Appendix B
Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers

Amy Allina is the program director of the National Women’s Health Network (NWHN), a nonprofit organization based in Washington, DC, that works to improve the health of all women by influencing health policy and supporting informed consumer decision making. She plans and implements the NWHN’s policy agenda in its high-priority subjects—reproductive and sexual health, menopause and aging, and access to health care—and represents the NWHN with Congress, the Food and Drug Administration, and the National Institutes of Health. Ms. Allina serves on the Board of Directors for the Guttmacher Institute and the Reproductive Health Technologies Project. Before joining the NWHN in 1999, she worked on women’s health issues at the public-policy consulting firm Bass and Howes. She was also previously a political organizer for the Maryland affiliate of NARAL and an associate editor of Multinational Monitor, a monthly magazine founded by Ralph Nader. She is a graduate of Harvard University.


D. Bruce Burlington, MD, an infectious-disease internist, is an independent consultant on pharmaceutical-product development and regulatory affairs. He has special interests in helping companies to plan development of their drugs on the basis of Food and Drug Administration (FDA) and European Union requirements, prepare for meetings with FDA and its advisory committees, develop risk-management plans, conduct product due-diligence evaluations, and set up process, organization, and staffing plans to achieve their regulatory obligations.

Dr. Burlington was executive vice president and worldwide head of regulatory affairs, human safety, and quality at Wyeth. He led the company



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Appendix B Biographic Information on Invited Speakers, Panelists, and Authors of Commissioned Papers Amy Allina is the program director of the National Women’s Health Net- work (NWHN), a nonprofit organization based in Washington, DC, that works to improve the health of all women by influencing health policy and supporting informed consumer decision making. She plans and implements the NWHN’s policy agenda in its high-priority subjects—reproductive and sexual health, menopause and aging, and access to health care—and repre- sents the NWHN with Congress, the Food and Drug Administration, and the National Institutes of Health. Ms. Allina serves on the Board of Direc- tors for the Guttmacher Institute and the Reproductive Health Technologies Project. Before joining the NWHN in 1999, she worked on women’s health issues at the public-policy consulting firm Bass and Howes. She was also previously a political organizer for the Maryland affiliate of NARAL and an associate editor of Multinational Monitor, a monthly magazine founded by Ralph Nader. She is a graduate of Harvard University. D. bruce burlington, MD, an infectious-disease internist, is an independent consultant on pharmaceutical-product development and regulatory affairs. He has special interests in helping companies to plan development of their drugs on the basis of Food and Drug Administration (FDA) and European Union requirements, prepare for meetings with FDA and its advisory com- mittees, develop risk-management plans, conduct product due-diligence evaluations, and set up process, organization, and staffing plans to achieve their regulatory obligations. Dr. Burlington was executive vice president and worldwide head of regulatory affairs, human safety, and quality at Wyeth. He led the company 67

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6 THE FDA 510(k) ClEARANCE PROCESS in the development and US and global registration of many products and in improving Wyeth’s compliance posture. He also successfully navigated the company through an FDA consent degree. During those 8 years—as a member of many Wyeth governance councils and committees, including the executive-licensing, capitol-expenditure, and commercial councils—he participated broadly and in depth in analyzing the complex business forces driving industry. Before joining Wyeth, Dr. Burlington served in FDA for 17 years. He was the first physician named as director at of the Center for Devices and Radiological Health (CDRH), where he led major changes, increased the rigor of clinical investigation of medical devices, and championed innova- tions in the center’s work with industry. Before that, he was a research immunologist and then a manager in the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research (CDER). In those centers, he had responsibility for viral vaccines, investigational biologics, review of biologic license applications, approval of new drug ap- plications, and generic drugs. As medical deputy director in CDER, he also oversaw policy and compliance decisions related to pharmaceuticals. David W. Feigal, Jr., MD, MPH, is the vice president for global regulatory affairs in Amgen in Thousand Oaks, California. His career in the develop- ment of medical therapeutics began with training as a physician epidemiolo- gist with an MD from Stanford University and an MPH from the University of California, Berkeley. He did his internal-medicine residency training at the University of California, Davis and a fellowship in clinical epidemiology at the University of California, San Francisco (UCSF). He joined the UCSF School of Medicine faculty in 1984 with joint appointments in the Depart- ment of Medicine and the Department of Epidemiology and Biostatistics and in 1989 moved to the Department of Medicine of the University of California, San Diego. Dr. Feigal came to the Food and Drug Administration (FDA) in 1992 and headed the Center for Drug Evaluation and Research Antiviral Drug Division, the Anti-Infective Drug Division, and ODE IV. In fall 1997, he moved to the Center for Biologics Evaluation and Research as medical deputy director. In spring 1999, Dr. Feigal became the director of the Cen- ter for Devices and Radiological Health (CDRH). At CDRH, he was an advocate for the center’s science and education programs and worked with Congress and industry to launch a medical devices user fee. In 2004, he left FDA to join a regulatory consulting group, NDA Partners, LLP, and resume teaching as a faculty associate at the Sandra Day O’Connor Law School of Arizona State University. In 2006, he joined Élan Pharmaceuticals in South San Francisco as senior vice president for global regulatory and global safety

