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Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop (2019)

Chapter: Appendix B: Workshop Speaker Biographical Sketches

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Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Page 73
Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Page 74
Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×
Page 75
Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×
Page 76
Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×
Page 77
Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×
Page 78
Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
×
Page 79
Suggested Citation:"Appendix B: Workshop Speaker Biographical Sketches." National Academies of Sciences, Engineering, and Medicine. 2019. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25502.
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Page 80

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Appendix B Workshop Speaker Biographical Sketches Linda Brady, Ph.D., serves as the director of the Division of Neuroscience and Basic Behavioral Science at the National Institute of Mental Health (NIMH). In this role, she provides scientific, programmatic, and administrative leadership for an extramural research program portfolio in basic neuroscience to support NIMH’s mission of transforming the understanding and treatment of mental illnesses. Dr. Brady has directed programs in neuropharmacology, drug discovery, and clinical therapeutics and organized consortia focused on ways to accelerate the development and clinical application of radiotracers in clinical research. She has provided leadership for many programs, including Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders, the National Cooperative Drug/Device Discovery/Development Groups for the Treatment of Mental Disorders, and First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders. Dr. Brady serves as co-chair of the Neuroscience Steering Committee for the Biomarkers Consortium, a public-private research partnership of the Foundation for the National Institutes of Health (FNIH) that focuses on discovery, development, and qualification of biological markers to support drug development, preventive medicine, and medical diagnostics. From 2004–2013, she co-led the Molecular Libraries and Imaging Program, a trans-NIH Common Fund initiative to provide biomedical researchers access to small organic molecules that can be used as chemical probes to study the functions of genes, cells, and biochemical pathways in health and disease. Dr. Brady was trained in pharmacology and neuroscience. She completed her Ph.D. at Emory University School of Medicine, followed by post-doctoral work and research positions at the Uniformed Services University of the Health Sciences and the NIMH Intramural Research Program. She is the author of more than 70 peer-reviewed scientific publications and is a member of the Society for Neuroscience and a Fellow in the American College of Neuropsychopharmacology. Dr. Brady has received NIH Director’s Awards and NIH Merit Awards in recognition of her activities in biomarker development and drug development for mental disorders. Jenna Bollyky, M.D., M.B.A., is a physician at Stanford who leads Livongo Health’s clinical research and analytics team. Dr. Bollyky’s research over the years has focused on various aspects of diabetes innovation, including Phase 1/2 clinical investigations of immunotherapies to preserve beta cell function and artificial pancreas technologies for type 1 diabetes (Benaroya PREPUBLICATION COPY: UNCORRECTED PROOFS 71

72 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES Research Institute at Virginia Mason, Seattle) and health outcomes (National Institute of Diabetes and Digestive and Kidney Diseases, RAND). She received her undergraduate degree in Economics at Princeton University, her M.D./M.B.A. from the University of California, Los Angeles, clinical training in Internal Medicine at Brigham and Women’s Hospital, and Endocrinology and Bioinformatics post-doctoral training at Stanford University. Silas Buchanan is an experienced underserved-community outreach and engagement strategist. As the Founding chief executive officer of the Institute for eHealth Equity, he leads partnerships with health care payers, providers, and government and academic stakeholders across the United States. Buchanan has expertise in crafting web-based ecosystems that solve for known, underserved-community outreach and engagement failure points. He developed AMECHealth.org as the official health information-sharing channel for the African Methodist Episcopal Church (2,000 congregations/2 million members). He is currently developing OurHealthyCommunity.com to more effectively recruit, activate, and connect underserved community members, and faith and community-based organizations with accountable care organizations, accountable communities of health, and other public/private stakeholders. Mr. Buchanan was selected as member of the White House Summit to Achieve eHealth Equity. He also served as co-chair of the Awareness Committee for Region V of The HHS National Partnership for Action to End Health Disparities. Mr. Buchanan has testified before the U.S. Department of Health and Human Services, HIT Policy Committee, and HHS Meaningful Use Workgroup, and is an inaugural member of the National eHealth Collaborative Consumer Committee. Noah