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Blinding in Early Clinical Development Trials

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Contributors

  • Jack Cook, Ph.D.

    Jack Cook, Ph.D. is a Vice President in the Clinical Pharmacology Department of the Global Product Development unit at Pfizer, Inc. Dr. Cook holds adjunct faculty positions at the Universities of Michigan and Florida Colleges of Pharmacy. He received B.S. degrees in Applied Mathematics and Pharmacy from Ferris State College, and his Ph.D. in Pharmaceutics from the University of Michigan. He has authored/co-authored over 70 peer-reviewed publications. He served as an industrial representative for the United States Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committees from 2012 to 2019. He is a fellow of the AAPS. His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs

  • Jitendra Kanodia, Ph.D.

    Jitendra Kanodia is the Director of Clinical and Translational Pharmacology at Theravance Biopharma in South San Francisco, California, USA. He is also the Project Team Leader for a Phase-1 clinical asset in development for treatment of pulmonary diseases. Jitendra is an incoming member of the IQ CPLG (Clinical Pharmacology Leadership Group) and an active participant in multiple IQ working groups including Unblinding in clinical trials, BCS-based biowaivers, Ophthalmology, Impact of COVID on PKPD and Organ impairment.

    Jitendra received his Ph.D. in Chemical and Biological Engineering from Princeton University, USA and has played a composite role of systems biologist, quantitative systems pharmacologist, non-clinical PKPD and clinical pharmacologist at current and previous positions. He is passionate about utilizing quantitative methods to enable more efficient decision-making during drug development and especially interested in the early phases of clinical development (e.g. experimental medicine and Phase 1-2 studies).

  • Sebastian Haertter, Ph.D.

    Dr. Haertter is currently Clinical Pharmacology Expert at Boehringer Ingelheim (BI). He is further member of Cardiometabolism Therapeutic Area leading bodies at BI (Clin Expert Committee, Ther Area Leading Committee). He is also representative of Translational Science and Clinical Pharmacology in the BI Clinical Pediatric Expert Group, the Global Labeling and Risk/Benefit Committee, and Inlicensing expert groups.

    Dr. Haertter is member of the IQ-Clin Pharm LG (CPLG) and chair of the IQ-CPLG Pediatrics WG and the Exploratory Trial Design WG. He is pharmacist by training, received his PhD in pharm chemistry and a lecturing degree (German Habilitation) in Pharmacology&Toxicology. He was in the past assistant professor at the University of Mainz (Germany), Adjunct Professor at the Universities of Ulm (Germany), Connecticut and Albany, NY and is author or co-author of > 100 peer reviewed publications. He served as PhRMA deputy topic lead for ICH M9-Working Group, is currently EFPIA topic lead in the ICH M13 (Bioequivalence) Working Group and member of the EFPIA expert group in support of ICH M12 – DDI.

February 25, 2021
Thu 10:30 AM EST

Duration 1H 30M

This live web event has ended.