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69 APPENDIX B surveillance before moving to Amgen in 2008. In August 2010, he will return to his consulting practice. Peter barton Hutt is a senior counsel in the Washington, DC, law firm of Covington & Burling, specializing in food and drug law. He began his law practice with the firm in 1960 and, except for his 4 years in the govern- ment, has continued at the firm ever since. From 1971 to 1975, he was chief counsel for the Food and Drug Administration (FDA). Since 1994, he has taught a full course on food and drug law during winter term at Harvard Law School. He is the coauthor of Food and Drug law: Cases and Materials (Foundation Press) and has published more than 175 book chapters and articles on food and drug law and on health policy. Mr. Hutt has represented the national trade associations of the food, prescription-drug, nonprescription-drug, dietary-supplement, and cosmetics industries. While at FDA, he drafted the legislation that became the Medical Device Amendments of 1976, and beginning in 1962 he has participated in the drafting of most of the major legislation amending the Federal Food, Drug, and Cosmetic Act. He has testified before the House of Representa- tives and Senate more than 100 times either as a witness or as counsel ac- companying a witness. Mr. Hutt has been a member of the Institute of Medicine (IOM) since it was formed in 1971. He has served on the IOM Executive Committee and other National Academy of Sciences (NAS) and IOM committees. He recently served on the Science Review Subcommittee of the FDA Science Board to review the FDA science needs to perform its regulatory mission. He serves on a wide variety of academic and scientific advisory boards, on the boards of directors of venture-capital startup companies, and on the advisory boards of six venture-capital firms. Mr. Hutt has served on the IOM Roundtable for the Development of Drugs and Vaccines Against AIDS, the Advisory Committee to the Direc- tor of the National Institutes of Health, the NAS Committee on Research Training in the Biomedical and Behavioral Sciences, the National Institutes of Health Advisory Committee to Review the Guidelines for Recombinant DNA Research, the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS established by the President’s Cancer Panel of the National Cancer Institute at the request of President Bush, and five Office of Technology Assessment advisory panels. He was a member of the New Foods Panel of the White House Conference on Food, Nutrition, and Health and wrote the panel report. In April 2005, Mr. Hutt was presented the Distinguished Alumni Award by FDA. In May 2005, he was given the Lifetime Achievement Award for research advocacy by the Foundation for Biomedical Research.

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70 THE FDA 510(k) ClEARANCE PROCESS David Jefferys, bSc, MD, FRCP, FFPM, FRSM, FRAPS, is the senior vice president for global regulatory, health-care policy, and corporate affairs of Eisai Europe and chairman of the Eisai Global Regulatory Council. He also sits as a member of the European Working Group of the United King- dom (UK) Ministerial Industry Strategy Group and UK Innovation Board. He is chairman of the Association of the British Pharmaceutical Industry Regulatory Affairs Group and a member of several European Federation of Pharmaceutical Industries and Associations committees. Dr. Jefferys joined Eisai in January 2005 on retirement from the UK civil service. He qualified in medicine in 1976 and after a career in clinical and academic medicines joined the UK Department of Health in 1984 to work on the review of medicines. He rose to become director of the Licensing Division and an executive director of the Medicines Control Agency. During that time he served as the principal assessor for the Committee on the Safety of Medicines. He was also a delegate to the Committee for Proprietary Medicinal Products (CPMP) from 1986 to 1994 and chaired the operations working party of the CPMP (now the Committee for Medicinal Products for Human Use, CHMP). From 1995 to 2000, he was the UK delegate on the CPMP (CHMP). He chaired the Mutual Recognition Facilitation Group and the Pharmaceutical Evaluation Reports Scheme Committee. He was a World Health Organization adviser. During that time, Dr. Jefferys was in- volved with the International Conference on Harmonisation and joined the CMR International Regulatory Board in 1992, becoming chairman of the Advisory Board from 2000 to 2004. He remains a member of the board. In February 2000, he was appointed chief executive director of the Medical Devices Agency for the Department of Health. He served on the Medical Device Expert Group of the European Union and on the Global Harmonization Task Force. He was a member of the Healthcare Industry Task Force and chaired its Regulatory and Patient Safety Group. On the creation of the Medicines and healthcare Products Regulatory Agency, he acted as joint chief executive until April 2004, when he transferred to be- come special adviser in advanced health-care technology to the Department of Health and worked on secondment with the European Medicines Agency on benefit–risk evaluation. Larry G. Kessler, ScD, is professor and chair of the Department of Health Services of the University of Washington School of Public Health. In that role, he directs more than 60 faculty members who provide education in a wide variety of health-services disciplines leading to degrees in public health, including a PhD program, a master’s of public health, a master’s of health administration, and a recently developed undergraduate major in public health. The department also contains four centers; three are concerned with

