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D Participant Biographies Jeff Allen, Ph.D., serves as the executive director of Friends of Cancer Research (Friends), a think tank and advocacy organization in Washing- ton, DC. Friends is one our countryâs leading voices in advocating for policies and developing solutions that will get treatments to patients in the safest and quickest way possible. As a thought leader on many issues related to the Food and Drug Administration, regulatory strategy, and health care policy, Dr. Allen is regularly published in prestigious medical journals and policy publications. In addition to participating in major sci- entific and policy symposiums around the country each year, Dr. Allen testifies before Congress and contributes his expertise to the legislative process on multiple occasions. Recent Friends initiatives include the es- tablishment of the new Breakthrough Therapies designation and the de- velopment of the Lung Cancer Master Protocol, a unique partnership that will accelerate and optimize clinical trial conduct for new drugs. He also serves on a variety of influential committees, boards, and advisory coun- cils. Dr. Allen received his Ph.D. in Cell and Molecular Biology from Georgetown University and his B.S. in Biology from Bowling Green State University. Margaret Anderson, M.S., serves as executive director of FasterCures, a Milken Institute center that works to speed up the process of getting new medicines from discovery to patients. She is a founding board mem- ber and past president of the Alliance for a Stronger FDA [Food and Drug Administration]; a member of the National Institutes of Health National Center for Advancing Translational Sciences Advisory Council and Cures Acceleration Network Review Board, the National Health Council Board of Directors, United for Medical Research Steering Committee, 87
88 FINANCIAL INCENTIVES and the Institute of Medicineâs Forum on Drug Discovery, Development, and Translation. Previously, Ms. Anderson was the deputy director and team leader of the Center on AIDS & Community Health at the Academy for Educational Development; program director at the Society for Wom- enâs Health Research; health science analyst at the American Public Health Association; and analyst and project director at the Congressional Office of Technology Assessment in the Biological Applications Pro- gram. Ms. Anderson holds a bachelorâs degree from the University of Maryland and a masterâs Degree in Science, Technology, and Public Pol- icy from George Washington University. Robert Armitage, J.D., M.S., is a consultant on intellectual property (IP) policy and strategy. He completed a decade of service as senior vice president and general counsel for Eli Lilly and Company at the end of 2012. Prior to assuming his general counsel role at Lilly, Mr. Armitage had been Lillyâs vice president and general patent counsel. Before his Lilly career, he spent 6 years as a partner in the Washington, DC, office of Vinson & Elkins LLP (1993â1999), where he established and led its DC-based IP practice. Among other positions, he has served as an ad- junct professor of law at George Washington University Law School (1996â2000), a member of the Board of Directors of Human Genome Sciences, Inc. (1995â1999), president of the Board of Directors of Hos- pice Care of Southwest Michigan, Inc. (1985â1987), and chief intellectu- al property counsel for The Upjohn Company (1983â1993), where he began his professional career as a patent trainee in 1974. He has served in a variety of leadership positions in the intellectual property bar, in- cluding as president of both the American Intellectual Property Law As- sociation (AIPLA) and the Association of Corporate Patent Counsel. Other leadership positions include service as chair of the following or- ganizations: the American Bar Association Intellectual Property Law Section, the National Council of Intellectual Property Law Associations, the Fellows of the American Intellectual Property Law Association, the Patent Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA), the Intellectual Property Committee of the National Association of Manufacturers, and the Intellectual Property Law Section of the State Bar of Michigan. He has also served as a member of the board of directors of both Intellectual Property Owners and the National Inventors Hall of Fame Foundation. Mr. Armitage currently serves as a member of the Advisory Board for the Bloomberg BNA Patent Trade- mark & Copyright Journal. He served as a trustee for Albion College,
APPENDIX D 89 which awarded him its Distinguished Alumni Award in 2006, and as a member of the Advisory Committee on International Economic Policy to the U.S. Department of State. He has received numerous recognitions for his work in the IP field. In 2004, the American Intellectual Property Law Association awarded him its highest recognition for lifetime achievement in intellectual property, the AIPLA Excellence Award. In 2008, the New Jersey Intellectual Property Law Association awarded Armitage its Jef- ferson Medal, an award recognizing exceptional contributions to the field of intellectual property. More recently, Mr. Armitage was inducted into the IP Hall of Fame in recognition of his decades-long advocacy of legis- lation to modernize the U.S. patent system and, in 2013, Managing Intel- lectual Property Magazine presented Armitage with its Outstanding Achievement in IP Award, recognizing the role he played in the success- ful effort to enact the America Invents Act, which made the most sweep- ing changes to U.S. patent law in the past 175 years. Marc Boutin, J.D., is the executive vice president and chief operating officer of the National Health Council, an organization that brings to- gether all segments of the health care community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers. In addition to overseeing finan- cial management and operations at the National Health Council, Mr. Boutin builds consensus among member patient advocacy organizations, enabling them to speak with one voice on systemic health research and health care policy initiatives. This results in legislation and regulations that address the collective needs of patients and their family caregivers. In addition, he provides guidance to patient organizations on various as- sociation issues, including corporate structure, government relations, fundraising, and outreach. He has been actively involved in health advo- cacy, policy, and federal and state legislation throughout his career. He is a member of the International Alliance of Patientsâ Organizations Gov- erning Board, Community Health Charities Board of Directors, Patient- Centered Outcomes Research Institute (PCORI) Advisory Panel on Pa- tient Engagement, Sanofi Partners in Patient Health Global Council, and the North America Advisory Board to the Drug Information Association. Lauren Chiarello, M.P.H., serves as Senior Director for Federal Gov- ernment Relations at the National Multiple Sclerosis Society (NMSS), where she drives and advances policy initiatives that could impact the full spectrum of multiple sclerosis (MS) research and access to approved
90 FINANCIAL INCENTIVES therapies. She is responsible for identifying, tracking, and engaging in relevant legislative and/or regulatory opportunities that could either cre- ate incentives for, or create barriers to, MS research. In past years, she has served in a variety of leadership positions in national coalitions, in- cluding leading the National Health Councilâs Food and Drug Admin- istration (FDA) Affinity Group and serving as a member of the Independence Through Enhancement of Medicare and Medicaid Coali- tion (ITEM) steering committee. Currently, she chairs the National Health Councilâs Government Relations Affinity Group. Prior to joining the NMSS Society, she was a senior associate of health policy at Avalere Health, where she conducted quantitative and qualitative research on health system trends. In this role, she primarily analyzed Medicare, FDA, and health care reform policies for a wide array of nonprofit and com- mercial clients. She also worked at the National Association of County & City Health Officials, where she helped to coordinate its national confer- ence. She has a masterâs degree in Public Health from George Washing- ton University and a bachelorâs degree in Public Policy from Vanderbilt University. Dennis Choi, M.D., Ph.D., is professor and chair of the Department of Neurology and director of the Neurosciences Institute at Stony Brook University, as well as director of the Brain Sciences Institute at the Korea Institute of Science and Technology. Prior positions have included exec- utive vice president at the Simons Foundation, vice president for Aca- demic Health Affairs at Emory University, executive vice president for Neuroscience at Merck Research Labs, and head of neurology at Wash- ington University Medical School. A Fellow of the American Associa- tion for the Advancement of Science (AAAS) and member of the Institute of Medicine, he has served previously as president of the Socie- ty for Neuroscience, vice president of the American Neurological Asso- ciation, and chair of the U.S./Canada Regional Committee of the International Brain Research Organization. He has been a member of the National Academy of Sciences Board on Life Sciences, and the Councils for the National Institute of Neurological Disorders and Stroke, the Na- tional Institute on Aging, the Society for Neuroscience, the Winter Con- ference for Brain Research, the International Society for Cerebral Blood Flow and Metabolism, and the Neurotrauma Society. Past or present ad- visory board service includes the Dana Alliance for Brain Research, the Cure Alzheimerâs Fund, the Christopher Reeve Paralysis Foundation, the Grass Foundation, the Hereditary Disease Foundation, the Harvardâ
