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Past Event

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.

Click here to access the full event agenda.

Agenda

Welcome, overview, and meeting objectives

Introductory keynotes: Framing the issues

M

Mark Rogge

Global Head of Clinical Pharmacology, Early Clinical Development - Biogen

J

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

C

Christopher Austin

Director, National Center for Advancing Translational Sciences - National Institutes of Health

J

James Barrett

Professor and Chair, Department of Pharmacology and Physiology - Drexel University

K

Karen Davis-Bruno

Acting Associate Director of Pharmacology/Toxicology, Center for Drug Evaluation and Research - U.S. Food and Drug Administration

V

Volker Fischer

Vice President, Drug Metabolism and Pharmacokinetics - AbbVie

The right dose for the right patient: Challenges and opportunities in dose optimization

S

Sandra Allerheiligen

Vice President, Pharmacokinetics Pharmacometrics Drug Metabolism, Quantitative Pharmacology & Pharmacometrics - Merck Research Laboratories

B

Brenda Cirincione

Group Director, Clinical Pharmacology and Pharmacometrics - Bristol-Myers Squibb

A

Amita Joshi

Senior Director of Clinical Pharmacology - Genentech

L

Lisa LaVange

Director, Office of Biostatistics, Center for Drug Evaluation and Research - U.S. Food and Drug Administration

M

Michael Maitland

Assistant Professor of Medicine - The University of Chicago Medicine

V

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

J

Jack Cook

Vice President, Clinical Pharmacology - Pfizer

C

Carl Peck

Adjunct Professor, Center for Drug Development Science, Department of Bioengineering and Therapeutic Sciences - Schools of Pharmacy and Medicine

S

Steve Ryder

Senior Vice President and Chief Development Officer - Alexion Pharmaceuticals

R

Robert Temple

Deputy Director for Clinical Science, Center for Drug Evaluation and Research - U.S. Food and Drug Administration

I

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

A

Alice Chen

Head, Early Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis - National Cancer Institute

R

Richard Moscicki

Deputy Center Director for Science Operations, Center for Drug Evaluation and Research - U.S. Food and Drug Administration

M

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

Co-Founder, Lab for Economic Opportunities - University of Notre Dame

Recap and closing remarks

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