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<title>Policy Forum-Regulation of Follow-on Biologics: Ensuring Quality and Patient Safety (National Press Club, Holeman Lounge, 529 14th Street, NW. Washington, DC)</title>
<copyright>Copyright (c) 2013 Thomas Jefferson University All rights reserved.</copyright>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21</link>
<description>Recent Events in Policy Forum-Regulation of Follow-on Biologics: Ensuring Quality and Patient Safety (National Press Club, Holeman Lounge, 529 14th Street, NW. Washington, DC)</description>
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<title>Introductory Remarks and Review of the Issues</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/10</link>
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<pubDate>Tue, 21 Apr 2009 08:30:00 PDT</pubDate>
<description>
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	<p>David B. Nash is the Founding Dean of the Jefferson School of Population Health on the campus of Thomas Jefferson University in Philadelphia, PA. Dr. Nash is also the Dr. Raymond C. and Doris N. Grandon Professor of Health Policy, an endowed professorship that is one of a handful of such chairs in the nation. His new appointment as the Founding Dean culminates a nearly twenty-year tenure at Jefferson.</p>
<p>Dr. Nash, a board certified Internist, founded the original Office of Health Policy in 1990. Thirteen years later, the Office evolved into one of the first Departments of Health Policy in an American medical college. In 2008, the Board of Thomas Jefferson University approved the creation of the new Jefferson School of Population Health. The new school represents the first time a health-sciences university has placed four Masters Programs under one roof, namely a Masters in Public Health, Health Policy, Healthcare Quality and Safety and Chronic Care Management. The goal of this innovative school is to produce a new type of healthcare leader for the future. Dr. Nash is internationally recognized for his work in outcomes management, medical staff development and quality-of-care improvement; his publications have appeared in more than 100 articles in major journals. He has edited seventeen books, including A Systems Approach to Disease Management, Connecting with the New Healthcare Consumer, The Quality Solution, Practicing Medicine in the 21st Century and, most recently, Governance for Health Care Providers: The Call to Leadership.</p>
<p>In 1995, he was awarded the Latiolais Prize by the Academy of Managed Care Pharmacy for his leadership in disease management and pharmacoeconomics. He also received the Philadelphia Business Journal Healthcare Heroes Award in October 1997 and was named an honorary distinguished fellow of the American College of Physician Executives in 1998. Finally, in 2006, he received the Elliot Stone Award for leadership in public accountability for health data from NAHDO.</p>
<p>Repeatedly named by Modern Healthcare to the top 100 most powerful persons in healthcare, his national activities include membership on the Board of Directors of the DMAA: The Care Continuum Alliance, Chair of a National Quality Forum Technical Advisory Panel and membership in the American College of Surgeons Health Policy Institute - three key national groups focusing on quality measurement and improvement. He continues as one of the principal faculty members for quality of care issues of the American College of Physician Executives in Tampa, FL and is the developer of the ACPE Capstone Course on Quality. He serves on the Board of the West Virginia Medical Institute (WVMI), the Medicare QIO for Pennsylvania. He recently ended his tenure as a member of the Board of Trustees of Catholic Healthcare Partners in Cincinnati, Ohio – one of the nation’s largest integrated delivery systems – and he chairs the Board Committee on Quality and Safety. Most recently, he was appointed to the Board of Main Line Health, a four hospital system in suburban Philadelphia, PA. Finally, he chairs the Highmark Blue Cross Board Quality Committee in Pittsburgh, PA.</p>
<p>Dr. Nash is a consultant to organizations in both the public and private sectors, including the Technical Advisory Group of the Pennsylvania Health Care Cost Containment Council (a group he has chaired for the last decade) and numerous corporations within the pharmaceutical industry. He is on the board of directors and advisory board of multiple healthcare companies. From 1984 to 1989, he was Deputy Editor, Annals of Internal Medicine, at the American College of Physicians. Currently, he is Editor-in-Chief of four major national journals including P&T, Population Health Management, Biotechnology Healthcare and the American Journal of Medical Quality. Through his writings, public appearances and his online presence (Nash on Health Policy blog), his message reaches more than 100,000 persons every month.</p>
<p>Dr. Nash received his BA in economics (Phi Beta Kappa) from Vassar College, Poughkeepsie, NY; his MD from the University of Rochester School of Medicine and Dentistry; and his MBA in Health Administration (with honors) from the Wharton School at the University of Pennsylvania. While at Penn, he was a Robert Wood Johnson Foundation Clinical Scholar and Medical Director of a nine physician faculty group practice in general internal medicine.</p>