APPENDIX D 91 Massachusetts Institute of Technology (MIT) Program in Health Scienc- es and Technology, the Max-Planck Institute in Heidelberg, the Korea Institute for Advanced Study, and the Food and Drug Administration, as well as multiple university-based research consortia, biotechnology com- panies, and pharmaceutical companies. He received his M.D. from the HarvardâMIT Health Sciences and Technology Program, as well as a Ph.D. in Pharmacology and Neurology Training from Harvard. Timothy Coetzee, Ph.D., is chief advocacy, services, and research of- ficer of the National Multiple Sclerosis Society (NMSS), which he joined in 2000. In this capacity he leads mission delivery in the areas of state and federal advocacy, service, and care management programs for people with multiple sclerosis (MS), as well as the Societyâs research program, which funds more than 375 academic and commercial research projects around the world. Most recently, he served as president of Fast Forward, a venture philanthropy of NMSS, where he was responsible for the Soci- etyâs strategic funding of biotechnology and pharmaceutical companies as well as partnerships with the financial and business communities. Pri- or to Fast Forward, Dr. Coetzee led the Societyâs translational research initiatives on nervous system repair and protection in multiple sclerosis. He is a member of the Institute of Medicineâs Forum on Neuroscience and Nervous System Disorders and serves on the Board of Directors of the American Society of Experimental Neurotherapeutics. He also chairs the Integration Panel for the MS Research Program of the Department of De- fense Congressionally Directed Medical Research Program. Dr. Coetzee received his Ph.D. in Molecular Biology from Albany Medical College in 1993 and has since been involved in the field of multiple sclerosis research. Adelina Comas-Herrera is a current Research Fellow at the London School of Economics and Political Science and also serves as the aca- demic project manager of the Modelling Dementia (MODEM) research project, which aims to estimate the impact, in terms of costs and quality of life, of making interventions that are known to work for people with dementia and their caregivers more widely available. Her current work focuses on the economics of dementia care, particularly the impact on unpaid caregivers. She has previously worked on making projections of future long-term care for the United Kingdom and other countries, and also on evaluating the potential role of private insurance and pri- vate/public partnerships in long-term care financing. Between 2010 and 2013, she was chair of the Westgate Community Trust (Canterbury), a
92 FINANCIAL INCENTIVES voluntary position. She is a Fellow of the Royal Society of Arts, Manu- facturing and Commerce. Alfred B. Engelberg, J.D., is an intellectual property lawyer. During a legal career of more than 40 years, he was a Patent Examiner in the U.S. Patent Office; a patent agent at Exxon Research & Engineering Co.; a patent trial attorney in the U.S. Department of Justice; and a member of the New York City law firm of Amster, Rothstein & Engelberg. He served as outside counsel to the Generic Pharmaceutical Association and played a leading role in the negotiations that passed the Hatch-Waxman Act of 1984, the landmark legislation that created the modern generic drug industry. Subsequently, he specialized in pharmaceutical patent liti- gation. In 1991, Engelberg founded the Engelberg Foundation to provide grants for innovative health care, youth development, and social service projects. It provided the concept and funding for the creation of Consumer Reports Best Buy Drugs; the Engelberg Center for Healthcare Reform at the Brookings Institution; and the Engelberg Center on Innovation Law and Policy at New York University (NYU) School of Law. Engelberg serves as a Trustee of NYU School of Law and the Brookings Institution and has served on many other nonprofit boards. He has retired from the practice of law, but remains active as a writer, adviser, and speaker on policy issues related to affordable medicines and intellectual property rights in the United States and around the world. Cartier Esham, Ph.D., serves as executive vice president for emerging companies at the Biotechnology Industry Organization (BIO). In this role, Dr. Esham manages and directs BIOâs policy development, advoca- cy, research, and educational initiatives for BIOâs emerging companies, approximately 90 percent of BIOâs membership. This includes capital formation policy and health policy impacting emerging companies, as well as research and analysis of the biopharmaceutical industry and life- science investment and financing. She has published papers in peer- reviewed science journals on water quality, marine microbial ecology, and bacterial phylogeny. Dr. Esham has a Ph.D. in Microbiology from the University of Georgia, a masterâs degree in Marine Biology from the University of North Carolina at Wilmington, and a B.S. from the Univer- sity of Kentucky. William Fisher, Ph.D., J.D., is the Wilmer Hale Professor of Intellectu- al Property Law and director of the Berkman Center for Internet and So-
APPENDIX D 93 ciety at Harvard University. Previously, he served as a law clerk to Judge Harry T. Edwards of the U.S. Court of Appeals for the D.C. Circuit and then to Justice Thurgood Marshall of the U.S. Supreme Court. His aca- demic honors include a Danforth Postbaccalaureate Fellowship and a Post-Doctoral Fellowship at the Center for Advanced Study in the Be- havioral Sciences in Stanford, California. Dr. Fisher received his under- graduate degree in American Studies from Amherst College and his graduate degrees (J.D. and Ph.D. in the History of American Civiliza- tion) from Harvard University. Brian Fiske, Ph.D., currently serves as vice president, research pro- grams, for The Michael J. Fox Foundation for Parkinsonâs Research, where he co-manages a team of research professionals who stay closely linked to the research community in order to develop an aggressive and innovative agenda for accelerating research and drug development for Parkinsonâs disease. This ensures that research priorities reflect and best serve the ultimate needs of patients. Dr. Fiske regularly meets with aca- demic and industry researchers around the world to identify promising proposals to support, providing troubleshooting and ongoing manage- ment of projects as they go forward. After completing postdoctoral re- search at Columbia University, he spent several years as an editor for the scientific journal, Nature Neuroscience. Dr. Fiske earned an undergradu- ate degree in Biology from Texas A&M University and a Ph.D. in Neu- roscience from the University of Virginia. Steven Hyman, M.D., M.A., is director of the Stanley Center for Psy- chiatric Research at the Broad Institute of Massachusetts Institute of Technology and Harvard University, a core faculty member of the Broad Institute, and Harvard University Distinguished Service Professor of Stem Cell and Regenerative Biology. From 2001 to 2011, he served as provost of Harvard University. As provost he had a special focus on de- velopment of collaborative initiatives in the sciences and engineering spanning multiple disciplines and institutions. From 1996 to 2001, he served as director of the National Institute of Mental Health, where he emphasized investment in neuroscience and emerging genetic technolo- gies. He also initiated a series of large practical clinical trials, including an emphasis on children, a population about which little was known. Dr. Hyman is the editor of the Annual Review of Neuroscience, founding president of the International Neuroethics Society (2008-2014), president (2015) of the Society for Neuroscience, and a member of the Institute of