Craft, M.D., Ph.D., is the co-founder of Science 37 and a physician–scientist– entrepreneur. Science 37 transforms the clinical research process, accelerating biomedical discovery and reducing clinical trial costs by shifting the center for research from traditional institutional investigative sites to the patient’s home and local health care system. The organization uses its patient-centered technology platform (NORA®) to create Metasites™, simplify the process of participating in trials, and connect patients safely and securely to the world’s best scientists—no matter where they live. For more than years, Dr. Craft has worked on the skin microbiome, parasite immunology, and cancer vaccine development. He also serves as a senior strategic advisor to both VisualDx and Direct Derm. He has published more than 45 peer- reviewed research manuscripts and holds multiple patents. Dr. Craft received a B.S. from Brown University and completed medical school, his residency, and his post-doctoral research at the University of California, Los Angeles. Donna Cryer, J.D., is a patient, patient advocate, and attorney who founded and leads the Global Liver Institute. She is a frequent speaker on topics of patient engagement in research and health care delivery redesign. She serves on several boards, including the People-Centered Research Foundation and Sibley Memorial Hospital in Washington, DC. Ms. Cryer is a graduate of Harvard/Radcliffe Colleges and Georgetown University Law Center. Steven Cummings, M.D., is a professor of medicine, epidemiology, and biostatistics emeritus at University of California, San Francisco (UCSF), and a senior scientist at Sutter Health Research. He is the founding director of the San Francisco Coordinating Center, an academic research organization, and he has designed and/or conducted several multicenter, industry-sponsored PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B 73 pivotal trials of treatments for osteoporosis. He founded “1747,” a start-up company that developed and conducted one of the first successful Internet-based clinical trials in 2000. He was also a founder and chief scientific officer of Mytrus, a company that developed technology for “Direct-to-Participant” trials and electronic informed consent (e-consent) and that proposed and conducted the Internet-based REMOTE trial funded by Pfizer. Dr. Cummings has also served as Innovator-in-Residence at Genentech-Roche to streamline their clinical trial protocols. He is the principal investigator of a large National Institutes of Health–funded randomized trial of a drug treatment to prevent fractures in patients with Parkinson’s that will be conducted entirely from patients’ homes. He authored the invited New England Journal of Medicine review on e-Consent and Internet-based Trials. Dr. Cummings also co-authored Designing Clinical Research (Williams and Wilkins), a textbook on clinical research and clinical trial methods, and teaches about trial methods at UCSF. He has published more than 500 original research papers and was elected to the National Academy of Medicine for his contributions to clinical research. Joshua Denny, M.D., M.S., FACMI, is a professor of biomedical informatics and medicine. He completed an internal medicine residency as a Tinsley Harrison Scholar at Vanderbilt. His research interests include natural language processing, accurate phenotype identification from electronic medical record (EMR) data, and using the electronic medical record to discover genome–phenome associations to better understand disease and drug response, including the development of the EMR-based phenome-wide association (PheWAS). At Vanderbilt, Dr. Denny is part of the PREDICT (Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment) program, which prospectively genotypes patients to tailor drug response. He is principal investigator (PI) of the Data and Research Center of the All of Us Research Program (previously called the Precision Medicine Initiative Cohort Program), which will eventually enroll at least 1 million Americans in an effort to understand the genetic, environmental, and behavioral factors that influence human health and disease. He is also PI for Vanderbilt sites in the Electronic Medical Records and Genomics (eMERGE) Network, Pharmacogenomics Research Network (PGRN), and the Implementing Genomics Into Practice (IGNITE) Network. Dr. Denny received the Homer Warner award from the American Medical Informatics Association (AMIA) in 2008 and 2009. He received the AMIA New Investigator Award in 2012 and was elected into the American College of Medical Informatics in 2013. He is a member of the National Academy of Medicine, a Fellow in the American College of Medical Informatics, and a Diplomate of the American Board of Internal Medicine. He serves on several local committees and remains active in teaching medical students and in clinical roles. Ray Dorsey, M.D., M.B.A., is the David M. Levy Professor of Neurology and director of the Center for Health + Technology at the University of Rochester. Through creative use of technology, he and his colleagues seek to enable anyone anywhere to receive care, participate in research, and benefit from therapeutic advances. Dr. Dorsey previously directed the movement disorders division and neurology telemedicine at Johns Hopkins and worked as a consultant for McKinsey & Company. His research has been published in leading medical, neurology, and economic journals and has been featured on National Public Radio, in The New York Times, and in The Wall Street Journal. In 2015, the White House recognized him as a “Champion for Change” for Parkinson’s disease. PREPUBLICATION COPY: UNCORRECTED PROOFS

