F

Committee and Staff Biographies

Thomas F. Boat, M.D. (Chair), is Vice President for Health Affairs and Christian R. Holmes Professor and Dean of the College of Medicine at the University of Cincinnati. He has been director of the Children’s Hospital Research Foundation and chair of the College’s Department of Pediatrics. He was also physician in chief of Children’s Hospital Medical Center of Cincinnati. Dr. Boat is a member of the Institute of Medicine (IOM) and has served as member or chair of a number of IOM and National Research Council committees, most recently serving as chair of the Committee on Accelerating Rare Diseases Research and Orphan Product Development. A pediatric pulmonologist by training, Dr. Boat worked early in his career to define the pathophysiology of airway dysfunction and develop more effective therapies for chronic lung diseases of childhood, such as cystic fibrosis. More recently, he has worked at local and national levels to improve research efforts, subspecialty training, and clinical care in pediatrics. He is immediate past board president of the Association of Accreditation of Human Research Protection Programs, Inc. He has also served as chair of the American Board of Pediatrics, president of the Society for Pediatric Research, and president of the American Pediatric Society.

Peter C. Adamson, M.D., is professor of pediatrics and pharmacology at the University of Pennsylvania School of Medicine, chief of the Division of Clinical Pharmacology and Therapeutics at The Children’s Hospital of Philadelphia (CHOP), and Director of Clinical and Translational Research at The Children’s Hospital of Philadelphia Research Institute. He is board certified in pediatric hematology/oncology and in clinical pharmacology. Dr. Adamson’s



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F Committee and Staff Biographies Thomas F. Boat, M.D. (Chair), is Vice President for Health Affairs and Christian R. Holmes Professor and Dean of the College of Medicine at the University of Cincinnati. He has been director of the Children’s Hospital Research Foundation and chair of the College’s Department of Pediatrics. He was also physician in chief of Children’s Hospital Medical Center of Cincinnati. Dr. Boat is a member of the Institute of Medicine (IOM) and has served as member or chair of a number of IOM and National Research Council committees, most recently serving as chair of the Committee on Accelerating Rare Diseases Research and Orphan Product Development. A pediatric pulmonologist by training, Dr. Boat worked early in his career to define the pathophysiology of airway dysfunction and develop more effective therapies for chronic lung diseases of childhood, such as cystic fibrosis. More recently, he has worked at local and national levels to im- prove research efforts, subspecialty training, and clinical care in pediatrics. He is immediate past board president of the Association of Accreditation of Human Research Protection Programs, Inc. He has also served as chair of the American Board of Pediatrics, president of the Society for Pediatric Research, and president of the American Pediatric Society. Peter C. Adamson, M.D., is professor of pediatrics and pharmacology at the University of Pennsylvania School of Medicine, chief of the Division of Clinical Pharmacology and Therapeutics at The Children’s Hospital of Phila- delphia (CHOP), and Director of Clinical and Translational Research at The Children’s Hospital of Philadelphia Research Institute. He is board certified in pediatric hematology/oncology and in clinical pharmacology. Dr. Adamson’s 387