94 FINANCIAL INCENTIVES Medicine, of the U.S. National Academies where he serves on the Coun- cil, is a member of the Board of Health Science Policy, and chairs the Forum on Neuroscience and Nervous System Disorders. He is a Fellow of the American Academy of Arts and Sciences; a Fellow of the Ameri- can Association for the Advancement of Science; a Fellow of the Ameri- can College of Neuropsychopharmacology; and a Distinguished Life Fellow of the American Psychiatric Association. Dr. Hyman received his B.A. summa cum laude from Yale College; a B.A. and an M.A. from the University of Cambridge, which he attended as a Mellon Fellow; and an M.D. cum laude from Harvard Medical School. Stephen Johnson, J.D., M.A., is the chief intellectual property (IP) and policy officer for One Mind. Mr. Johnson works on strategies that drive One Mindâs goals of hastening cures for patients through encouraging and enabling data sharing within and across disciplines; addressing barri- ers to data sharing on policy and technology levels; creating efficient public/private partnerships to leverage public, private, and philanthropic resources to advance research and cures; and focusing on incentives to innovation in neuroscience. Before joining One Mind, Mr. Johnson had more than 30 years of experience in IP law at Kirkland & Ellis LLP, where he was a founding partner of its New York and San Francisco of- fices and the former head of its New York and San Francisco IP. He be- gan his career at Bird & Bird in London. Mr. Johnson obtained a degree in Natural Sciences (Genetics) from Cambridge University in England, and graduated from law schools in London and Chicago. Jeff Jonas, M.D., joined SAGE as CEO in 2013 and has more than 20 years of experience on both the scientific and business sides of the phar- maceutical and health care industries, particularly in the central nervous system field. Before joining the SAGE team, he served as president of the Regenerative Medicine Division of Shire Plc and previously as senior vice president of research and development, Pharmaceuticals at Shire. Earlier, he served as executive vice president of ISIS Pharmaceuticals; as chief medical officer and executive vice president of Forest Laboratories, Inc.; and in senior-level positions at Upjohn Laboratories. Dr. Jonas founded AVAX Technologies, where he served as CEO and president, and SCEPTOR Industries, where he served as chair, president, and chief technology officer. Previously, he was independent director at Cara Therapeutics, Inc., and director of AVAX Technologies. He has pub- lished more than 70 scientific papers and chapters; authored more than
APPENDIX D 95 100 books, scientific articles, and abstracts; and received numerous awards. He received his B.A. from Amherst College and his M.D. from Harvard Medical School. He completed a residency in Psychiatry at Har- vard and then served as Chief Resident in Psychopharmacology at McLean Hospital, Harvard Medical School. The Honorable Patrick Kennedy served in the U.S. House of Repre- sentatives (D-RI) for 16 years and is predominantly known as author and lead sponsor of the Mental Health Parity and Addiction Equity Act of 2008. This legislation provides tens of millions of Americans who were previously denied care with access to mental health treatment. Now, Rep. Kennedy is the co-founder of One Mind, a national coalition seeking new treatments and cures for neurologic and psychiatric diseases of the brain afflicting one in every three Americans. One Mind is dedicated to en- hancements in funding and collaboration in research across all brain dis- orders in the next decade. This endeavor unites efforts of scientists, research universities, government agencies, and industry and advocacy organizations throughout the world. Rep. Kennedy is bringing everyone together to design the first blueprint of basic neuroscience, and to guide efforts in seeking cures for neurological disorders affecting Americans. Rep. Kennedy is the founder of the Kennedy Forum on Community Mental Health, which served as a vehicle to celebrate the 50th anniver- sary of President Kennedyâs signing of the Community Mental Health Act, the landmark bill that laid the foundation of contemporary mental health policy and provided Patrick Kennedy with the platform to launch a bold, ongoing effort to advance the work President Kennedy began. The Kennedy Forum continues to advocate for mental health parity. Aaron Kesselheim, M.D., J.D., M.P.H., is an associate professor of medicine at Harvard Medical School and a faculty member in the Divi- sion of Pharmacoepidemiology and Pharmacoeconomics in the Depart- ment of Medicine at Brigham and Womenâs Hospital (BWH). His research focuses on the effects of intellectual property laws and regulato- ry policies on pharmaceutical development, the drug approval process, and the costs, availability, and use of prescription drugs both domestical- ly and in resource-poor settings. At BWH, Dr. Kesselheim leads the Program On Regulation, Therapeutics, And Law (PORTAL), an interdis- ciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory prac- tices and the law. In 2013, Dr. Kesselheim was named a Greenwall Fac-
96 FINANCIAL INCENTIVES ulty Scholar in Bioethics by the Greenwall Foundation, which supports innovative empirical research in bioethics. His work was also recently funded by the Harvard Program in Therapeutic Science, the Food and Drug Administration, and by a Robert Wood Johnson Foundation Inves- tigator Award in Health Policy Research. He has testified numerous times before Congress on pharmaceutical policy and medical device reg- ulation, and has consulted for the National Institutes of Health, Institute of Medicine, U.S. Patent and Trademark Office, and various state gov- ernment offices. In 2012, he was named to the Perspectives Advisory Board of the New England Journal of Medicine. Dr. Kesselheim also is a faculty supervisor for the Petrie-Flom Center for Health Law Policy, Bio- technology, and Bioethics at Harvard Law School, the Harvard Center for Bioethics, and is a research associate in the Department of Health Policy and Management at the Harvard School of Public Health. For the 2014â 2015 academic year, he was appointed as a Visiting Associate Professor of Law at Yale Law School, where he taught Food and Drug Administration Law. He is Board Certified in Internal Medicine, working as a primary care physician at the Phyllis Jen Center for Primary Care at BWH. Bruce Kinon, M.D., is the U.S. Therapeutic Head, Psychosis, at Lundbeck LLC, the U.S. affiliate of the global pharmaceutical company H. Lundbeck A/S headquartered in Denmark. Lundbeck is engaged in the research and development, production, marketing, and sale of drugs for the treatment of disorders in the central nervous system and is committed to improve the quality of life of people suffering from psychiatric and neurological disorders. Dr. Kinonâs responsibilities include the develop- ment of innovative drug treatments for schizophrenia and the effective delivery into clinical practice of new pharmacologic therapies for psy- choses. He has had a long and productive career in the field of neuropsy- chopharmacology spanning many years in academic research and practice at the Long Island JewishâHillside Medical Center in New York, a National Institute of Mental Health center of schizophrenia re- search, and in pharmaceutical drug development, first at Eli Lilly and Company, where he led in part the development and commercialization of the eminently successful, atypical antipsychotic drug Zyprexa and lat- er the development of novel glutamate-based schizophrenia therapies, and now at Lundbeck LLC. Dr. Kinon is an internationally recognized expert who has contributed significantly to safety and efficacy assess- ments, outcomes research, global marketing, and comprehensive knowledge of the schizophrenia disease state. He has published exten-
APPENDIX D 97 sively in internationally recognized peer-reviewed journals and is an of- ten-invited chair or participant in panels at international psychopharma- cology scientific congresses. Dr. Kinon received his M.D. training at the New York University (NYU) School of Medicine and completed his res- idency in Psychiatry at the NYU-Bellevue Hospital Medical Center. Walter Koroshetz, M.D., became acting director of National Institute of Neurological Disorders and Stroke (NINDS) in 2014. Previously, he served as deputy director under Dr. Story Landis. Together, they directed program planning and budgeting, and oversaw the scientific and adminis- trative functions of the Institute. He has held leadership roles in a number of the National Institutes of Health (NIH) and NINDS programs, includ- ing NIHâs BRAIN Initiative, the Traumatic Brain Injury Center collabo- rative effort between the NIH intramural program and the Uniformed Services University of the Health Sciences, and the multiyear effort to develop and establish the NIH Office of Emergency Care Research to coordinate research and research training. Before joining NINDS, Dr. Koroshetz served as vice chair of the neurology service and director of stroke and neurointensive care services at Massachusetts General Hospi- tal (MGH). He was a professor of neurology at Harvard Medical School (HMS) and led neurology resident training at MGH between 1990 and 2007. During that time he co-directed the HMS Neurobiology of Disease Course with Drs. Edward Kravitz and Robert H. Brown. Dr. Koroshetz graduated from Georgetown University and received his M.D. from the University of Chicago. He trained in internal medicine at the University of Chicago and MGH. He trained in neurology at MGH, after which he did post-doctoral studies in cellular neurophysiology at MGH with Dr. David Corey, and later at the Harvard neurobiology department with Dr. Ed- ward Furshpan, studying mechanisms of excitoxicity and neuroprotec- tion. He joined the neurology staff, first in the Huntingtonâs disease (HD) unit, followed by the stroke and neurointensive care service. A major focus of his clinical research career was to develop measures in patients that reflect the underlying biology of their conditions. With the MGH team he discovered increased brain lactate in HD patients using MR spectroscopy. He helped the team pioneer the use of diffusion/perfusion- weighted MR imaging and CT angiography/perfusion imaging in acute stroke. Active in the American Academy of Neurology (AAN), Dr. Koroshetz chaired its public information committee, led its efforts to es- tablish acute stroke therapy in the United States, founded the Stroke Sys- tems Working Group, and was a member of the AAN Board of Directors.
