Successful 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.
This webinar will focus on lead optimization pharmacology and toxicology and a fail fast strategy that many companies are using. The advantages and disadvantages of incorporating safety and toxicology endpoints in pharmacology studies will be discussed along with case studies demonstrating their potential value.
Speaker
Shawn Heidel, D.V.M., Ph.D., Executive Director, Global Discovery Pharmacology & Toxicology, Covance
Dr. Shawn Heidel acquired his Ph.D. in Immunotoxicology from the University of Wisconsin and now directs the strategic plan for lead optimization toxicology, pathology, and molecular and anatomic imaging groups at Covance. He also serves at Covance as a subject matter expert for biotherapeutics development and consults on business and scientific matters with client senior leadership.
Dr. Heidel has experience in safety and efficacy evaluation of both small molecules and biotherapeutics with more than 13 years of experience in small and large molecule drug development, from early discovery to post-marketing. Prior to this position, Dr. Heidel has served as the Director of Toxicology at Eli Lilly & Co., received 2 Lilly Research Labs President’s Awards for scientific achievement, and led the Toxicology Project Leader and Study Monitor groups. He currently serves as an expert working group member of ICHS1 and has been an expert working group member and signatory of ICHS6(R1). Additionally, he is serving as a current member and past-chair of the BioSafe Leadership Committee.
Dr. Heidel has been published in many leading pharmacology and toxicology related journals and has been invited to speak at numerous regulatory and Pharmaceutical industry meetings in the U.S.A, the E.U., and Japan.
Message PresenterWho Should Attend?
This webinar is intended for Drug development scientists and decision makers with a focus on lead optimization pharmacology & toxicology
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Covance
Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 11,000 employees in more than 60 countries. Covance has the people, processes, client service, and global resource capabilities to respond to biotechnology and Pharmaceutical clients’ toughest drug development challenges.
Covance Discovery and Translational Services more effectively and efficiently bridges research gaps by providing integrated solutions throughout preclinical and clinical phases of development. Only Covance drives innovative pipeline development—by integrating Lead Optimization safety and efficacy services with expert capabilities in Biomarkers, Genomics, Antibody Products & Immunology Services.
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