Improving productivity in pharmaceutical research and development
Past Event
Introductory keynotes: Framing the issues
The high failure rate of investigational compounds during drug development, especially in late stages of the clinical development process, is widely seen as a key contributor to the outsize amount of time and resources necessary to develop new drugs. Advances in clinical pharmacology and experimental medicine have the potential to rebalance these trends by providing researchers with the tools to more efficiently and systematically identify promising targets and compounds, appropriate patient populations, and adequate doses for study much earlier in development.
On July 28, the Center for Health Policy at Brookings, in collaboration with the International Consortium for Innovation & Quality in Pharmaceutical Development and the U.S. Food and Drug Administration (FDA), hosted a public meeting to tackle these issues. Through presentations and case studies, leading experts from industry, academia, and government agencies explored the evolving role of clinical pharmacology tools in pre-clinical and clinical development, existing gaps in the application of those tools, and how emerging science could be better leveraged to improve the efficiency of drug development programs and better optimize treatments. Discussion at this event will potentially be harnessed to inform downstream guidance documents, to establish best practices for the application of emerging clinical pharmacology tools, or to support academic publications. Speakers will convene privately to discuss such downstream deliverables and key takeaways from the conference.
Agenda
Welcome, overview, and meeting objectives
Introductory keynotes: Framing the issues
Mark Rogge
Global Head of Clinical Pharmacology, Early Clinical Development - Biogen
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Optimizing target and compound selection to enhance early stage decision-making
Christopher Austin
Director, National Center for Advancing Translational Sciences - National Institutes of Health
James Barrett
Professor and Chair, Department of Pharmacology and Physiology - Drexel University
Karen Davis-Bruno
Acting Associate Director of Pharmacology/Toxicology, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
Volker Fischer
Vice President, Drug Metabolism and Pharmacokinetics - AbbVie
Piet Hein van der Graaf
Director of Research, Academic Center for Drug Research - Leiden University
Paul Morgan
Head of Translational Safety - AstraZeneca
The right dose for the right patient: Challenges and opportunities in dose optimization
Sandra Allerheiligen
Vice President, Pharmacokinetics Pharmacometrics Drug Metabolism, Quantitative Pharmacology & Pharmacometrics - Merck Research Laboratories
Brenda Cirincione
Group Director, Clinical Pharmacology and Pharmacometrics - Bristol-Myers Squibb
Amita Joshi
Senior Director of Clinical Pharmacology - Genentech
Lisa LaVange
Director, Office of Biostatistics, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
Michael Maitland
Assistant Professor of Medicine - The University of Chicago Medicine
Vikram Sinha
Director, Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
Applications of clinical pharmacology to support demonstration of efficacy
Alasdair Breckenridge
Partner - NDA Partners LLC
Jack Cook
Vice President, Clinical Pharmacology - Pfizer
Carl Peck
Adjunct Professor, Center for Drug Development Science, Department of Bioengineering and Therapeutic Sciences - Schools of Pharmacy and Medicine
Steve Ryder
Senior Vice President and Chief Development Officer - Alexion Pharmaceuticals
Robert Temple
Deputy Director for Clinical Science, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
Issam Zineh
Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
Precision medicine: Trial enrichment, biomarker science, and mechanistic reasoning to optimize patient selection
Alice Chen
Senior Fellow - USC Schaeffer Center
Associate Professor - USC Price School of Public Policy
Co-Moderator: Stephen Friend
President, Sage Bionetworks
Richard Moscicki
Deputy Center Director for Science Operations, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
Michael Pacanowski
Associate Director for Genomics and Targeted Therapy, Office of Clinical Pharmacology, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
James X. Sullivan
Professor of Economics - University of Notre Dame
Co-Founder - Wilson Sheehan Lab for Economic Opportunities
Vissia Viglietta
Director of Medical Research - Biogen
Recap and closing remarks
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