98 FINANCIAL INCENTIVES Alex John London, Ph.D., is professor of philosophy and director of The Center for Ethics and Policy at Carnegie Mellon University. Profes- sor London is an elected Fellow of the Hastings Center, whose research focuses on foundational ethical issues in human-subjects research, on issues of social justice in the transnational context, and on methodologi- cal issues in theoretical and applied ethics. He is the author of more than 50 papers, which have appeared in Mind, Science, Lancet, PLoS Medi- cine, and numerous other journals and collections. He is co-editor of Eth- ical Issues in Modern Medicine, one of the most widely used textbooks in medical ethics. In 2012, Professor London joined the Working Group on the Revision of the Council for International Organizations of Medi- cal Sciences 2002 International Ethical Guidelines for Biomedical Re- search Involving Human Subjects. In 2011, he was appointed to the Steering Committee on Forensic Science Programs for the International Commission on Missing Persons. Since 2007 he has served as a member of the Ethics Working Group of the HIV Prevention Trials Network. He has testified before the Presidential Commission for the Study of Bioeth- ical Issues and has been commissioned to write papers for the Centers for Disease Control and Prevention and the Institute of Medicine. He has served as an ethics expert in consultations with numerous national and international organizations, including the National Institutes of Health, the World Health Organization, the World Medical Association, and the World Bank. Raj Long, M.S., M.Sc., is a senior executive with more than 20 years of experience in the pharmaceutical industry. She offers a wide range of expertise in regulatory strategy, and has worked with the Food and Drug Administration, European Medicines Agency, Council of Federal Do- mestic Assistance, and other Brazil, the Russian Federation, India and China regulatory authorities. She is currently a senior regulatory officer at The Bill & Melinda Gates Foundation, where she works in malaria and neglected infectious diseases. Previously, she was the global head of regu- latory GE Healthcare-MDx in the United Kingdom, responsible for regulatory organization and access in Europe, Middle East, Africa, the Americas, and Asia. Prior to joining GE Healthcare, Ms. Long was vice president of Regulatory International AGL both in Novartis, Switzerland, and at Bristol-Myers Squibb, Princeton, New Jersey. She was responsible for implementing strategic organizational models in Asia, Latin America, Middle East, and Africa with a strategic focus on early access. In 2014, she was invited by the U.K. Secretary of State to be a member to the
APPENDIX D 99 World Dementia Council as a global regulatory expert. In addition, she was appointed by the U.K. government as director, integrated develop- ment to lead innovative approaches in the regulatory development of clinically relevant therapies for dementia. She has a double masterâs in Psychology and in Nursing Education from the University of Glasgow and Edinburgh, Scotland, respectively. Roger Longman, M.A., is CEO of Real Endpoints, a start-up company focused on pharmaceutical reimbursement, and aiming to help both pay- ers and product developers improve the value of pharmacotherapy. Its first product assessesâsystematically, objectively, and transparentlyâ the value of drugs relative to their competitors. Until 2009, Mr. Longman was managing director, pharma at Elsevier Business Intelligence, a Reed Elsevier company. He has been involved with the health care industry for more than 25 years. From 1990 through 2008, Mr. Longman was co- CEO and managing director of Windhover, an information company providing sophisticated analysis and data on pharmaceutical and medical device business strategy through publications, databases, and confer- ences. Mr. Longman co-founded and built the company through internal development (with publications, e.g., IN VIVO, Start-Up, and The RPM Report; several databases, including The Strategic Transactions Data- base; and a series of senior-executive conferences), and through acquisi- tion. In 2008, Windhover was acquired by Reed Elsevier and merged with its FDC Reports division (publishers of The Pink Sheet, The Gray Sheet, and many other medical industry newsletters), creating Elsevier Business Intelligence. Mr. Longman ran the combined groupâs pharma- ceutical business until he left in 2010 to begin working on Real End- points with Norman Selby, who had been Windhoverâs chair and lead investor. Gail Maderis, M.B.A., is president and CEO of BayBio, the industry organization representing and supporting Northern Californiaâs life sci- ence community. As a former biotech CEO, she brings deep experience and commitment to supporting the industry through enterprise develop- ment, peer-to-peer experience sharing, and advocacy and support of edu- cation and workforce development. From 2003 to 2009, Ms. Maderis served as president and CEO of Five Prime Therapeutics, Inc., a private- ly held protein discovery and development company. At Five Prime, she successfully funded the companyâs rapid growth through substantial pri- vate equity financings and corporate partnerships and took the compa-
100 FINANCIAL INCENTIVES nyâs first novel cancer therapeutic from discovery into clinical trials. Pri- or to Five Prime, she held senior executive positions at Genzyme Corpo- ration, including founder and president of Genzyme Molecular Oncology. She practiced management and strategy consulting with Bain & Co. Ms. Maderis serves on the boards of NovaBay Pharmaceuticals, Opexa Therapeutics, BayBio, the Mayorâs Biotech Advisory Council of San Francisco, and the HBS Healthcare Initiative. She earned a B.S. in Business from University of California, Berkeley, and an M.B.A. from Harvard Business School. Nicholas Manetto designs, directs, and implements successful public policy advocacy campaigns. With more than a decade in government affairs, public policy, and strategic communications, he is an experienced strategist in the process of high-stakes initiatives from start to finish. Mr. Manetto manages client teams and projects focused on health care deliv- ery and payment models, biomedical research, drug development, and public health. His work spans projects focused on Congress as well as federal departments and agencies. Frequently, initiatives include a public or media component through crafting and placing op-eds, designing and launching campaign websites, and a variety of traditional and new media strategies and tactics. Many of these projects are coalitions designed to bring multiple diverse voices to an issue. Bonnie Weiss McLeod, Ph.D., J.D., is a Partner in the Intellectual Property Practice Group for Cooley, LLP, bringing her in-depth experi- ence serving the life science industry in the prosecution of biotechnology and pharmaceutical patent applications. She has managed many intellec- tual property due diligence analyses in collaboration with other Cooley partners in relation to public offerings, venture capital financing, and life science corporate transactions. Dr. McLeod specializes in counseling clients ranging from non-profits and small to mid-size biotech companies with regard to developing and maintaining a patent strategy that is con- sistent with business goals. Dr. McLeod is a former patent examiner in the biotechnology group of the U.S. Patent and Trademark Office. Her practice focuses on the biotechnology arts, including molecular biology, cellular biology, bacterial and eukaryotic genetics, immunology and au- toimmunity, neuroscience, recombinant antigens and vaccines, gene therapy, genetic engineering, genomics, microarray technologies, virolo- gy, and RNA interference. Dr. McLeod is a graduate of the Columbus School of Law at Catholic University of America (CUA), where she