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<author>David B. Nash, MD, MBA</author>


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<title>Keynote Address:  Follow-on Biologics:  Getting Past the Exclusivity Debate</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/9</link>
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<pubDate>Tue, 21 Apr 2009 08:45:00 PDT</pubDate>
<description>
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	<p>Michael McCaughan is Editor-in-Chief of FDC-Windhover’s Biopharma Group, the leading publisher of news and information services for the pharmaceutical industry, including The Pink Sheet, IN VIVO, The RPM Report, PharmAsia News, and The IN VIVO Blog. McCaughan speaks frequently on regulatory and policy developments affecting the biopharmaceutical industry.  McCaughan joined "The Pink Sheet" in 1990 as a business reporter. He became Assistant Managing Editor in 1993, Managing Editor in 1995 and Editor-In-Chief in 1996. He oversees an editorial staff of 35, and helped launch affiliated publications and on-line services, including Pharmaceutical Approvals Monthly, FDAAdvisoryCommittee.com, “The Pink Sheet” On The Web, “The Pink Sheet” DAILY and The RPM Report. McCaughan is a summa cum laude graduate of Yale University.</p>

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<author>Michael McCaughan</author>


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<title>Regulatory Review and Approval Processes Under Current US Guidelines and Across the Globe</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/7</link>
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<pubDate>Tue, 21 Apr 2009 10:00:00 PDT</pubDate>
<description>
	<![CDATA[
	<p>Gundu H. R. Rao obtained his B.Sc degree from the University of Mysore and B.Sc (Hons) and M.Sc., degrees from the Poona University. He worked for a year with the Commonwealth Institute of Biological Control, Bangalore and five years at the Central Food Technological Research Institute, Mysore. He immigrated to the USA in 1965 and specialized in grain storage technology and obtained his PhD from the Kansas State University, Manhattan, Kansas. After working as a post-doctoral fellow at the Texas A&M University and University of Minnesota, he joined the department of Pharmacology as an NIH fellow to get training in toxicology.</p>
<p>He has been with the University of Minnesota Medical School for over 34 years. He is a naturalized US citizen and a tenured professor in the department of Laboratory Medicine and Pathology. He also has faculty appointments in Anesthesiology, Lillehei Heart Institute, and Biomedical Engineering Institute. He is an author or co-author of over 300 publications in the field of interest (thrombosis and stroke). In the past, he has consulted various medical device development companies in the Twin Cities including 3M, Medtronic Inc, St Jude Medical, Medical CV Inc, Vascular Solutions, APP Tech, Endocardial Solutions, PlaCor Inc., Medical Innovations Inc, ATS Medical Inc, Hypertension Diagnostics Inc. and Boston Scientific on problems related to blood biocompatibility, thrombosis and stroke.</p>
<p>He was the visiting Professor in the Royal College of Surgeons, England in the summer of 1987, Department of Surgery King’s College in 1988 and in the Thrombosis Research Institute, London in 1989. He also served as senior consultant to the Government of India, for three successive years (1990-93), under a United Nations program called TOKTEN. He also served as a visiting professor in the Institute of Human Physiology, University of Padua, Italy during 1995-96. He started a society (South Asian Society on Atherosclerosis and Thrombosis, SASAT) to create awareness on vascular diseases in 1993. Since then he is organizing international symposiums on Atherosclerosis and Thrombosis in India, every other year. He has edited five books: Handbook of Platelet Physiology and Pharmacology 1999, Coronary Artery Disease in South Asians: Epidemiology, Risk Factors and Prevention, 2001, and Coronary Artery Disease in Indians: Risk Factors, Pathophysiology and Prevention, 2005, Handbook on Blood Banking and Transfusion Medicine, 2006 and Type 2 Diabetes in South Asians: Epidemiology, Risk Factors and Prevention, 2006. He is on the advisory board of many medical, scientific and device development organizations. He is also a Senior Specialist in the Fulbright Program.</p>

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<author>Gundu H.R. Rao, PhD.</author>


