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Appendix C: Speaker Biographical Sketches
Pages 107-116

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From page 107...
... Dr. Blanchard has led several drug development teams across early- and late-stage development, with a recent focus on the identification of predictive biomarkers for drug response.
From page 108...
... Common Fund programs on extra­ cellular RNA communication. He also works with the Office of Rare Diseases Research as a liason to several consortia within the Rare Disease Clinical Research Network.
From page 109...
... She is a member of the scientific and medical advisory board of the United Mitochondrial Disease Foundation (UMDF) ; a member of the scientific advisory board of the Genesis Project; a founding member of the CHOP Center for Mitochondrial and Epigenomic Medicine; a CHOP-site PI of the North American Mitochondrial Disease ­ Consortium; and a member of the Mitochondrial Medicine Society, the Society for Prevention Research, the Society for Inherited Metabolic Dis­ orders, the American Society of Human Genetics, and the American College of Medical Genetics and Genomics.
From page 110...
... He has a special interest and expertise in the field of cardiovascular disease in diabetic patients. He is currently the project officer for numerous clinical trials on questions related to diabetes and heart disease including the National Institutes of Health–sponsored FREEDOM trial and coordinates clinical studies in G ­ renada and Colombia.
From page 111...
... In addition, she is responsible for the scientific and operational oversight of the API clinical trials program. Her research interests include the preclinical detection, tracking, and scientific study of Alzheimer's disease, including the design and execution of Alzheimer's disease prevention trials; the development of composite cognitive test scores for use as primary endpoints in clinical trials, including the API ADAD composite cognitive test score and the API preclinical composite cognitive test score; the development of recruitment registries to accelerate enrollment into studies; and assessing the impact of genetic testing and disclosure in the ­ era of Alzheimer's prevention research.
From page 112...
... He came to UCSF in 2006 from the Division of Intramural Research of the National Human Genome Research Institute at the National Institutes of Health, where he served for 12 years as the chief of the Genetic Diseases Research and Inherited Disease Research Branches. He received his training in medicine in the Harvard University–Massachusetts Institute of Technology Joint Program in Health Technology, his internal medicine training at Barnes Hospital/Washington University, and his genetics training at Baylor College of Medicine.
From page 113...
... For example, she has been on the steering committee of the Clinical Trials Transformation Initiative and is involved in their projects related to improving informed consent, establishing best practices for data monitoring committees, the use of a single institutional review board for multi-site trials, and the use of real-world evidence. She has also have been involved in a number of National Cancer Institute working groups and in Reagan-Udall's Integrated Medical Environment Decision Support steering committee, and she co-chairs the Patient-Centered Outcomes Research Institute Patient Engagement Advisory Board, the Multi-Regional Clinical Trials Returning Results Work Group, and the National Academies of Sciences, Engineering, and Medicine consensus committee on Biomarkers for Molecularly Targeted Therapies.
From page 114...
... . He led multidisciplinary teams that identified new genetic risk factors for RA and other complex traits, performed functional studies of risk alleles to understand fundamental disease mechanisms, analyzed clinical data from electronic medical records for discovery research in collaboration with i2b2, and investigated pharmacogenomic predictors of efficacy and toxicity as part of the National Institutes of Health–funded Pharmacogenomic Research Network.
From page 115...
... He has experience in all phases of drug development from exploratory to postmarket research. In addition he was a postdoctoral research fellow at Center for Human Genetic Research (June 2010 to May 2013)
From page 116...
... His particular interests include identifying disparate g treatment effects and novel response loci in diverse patient populations. His work includes methods to account for underlying population structure and ancestral diversity in pharmacogenomics studies, as well as ways to leverage medical records data in order to assess drug exposure continuously and longitudinally in large patient populations (i.e., without the need for clinical trials)


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