APPENDIX D 101 graduated magna cum laude. She is currently an adjunct professor at CUA, where she teaches a course on patent prosecution. Dr. McLeod is admitted to practice in Virginia, Washington, DC, and before the U.S. Patent and Trademark Office, and is a member of American Intellectual Property Law Association and the American Bar Association. She serves on the pro bono committee for Cooleyâs Washington, DC, office and is actively involved in various pro bono matters. She is a frequent speaker at universities and local life science organizations and has spoken on top- ics such as developing a global patent strategy, the business side of intel- lectual property, joint inventorship issues, developing a patent portfolio that will attract investors, and the Myriad and Prometheus Supreme Court decisions. Dr. McLeod was awarded her Ph.D. in Molecular Biol- ogy from the University of Maryland College Park. Dr. McLeod also completed post-doctoral work in the study of molecular mechanisms of co-stimulatory signaling in T-cells. David Meeker, M.D., was appointed president and chief executive of- ficer of Genzyme in 2011. Genzyme is a global biotechnology company committed to discovering and delivering transformative therapies for patients with rare and special unmet medical needs. Dr. Meeker oversees and provides the vision for the companyâs two business unitsâRare Dis- eases and Multiple Sclerosisâas well as its long-standing relationships with patient communities and dedicated workforce of nearly 10,000 em- ployees. In his career with Genzyme, Dr. Meeker has held key positions of increasing responsibility, most recently as chief operating officer. In this role, he was responsible for Genzymeâs commercial organization, overseeing its business units¸ country management organization, and global market access functions. As chief operating officer, he played an important role in the integration with Sanofi. Dr. Meeker joined Gen- zyme in 1994 as medical director to work on the Cystic Fibrosis Gene Therapy program. Subsequently, as Vice President, medical affairs, he was responsible for the development of rare disease therapies that today represent transformative and life-saving advancements in medicine for patients. Prior to joining Genzyme, Dr. Meeker was the director of the Pulmonary Critical Care Fellowship at the Cleveland Clinic and an assis- tant professor of medicine at Ohio State University. He has authored more than 40 articles and multiple book chapters. Dr. Meeker received his M.D. from the University of Vermont Medical School. He completed the Ad- vanced Management Program at Harvard Business School in 2000.
102 FINANCIAL INCENTIVES Bernard H. Munos, M.B.A., M.S., is a Senior Fellow at FasterCures, a center of the Milken Institute, and the founder of the InnoThink Center for Research in Biomedical Innovation, a consultancy that helps biomed- ical research organizations become better innovators. Before that, he served as an advisor for corporate strategy at Eli Lilly, where he focused on disruptive innovation and the radical redesign of research and devel- opment. He is also a member of National Center for Advancing Transla- tional Sciencesâ Advisory Council and Cures Acceleration Network, a non-executive director of Glenmark Pharmaceuticals, a member of the Advisory Board of Science Translational Medicine, and an advisor to or board member of a dozen other companies or publicly financed research organizations. His research has been profiled by Forbes magazine; he blogs about biomedical innovation on the Forbes and FasterCures web- sites; and the popular industry newsletter FiercePharma named him 1 of the 25 most influential people in biopharma. He received his M.B.A. from Stanford University and holds other graduate degrees in Animal Science and Agricultural Economics from the Paris Institute of Technol- ogy for Life, Food and Environmental Sciences and the University of California, Davis. Michele M. Oshman, Pharm.D., director of federal advocacy relations for Eli Lilly and Company, works in the companyâs Washington, DC, office. Dr. Oshman joined Lilly in 2002 as a clinical neuroscience re- searcher and has served in multiple clinical development and corporate leadership roles. She earned a Six Sigma Black Belt in 2005 and led mul- tiple transformational efforts across the company. She joined the Advo- cacy team in 2007 and now leads Lillyâs policy engagement with a large portfolio of patient advocacy groups, professional societies, and trade associations. She serves as a strategic advisor to multiple business unit leaders and senior leadership, and in 2012, she was appointed chair of the BIO Alliance Development section. Prior to joining Lilly, Dr. Oshman conducted clinical research under former National Institute on Drug Abuse Director Dr. Robert Dupont. Dr. Oshman serves on the Boards of Directors for the National Alliance on Caregiving, the American Brain Coalition, and Green Door. She also chairs the Arthritis Foundation and Arthritis Industry Forum and sits on multiple corporate advisory councils for national and international advocacy organizations. In 2013, she was appointed to the Board of Directors of Green Door, a Washington, DC, community mental health center. She works with honorary Green Door leadership, including former members of Congress and other prominent
APPENDIX D 103 community members on strategic initiatives to ensure that area residents struggling with severe persistent mental illnesses can access timely and high-quality treatment, regardless of their financial situation. A 1993 graduate of American University in Washington, DC, where she studied Political Science and Communication, Dr. Oshman pursued a Doctor of Pharmacy at the University of Maryland, Baltimore. Steven Paul, M.D., M.S., is Voyager Therapeuticsâ president and CEO, a member of the Board of Directors, and a venture partner at Third Rock Ventures. Dr. Paul brings to Voyager more than 35 years of neuroscience expertise and an extensive track record in central nervous system drug discovery and development. As a venture partner at Third Rock, he helps lead the ideation and development of new companies, including Voyag- er. Before joining Voyager as CEO, Dr. Paul was the founding director of the Appel Alzheimerâs Disease Research Institute, where he was the Principal Investigator of the Instituteâs novel adeno-associated virus gene therapy program for Alzheimerâs disease, as well as professor of neuro- science, psychiatry, and pharmacology at Weill Cornell Medical College. Earlier, he spent 17 years at Eli Lilly, during which time he held several key leadership roles, including president of the Lilly Research Laborato- ries and vice president of discovery research and neuroscience research. As president of the Lilly Research Laboratories, he was responsible for the companyâs overall research and development strategy, expanding its efforts in oncology and biotechnology and resulting in a pipeline of ap- proximately 70 new molecular entities. Prior to Lilly, Dr. Paul served as scientific director of the National Institute of Mental Health. He has also served as medical director in the Commissioned Corps of the U.S. Public Health Service. Dr. Paul has authored or co-authored more than 500 pa- pers and book chapters. He is an elected Fellow of the American Associ- ation for the Advancement of Science and a member of the Institute of Medicine. He currently serves on the board or as a trustee of several or- ganizations, including SAGE Therapeutics, Alnylam Pharmaceuticals, the Sigma Aldrich Company, and the Foundation for the National Insti- tutes of Health. Dr. Paul holds a B.A. in Biology and Psychology from Tulane University and an M.S. and an M.D. from the Tulane University School of Medicine. William Z. Potter, M.D., Ph.D., spent 25 years positions in Intramural positions at the National Institutes of Health (NIH), where his research focused on translational neuroscience. While at NIH, Dr. Potter was
