Health Care Policy
A first look at outcomes under the No Surprises Act arbitration process
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.
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
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July 28
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Introductory keynotes: Framing the issues
9:10 am - 9:40 am
MRMark Rogge Global Head of Clinical Pharmacology, Early Clinical Development - BiogenJWJanet 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
CAChristopher Austin Director, National Center for Advancing Translational Sciences - National Institutes of HealthJBJames Barrett Professor and Chair, Department of Pharmacology and Physiology - Drexel UniversityKDKaren Davis-Bruno Acting Associate Director of Pharmacology/Toxicology, Center for Drug Evaluation and Research - U.S. Food and Drug AdministrationVFVolker Fischer Vice President, Drug Metabolism and Pharmacokinetics - AbbViePHvdGPiet Hein van der Graaf Director of Research, Academic Center for Drug Research - Leiden UniversityPMPaul 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
SASandra Allerheiligen Vice President, Pharmacokinetics Pharmacometrics Drug Metabolism, Quantitative Pharmacology & Pharmacometrics - Merck Research LaboratoriesBCBrenda Cirincione Group Director, Clinical Pharmacology and Pharmacometrics - Bristol-Myers SquibbAJAmita Joshi Senior Director of Clinical Pharmacology - GenentechLLLisa LaVange Director, Office of Biostatistics, Center for Drug Evaluation and Research - U.S. Food and Drug AdministrationMMMichael Maitland Assistant Professor of Medicine - The University of Chicago MedicineVSVikram 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
ABAlasdair Breckenridge Partner - NDA Partners LLCSRSteve Ryder Senior Vice President and Chief Development Officer - Alexion PharmaceuticalsRTRobert Temple Deputy Director for Clinical Science, Center for Drug Evaluation and Research - U.S. Food and Drug AdministrationIZIssam 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
Alice Chen Senior Fellow - USC Schaeffer Center, Associate Professor - USC Price School of Public Policy @alicejychenCSFCo-Moderator: Stephen Friend President, Sage BionetworksRMRichard Moscicki Deputy Center Director for Science Operations, Center for Drug Evaluation and Research - U.S. Food and Drug AdministrationMPMichael 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 OpportunitiesVVVissia Viglietta Director of Medical Research - Biogen
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