74 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES Sherine El-Toukhy, Ph.D., is an Earl Stadtman tenure-track investigator and a National Institutes of Health (NIH) Distinguished Scholar in the Division of Intramural Research of the National Institute on Minority Health and Health Disparities (NIMHD). Prior to joining NIMHD, she was an intramural training award post-doctoral Fellow in the Intramural Research Programs of the National Heart, Lung, and Blood Institute (NHLBI) and NIMHD. She received her doctorate from the University of North Carolina at Chapel Hill in Mass Communication, where she also earned a graduate certificate in Interdisciplinary Health Communication. She holds a bachelor’s in Broadcast Journalism and a master’s in Mass Communication from Cairo University, Egypt. At NIH, she gained additional training in epidemiological and clinical research. Dr. El-Toukhy’s research is aimed at improving minority health and reducing health disparities through digital public health interventions. She has multidisciplinary theoretical and methodological training in communication, psychology, and public health. Dr. El-Toukhy has a decade’s worth of experience in health communication campaigns and interventions funded by national and international organizations such as the Egyptian Ministry of Health and Population, Ministry of Environment, UNICEF, and the U.S. Agency for International Development. She led projects centered on promoting reproductive health, children’s vaccines, HIV prevention, a clean environment, and gender equality, among others. She is a recipient of several research awards, including a visiting scholar award from Cairo University, Egypt; a William R. Kenan Jr. Fellowship from the University of North Carolina at Chapel Hill; the 2013 Health Dissertation of the Year award from the National Communication Association and the International Communication Association; and three top-paper awards. Her work has appeared in journals such as Pediatrics, Tobacco Control, and Preventive Medicine. Her research has been funded by The National Science Foundation and NIMHD. Kimberly Hawkins, M.P.H., has 25 years of operational experience managing all phases of the drug development process. She started her career at Boston Medical Center as a research assistant working on pediatric AIDS and oncology trials. After working in academia, she moved into industry and held various clinical operations positions at Boston-area biotechnology/pharmaceutical companies, including Genzyme, Antigenics, and Novelos Therapeutics, where she was the vice president of clinical development. Ms. Hawkins joined Sanofi 5 years ago and is the clinical operations lead for the Sanofi Genzyme business unit that includes Rare Disease, Multiple Sclerosis/Neurology, Immunology, and Oncology. She is a graduate of Boston University with a bachelor’s degree in Human Physiology and a master’s degree in Public Health. Adrian Hernandez, M.D., M.H.S., is a cardiologist with extensive experience in clinical research ranging from clinical trials to health services policy research. Since 2017, he has been the vice dean for clinical research at the Duke University School of Medicine. Previously, he was a faculty associate director of Duke Clinical Research and director of health services and outcomes research at the Duke Clinical Research Institute. He is the coordinating center principal investigator (PI) for multiple networks and clinical trials, such as the National Heart, Lung, and Blood Institute’s Heart Failure Research Network, Patient-Centered Outcomes Research Institute’s National Patient-Centered Clinical Research Network (PCORnet), and the National Institutes of Health’s Health Care Systems Research Collaboratory. He has served as the Steering Committee Chair or PI of multiple large studies in the field of cardiovascular medicine and diabetes. Dr. Hernandez has more than 450 published articles in high-tier journals, including the PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B 75 New England Journal of Medicine, Journal of the American Medical Association, and Lancet. He is an elected member of the American Society of Clinical Investigation and the Association of American Physicians. He received his bachelor’s Degree from Rice University and his M.D. from the University of Texas–Southwestern School of Medicine. He completed an internship and a residency in the Department of Medicine at the University of California, San Francisco, and a cardiology Fellowship at Duke University. Kathy Hudson, Ph.D., is the former deputy director for science, outreach, and policy at the National Institutes of Health (NIH). Dr. Hudson led the science policy, legislation, communications, and outreach efforts of NIH and served as senior advisor to the NIH director. She directed the agency’s efforts to advance biomedical science through policy development and innovative projects and partnerships. Dr. Hudson created major new strategic and scientific initiatives, including the National Center for Advancing Translational Sciences, the BRAIN Initiative, the NIH Precision Medicine Initiative, and the Cancer Moonshot. She led the development of major policies that enable science to advance more rapidly, including enhancing