104 FINANCIAL INCENTIVES widely published and appointed to many societies, committees, and Boards. This enabled him to develop a wide reputation as an expert in psychopharmacological sciences and championing the development of novel treatments for central nervous system (CNS) disorders. Dr. Potter left NIH in 1996 to accept a position as executive director for early clini- cal neuroscience at Lilly Research Labs, and in 2004 joined Merck Re- search Labs (MRL) as Vice President of clinical neuroscience and then translational neuroscience, a position from which he retired in 2011. His experience at Lilly and MRL in identifying, expanding, and developing methods of evaluating CNS effects of compounds in the human brain cover state-of-the-art approaches across multiple modalities. These include brain imaging and cerebrospinal fluid proteomics (plus metabolomics) as well as development of more sensitive clinical, psychophysiological, and performance measures allowing a range of novel targets to be tested in a manner which actually addresses the underlying hypotheses. Dr. Potter continues as an emeritus co-chair of the Neuroscience Steering Commit- tee of the Foundation for the National Institutes of Health and serves as a senior advisor to the director of the National Institute of Mental Health, where he champions the position that more disciplined hypothesis testing of targets in humans through public/private partnerships is the best near- term approach to moving CNS drug development forward for important neurologic and psychiatric illnesses. Arti Rai, J.D., Elvin R. Latty Professor of Law and co-director, Duke Law Center for Innovation Policy, is an internationally recognized expert in intellectual property (IP) law, administrative law, and health policy. Ms. Rai has also taught at Harvard, Yale, and the University of Pennsyl- vania law schools. Ms. Raiâs research on IP law and policy in biotech- nology, pharmaceuticals, and software has been funded by the National Institutes of Health, the Kauffman Foundation, and the Woodrow Wilson Center. She has published more than 50 articles, essays, and book chap- ters on IP law, administrative law, and health policy. Her publications have appeared in both peer-reviewed journals and law reviews, including Science, the New England Journal of Medicine, the Journal of Legal Studies, Nature Biotechnology, and the Columbia, Georgetown, and Northwestern law reviews. She is the editor of Intellectual Property Law and Biotechnology: Critical Concepts (Edward Elgar, 2011) and the co- author of a 2012 Kauffman Foundation monograph on cost-effective health care innovation. From 2009â2010, Ms. Rai served as the adminis- trator of the Office of External Affairs at the U.S. Patent and Trademark
APPENDIX D 105 Office (USPTO). As external affairs administrator, Ms. Rai led policy analysis of the patent reform legislation that ultimately became the America Invents Act and worked to establish USPTOâs Office of the Chief Economist. Prior to that time, she had served on President-Elect Obamaâs transition team reviewing the USPTO. Before entering academ- ia, Ms. Rai clerked for the Honorable Marilyn Hall Patel of the U.S. Dis- trict Court for the Northern District of California; was a litigation associate at Jenner & Block (doing patent litigation as well as other liti- gation); and was a litigator at the Federal Programs Branch of the U.S. Department of Justiceâs Civil Division. Ms. Rai regularly testifies before Congress and relevant administrative bodies on IP law and policy issues and regularly advises federal agencies on IP policy issues raised by the research that they fund. She is a member of the National Advisory Coun- cil for Human Genome Research and of an Expert Advisory Council to the Defense Advanced Projects Research Agency. Ms. Rai is a public member of the Administrative Conference of the United States, a mem- ber of the American Law Institute, and co-chair of the IP Committee of the Administrative Law Section of the American Bar Association. Ms. Rai is currently a member of the Institute of Medicine Committee on Strategies for Responsible Sharing of Clinical Trial Data and has served on, or as a reviewer for, numerous National Academy of Sciences com- mittees. In 2011, Ms. Rai won the World Technology Network Award for Law. She graduated from Harvard College, magna cum laude, with a degree in Biochemistry and History (History and Science), attended Har- vard Medical School for 1 year, and received her J.D., cum laude, from Harvard Law School. Kiran Reddy, M.D., M.B.A., is senior director of corporate strategy at Biogen Idec. Prior to joining Biogen Idec, Dr. Reddy was principal and associate partner at Third Rock Ventures. He helped create and grow several Third Rock-backed companies, including SAGE Therapeutics, where he was interim chief operating officer and chief business officer, and Foundation Medicine, where he was interim head of operations. Dr. Reddy is a Board-certified neurologist who completed training at Massa- chusetts General Hospital and Brigham and Womenâs Hospital. He com- pleted his B.S., M.D., and M.B.A. degrees at Georgetown University. Robert Ring, Ph.D., currently serves as chief science officer (CSO) for Autism Speaks, a role he has held since 2013. Autism Speaks is a leading science and advocacy foundation founded in 2005, which has been re-
106 FINANCIAL INCENTIVES sponsible for funding more than $200 million in research into causes, prevention, and treatment of autism spectrum disorder (ASD). A neuro- scientist by training, Dr. Ring is responsible for leading the science pro- gram at Autism Speaks, which is focused on âputting scientific breakthroughs to work for families.â This program at Autism Speaks fea- tures a diverse portfolio of research investments targeting etiology and environmental science, medical research, public health, innovative tech- nologies, and genomic discovery. As CSO, Dr. Ring has specifically helped launch the Autism Speaks signature genomics discovery program, MSSNG (also known as âAut10Kâ program), which has partnered with Google to develop an unprecedented open-access database of genomic sequence information to support the autism research ecosystem. Dr. Ring joined Autism Speaks in 2011 as vice president and head of translational research. In this role, Dr. Ring was responsible for launching the founda- tionâs innovative venture philanthropy arm Delivering Scientific Innova- tion for Autism (also known as âDELSIAâ), which support entrepreneurs and early-stage companies developing products that address unmet needs of the ASD community. Dr. Ring played an instrumental role in organiz- ing the first Autism Investment Conference, which continues to run as an annual event supporting the rapidly growing marketplace for new prod- uct and business development to serve the needs of the people with au- tism. Dr. Ring also leads a collaborative partnership with the Simons Foundation to form a new international brain banking network now known as Autism BrainNet. Dr. Ring was appointed in 2014 by then- Secretary Kathleen Sebelius to serve as a public member of the Inter- agency Autism Coordinating Committee, the federal advisory committee that coordinates all efforts within the Department of Health and Human Services concerning ASD. Prior to joining Autism Speaks, Dr. Ring served as senior director and head of the Autism Research Unit at Pfizer Worldwide Research and Development in Groton, Connecticut. There he led the first dedicated research group in the pharmaceutical industry fo- cused specifically on the discovery and development of medicines for neurodevelopmental disorders, specifically ASDs. Prior to Pfizer, Dr. Ring worked for more than 10 years in psychiatric medicines discovery and development at Wyeth Research in Princeton, New Jersey. Dr. Ring holds separate adjunct faculty appointments in the Department of Psy- chiatry at Mount Sinai School of Medicine (New York) and the Depart- ment of Pharmacology and Physiology at Drexel University College of Medicine (Philadelphia). He holds a B.A. in both Fine Art and Biology (double major) from Westmont College in Santa Barbara, California, and
