Enabling Precision Medicine The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop (2017) / Chapter Skim
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Appendix B: Statement of Task and Workshop Agenda
Appendix B: Statement of Task and Workshop Agenda
Pages 99-106
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From page 99... ...
An ad hoc committee will plan and conduct a 1-day public workshop that will examine and discuss successes, challenges, and best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. Topics covered could include strategies for including genetically focused populations in clinical trial 99
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Geoffrey Ginsburg, Co-Chair of the Roundtable on Genomics and Precision Health Director, Duke Center for Applied Genomics and Precision Medicine; Professor of Medicine, Pathology, and Biomedical Engineering Duke University Medical Center 8:35 a.m. Charge to the Speakers and Participants Laura Nisenbaum, Workshop Co-Chair Advisor, Chorus Clinical Development Eli Lilly and Company
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• Explore issues that pertain to the regulatory pathway for genetic tests and biomarkers used in clinical drug development. Moderator: Laura Nisenbaum, Advisor, Chorus Clinical Development, Eli Lilly and Company 8:45 a.m.
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Break SESSION II: CASE STUDIES IN PRECISION DRUG DEVELOPMENT Session Objectives: • Explore recent examples of precision drug development in order to identify lessons that can be applied across disease fields. • Examine clinical development plans for precision medicines, including o sing our understanding of the underlying biology to inform u trial design and product development; o ffects on research costs and timeline; and e o atient recruitment and stratification.
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From page 103... ...
• Survey innovative ways to engage participants in precision clinical trials, including communication, outreach, and education-based initiatives, with additional attention paid to increasing the diversity of such trials. • Discuss additional logistical challenges associated with the execu tion of a successful genetics-based clinical trial for a complex dis ease, including o t echniques for patient stratification, including considerations for employing genetic risk scores; and o t imelines for developing molecularly targeted therapies, includ ing trial execution.
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Panel Discussion with Audience and Speakers G Scott Chandler Vice President and Global Head of Licensing and Early Development Safety Genentech/Roche Jessica Langbaum Principal Scientist Banner Alzheimer's Institute Mark Trusheim Visiting Scientist Massachusetts Institute of Technology Sloan School of Management
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Break SESSION IV: FINDING INNOVATIVE WAYS TO INTEGRATE GENETICS RESEARCH INTO THE DRUG DEVELOPMENT PROCESS Session Objective: • Explore innovative, "outside-the-box" ideas for genetics-based clinical trials that could make the therapeutic development path way more efficient. Moderator: Bray Patrick-Lake, Director of Stakeholder Engagement, Duke University, Clinical and Translational Science Institute 3:35 p.m.
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Computer Science Stanford University 5:20 p.m. Summary of Key Points -- Session IV Bray Patrick-Lake Director, Stakeholder Engagement Duke University, Clinical and Translational Science Institute 5:25 p.m.
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