clinical trials, data sharing, and participation of patients as partners in research. She was the key NIH architect responsible for modernizing the regulations governing research with human subjects. Her professional experience includes serving as the acting deputy director of the National Center for Advancing Translational Sciences, NIH; the NIH chief of staff; the assistant director of the National Human Genome Research Institute, NIH; and the founder and director of the Genetics and Public Policy Center at John Hopkins University. Also at John’s Hopkins, Dr. Hudson was an associate professor in the Berman Institute of Bioethics, Institute of Genetic Medicine, and Department of Pediatrics. Dr. Hudson holds a Ph.D. in Molecular Biology from the University of California, Berkeley, an M.S. in Microbiology from the University of Chicago, and a B.A. in Biology from Carleton College. Clay Johnston, M.D., Ph.D., has served as the inaugural Dean of the Dell Medical School at The University of Texas at Austin since 2014. In this position, he plans to build a world-class academic medical center focused on providing new models of education and health care delivery. He is also professor of neurology, specializing in stroke care and research. Dr. Johnston arrived in Austin from the University of California, San Francisco (UCSF), where he directed the Clinical and Translational Science Institute, overseeing the planning, development, and implementation of a $112 million, 5-year National Institutes of Health grant award, the second largest among the 60-member national Clinical and Translational Science Awards consortium. Working with a team of 300+ faculty and staff serving all four schools at UCSF, Dr. Johnston positioned the Institute as a catalyst in efforts to accelerate research to improve health on campus and throughout the University of California system. He founded the Center for Healthcare Value at UCSF in order to engage faculty and trainees in lowering the costs of health care while improving quality. He was also instrumental in cultivating and securing partnerships with leading biotech companies, foundations, and private funders. In his role as associate vice chancellor of research, Dr. Johnston was integrally involved in efforts to realize the University’s vision of being the world’s preeminent health sciences innovator. After receiving his undergraduate education at Amherst College, he completed medical school at Harvard University. He later received a Ph.D. in Epidemiology from the University of California, Berkeley, and was a resident in neurology at UCSF, where he later trained in vascular neurology. During his 20 years at UCSF, he rose through the academic ranks to professor of neurology and PREPUBLICATION COPY: UNCORRECTED PROOFS

76 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES epidemiology, and directed the Stroke Service. Dr. Johnston has authored more than 300 publications in scientific journals and has won several national awards for his research and teaching. In particular, he has published extensively in the prevention and treatment of stroke and transient ischemic attack. He is perhaps best known for his studies describing the short-term risk of stroke in patients with transient ischemic attack and identifying patients at greatest risk, and also for his work related to measuring the impact of research. He has led several large cohort studies of cerebrovascular disease and three international multicenter randomized trials, two of which are ongoing. Craig Lipset is the head of clinical innovation within Global Product Development at Pfizer Inc. Mr. Lipset’s team is impacting clinical research through digital tools, innovative research approaches, and game-changing collaborations. He previously served as venture partner in Pfizer Venture Investments (Pfizer’s venture capital arm), where he focused on diversifying the company’s $50M annual budget for private investments in the areas of diagnostics and health technology. Mr. Lipset was also senior director in molecular medicine, where he spearheaded initiatives driving innovation in clinical research and personalized medicine by drawing on tools from health information technology, telemedicine, and eHealth. He brings more than 15 years of leadership and innovation in the field of drug development. He previously served as associate vice president of program management at Adnexus Therapeutics (acquired by Bristol-Myers Squibb), and on the founding management team for Perceptive Informatics (now part of PAREXEL International). Mr. Lipset has been listed among the PharmaVOICE most inspiring people in the life sciences, Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top Innovators, and AlleyWatch Who’s Who in eHealth. He serves on the Editorial Board for Therapeutic Innovation & Regulatory Science. Outside of Pfizer, Mr. Lipset serves on the Board of Directors for the People-Centered Research Foundation, Foundation for Sarcoidosis Research, and MedStar Health Research Institute, and is a mentor at health tech accelerator Blueprint Health. Leanne Madre, J.D., M.H.A., advises and supports the executive director in setting and carrying out organizational strategies in support of the Clinical Trials Transformation Initiative’s (CTTI’s) mission. She provides senior leadership on communication and membership strategies and programs and is responsible for maintaining awareness and assessing related efforts of government and