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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
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Appendix A

Workshop Agenda

New Paradigms in Drug Discovery: How Genomic Data Are Being Used to Revolutionize the Drug Discovery and Development Process—A Workshop

March 21, 2012

20 F Street NW Conference Center
20 F Street, NW
Washington, DC 20001



WORKSHOP OBJECTIVES

•   To examine the impact of and investment in the use of genetic and genomic data in drug development.

•   To discuss how genomic and genetic data have been and will be used in the drug development process to improve aspects such as target identification, clinical trial design, pharmacogenomic approaches, biomarker development, and understanding of disease biology.

•   To investigate the economic drivers, incentives, and models for genomic-based strategies for drug development.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
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8:30–8:35 A.M.

WELCOMING REMARKS

Wylie Burke, Roundtable Chair
Professor and Chair, Department of Bioethics and Humanities, University of Washington

 
8:35–8:45 A.M.

CHARGE TO WORKSHOP SPEAKERS AND PARTICIPANTS

Geoffrey Ginsburg
Director, Center for Genomic Medicine, Duke University

 
8:45–10:15 A.M.

CURRENT LANDSCAPE

Session Moderator: Aidan Power, Pfizer Inc.

 
8:45–9:00 A.M.

Current Use of Genetic and Genomic Strategies in Drug Development

Nicholas Davies
Partner, Pharmaceutical and Life Sciences Practice, PwC

 
9:00–9:15 A.M.

Economic Incentives for Genetic and Genomic Strategies

Mark Trusheim
Visiting Scientist and Executive-in-Residence, MIT Sloan School of Management; President, Co-Bio Consulting

 
9:15–9:30 A.M.

Perceived Challenges in Genomic-Based Drug Development

Garret A. FitzGerald
Professor of Medicine and Pharmacology and McNeil Professor in Translational Medicine and Therapeutics; Associate Dean for Translational Research; Chair, Department of Pharmacology; Director, Institute for Translational Medicine and Therapeutics, University of Pennsylvania School of Medicine

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
 
9:30–10:15 A.M.

Discussion with Speakers and Attendees

 
10:15–10:30 A.M.

BREAK

 
10:30 A.M.–12:15 P.M.

DRUG DISCOVERY AND DEVELOPMENT: CASE STUDIES OF GENOMICS-BASED DRUG DEVELOPMENT

Session Moderator: Michelle Penny, Eli Lilly and Company

 
10:30–10:50 A.M.

Development of Crizotinib for Treatment of Non-Small-Cell Lung Cancer

Steffan N. Ho
Director, Translational Oncology, Pfizer Inc.

 
10:50–11:10 A.M.

Use of Genetics to Inform Drug Development of a Novel Treatment for Schizophrenia

Laura Nisenbaum
Senior Research Advisor, Pharmacogenomics, Translational Medicine and Tailored Therapeutics, Eli Lilly and Company

 
11:10–11:30 A.M.

A Genetic Approach to the Treatment of Cystic Fibrosis

Peter Mueller
Executive Vice President, Global Research and Development; Chief Scientific Officer, Vertex Pharmaceuticals Incorporated

 
11:30 A.M.–12:15 P.M.

Discussion with Speakers and Attendees

 
12:15–1:00 P.M.

WORKING LUNCH

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
 
1:00–2:15 P.M.

UTILITY OF EMERGING GENOMICS TECHNOLOGY IN DRUG DEVELOPMENT

Session Moderator: Geoffrey Ginsburg, Duke University

 
1:00–1:15 P.M.

Large-Scale Whole-Genome Sequencing for Disease Understanding, Drug Development, and Genomic Medicine

Radoje Drmanac
Co-Founder and Chief Scientific Officer, Complete Genomics

 
1:15–1:30 P.M.

Clinical Next Generation Sequencing—Value to Drug Developers

Gary Palmer
Senior Vice President, Medical Affairs and Commercial Development, Foundation Medicine

 
1:30–1:45 P.M.

Pharma Perspective

Jane Fridlyand
Senior Statistical Scientist, Genentech

 
1:45–2:15 P.M.

Discussion with Speakers and Attendees

 
2:15–4:15 P.M.

EVOLVING PARADIGMS

Session Moderator: Sharon Terry, Genetic Alliance

 
2:15–2:30 P.M.

Foundations and Drug Development

Walter Capone
Chief Operating Officer, Multiple Myeloma Research Foundation

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
 
2:30–2:45 P.M.

Genomics and Regulatory Science

Michael Pacanowski
Team Leader, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

 
2:45–3:00 P.M.

BREAK

 
3:00–3:15 P.M.

Repurposing of Drugs

Christopher Austin
Director of the Division of Pre-Clinical Innovation; Scientific Director, NIH Center for Translational Therapeutics; National Center for Advancing Translational Sciences, National Institutes of Health

 
3:15–3:30 P.M.

Pharmacy Benefit Management and Pharmacogenomics

Felix W. Frueh
President, Medco Research Institute

 
3:30–4:15 P.M.

Discussion with Speakers and Attendees

 
4:15–5:30 P.M.

LEADING THE STRATEGY FOR PERSONALIZED MEDICINE: PHARMA, GOVERNMENT, ACADEMIA—HOW DO WE ALL WORK TOGETHER?

Session Moderator: Thomas Lehner,
National Institute of Mental Health, National Institutes of Health

Discussants:

Deborah Dunsire
President and Chief Executive Officer, Millennium: The Takeda Oncology Company

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×

Victor Dzau
Chancellor for Health Affairs, Duke University; President and Chief Executive Officer, Duke University Health System

Margaret Hamburg
Commissioner, U.S. Food and Drug Administration

Kathy Hudson
Deputy Director for Science, Outreach, and Policy; Acting Deputy Director, National Center for Advancing Translational Sciences, National Institutes of Health

 
5:30–5:45 P.M.

CONCLUDING REMARKS

Geoffrey Ginsburg
Director, Center for Genomic Medicine, Duke University

 
5:45 P.M.

ADJOURN

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
Page 59
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
Page 60
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
Page 61
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
Page 62
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
Page 63
Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2012. Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13436.
×
Page 64
Next: Appendix B: Speaker Biographical Sketches »
Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary Get This Book
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The number of new drug approvals has remained reasonably steady for the past 50 years at around 20 to 30 per year, while at the same time the total spending on health-related research and development has tripled since 1990. There are many suspected causes for this trend, including increases in regulatory barriers, the rising costs of scientific inquiry, a decrease in research and development efficiency, the downstream effects of patient expirations on investment, and the lack of production models that have successfully incorporated new technology. Regardless, this trajectory is not economically sustainable for the businesses involved, and, in response, many companies are turning toward collaborative models of drug development, whether with other industrial firms, academia, or government. Introducing greater efficiency and knowledge into these new models and aligning incentives among participants may help to reverse the trends highlighted above, while producing more effective drugs in the process.

Genome-Based Therapeutics explains that new technologies have the potential to open up avenues of development and to identify new drug targets to pursue. Specifically, improved validation of gene-disease associations through genomics research has the potential to revolutionize drug production and lower development costs. Genetic information has helped developers by increasing their understanding of the mechanisms of disease as well as individual patients' reactions to their medications. There is a need to identify the success factors for the various models that are being developed, whether they are industry-led, academia-led, or collaborations between the two.

Genome-Based Therapeutics summarizes a workshop that was held on March 21, 2012, titled New Paradigms in Drug Discovery: How Genomic Data Are Being Used to Revolutionize the Drug Discovery and Development Process. At this workshop the goal was to examine the general approaches being used to apply successes achieved so far, and the challenges ahead.

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