Preclinical Safety Strategies to Impact Early Decision-Making




Recorded September 15, 2015

 

Sponsored by
Elsevier  

Webinar Description:

The educational seminar is intended to provide the current thinking on critical bottlenecks that drug development companies and regulatory agencies continue to face. Leading experts in PK/PD, safety pharmacology and toxicology come together to discuss translational issues that remain challenges even today, despite huge advances in technology and data mining. Issues include, identifying species specific responses, dose selection for first-in-human studies, and more proactive investigation of potential adverse effects to help streamline clinical trials. Hear about the innovative methods that leading companies are using to meet these challenges. The discussion will be limited to preclinical and early clinical development (phases I and phase II studies).

Learning Objectives:

  • Gain insights from leading drug development companies on innovative drug safety assessments programs
  • Listen to thought leader’s solutions around dose and species selection for biologics
  • Explore how improving translational research may have a positive impact in early clinical trials
  • Perspectives on non-traditional approaches and predictive tools being developed for early safety assessments

Speakers:

Laszlo UrbanLaszlo Urban, M.D., Ph.D.

Global Head of Preclinical Secondary Pharmacology (PSP)

Novartis Institutes for Biomedical Research (NIBR)

Laszlo Urban is Global Head of Preclinical Secondary Pharmacology (PSP) at the Novartis Institutes for Biomedical Research (NIBR), Cambridge, MA, USA. He has been with Novartis since 1996, leading various global pharmaceutical research areas.

As the founding leader of PSP, he developed and implemented the early in vitro preclinical safety profiling program for NIBR. Recognising the need for new tools to assess large volumes of data from different sources, he and his team are developing “decision support IT tools” for NIBR, which provide general and easy access to integrated information.

Dr. Urban received his M.D. and Ph.D. in neuropharmacology from Debrecen University, Hungary. He is Honorary Lecturer of the University College London and was a visiting professor at Duke University.

He has published over 160 articles, book chapters and patents, edited 5 books and has served on the editorial board of several journals while also serving as President of the European Neuropeptide Club.

Dr. Bernard FerminDr. Bernard Fermini, Ph.D.

Manager: Ion Channel Safety Group

Pfizer

 

Dr. Bernard Fermini manages the Ion Channel Safety group at Pfizer in Groton, CT. He obtained a PhD in Biophysics (University of Sherbrooke) in 1987 and has over 25 years of experience in cardiac electrophysiology and pharmacology. His current work focuses on studying the effects of new chemical entities on ion channels involved in cardiac repolarization, and the development of various in vitro models for assessing the potential for drug-induced QT interval changes.

Noël Dybdal, D.V.M., Ph.D., D.A.C.V.P.

Director and Principal Scientist-Pathologist

Genentech

 

Noël Dybdal, D.V.M., Ph.D., D.A.C.V.P. is a Director and Principal Scientist-Pathologist in the Development Sciences organization at Genentech. She leads the Safety Assessment Pathology group. Noël joined Genentech in 1992 as a Scientist-Pathologist. In her positions there she has been part of many drug development projects supporting Genentech’s many large and small molecule drug development programs.

Moderator:
William MattesWilliam B Mattes, Ph.D., DABT

Director of the Division of Systems Biology

FDA’s National Center for Toxicological Research

William B Mattes, Ph.D., DABT is the Director of the Division of Systems Biology, part of the FDA’s National Center for Toxicological Research in Jefferson, Arkansas. He has been an independent consultant as well as Director of Toxicology at the Critical Path Institute where he developed and directed the Predictive Safety Testing Consortium (PSTC), a collaboration of 16 of the world’s major pharmaceutical companies, with FDA and EMEA advisors, with the goal of qualifying new biomarkers for drug safety in a regulatory setting. Dr. Mattes also developed the COPD Biomarkers Qualification Consortium, serving as its Senior Director and overseeing interactions with the FDA. Dr. Mattes other positions included senior scientific director of Toxicogenomics at Gene Logic, Associate Director of Toxicogenomics and Group Leader of Genetic Toxicology at Pharmacia Corp, Kalamazoo, MI, Group Leader of Experimental Toxicology and Metabolism at Ciba Pharmaceuticals, Summit, NJ, and Group Leader of Molecular and Cellular Toxicology, Ciba-Geigy Agricultural Chemical Division, Farmington, CT. Dr. Mattes received his BA from the University of Pennsylvania and Ph.D. in biological chemistry from the University of Michigan, Ann Arbor. He did his postdoctoral training in biochemistry at the Johns Hopkins University, and was a staff fellow at the National Cancer Institute, the National Institutes of Health (NCI/NIH).



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