private-sector organizations, developing and implementing appropriate plans for CTTI in light of those initiatives. Ms. Madre has more than 15 years of experience working on clinical and translational research issues. She previously served as program director of the Centers for Education and Research on Therapeutics (CERT) Coordinating Center, where she played an instrumental role in creating and managing the CERT program organization, including the creation of a model for public–private partnership. While at Duke University, Ms. Madre also served as manager of strategic relations and client services for the Duke Clinical Research Institute. Prior to joining Duke, she served as an attorney for Sentara Health System. Ms. Madre received her J.D. from the University of Richmond, her M.H.A. from the Medical College of Virginia/Virginia Commonwealth University, and her B.S. (Biochemistry) from North Carolina State University. Deven McGraw, J.D., M.P.H., is the general counsel and chief regulatory officer for Ciitizen, a consumer health technology start-up. Prior to joining Ciitizen, she directed U.S. health privacy PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B 77 and security through her roles as deputy director, health information privacy at the U.S. Department of Health and Human Services Office for Civil Rights (the office that oversees Health Insurance Portability and Accountability Act (HIPAA) policy development and enforcement) and chief privacy officer (acting) of The Office of the National Coordinator for Health Information Technology. Widely recognized for her expertise in health privacy and security, she directed the Health Privacy Project at the Center for Democracy & Technology (a nonprofit civil liberties organization) for 6 years and led the privacy and security policy work for the Health Information Technology for Economic and Clinical Health Act of 2009’s Health IT Policy Committee. She also served as the chief operating officer of the National Partnership for Women and Families. She has also advised health industry clients on HIPAA compliance and data governance while a partner at Manatt, Phelps & Phillips, LLP. Ms. McGraw graduated magna cum laude from the Georgetown University Law Center and has an M.P.H. from John’s Hopkins University. Matthew McIntyre, Ph.D., M.S., joined 23andMe in 2013. He is responsible for ensuring that the company maintains high-quality information about its research participants’ health and traits in order to conduct innovative genetic research. Previously, he completed a post-doctoral Fellowship at Harvard School of Public Health and taught anthropology at the University of Central Florida, where his research focused on hormones and child growth. Dr. McIntyre earned his Ph.D. in Anthropology and M.S. in Epidemiology, both from Harvard University Will McIntyre has been in the technology industry for the better part of two decades. He has worked in all parts of the industry, from selling to customers to distribution support and management. Mr. McIntyre was diagnosed with Parkinson’s disease in October 2013. He has been working on a volunteer basis with The Michael J. Fox Foundation in several capacities for the past few years. Sally Okun, B.S.N., R.N., M.M.H.S., is vice president for policy and ethics at PatientsLikeMe. Since joining the company in 2008, she has overseen numerous aspects of the site’s early development related to health data integrity, medical ontology, drug safety platforms, and more, recently leading the development of the company’s Ethics and Compliance Advisory Board. Ms. Okun ensures that patient voice and insight are integrated into diverse health policy initiatives at the national and global levels, and is the company’s liaison with external organizations, government, and regulatory agencies. She oversees the company’s Research Collaboration Agreement with the U.S. Food and Drug Administration and is a member of numerous advisory groups, including the National Academy of Medicine’s Leadership Consortium on Science and Value Driven Healthcare; the Commonwealth Fund’s National Advisory Group on Health Care Delivery System Reform; the Board of Directors for Public Responsibility in Medicine and Research; and the Advisory Group for the Duke Margolis Center for Health Policy Collaborative on Real-World Evidence. A Registered Nurse, she practiced as a community-based palliative and end-of-life care specialist for many years. Ms. Okun completed her graduate studies at The Heller School for Social Policy & Management at Brandeis University. She was a 2010 Fellow in Biomedical Informatics for the National Library of Medicine and a 2014 Salzburg Global Fellow in New Paradigms for Behavioral and Mental Health. PREPUBLICATION COPY: UNCORRECTED PROOFS