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<title>Regulatory Review and Approval Processes Under Current US Guidelines and Across the Globe</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/8</link>
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<pubDate>Tue, 21 Apr 2009 09:30:00 PDT</pubDate>
<description>
	<![CDATA[
	<p>Brian E. Harvey, MD, PhD is Vice President, Regulatory Policy for sanofi-aventis, reporting to the global head of Regulatory Affairs. He leads the Corporate Regulatory Affairs (CRA) office in Bethesda, MD and interacts with the Food and Drug Administration (FDA), C-Path Institute and key industry representatives on behalf of sanofi-aventis. Dr. Harvey serves on the Pharmaceutical Research and Manufactures of America (PhRMA) Regulatory Affairs Coordination Committee (RACC), Asian Pacific Technical Committee and International Biologics and Biotechnology Taskforce/Biologics Key Issues Team. He is a member of the Biotechnology Industry Organization (BIO) Regulatory Affairs Committee (RAC).</p>
<p>Previously, Dr. Harvey worked for the FDA in the medical devices (CDRH), biologics (CBER) and drugs (CDER) centers. Most recently, he was the director of FDA’s Division of Gastroenterology Products. He was previously the Deputy Office Director for CDER’s Office of Drug Evaluation, having come to CDER from CBER in 2003. He started at FDA in 1995 as a medical officer in CDRH’s Gastroenterology and Renal Devices Branch. In 2000-2001, Dr. Harvey represented FDA as an American Political Science Association (APSA) Congressional Fellow, where he worked on health and scientific issues in the U.S. Senate.</p>
<p>Dr. Harvey graduated with honors from Middlebury College in Vermont. He completed his PhD in biochemistry, followed by his MD degree, at the University of Connecticut. He conducted post-doctoral research at Harvard Medical School and completed his internal medicine internship and residency at Boston’s Beth Israel Hospital. He completed a three-year gastroenterology fellowship at the Johns Hopkins Hospital. He continues to care for patients on weekends as a part-time hospitalist at Anne Arundel Medical Center in Annapolis, Maryland.</p>

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<author>Brian Harvey, MD, PhD.</author>


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<title>Legislative Update- A comparison of Legislative Proposals and Implications</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/6</link>
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<pubDate>Tue, 21 Apr 2009 10:45:00 PDT</pubDate>
<description>
	<![CDATA[
	<p>Ann Witt, JD, is currently Health Counsel for the House Committee on Energy and Commerce. Since 2002, she has worked for Congressman Henry Waxman. Prior to this role, Ms. Witt held a position with FDA and took a 7-month leave of absence in 2000 to work as staff director of an investigation for the World Health Organization into covert attempts by the tobacco industry to influence WHO. While at FDA, she spent one year as Acting Director of the Division of Drug Marketing and Advertising in CDER, then joined the Office of the Commissioner in 1992, working on a variety of issues including tobacco regulation, advisory committees and conflicts of interest, and pediatric labeling for new drugs. Ms. Witt joined FDA in 1980, working for the Office of the Chief Counsel until 1991, where her primary responsibilities included providing legal counseling on new drug and device issues to FDA’s Center for Drug Research and Evaluation (CDER) and Center for Devices and Radiological Health (CDRH). Before joining FDA, she clerked for the Ninth Circuit Court of Appeals, Staff Attorney’s Office. Ms. Witt earned an AB from Bryn Mawr College, and a JD from Stanford Law School.</p>

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<author>Ann Witt, JD</author>


