Advancing Regulatory Science for Medical Countermeasure Development Workshop Summary (2011) / Chapter Skim
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Appendix B: Participant Biographies
Appendix B: Participant Biographies
Pages 99-132
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From page 99... ...
More recently Dr. Anderson has developed novel technologies for quantitation of protein biomarkers using mass spectrometry, receiving the 2009 HUPO Distin guished Achievement Award in Proteomic Science.
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From page 100... ...
. Elected to IOM membership in 1987, he has chaired the following committees: Clinical Applications of Mifepristone RU486 and Other Antiprogestins; Pharmacokinetics and Drug Interactions in the Elderly and Special Issues in Elderly African-American Populations; and Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents.
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From page 101... ...
She has over 20 years' experience in drug development, clinical risk mitigation, regulatory negotiations, and strategic planning.
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She serves on the Pandemic Influenza Task Force of the Infectious Diseases Society of America. She has previously served on their Global and Public Health Committee and on the National Research Council's committee on Methodological Improvements to the
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From page 103... ...
He is on the FDA's Advisors and Consultants Staff, having served for six years on the AntiInfective Drug Advisory Committee. He sits on the Infectious Diseases Society's Task Force on Antimicrobial Drug Availability, whose charge is to bring together members of Congress, FDA, and the pharmaceutical industry to facili tate antibiotic discovery and approval for antibiotic-resistant bacterial pathogens.
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From page 104... ...
He has organized and chaired numerous symposia and courses in the field including the American Course in Drug Development and Regulatory Science, and has been a member of several trade association and public committees as well as four boards of directors (currently AstraZeneca and Cangene) and three pharmaceutical company scientific advisory boards.
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From page 105... ...
Dr. Cassell has recently retired as Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company in Indianapolis, Indiana.
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Chu completed 6.5 years service at the World Health Organization (WHO) where she served as team leader for Laboratory Alliances and Biosafety in the International Health Regulations Coordination Department and briefly served as the Associate Director for Laboratory Science in the Division of Preparedness and Emerging Infec tions, National Center for Emerging and Zoonotic Infectious Diseases.
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From page 107... ...
Dr. Cox is board certified in Internal Medicine and Infectious Diseases.
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From page 108... ...
Dr. Felciano leads the company's strategic R&D and collaborations in countermeasures research; systems biology; and predictive analytics for drug and biomarker discovery, large-scale scientific data integration, sci entific drug discovery services, and research informatics for distributed drug discovery and development.
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From page 109... ...
richard forshee, Ph.d., is the Associate Director for Research for the Office of Biostatistics and Epidemiology at the Center for Biologics Evaluation and Research in the U.S. Food and Drug Administration.
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From page 110... ...
As a clinician, Dr. Francis was an assistant professor of medi cine at the Johns Hopkins University School of Medicine's Division of Infectious Diseases where he served as the Principal Medical Officer of the Broadway Women's Drug Use Center and as the Ryan White Title III investigator and Medical Director of the Baltimore City Department of Health's Sexually Transmitted Diseases clinics.
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Dr. Frucht's laboratory has published numerous original research papers and review articles related to anthrax toxin.
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From page 112... ...
. Prior to joining FDA, he was Professor of Medicine and Chief of Infectious Diseases at the University of Minnesota, where he directed the multihospital infectious diseases research, training, and clinical programs, and where his NIH-funded laboratory first isolated and characterized Anaplasma phagocytophilum, the infectious agent causing a new tick-borne disease, human granulocytic ehrlichiosis.
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From page 113... ...
His primary responsibilities include oversight of programs relating to strategic science and innovation, stra tegic affairs and reporting, the development of science and preparedness policy, human resources, communications, and organizational marketing. Previously, he served as Director for Medical Preparedness Policy on the White House National Security Staff where he worked on a wide array of issues related to medical countermeasures development, the 2009 H1N1 pandemic, and pandemic preparedness more broadly.
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From page 114... ...
Her group is responsible for several resources within the Division of Microbiology and Infectious Diseases, namely contract programs providing animal models of infectious diseases, microbiology and infectious diseases biological resource repository, and in vitro assessments for antimicrobial activity. These programs all build upon successful prior efforts dedicated to bio defense, which are now being broadened to provide critical infrastructure capabilities for all pathogens of interest to DMID.