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388 SAFE AND EFFECTIVE MEDICINES FOR CHILDREN primary research focus is on pediatric cancer drug development. He served until 2008 as chair of the Children’s Oncology Group (COG) Developmen- tal Therapeutics Programs and principal investigator of the COG Phase 1 Consortium. He became chair-elect of COG on January 1, 2010. Prior to becoming the director of Clinical and Translational Research at CHOP, he was the program director of the General Clinical Research Center and principal investigator of its Pediatric Pharmacology Research Unit, funded by the National Institute of Child Health and Human Development. He is codirector of the University of Pennsylvania-CHOP Clinical Translational Science Award. He was a member of the Institute of Medicine (IOM) com- mittee on shortening the timeline for new cancer treatments and coedited the 2005 IOM report Making Better Cancer Drugs for Children. Most recently he served as a member of the IOM Committee on Accelerating Rare Diseases Research and Orphan Product Development. Richard E. Behrman, M.D., is a consultant to nonprofit health care and educational institutions. From 2002 to 2007, he was executive director of the Federation of Pediatric Organizations. Until July 1, 2002, he was senior vice president for medical affairs at the Lucile Packard Foundation for Children’s Health and senior advisor for health affairs at the David and Lucile Packard Foundation. He continues clinical faculty appointments at the University of California, San Francisco, and George Washington Uni- versity. He is a member of the Institute of Medicine (IOM) and has served as chair of the IOM Committee on Palliative and End-of-Life Care for Chil- dren, the Committee on the Ethical Conduct of Clinical Research Involving Children, and the Committee on Understanding Premature Birth and As- suring Healthy Outcomes. Dr. Behrman’s areas of special interest include perinatal medicine, intensive and emergency care of children, the provision and organization of children’s health and social services, and related issues of public policy and ethics. Among other publications, he has been editor in chief of the Nelson Textbook of Pediatrics (Elsevier). F. Sessions Cole III, M.D., is Park J. White, M.D., Professor of Pediatrics and professor of cell biology and physiology, Washington University School of Medicine, and chief medical officer, St. Louis Children’s Hospital. He is a member of the Society of Pediatric Research, the American Society for Clinical Investigation, and the American Pediatric Society. Dr. Cole served on the Institute of Medicine Committee on Premature Birth, the Committee on the Ethical Conduct of Research Involving Children, and the Commit- tee on Palliative Care for Children and Their Families, and he chaired the National Institute of Child Health and Human Development consensus conference panel on the use of inhaled nitric oxide therapy in premature in- fants. His areas of clinical interest include inherited lung diseases of infancy,

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389 APPENDIX F surfactant protein B deficiency, newborn immunity, newborn infections, and family-centered care. Dr. Cole’s research interests focus on the contributions of genetic variation in genes of the pulmonary surfactant metabolic path- way to the risk of neonatal respiratory distress syndrome. Brian Feldman, M.D., M.Sc., is professor of pediatrics, medicine, and health policy, management, and evaluation and professor of the Dalla Lana School of Public Health at the University of Toronto, where he has taught both critical appraisal (Introduction to Clinical Epidemiology) and advanced clinical trials courses for the past 14 years. He is also senior scientist and head, Division of Rheumatology, Hospital for Sick Children. Previously, Dr. Feldman was an Ontario Ministry of Health career scientist and held the Canada Research Chair in Childhood Arthritis. His areas of interest include the development of methods and measurement tools for the study of rare diseases and practical clinical trials in pediatric joint disease. Dr. Feldman currently holds research grants from Baxter Heathcare Corporation for the study of the burden of illness of severe hemophilia in Brazil and from Bayer Schering Pharma for the study of the outcomes of hemophilia prophylaxis. The grants are awarded through the Hospital for Sick Children under poli- cies that provide for institutional ownership of the research data, informa- tion, and reports resulting from the research and for independence in the publication of research findings. Dr. Feldman serves on a data monitoring committee for Novartis that, among other studies, monitors one pediatric study of canakinumab. He has been active in national and international rheumatic disease organizations, including the Canadian Arthritis Network, the Childhood Arthritis and Rheumatology Research Alliance, the Inter- national Hemophilia Prophylaxis Study Group, the Pediatric Rheumatol- ogy Collaborative Study Group, the Pediatric Rheumatology International Trials Organization, and the International Myositis Assessment Collabora- tive Study Group. Pat Furlong, B.S.N., is the founding president and chief executive officer of Parent Project Muscular Dystrophy, the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duch- enne). Its mission is to improve the treatment, quality of life, and long-term outlook for all individuals affected by Duchenne through research, advo- cacy, and education. Ms. Furlong is the mother of two sons who lost their battle with Duchenne in their teenage years. She has served on the boards of the Genetic Alliance and the Muscular Dystrophy Coordinating Committee (U.S. Department of Health and Human Services) and on the Data Safety Monitoring Board for both the Rare Diseases Clinical Research Network and the Cooperative International Neuromuscular Research Group. She was a member of the Institute of Medicine Committee on Accelerating