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<title>Panel: The Interplay of Economic and Clinical Issues</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/5</link>
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<pubDate>Tue, 21 Apr 2009 14:00:00 PDT</pubDate>
<description>
	<![CDATA[
	<p>Dr. Jones is a clinical pharmacologist/pharmacoepidemiologist trained in geriatrics and internal medicine with a longstanding interest in the study of adverse drug reactions, drug utilization, and drug development and regulation. She received her medical training at Baylor College of Medicine, followed by clinical training in internal medicine, a fellowship in clinical pharmacology, and a PhD in developmental pharmacology at University of California, San Francisco.</p>
<p>Interested in the translation of basic pharmacology information to the practice site, she practiced, taught clinical pharmacology, and carried out early research in drug utilization at Pacific Medical Center in San Francisco until 1978, when she came to Washington, DC as Director of the FDA's Division of Drug Experience (now the Office of Drug Safety) until 1984.</p>
<p>Leaving the FDA, she returned to practice medicine and geriatrics at Georgetown University, where she continues as Adjunct Clinical Professor of Pharmacology. She also holds Adjunct Professor appointments at George Washington University School of Public Health, and the University of Michigan School of Public Health Summer Epidemiology program where she teaches a one-week course in pharmacoepidemiology. She has also served as a PhD Examiner at the Karolinska Institute, and as a member of several NIH and AHRQ Study Sections.</p>
<p>In 1988, she began a consulting business, The Degge Group, Ltd. (Degge). The mission of The Degge Group, Ltd. is to optimize the therapy and prevention of disease in populations in the U.S. and abroad through regulatory support, innovative epidemiological research, education, and product development. In pursuit of this mission, Degge works on behalf of pharmaceutical and consumer healthcare company clients, healthcare systems, and government agencies. Degge provides timely and novel solutions to safety issues from regulatory, scientific, and public health perspectives. Dr. Jones also serves as President of the Pharmaceutical Education and Research Institute (PERI) a non-profit organization that provides a range of educational courses on drug development.</p>
<p>Throughout her career, Dr. Jones has been dedicated to international cooperation and communication in the field of drug safety. Beginning in 1978, while at FDA, Dr. Jones represented the FDA to the World Health Organization (WHO) Collaborating Center for International Drug Monitoring in Uppsala, Sweden, serving as Chair from 1981-85. She has served on the International Society for Pharmacoepidemiology Board since 1989, including terms as President and VP Finance. In 1990, she helped found and served on the Executive Committee of The International Medical Benefit Risk Foundation - RAD-AR, Geneva, Switzerland. Dr. Jones has chaired the Committee on Drug Utilization for the U.S. Pharmacopoeia (USP) in the early 1990’s, and is a member the Council for International Organizations of Medical Sciences (CIOMS) Standardized Medical Query (SMQ) Working Group since 2004. She has represented international pharmaceutical companies before U.S., European and other international regulatory bodies on drug development, safety and risk management issues.</p>
<p>Dr. Jones has published numerous articles relating to adverse reactions, post marketing surveillance of drugs, pharmacoepidemiology and natural history of disease, drugs in populations (i.e., geriatric, pediatric patients) and drug information for patients and physicians.</p>

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<author>Judith K. Jones, MD, PhD.</author>


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<title>Panel: The Interplay of Economic and Clinical Issues</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/4</link>
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<pubDate>Tue, 21 Apr 2009 14:30:00 PDT</pubDate>
<description>
	<![CDATA[
	<p>R.T. (Terry) Hisey is the Vice Chairman and U.S. Life Sciences Leader of the member firms of Deloitte. In this role, he serves the Life Sciences industry in bringing Tax, Audit, Consulting, and Financial Advisory Services to assist clients in achieving sustainable competitive advantage through strategic change. The Life Science activities span the entire value chain including Drug Discovery and Development, Commercial Operations, Production and Distribution, and Regulatory Compliance. In addition to Life Sciences, his responsibilities also include linking the Life Science effort with those in Health Providers, Health Plans, and Government to identify and capitalize on the unique capabilities that Deloitte offers based on our depth in all aspects of the value chain. Mr. Hisey is Chairman of the Life Sciences Advisory Board for Deloitte Research and is a Steering Committee member for the Deloitte Center for Health Solutions in Washington, DC.</p>
<p>Mr. Hisey was previously the Vice President and National Leader of the Life Science Practice of a major global consulting and integration firm and was a global leader in their efforts regarding Life Science thought leadership in strategy, transformation, and operations. He has personal client service related to Strategy and Operations with a number of pharmaceutical and biotechnology firms that includes Abbott, Amgen, Astellas, Genentech, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck, Pfizer, Wyeth Biopharmaceuticals, and other major and mid-size Life Science companies.</p>
<p>In addition to his client work, Mr. Hisey is a noted industry authority, a frequent speaker, a member of the Editorial Advisory Board for Pharmaceutical Executive Magazine and a guest lecturer at several schools including the University of Pennsylvania, Drexel University, and the University of California at Berkeley. In addition, he is a member of several industry associations and advisory boards. Mr. Hisey has a BS in Engineering from Pennsylvania State University and a MS in Business Management and Organizational Dynamics from the University of Pennsylvania.</p>

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<author>R. Terry Hisey</author>