78 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES Josh Rose, M.B.A., is the vice president and global head of strategy for the R&D Solutions business unit at IQVIA. In this role, Mr. Rose is responsible for building the overarching strategy for the clinical development business, establishing and governing strategic initiatives, and leading the identification of acquisition candidates. He focuses specifically on bringing to market new solutions that drive growth and differentiation across the company. He also leads the Virtual Trial service business within the R&D Solutions business unit. Leonard Sacks, M.D., was born in South Africa, where he received his medical education at the University of the Witwatersrand. In 1988 he moved to the United States and completed a Fellowship in Immunopathology at Upstate Medical Center in Syracuse, New York, and a Fellowship in Infectious Diseases at the U.S. Department of Veteran Affairs Medical Center in Washington, DC. Since then he has worked as an attending physician in infectious diseases both in Washington, DC, and in South Africa, with particular interests in antimicrobial therapy, tuberculosis, and tropical diseases. In 1998 he joined the staff of the U.S. Food and Drug Administration, where he has served as a medical reviewer and team leader in the Division of Special Pathogens and Immunological Drug Products at the Center for Drug Evaluation and Research (CDER), and is currently the associate director for clinical methodology in the Office of Medical Policy (CDER). He holds an academic position as associate clinical professor of medicine at The George Washington University. Kelly Simcox, M.S., serves as the head of the Americas, Clinical Study Units and Clinical Operations at Sanofi (formerly Rhone-Poulenc Rorer, and Aventis and Sanofi-Aventis). She has been a role model regarding staff development and team building, fostering a business mindset as well as a culture of excellence and continuous improvement. After her pre-clinical experience, Ms. Simcox moved to clinical development as a monitor and now manages a group of more than 650 clinical operations in the Americas. A seasoned global pharmaceutical executive, Simcox has a proven record of accomplishment in clinical development, project management, and global operations. Simcox has significant leadership experience, having served as one of only 70 leaders in research and development to be selected to participate in the exclusive Evolve Center for Leadership training. Her contributions have been recognized among the industry—she was honored as a Healthcare Businesswomen’s Association Rising Star in 2012. She represents her member company among industry initiatives, such as TransCelerate BioPharma Inc. Simcox received her undergraduate degree from Muhlenberg College and received a master’s degree from Temple University. Wendy Weber, M.D., Ph.D., M.P.H., is the acting deputy director at the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). She also serves as branch chief for clinical research in the Complementary and Integrative Health Branch in the Division of Extramural Research at NCCIH. She joined NCCIH as a program director in 2009. The Clinical Research Branch is responsible for the oversight of all NCCIH- supported clinical trials. Dr. Weber is coordinator of NCCIH’s Clinical Trial Specific Funding Opportunity Announcements (FOAs) and point of contact for all natural product-related clinical trial FOAs. She is a member of the NIH Common Fund-supported Health Care Systems Research Collaboratory and the program officer for the Coordinating Center. Weber is also a member of the planning and oversight team for NIH/U.S. Department of Defense/U.S. Department of Veterans Affairs Nonpharmacologic Approaches to Pain Management PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B 79 Collaboratory and project scientist for its Coordinating Center. At NCCIH, Dr. Weber oversees a portfolio of pragmatic clinical trials, natural product clinical trials, studies of complementary medicine to promote healthy behavior, and complex complementary/integrative medicine intervention research. Dr. Weber’s interests include the use of complementary medicine interventions for common pediatric conditions, mental health conditions, promoting healthy behaviors, and health services research. Dr. Weber earned a Ph.D. in Epidemiology and an M.P.H. from the University of Washington. She earned a Doctorate of Naturopathic Medicine (N.D.) from Bastyr University. Prior to joining NCCIH, she was a research associate professor at Bastyr University, where her research included the study of herbal treatments for pediatric conditions. Her clinical practice focused on the treatment of children and adolescents with mental health conditions, abdominal pain, headaches, and allergies. She has published on treatment of pain with complementary health approaches, echinacea’s effect on colds in children, naturopathic treatment of children, and complementary medicine treatments for attention-deficit hyperactivity disorder Jon White, M.D., serves as the deputy national coordinator for health information technology. The family physician has dedicated his career to improving health and health care quality through the use and sharing of electronic health information. At The Office of the National Coordinator for Health Information Technology (ONC), Dr. White provides high-level executive direction and leadership for all ONC programs and policies, and advances key priorities. He has led mission-critical activities, including the publication of high priority, nationally impactful regulations, the publication of the Shared Nationwide Interoperability Roadmap, a widely publicized congressional report on information blocking, and ONC’s efforts in the precision medicine initiative. PREPUBLICATION COPY: UNCORRECTED PROOFS

Next: Appendix C: Examples of Virtual Clinical Trials Included in Workshop Handout »
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Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice.

On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

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