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390 SAFE AND EFFECTIVE MEDICINES FOR CHILDREN Rare Diseases Research and Orphan Product Development. Currently, she serves on the Board of the National Organization for Rare Disorders and the Steering Committee of Treat NMD. Eric Kodish, M.D., is the director of the Center for Ethics, Humanities, and Spiritual Care at Cleveland Clinic, where he holds the F.J. O’Neill Professor and Chair of Bioethics. He is executive director of the Cleveland Fellowship in Advanced Bioethics and professor of pediatrics at the Lerner College of Medicine of Case Western Reserve University. From 1993 to 2004, he cared for children with cancer and blood diseases at Rainbow Babies and Chil- dren’s Hospital, where he was also the founding director of the Rainbow Center for Pediatric Ethics. Dr. Kodish has been principal investigator on a series of three National Institutes of Health (NIH)-funded multisite studies of informed consent in childhood cancer. He served as chair of the Bioethics Committee of the Children’s Oncology Group from 2002 to 2008, a mem- ber of the Committee on Bioethics of the American Academy of Pediatrics from 1999 to 2005, and director at large of the Association of Bioethics Program Directors from 2008 to 2010. He has also served on the NIH Recombinant DNA Advisory Committee and on the National Cancer Insti- tute’s Pediatric Central Institutional Review Board. He currently chairs the Board of Trustees of the Northeast Ohio Medical University (NEOMED). Among other publications, he is the editor of Ethics and Research with Children: A Case-Based Approach (Oxford University Press, 2005). Jennifer Li, M.D., M.H.S., is professor of pediatrics (cardiology), professor of medicine (cardiology), and director of Pediatric Clinical Research at the Duke Clinical Research Institute (DCRI); Core Director of Pediatrics at the Duke Translational Medicine Institute; and division chief of Pediatric Car- diology, Duke University Health System. In addition to her medical degree, she has a master’s degree in clinical research. Under her leadership, the DCRI has coordinated multiple National Institutes of Health (NIH)- and industry-sponsored projects in pediatric cardiology, rheumatology, infec- tious diseases, and neuropsychiatry. Dr. Li has also been the protocol chair and primary author of several industry-sponsored international multicenter studies, including studies to evaluate the safety and effectiveness of fosino- pril doses in children with hypertension and to evaluate the pharmacody- namics and safety of clopidogrel in infants with cyanotic congenital heart disease and Blalock-Taussig shunts. Among other current activities, she is the principal investigator for the Duke/North Carolina Consortium of the National Heart, Lung, and Blood Institute-sponsored Pediatric Heart Network. She also serves on the Child Health Oversight Committee of the Clinical and Translational Sciences Award program at the National Institutes of Health and Pediatric Hypertension Treatment Working Group

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391 APPENDIX F of the National Institute of Child Health and Human Development Best Pharmaceuticals for Children Act. She recently served as a special govern- ment employee to provide expertise in the analysis of safety in the pediatric population to the Office of Pediatric Therapeutics of the Food and Drug Administration (FDA) and contributed to analyses that supported legisla- tion that expanded access to pediatric data submitted to the FDA. Christina M. Markus, J.D., is a partner in the law firm of King and Spald- ing, where she is also deputy practice leader of the FDA and Life Sciences Group. Her practice focuses on the regulation of drugs, biologics, and other products by the Food and Drug Administration, the U.S. Drug Enforcement Administration, and related state agencies (e.g., boards of pharmacy). Ms. Markus represents companies and health care institutions in a range of regulatory compliance, enforcement, and business transactions involving product development and approval, marketing and advertising, and supply chain. She provides advice on operational, transactional, and enforcement issues in areas ranging from product research, development, and marketing approval to labeling and promotion, good manufacturing practice require- ments, clinical trials registration, adverse event monitoring and reporting, licensure, distribution requirements, and market exclusivity and related protections. Milap C. Nahata, Pharm.D., is division chair and professor, College of Phar- macy, and professor of pediatrics and internal medicine, College of Medicine, of the Ohio State University. He specializes in research on the effectiveness and safety of medications for a variety of human illnesses and is an expert in developing drug formulations for safe use by children. He has also studied drug stability and pharmacokinetics (the analysis of how pharmaceuticals are absorbed, distributed, metabolized, and eliminated by the body). Dr. Nahata is a member of the Institute of Medicine (IOM) and served on an IOM sub- committee that examined medications to treat children in emergency depart- ments. He has received research achievement awards from both the American Association of Pharmaceutical Scientists and the American Pharmacists As- sociation. Among many other publications, he is the author of three books on medications for pediatric patients. Mark A. Riddle, M.D., is professor of psychiatry and pediatrics and direc- tor of the Children’s Interventions Research Program in Psychiatry at the Johns Hopkins University School of Medicine. Dr. Riddle’s research, teach- ing, and clinical practice focus on pediatric psychopharmacology, especially medication side effects. His publications include more than 200 research articles, reviews, chapters, and edited volumes. He serves as a member of the National Institute of Child Health and Human Development-sponsored