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<title>Is Interchangeability Possible?  Understanding and Evaluating the Evidence Base-Implications for Quality and Safety</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/3</link>
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<pubDate>Tue, 21 Apr 2009 13:00:00 PDT</pubDate>
<description>
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	<p>Geno Merli, a board-certified specialist in internal medicine and physical medicine and rehabilitation, is Director of the Jefferson Center for Vascular Disease at Jefferson Medical College and Senior Vice President and Chief Medical Officer at Thomas Jefferson University Hospital.</p>
<p>Dr. Merli received his medical degree from Jefferson Medical College and completed his residency in rehabilitation medicine and internal medicine at Thomas Jefferson University Hospital. Dr. Merli is a nationally recognized expert in the areas of prophylaxis for and management of deep-vein thrombosis and pulmonary embolism (DVT/PE), as well as for the medical consultation of surgical patients. His research interests have focused on prophylaxis for DVT/PE and the management of DVT in acute spinal cord injury, total joint replacement, trauma, and high-risk cancer patients.</p>
<p>Former editor-in-chief of Internal Medicine, Dr. Merli currently serves on the editorial board of Patient Care, Journal of the Society of Hospital Medicine, and The Hospitalist. He is also a reviewer for the Archives of Internal Medicine, Annals of Internal Medicine, Chest, Journal of Thrombosis and Thrombolysis, Journal of Thrombosis and Hemostasis and JAMA. He is co-editor of the book Medical Management of the Surgical Patient and co-chairs for a national course on the perioperative care of the surgical patient with medical problems.</p>
<p>Dr. Merli is a fellow of the American College of Physicians and a member of American Venous Forum, the Society of Hospital Medicine, American Medical Association, Society of Vascular Medicine and Biology, and the International Society of Thrombosis and Hemostasis.</p>

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<author>Geno J. Merli, MD</author>


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<title>Panel: The Interplay of Economic and Clinical Issues</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/2</link>
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<pubDate>Tue, 21 Apr 2009 14:10:00 PDT</pubDate>
<description>
	<![CDATA[
	<p>Laurence J. Kotlikoff is Professor of Economics at Boston University, Research Associate of the National Bureau of Economic Research, Fellow of the American Academy of Arts and Sciences, Fellow of the Econometric Society, and President of Economic Security Planning, Inc., a company specializing in financial planning software. Professor Kotlikoff received his B.A. in Economics from the University of Pennsylvania in 1973 and his Ph.D. in Economics from Harvard University in 1977. From 1977 through 1983 he served on the faculties of economics of the University of California, Los Angeles and Yale University. In 1981-82 Professor Kotlikoff was a Senior Economist with the President's Council of Economic Advisers. Professor Kotlikoff has served as a consultant to the International Monetary Fund, the World Bank, the Harvard Institute for International Development, the Organization for Economic Cooperation and Development, the Swedish Ministry of Finance, the Norwegian Ministry of Finance, the Bank of Italy, the Bank of Japan, the Bank of England, the Government of Russia, the Government of Ukraine, the Government of Bolivia, the Government of Bulgaria, the Treasury of New Zealand, the Office of Management and Budget, the U.S. Department of Education, the U.S. Department of Labor, the Joint Committee on Taxation, The Commonwealth of Massachusetts, The American Council of Life Insurance, Merrill Lynch, Fidelity Investments, AT&T, AON Corp., and other major U.S. corporations. He has provided expert testimony on numerous occasions to committees of Congress including the Senate Finance Committee, the House Ways and Means Committee, and the Joint Economic Committee. Professor Kotlikoff is author or co-author of 13 books and hundreds of professional journal articles. His most recent book, co-authored with Scott Burns, is forthcoming with Simon & Schuster and is entitled Spend ‘Til the End.</p>
<p>Professor Kotlikoff publishes extensively in newspapers and magazines on issues of deficits, generational accounting, the tax structure, social security, Medicare, health reform, pensions, saving, insurance, and personal finance.</p>

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<author>Laurence J. Kotlikoff</author>


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<title>Panel: The Interplay of Economic and Clinical Issues (Question and Answer session with entire panel)</title>
<link>http://jdc.jefferson.edu/jsph_biologics_quality_and_patient_safety/2009/Apr21/1</link>
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<pubDate>Tue, 21 Apr 2009 14:45:00 PDT</pubDate>
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	<p>Panel discussion on safety, liability, cost and access.</p>

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<author>Judith K. Jones, MD, PhD et al.</author>


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