Global Health Risk Framework Research and Development of Medical Products: Workshop Summary (2016) / Chapter Skim
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Appendix D: Workshop Speaker Biographies
Appendix D: Workshop Speaker Biographies
Pages 101-124
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From page 101... ...
Most recently, he founded Practical Innovation Strategy, consulting on innovation management and translational research for nonprofit organizations and on intellectual property (IP) strategy for a major multinational pharmaceutical company.
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From page 102... ...
Beth P Bell, MD, MPH, is the director of the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
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Robert M Califf, MD, MACC, is Deputy Commissioner for Medical Products and Tobacco for the U.S.
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Dr. Califf co-chaired the Clinical Trials Transformation Initiative, a public–private partnership co-founded by Duke and FDA to identify and promote practices that will increase the quality and efficiency of clinical trials.
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Peter Dull, MD, MS, is Deputy Director for Integrated Clinical Vaccine Development within the Global Health Division at The Bill & Melinda Gates Foundation. In this role he provides technical and strategic guidance to the foundation's program strategy teams and external partners.
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From page 106... ...
He attended medical school at the University of Wisconsin–Madison and completed his internal medicine training at Oregon Health & Science University in Portland, Oregon. After his service as an Epidemic Intelligence Officer, he completed subspecialty training in infectious diseases at Emory University.
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From page 107... ...
Ella developed the ROTAVAC vaccine in collaboration with the government of India's Department of Biotechnology, The Bill & Melinda Gates Foundation, PATH, CDC-Atlanta, and NIH-USA, and the first novel vaccine was launched by the Honorable Prime Minister of India. Bharat Biotech entered into a partnership with the University of Maryland to work on nontyphoid Salmonella vaccines for Africa with a grant of $4 million from Wellcome Trust.
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Charles Goldstein, PhD, MA, MSE, is Chief Scientific Officer, Greater Asia, Becton Dickinson (BD) Technologies, a position he assumed in October 2013.
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Dr. Gray's prior research has focused on studies of prevention of mother-tochild transmission, pediatric treatment trials, large-scale HIV clinical trials (including HIV vaccine trials)
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She launched a nationwide public–private effort to strengthen regulatory science as a means for advancing the development and evaluation of innovative, breakthrough medical products, and led FDA's transformation into a global regulatory agency capable of ensuring the safety and quality of imported food, drugs, and medical devices. Before taking on the post of FDA Commissioner, Dr.
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From page 111... ...
Andre Kalil, MD, MPH, FACP, FIDSA, FCCM, is currently a Professor of Medicine at the University of Nebraska Medical Center, Omaha, Nebraska. He is a faculty member of the division of Infectious Diseases, Department of Internal Medicine, Department of Pathology and Microbiology, and Department of Anesthesiology and Critical Care.
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From page 112... ...
Ashford Award of the American Society of Tropical Medicine and Hygiene, and the Squibb Award of the Infectious Diseases Society of America. He is a past president of the International Society for Infectious Diseases.
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He is the Corporate Secretary and chaired the initial Operations Committee for Transcelerate Biopharma, which is a not-for-profit collaborative effort across approximately 20 pharmaceutical companies. He joined the company in 1993 working in the Infectious Diseases Clinical organization with increasing levels of accountability.
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She recently received the South African Department of Science and Technology/SARIMA award for Excellence in the Leadership of Innovation Management. Ceci Mundaca-Shah, MD, DrPH, is a senior program officer with the National Academies of Sciences, Engineering, and Medicine Board on Global Health.
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From page 115... ...
Mundel's leadership, the Global Health Division also works on platform technologies to accelerate development of global health solutions. All of this work occurs in collaboration with an international network of grantees and partners. Prior to joining the foundation in 2011, he was global head of development with Novartis, and previously was involved in clinical research at Pfizer and Parke-Davis.
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From page 116... ...
His research as well as his entrepreneurial career is driven by medical needs and the passion to advance and significantly impact medicine. In 1994, he co-founded Janssen Infectious Diseases-Diagnostics BVBA.
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Pfleiderer is a member of a number of advisory boards, in particular with regard to issues related to pandemic influenza vaccines and pandemic preparedness planning. On the European level, Dr.
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Robin Robinson, PhD, was appointed in April 2008 as the first director of the newly, created federal agency, Biomedical Advanced Research and Development Authority (BARDA) , and Deputy Assistant Secretary in the Office of the Assistant Secretary for Preparedness and Response within HHS by the Pandemic and All-Hazards Preparedness Act of 2006. BARDA develops and provides medical countermeasures to man-made and natural threats, including chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.
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From page 119... ...
Dr. Robinson was recruited by HHS from the vaccine industry in May 2004 to establish a Manhattan-like program with scientific and technical experts to implement the strategic plans and policies for medical countermeasures outlined in the National Strategy for Pandemic Influenza (November 2005)
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From page 120... ...
He was also named the Commemorative Fund Lecturer of the American Society of Tropical Medicine & Hygiene in 2006. Mel Spigelman, MD, is the President and Chief Executive Officer of the Global Alliance for TB Drug Development (TB Alliance)
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Dr. Stoffels studied medicine at the University of Diepenbeek and the University of Antwerp in Belgium, as well as infectious diseases and tropical medicine at the Institute of Tropical Medicine in Antwerp, Belgium.
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From page 122... ...
He led the development and implementation of the National Strategy for Pandemic Influenza, as well as Presidential directives on medical countermeasures and public health preparedness. Prior to his positions at the White House, he was 1 of 13 individuals appointed by President Bush to the nonpartisan White House Fellowship program.
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From page 123... ...
In this position, he oversaw grants totaling more than $9 billion in programs directed at applying technologies to address major health challenges of the developing world including TB, HIV, malaria and other infectious diseases, malnutrition, and maternal and child health. He was formerly Chairman, Research and Development, and a Member of the Board of Directors of GSK and before that he was Chair of the Department of Internal Medicine and Physician-in-Chief at the University of Michigan Medical Center.
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