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From page 115... ...
She is the Agency focal point coordinating all influenza activities across the medical product Centers, and is the Agency representative to various influenza working groups constituted within the federal government. Likewise, as acting Director for the FDA MCMi Regulatory Science, she speaks on behalf of the Agency regarding the progress of various regulatory science projects and programs.
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From page 116... ...
He left UNMC in 1997 and led programs in cardiovascular disease, drug metabolism, muscular dystrophy, and antiviral drug development at AVI BioPharma. He developed broad experience in nearly every project from drug discovery, intellectual property protection, hypothesis development and study design, publication of scientific findings, preclinical toxicology design and evaluation, and preparation of IND and clinical protocols.
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From page 117... ...
Army Medical Department in 2008, where he had served in a number of leadership roles, including the Commander of the U.S. Army Medical Research Institute of Infectious Diseases and the Director of the Department of Defense Medical Chemical and Biological Defense Research Program.
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Army Medical Research Institute of Infectious Diseases (USAMRIID) , her research focused on developing inhalation animal models for a number of biothreat agents.
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He was Professor of Medicine and Director of the Center for Infectious Disease and Immunity. His research during that time focused on the application of molecular biology techniques to animal models of infection in order to move therapeutics for infectious diseases from basic science into human use.
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Dr. Magill is ABIM board certified in internal medicine and infectious diseases.
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Malin received his M.D. from the Medical College of Ohio and did his residency and fellowship training in Anes thesiology and Critical Care at the Georgetown University Hospital in Washington, DC.
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OTS comprises the Office of Biostatistics, the Office of Clinical Pharmacology, and the Immediate Office, which provides oversight to CDER research involving human subjects, CDER regulatory science research, and the CDER Computa tional Science Center. OTS is responsible for providing coordination for Critical Path initiatives across CDER in partnership with individual CDER offices.
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Dr. Miller directs the Clinical Microbiology group at GSK that includes Anti-bacterial and Anti-viral drug development and has responsibilities across the Infectious Diseases pipeline from discovery to development and throughout the life cycle of the drugs.
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He served as a new drug reviewer, drug abuse scheduling expert, epidemiology team leader, Director of the Center for Drug Evaluation & Research (CDER) Staff College, and as Associate Director, Office of Epidemiology & Biostatistics, before his retirement in 1998.
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Army Medical Research Institute of Infectious Diseases and the U.S. Army Walter Reed Army Institute of Research.
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From page 126... ...
In 1980, Dr. Peck became Director of the Division of Clinical Pharmacology and, Professor, Departments of Medi cine and Pharmacology, Uniformed Services University, Bethesda, Mary land.
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and Chinese (2009) Courses in Drug Development and Regulatory Science (ACDRS, CCDRS)
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From page 128... ...
. John served on the faculty of the University of Texas Medical School at Houston from 1992 to 2002 during which time his work focused on laboratory studies of novel antifungal agents, clinical trials of novel antifungal agents, and hospital epidemiology.
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From page 129... ...
His research on the basic biology of tuberculosis and other bacteria and the mathematical modeling of complex biological systems has been funded by the NIH, NSF, DARPA, the Global Alliance for TB Drug Discovery, and the DoD. He has published over 90 papers in peer-reviewed journals as well as numerous scientific reviews and book chapters.
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From page 130... ...
At UM, she regularly collaborated with scientists and epidemiologists on infectious disease research. She also spent a year of sabbatical leave and several summers at the Biometric Research Branch of the National Cancer Institute work ing on statistical issues in clinical trials.
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From page 131... ...
A major role of his functioning as a medical officer in the Obstetric and Pediatric Pharmaceutical Branch at NICHD has been the identification of WMD-related medical countermeasures gaps as well as the facilitation of the development of WMDrelated medical countermeasures for pregnant women and children. He is the obstetric/pediatric representative from NIH on various Biomedical Advanced Research and Development working groups as well the NIH representative to the Federal Education and Training Interagency Group.
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From page 132... ...
He is currently at GlaxoSmithKline where he is directing a group that provides statistical analysis and modeling, and clinical trials simulation expertise to early-phase drug discovery and development activities for new medicines targeted at infectious diseases. carolyn Wilson, Ph.d., received her Ph.D.
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