APPENDIX D 107 a Ph.D. in Molecular Neurobiology from City of Hope National Medical Center in Southern California. Rhonda Robinson Beale, M.D., is a seasoned health care executive with more than 20 years of experience in health care systems, managed care, and quality improvement, with demonstrated accomplishments for both behavioral health and medical systems. Dr. Robinson Beale has worked as a chief medical officer/physician executive for behavioral and medical in her work with several large national and local health care organiza- tions, such as Optum, a subsidiary within UnitedHealth Group, Pacifi- Care, Cigna, Blue Cross Blue Shield of Michigan, and Health Alliance Plan. She has also been involved with many national organizations as a subject matter expert, including the National Institute of Mental Health, the Institute of Medicine (IOM), National Quality Forum, American Psy- chiatric Association, American Psychological Association, American Society of Addiction Medicine, National Committee for Quality Assur- ance, and others. She is currently on the IOM Board on the Health of Select Populations and National Quality Forum Map for Dual Eligibles and Behavioral Health. Dr. Robinson Beale has been involved in influ- encing local and national legislation, particularly around Parity and the Affordable Care Act. She testified before the Senateâs Health, Education, Labor and Pension Committee due to her work on the IOM study Cross- ing the Quality Chasm. Dr. Robinson Beale also has experience as a health plan administrator, hospital medical director, and as a capitated practice owner who delivered care to patients. Michael Rogawski, M.D., Ph.D., is professor of neurology and member of the Center for Neuroscience at the University of California, Davis. He is immediate past president of the American Society for Experimental Neurotherapeutics, a professional organization dedicated to advancing the development of improved therapies for nervous system disorders. Until 2006, he was senior investigator and chief of the Epilepsy Research Section at the National Institute of Neurological Disorders and Stroke (NINDS). Dr. Rogawskiâs research encompasses cellular neurophysio- logical studies, animal models, and clinical trials of new treatments for seizures and epilepsy. Laboratory studies conducted by Dr. Rogawski on AMPA receptors and neurosteroids have been translated to new epilepsy treatment approaches. In recognition of his research contributions, Dr. Rogawski has received the National Institutes of Health Directorâs Award, the Epilepsy Research Award from the American Society for
108 FINANCIAL INCENTIVES Pharmacology and Experimental Therapeutics, and the Service Award from the American Epilepsy Society. He presented the British Pharmaco- logical Society Lecture, the Killam Lecture of the Montreal Neurological Institute, and the American Epilepsy Societyâs William G. Lennox Lec- ture. Dr. Rogawski is a founder and was chief editor of Epilepsy Cur- rents, the journal of the American Epilepsy Society, and he was associate editor of Neurotherapeutics, the journal of the American Society for Ex- perimental Neurotherapeutics. He currently serves as a special govern- ment employee to the Food and Drug Administration. Dr. Rogawski received his B.A. from Amherst College and his M.D. and his Ph.D. (Pharmacology) from Yale University. After serving as a Post-Doctoral Fellow in the Laboratory of Neurophysiology, NINDS, he completed residency training in neurology at Johns Hopkins. Benjamin Roin, J.D., is an assistant professor of technological innova- tion, entrepreneurship, and strategic management at the Massachusetts Institute of Technology Sloan School of Management. He is also an as- sociate member of the Broad Institute. Mr. Roinâs work focuses on en- trepreneurship, intellectual property, and innovation policy. His primary areas of research are patent law, biopharmaceutical innovation, and gov- ernment regulation of the pharmaceutical industry. He has written about the market-exclusivity protections available for old and repurposed drugs, the implications of the finite patent term and limited patent-term extensions for drug development strategy, public and private insurer re- imbursement policies, and Hatch-Waxman litigation. In 2013, he re- ceived the Kauffman/iHEA Award for Health Care Entrepreneurship and Innovation Research (along with Eric Budish and Heidi Williams). In addition to his academic research, he currently works with the National Health Council and the Multi-Regional Clinical Trial Center on issues related to patent law, Food and Drug Administration law, clinical trial regulations, and pharmaceutical innovation policy. Prior to joining the Sloan faculty in 2014, Roin was the Hieken Assistant Professor of Patent Law at Harvard Law School, where he taught courses on patent law, trade secrecy, and torts. Before joining the Harvard Law School faculty in 2008, he was an Academic Fellow at the Petrie-Flom Center at Har- vard Law School, and clerked for Judge Michael McConnell on the U.S. Court of Appeals for the Tenth Circuit. He received his B.A. from Am- herst College and his J.D. from Harvard Law School.
APPENDIX D 109 Edward F. Rover, J.D., is the chair, president, and CEO of the Charles A. Dana Foundation and of the Dana Alliance for Brain Initiatives, pri- vate philanthropic organizations committed to advancing brain research and to educating the public in a responsible manner about the potential of research to (1) develop a better understanding of the brain and its func- tions; (2) speed the discovery of treatments for brain disorders; and (3) combat the stigma of brain disorders through education. The Foundation, founded in 1950, works to achieve its goals through grants to institutions engaged in innovative neuroscience research and through public outreach efforts. Mr. Rover has practiced law since 1964 at White & Case LLP, currently as Of Counsel. He has served as a Trustee of numerous charita- ble organizations. Katie Sale is the executive director of the American Brain Coalition (ABC), a nonprofit organization composed of some of the United Statesâ leading professional neurological, psychological, and psychiatric associa- tions and patient organizations. ABC seeks to advance the understanding of the functions of the brain and to reduce the burden of brain disorders through public advocacy. Ms. Sale has been executive director since ABC was incorporated in 2004. She initiated its Board procedure, by- laws, standard operating procedures, website, and media relations and marketing materials. She also established the ABC Board and commit- tees. She has also secured the ABC membership, which has grown from 5 founding members to more than 90 member organizations. Ms. Sale provides executive leadership over the administration and manages its daily operations to ensure strong integration among all programs and advocacy activities. She provides broad guidance on operations and poli- cy implementation. Ms. Sale participates with the Board in planning and establishing program policies, objectives, and priorities as well as direct- ing the development and implementation of ABCâs strategic action plans. Ms. Sale services the needs of ABCâs membership, composed of pa- tients, families, physicians, clinicians, industry, and government agen- cies. She has nearly 20 years of experience in nonprofit administration. Prior to joining ABC, she served as the senior director for planning and membership for the Society for Neuroscience. In this role, Ms. Sale coordinated the governance activities for the Society, supported its Council-driven strategic planning effort, supervised and serviced its membership and chapters, and managed the functions of the executive directorâs office. Ms. Sale received her B.S. in Speech Communications
110 FINANCIAL INCENTIVES with a Public Relations concentration and a minor in Human Relations from St. Cloud State University in Minnesota. Andrew Sperling, J.D., M.A., is the director of federal legislative advo- cacy for the National Alliance on Mental Illness (NAMI). In this posi- tion, he leads NAMIâs legislative advocacy initiatives in Congress and before federal agencies. Mr. Sperling works on issues affecting the men- tal health community with a focus on improving the lives of people with severe mental illnesses. Since 1994, Mr. Sperling has also served as co- chair of the Consortium for Citizens with Disabilities Housing Task Force. Prior to joining NAMI, Mr. Sperling held the position of deputy director of government relations for the National Community Mental Healthcare Council and was a legislative assistant for U.S. Representa- tive Dick Swett (D-NH). Mr. Sperling earned his B.A. from Tulane Uni- versity. He received an M.A. from George Washington University and a J.D. from the Franklin Pierce Law Center. Maike Stenull, M.B.A., is the senior director, strategic projects and transformational leadership at the Office of the Chief Medical Officer at Johnson & Johnson (J&J). Ms. Stenull leads and manages transforma- tional cross-sector, cross-functional initiatives that are integral to the op- erational effectiveness objectives. She is responsible for driving process, content, and business impact for large, complex transformational pro- jects. Ms. Stenull has responsibility for J&Jâs Research & Development (R&D) Management Committee as the decision support lead. She is also the co-lead on the Global Alzheimerâs Platform workstream focused on alternative finance options. Previously, she served as finance controller of the Neuroscience Therapeutic Area within Janssen R&D. Ms. Stenull has more than 20 years of cross-sector, cross-regional business experi- ence within J&J. She has worked in medical devices and diagnostics, consumer and pharma, in various European countries and the United States. Ms. Stenull holds an M.B.A. from the Wirtschaftsakademie Ham- burg in Germany. She is also a certified Six Sigma Black Belt (Process Excellence). Paul Summergrad, M.D., is the Dr. Frances S. Arkin Professor and Chair of the Department of Psychiatry and professor of medicine at the Tufts University School of Medicine and psychiatrist-in-chief of Tufts Medical Center. Dr. Summergrad is the president of the American Psy- chiatric Association. He also serves as chair, interim president, and CEO