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71 APPENDIX B different aspects of public-health research, and the fourth is the Northwest Center for Public Health Practice. Before joining the faculty of the University of Washington, he worked for 30 years in the federal government, first in the National Institute of Men- tal Health, then in the National Cancer Institute (NCI), and most recently in the US Food and Drug Administration (FDA) Center for Devices and Radiological Health. He obtained his degree in operations research from the Johns Hopkins School of Public Health in 1978. In September 2002, Dr. Kessler was appointed director of the Office of Science and Technology in FDA’s Center for Devices and Radiological Health (CDRH). In that position, he directed the efforts of the laboratories of CDRH and the Standards Coordination Program. The office became the Office of Science and Engineering Laboratories (OSEL) in a reorganization effort designed to integrate science and engineering into the function and mission of CDRH. OSEL plays a crucial role in identifying key scientific questions and solutions concerning device safety and effectiveness. In June 1995, he joined CDRH as the director of the Office of Surveil- lance and Biometrics. Under his leadership, the office has implemented the medical device reporting regulation for user reporting, has developed a program for reducing the burden on industry for repetitive reporting, and has completed a pilot program to develop a sentinel system for user-facility reporting of adverse events. In addition, he has helped to develop a new program that encourages the application of a wide variety of new statistical methods, with a focus on Bayesian methods, for the device review process. From 1996 through 2001, he served as chair of Study Group 2 of the Global Harmonization Task Force (GHTF), concentrating on postmarket vigilance and surveillance. Dr. Kessler was chair of the GHTF from 2007 to 2008. Joshua Makower, MD, MbA, has dedicated his life to the creation of medi- cal technologies that improve patients’ quality of life and is the founder and CEO of ExploraMed Development, LLC, a medical device incubator based on the West Coast. He also serves as a consulting associate professor of medicine in Stanford University Medical School and cofounded Stanford’s Biodesign Innovation Program. A compendium of the materials created to support the teaching efforts in the Stanford biodesign program has recently been published by Cambridge University Press: Biodesign: The Process of Innovating Medical Technologies. Dr. Makower is a venture partner with New Enterprise Associates, where he supports investing activity in the medical device arena. He has founded several companies through the ExploraMed incubator that have achieved successful M&A transactions, including Acclarent, Inc., a company focused on developing novel therapies in ENT, which was acquired by Johnson & Johnson in 2010; TransVascular, Inc., a company focused on the development of a completely catheter-based

