Register

July

28
2015

8:30 am EDT - 5:00 pm EDT

Past Event

Improving productivity in pharmaceutical research and development

  • Tuesday, July 28, 2015

    8:30 am - 5:00 pm EDT

Embassy Row Hotel
Ambassador Ball Room

2015 Massachusetts Avenue
Washington, DC
20036

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.

Optimizing target and compound selection to enhance early stage decision-making

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

Precision medicine: Trial enrichment, biomarker science, and mechanistic reasoning to optimize patient selection

Applications of clinical pharmacology to support demonstration of efficacy

Agenda

  • July 28
    • Introductory keynotes: Framing the issues

      9:10 am - 9:40 am

      MR
      Mark Rogge Global Head of Clinical Pharmacology, Early Clinical Development - Biogen
      JW
      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

      9:40 am - 11:00 am

      CA
      Christopher Austin Director, National Center for Advancing Translational Sciences - National Institutes of Health
      JB
      James Barrett Professor and Chair, Department of Pharmacology and Physiology - Drexel University
      KD
      Karen Davis-Bruno Acting Associate Director of Pharmacology/Toxicology, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
      VF
      Volker Fischer Vice President, Drug Metabolism and Pharmacokinetics - AbbVie
      PHvdG
      Piet Hein van der Graaf Director of Research, Academic Center for Drug Research - Leiden University
      PM
      Paul Morgan Head of Translational Safety - AstraZeneca
    • The right dose for the right patient: Challenges and opportunities in dose optimization

      11:10 am - 12:30 pm

      SA
      Sandra Allerheiligen Vice President, Pharmacokinetics Pharmacometrics Drug Metabolism, Quantitative Pharmacology & Pharmacometrics - Merck Research Laboratories
      BC
      Brenda Cirincione Group Director, Clinical Pharmacology and Pharmacometrics - Bristol-Myers Squibb
      AJ
      Amita Joshi Senior Director of Clinical Pharmacology - Genentech
      LL
      Lisa LaVange Director, Office of Biostatistics, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
      MM
      Michael Maitland Assistant Professor of Medicine - The University of Chicago Medicine
      VS
      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

      3:25 pm - 4:45 pm

      AB
      Alasdair Breckenridge Partner - NDA Partners LLC
      JC
      Jack Cook Vice President, Clinical Pharmacology - Pfizer
      CP
      Carl Peck Adjunct Professor, Center for Drug Development Science, Department of Bioengineering and Therapeutic Sciences - Schools of Pharmacy and Medicine
      SR
      Steve Ryder Senior Vice President and Chief Development Officer - Alexion Pharmaceuticals
      RT
      Robert Temple Deputy Director for Clinical Science, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
      IZ
      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

      1:45 pm - 3:15 pm

      fig 1
      Alice Chen Senior Fellow - USC Schaeffer Center, Associate Professor - USC Price School of Public Policy
      CSF
      Co-Moderator: Stephen Friend President, Sage Bionetworks
      RM
      Richard Moscicki Deputy Center Director for Science Operations, Center for Drug Evaluation and Research - U.S. Food and Drug Administration
      MP
      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
      James X. Sullivan Professor of Economics - University of Notre Dame, Co-Founder - Wilson Sheehan Lab for Economic Opportunities
      VV
      Vissia Viglietta Director of Medical Research - Biogen