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392 SAFE AND EFFECTIVE MEDICINES FOR CHILDREN Data Monitoring Board for the Best Pharmaceuticals for Children Act and as a psychopharmacology consultant to the Task Force on Mental Health of the American Academy of Pediatrics. He is the principal investigator of a National Institute of Mental Health-sponsored, multisite study of interven- tions for children who have gained weight on antipsychotic medication and the site principal investigator of a 6-year follow-up study of preschoolers who were treated with medication for attention deficit hyperactivity disor- der. He was the director of the Division of Child and Adolescent Psychiatry at Johns Hopkins from 1993 to 2009 and was the founding chair of the National Institute of Mental Health’s Review Committee on Interventions for Disorders Involving Children and Their Families. Joseph W. St. Geme, III, M.D., is the James B. Duke Professor and Chair of Pediatrics and professor of molecular genetics and microbiology at Duke University Medical Center. Dr. St. Geme is an expert in the management of pediatric infectious diseases and in basic research on the molecular and cellular determinants of bacterial infection, with a focus on Haemophilus influenzae and Kingella kingae. He is a member of the American Society for Clinical Investigation, the Association of American Physicians, the American Academy of Microbiology, and the American Association for the Advancement of Science. He has served as president of the Pediatric Infectious Disease Society and was elected a member of the Institute of Medicine in 2010. Robert Ward, M.D., is professor of pediatrics and founder of the Univer- sity of Utah Pediatric Pharmacology Program. Dr. Ward’s research focuses on perinatal, neonatal, and pediatric pharmacology with an emphasis on neonatal analgesia. His early studies focused on treatment for persistent pulmonary hypertension of the newborn and developmental cardiovascular physiology and pharmacology. From 1997 to 2001, he chaired the Ameri- can Academy of Pediatrics Committee on Drugs and participated in the drafting of the Food and Drug Administration Modernization Act, the Best Pharmaceuticals for Children Act, and the Pediatric Research Equity Act. From 1997 to 2011, he directed the University of Utah Pediatric Pharma- cology Program, which has coordinated more than 70 pediatric studies of all classes of medications in more than 900 pediatric patients by more than 100 pediatric faculty members. From 2003 to 2010, he served as principal investigator for 1 of 13 U.S. sites in the National Institute of Child Health and Human Development Pediatric Pharmacology Research Unit network. His recent clinical studies have ranged from the kinetics of antimicrobials and proton pump inhibitors in newborns to the pharmacology of inhaled corticosteroids in children with asthma.

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393 APPENDIX F Study Staff Marilyn J. Field, Ph.D., study director, is a senior program officer at the Institute of Medicine (IOM). Her recent projects at IOM have examined rare diseases; conflicts of interest in medical research, education, and prac- tice; and the safety of medical devices for children. Among earlier proj- ects, she has directed three studies of the development and use of clinical practice guidelines, two studies of palliative and end-of-life care, and con- gressionally requested studies of employment-based health insurance and Medicare coverage of preventive services. Past positions include associate director of the Physician Payment Review Commission, executive director for Health Benefits Management at the Blue Cross and Blue Shield Associa- tion, and assistant professor of public administration at the Maxwell School of Citizenship and Public Affairs, Syracuse University. Her doctorate in political science is from the University of Michigan, Ann Arbor. Claire F. Giammaria, M.P.H., is a research associate for the Board on Health Sciences Policy. Before joining the Institute of Medicine, she was the research associate for the Technology and Liberty Program at the American Civil Liberty Union’s Washington Legislative Office, where she primarily worked on issues concerning genetics and privacy. Ms. Giammaria received a master’s degree from the Department of Health Management and Policy of the University of Michigan, Ann Arbor, and a certificate in public health genetics. Ms. Giammaria received a B.A. in biology from Grinnell College. Robin E. Parsell is a senior program assistant for the Board on Health Sci- ences Policy. Before joining the Institute of Medicine, she gained 3 years of community-based preparatory research experience with special populations as the project director at the Johns Hopkins University Center on Aging and Health and other applied research experience at the Pennsylvania State University. Ms. Parsell graduated with a B.S. in biology (focus in molecular genetics and biochemistry) and a Certificate in Gerontology from the Uni- versity of Alabama at Birmingham.

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