overview of key considerations for drug discovery programs, including establishing a clear Target Product Profile and a fit-for-purpose testing funnel to efficiently obtain early signs of efficacy. Additionally, this seminar will cover how to integrate exposure analysis and creative safety assessment designs into a program for effectively making go/no-go decisions, as well as satisfying regulatory expectations.

Seminar Topics Include:

• How the critical pillars of a drug discovery program integrated with a well-defined Target Product Profile help enable informed go/no-go decisions.
• Strategies for effectively selecting the right preclinical model to assess disease pharmacology and improve translation to the clinic.
• Creatively designing your exploratory toxicology program for early de-risking.
• What the regulatory agencies expect from a comprehensive safety assessment package.
• Q&A and Consultation Session With Inotiv Scientists

Noel Horton, PhD, DABT, Senior Director Toxicology

Noel joined Inotiv in April 2021 as a Senior Director in Toxicology. He has more than 25 years of experience in Pharmaceutical Development and Contract Research serving as a Drug Development Team Toxicologist, Study Director, Research Advisor, and IACUC Chair.

J. Matthew Hutzler, PhD, Executive Director, Scientific Engagement, Discovery & Translational Sciences (DTS)

He received a Ph.D. in Basic Pharmaceutical Sciences from West Virginia University, specializing in drug metabolism, and completed his postdoctoral training at Pharmacia in Kalamazoo, MI. Dr. Hutzler began his pharmaceutical career at Pfizer Inc. in St. Louis where he helped lead an In Vitro Drug Metabolism core lab and was a DMPK lead for numerous drug discovery programs. Dr. Hutzler also spent five years at Boehringer-Ingelheim Pharmaceuticals as a DMPK project lead in drug discovery, where he worked on integrated project teams supporting inflammation and atherosclerosis therapeutic areas for the nomination of pre-clinical drug candidates. With 20 years of experience in the industry to support drug discovery, Dr. Hutzler’s research has focused on characterizing atypical enzyme kinetics for cytochrome P450 enzymes, mechanistic understanding of clinical drug-drug interactions (DDI), and extrapolation of in vitro data for human pharmacokinetic predictions. Dr. Hutzler has published over 30 peer-reviewed articles in high impact journals and has written three book chapters.

Kelly Long, MS, DABT, Senior Director, Scientific Engagement, Discovery & Translational Sciences (DTS).

Kelly brings over 20 years of pharmaceutical experience in drug discovery to Inotiv, with an emphasis on in vivo pharmacology and toxicology. She received her Master’s Degree in Nutritional Sciences from University of Illinois at Urbana-Champaign. Kelly began her career at Monsanto/Pharmacia/Pfizer in 1998 as an in vivo pharmacologist and functioned as a pharmacology project team leader. She joined Inotiv’s legacy company, Seventh Wave Laboratories, in 2010, as a Study Director and has held roles of increasing responsibility in the Inotiv in-life operation. In her current role as Senior Director of Scientific Engagement, Kelly designs and executes programs for Sponsors to help them achieve their next milestone while providing leadership, strategic direction, and fostering cross-site alignment for pharmacology, toxicology, and other in-life-related topics at Inotiv. She has been a Diplomate of the American Board of Toxicology since 2011 and is a member of the American College of Toxicology, the Society of Toxicology, and the American Society of Gene & Cell Therapy.

Host or Publisher Inotiv