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7 THE FDA 510(k) ClEARANCE PROCESS coronary-bypass technology, which was acquired by Medtronic, Inc., in 2003; and EndoMatrix, Inc., a company focused on the development of a novel therapy for incontinence and gastrointestinal reflux, which was ac- quired by C.R. Bard in 1997. Dr. Makower was a founder and until 1995 manager of Pfizer’s Strategic Innovation Group, a group chartered to create new medical device technologies and businesses for Pfizer. He serves on the Board of Directors for NeoTract, Inc., Moximed, Inc., Intrinsic Therapeu- tics, Inc., ExploraMed III, Inc., and Vibrynt, Inc. Dr. Makower holds more than 60 patents for various medical devices in the fields of orthopedics, otorhinolaryngology, cardiology, general surgery, drug delivery, and urology. He holds an MBA from Columbia University, an MD from the New York University School of Medicine, and an SB in mechanical engineering from the Massachusetts Institute of Technology. Doug Mowen is a managing director in the US Life Sciences advisory practice of PricewaterhouseCoopers. For the last 12 years, he has worked broadly in the medical device industry, including orthopedic, cardiac-rhythm management, and medical equipment companies. His focus has been on commercial compliance, supply and quality operations, patient-manage- ment businesses, and customer strategies. Before his current role, he was a partner in KPMG, a managing director of the life-sciences practice in BearingPoint, a marketing manager for the Hewlett-Packard company, and a design engineer for Unisys. Mr. Mowen has a BS in computer science and mathematics from the University of Pittsburgh. Philip J. Phillips, MbA, is president of Phillips Consulting Group, LLC. He has 28 years of experience in Food and Drug Administration (FDA) regulation of medical devices, having focused on the development and implementation of numerous regulatory strategies regarding the design, manufacture, and marketing of medical devices in the United States. Mr. Phillips has expertise in a wide array of regulatory matters, including FDA jurisdiction, device classification, clinical trials, human-subject protection, and product labeling, promotion, and advertising. His device experience crosses all medical specialties, including in vitro diagnostic devices. He has promulgated regulations and developed numerous guidance documents aimed at clarifying FDA premarket requirements and expectations. Mr. Phillips has extensive experience in explaining and defending po- sitions before Congress, the Department of Health and Human Services (HHS), FDA and its advisory committees, and other federal agencies. He has represented the US government in negotiations with the European Union and is an authority on dispute resolution and effective interaction with FDA and related agencies. Also recognized as an authority in device regulation,

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7 APPENDIX B he has served as an expert witness in court proceedings and is a frequently invited speaker at scientific and regulatory forums. He has received numerous HHS, FDA, and Center for Devices and Radiological Health (CDRH) awards, including two HHS Distinguished Service Awards and three FDA Awards of Merit. During his 24-year FDA tenure, Mr. Phillips streamlined medical device review processes and launched numerous agency initiatives aimed at enhanc- ing public health while lessening regulatory burden. In addition to serving as the Office of Device Evaluation deputy director for science and regula- tory policy, he served as director of program operations, interim director for the Division of General and Restorative Devices, deputy director for the Division of Ophthalmic Devices, and chief of the Diagnostic and Surgical Devices Branch. Mr. Phillips began his FDA career as an interdisciplinary scientist. He holds a bachelor’s degree in microbiology from the University of Maryland and an MBA from the George Washington University. He also completed the George Washington University Contemporary Executive Development Program. Janet E. Trunzo, MS, is executive vice president, technology and regulatory affairs, of the Advanced Medical Technology Association (AdvaMed). Dur- ing her tenure at AdvaMed, she has focused on the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and led the industry effort in negotiations with the Food and Drug Administration on the reauthorization of MDUFMA, which was enacted in September 2007. She also concentrates on regulatory harmonization in global economies, including those of Japan and China. Ms. Trunzo represents the US device industry on the Global Harmonization Task Force and just completed her term as vice chair of its Steering Committee. She is a member of the Board of Trustees of the international Global Medical Device Nomenclature Agency. Before joining AdvaMed, Ms. Trunzo held positions at Hybritech, Inc., a medical device and diagnostics manufacturer, and Scripps Clinic and Research Foundation, a hospital, diagnostic clinic, and research institute. Ms. Trunzo received her MS in health physics from Rutgers University and her BS in Chemistry from California State College. Timothy A. ulatowski is the director of the Office of Compliance of the Food and Drug Administration (FDA) Center for Devices and Radiological Health. He manages four divisions tasked with promoting consumer health and safety, promoting compliance and product quality, and enforcing the medical device and radiologic-health laws and regulations. Mr. Ulatowski has been with FDA since 1974 and with the Office of Compliance since January 2003. Before his position in compliance he was a division director in

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7 THE FDA 510(k) ClEARANCE PROCESS the Office of Device Evaluation and was active in domestic and international standards development. He was until recently the head of the US delegation to the Global Harmonization Task Force. Mr. Ulatowski holds undergradu- ate and graduate degrees in microbiology and biomedical engineering. William vaughan is a consultant to Consumers Union on Food and Drug Administration issues. Starting in 1965, he worked for various members of the US House of Representatives Committee on Ways and Means. He retired in 2001 as staff director for the minority on the Subcommittee on Health. He worked as a lobbyist for Families USA from 2003 to 2005 and has been a senior health-policy analyst with Consumers Union, the independent, nonprofit publisher of Consumer Reports, from 2005 to February 2008 and from February to December 2009. He is a member of the board of the National Committee to Preserve Social Security and Medicare and a policy adviser to the Medicare Rights Center.