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1 Introduction
Pages 1-8

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From page 1...
... hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development (see Box 1-1 for the Statement of Task) .2 This workshop, co-chaired by Esteban Burchard, professor in the Departments of Bioengineering and Therapeutic Sciences and Medicine at the University of California, San Francisco, and Laura Nisenbaum, advisor at Chorus Clinical Development of Eli Lilly and Company, examined successes, chal 1  This workshop was organized by an independent planning committee whose role was limited to identification of topics and speakers.
From page 2...
... 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 utilizing ­ enetic information in the design and implementation of clinical trials to g 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 popula tions in clinical trial design, logistical challenges in conducting genetics-based clinical trials, and mechanisms for engaging with and educating potential trial participants.
From page 3...
... The purpose of the March 2017 workshop, Nisenbaum said, was to focus on the latter stages of drug development and explore how genetically identified populations can be integrated into clinical trials. 3  Resources from the Deriving Drug Discovery Value from Large-Scale Genetic Bioresources workshop are available online at http://www.nationalacademies.org/hmd/Activities/Research/ GenomicBasedResearch/2016-MARCH-22.aspx (accessed May 10, 2017)
From page 4...
... What, she asked, might serve as a disruptive force for translating knowledge of human genetics into new precision medicines within the next 3 to 5 years? OVERVIEW OF CROSS-CUTTING TOPICS HIGHLIGHTED DURING PRESENTATIONS AND DISCUSSIONS4 A number of themes emerged across workshop presentations and discussions as speakers and participants considered various aspects of integrating genetics into the drug development process.
From page 5...
... According to some workshop participants, developing educational tools and establishing new resources, such as a more user-friendly clinical trials database, may help empower providers to identify patients with genetic diseases or diseases with an underlying genetic component, discuss clinical trials as treatment options when necessary, and assist in enrolling patients in trials. Discussions at the workshop also focused on the idea that patients should be partners in the research process, providing input on where research efforts and clinical trial development are most needed to address unmet needs.
From page 6...
... Some workshop participants noted a number of potential partners for collaborative efforts, including disease consortia that house registries and biorepositories, bio­ harmaceutical p companies, academic medical centers, health care providers, researchers, disease advocacy and patient-focused groups, government and regulatory
From page 7...
... Partnerships ­ between researchers and patient groups can help facilitate research on patient biospecimens, which could accelerate the development of assays necessary for drug development. Engaging Regulatory Authorities Early in Development Interacting with regulatory agencies as early as possible in the drug development pathway could potentially streamline genetics-enabled drug development, said Michael Pacanowski, a workshop speaker and associate director for genomics and targeted therapy in the Center for Drug Evaluation and Research at the U.S.


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