APPENDIX D 111 of the Tufts Medical Center Physicians Organization and as a member of the Tufts Medical Center Board of Trustees. Prior to his arrival at Tufts in 2004, he served at the Massachusetts General Hospital (MGH) and Harvard Medical School, where he was associate professor of psychiatry and chief of inpatient psychiatric services at MGH. He also served as network director of the Partners Psychiatry & Mental Health System. In that role he also served as psychiatrist-in-chief of the North Shore Medi- cal Center, where he was executive vice president for medical affairs and chief medical officer and a member of the Partners Executive Commit- tee. A 1978, Alpha Omega Alpha graduate of the School of Medicine at the State University of New York of Buffalo, he trained in internal medi- cine at the Boston City Hospital from 1978â1981 and in psychiatry at the Massachusetts General Hospital from 1982â1985 where he was chief resident. He graduated from psychoanalytic training at the Boston Psy- choanalytic Society and Institute, where he is a member. He is Board certified in internal medicine, psychiatry, psychosomatic medicine, and geriatric psychiatry. Dr. Summergrad has published extensively on the history and development of psychiatry, medical psychiatry, neuropsychi- atry, psychopharmacology, and strategic planning in academic medical centers, including editing with Roger Kathol the recent book Integrated Care in Psychiatry. His research focuses on mood disorders, medical- psychiatric illness, and health system design. He is a Distinguished Fel- low of the American Psychiatric Association and a Fellow of both the American College of Psychiatrists and the American College of Physi- cians. In addition to his clinical, academic, and administrative roles, Dr. Summergrad is immediate past president of the American Association of Chairs of Departments of Psychiatry and immediate past chair of the American Hospital Association Governing Council for Psychiatry and Substance Abuse Services. He served as the chair of the American Psy- chiatric Association (APA) Board of Trustees Ad Hoc Workgroup on the Role of Psychiatry in Healthcare Reform and served as a member of the APA Board of Trustees DSM-5 Scientific Review Committee. He has served as a member of the Finance and Budget Committee, the Assembly of the Steering Committee on Practice Guidelines, and the Council on Medical Education. He is a past president of the Massachusetts Psychiatric Society and the American Association of General Hospital Psychiatrists. William Thies, Ph.D., is Senior Scientist in Residence with the Alz- heimerâs Association. Dr. Thies is formerly chief medical and scientific officer of the Alzheimerâs Association, where he oversaw the worldâs
112 FINANCIAL INCENTIVES largest private, nonprofit Alzheimerâs disease research grants program. During his tenure, the organizationâs annual grant budget more than dou- bled. Since its inception in 1982, the Alzheimerâs Association grants program committed more than $300 million for Alzheimerâs disease re- search. Dr. Thies was instrumental in bringing the Alzheimerâs Associa- tion International Conference (AAIC) under the umbrella of Association activities. AAIC is the worldâs largest gathering of Alzheimer and de- mentia researchers, regularly drawing more than 5,000 attendees. In ad- dition, Dr. Thies played a key role in launching the peer-reviewed journal Alzheimerâs & Dementia: The Journal of the Alzheimerâs Associ- ation and the Associationâs Research Roundtable. The Roundtable pro- vides a unique forum for senior scientists from the pharmaceutical industry, biotech, imaging, academia, the National Institutes of Health, and regulatory agencies to discuss common issues and obstacles in Alz- heimerâs disease research and drug development. Before joining the Alz- heimerâs Association, Dr. Thies was a director and senior scientist at the American Heart Association. He previously held faculty positions at In- diana University and the University of Pittsburgh. Peter Ubel, M.D., is a physician and behavioral scientist whose research and writing explores how people make decisions related to health and health care. He is the Madge and Dennis T. McLawhorn University Pro- fessor of Business, Public Policy, and Medicine at Duke University. His research explores the role of values and preferences in health care deci- sion making, from decisions at the bedside to policy decisions. He uses the tools of decision psychology and behavioral economics to explore topics such as informed consent, shared decision making, and health care cost containment. He has authored more than 250 academic publications, the majority of which involve empirical explorations of decision psy- chology as it pertains to health care. He has also written for the New York Times, the Los Angeles Times, the Atlantic, and the New Yorker. Dr. Ubel is a regular contributor at Forbes. His books include Pricing Life (MIT Press, 2000), Free Market Madness (Harvard Business Press, 2009), and Critical Decisions (HarperCollins, 2012). George Vradenburg, J.D., is the chair and co-founder of USAgainstAlz- heimerâs, an education and advocacy campaign committed to mobilizing America to stop Alzheimerâs, and convener of the Global CEO Initiative (CEOi) on Alzheimerâs. Through his USA2 work, he has brought together powerful voices to escalate the fight against Alzheimerâs, as co-convener
APPENDIX D 113 of Leaders Engaged on Alzheimerâs Disease (LEAD) (a network of major Alzheimerâs-serving organizations from the not-for-profit, foundation, ac- ademic, corporate, and government sectors) and as convener of the Global CEO Initiative Against Alzheimerâs (a publicâprivate initiative to link public, private, and nongovernmental organization efforts to implement the National Alzheimerâs Goal to stop Alzheimerâs by 2025). He was named by former Health and Human Services Secretary Kathleen Sebe- lius to serve on the National Alzheimerâs Advisory Council to advise on the first-of-its-kind National Alzheimerâs Strategic Plan. Among other efforts, Mr. Vradenburg has testified before Congress about the global Alzheimerâs pandemic; has conceived and supported the Alzheimerâs Study Group; and, through the Vradenburg Foundation, has supported the Alzheimerâs disease International World Alzheimerâs Reports and the Na- tional Institutes of Healthâs Global Alzheimerâs Research Summit. Mr. Vradenburg was appointed to the bipartisan Commission on Long-Term Care in 2013. Before his retirement, he served in senior executive positions at AOL/Time Warner, Fox, and CBS. He is a member of the Council on Foreign Relations and the Economic Club of Washington. Mr. Vradenburg received his B.A. from Oberlin College, magna cum laude, and his J.D. from Harvard Law School, cum laude. David Wholley, M.Phil., manages the Research Partnerships Division of the Foundation for the National Institutes of Health. Programs under the Research Partnerships Division include The Biomarkers Consortium, Accelerating Medicines Partnership, and LungMAP, a multidrug âmaster protocolâ trial in squamous cell lung cancer. He has also served as direc- tor of the Genetic Association Information Network, a publicâprivate partnership dedicated to helping discover the genetic basis of common disease, and led the development of a major publicâprivate partnership in drug safety with the biopharmaceutical industry and Food and Drug Ad- ministration. Prior to joining the Foundation in 2006, Mr. Wholleyâs ca- reer spanned nearly 25 years in health care technology management, including extensive experience in product development, sales, marketing, corporate strategy, and partnership and project development. Mr. Wholley has held senior management roles in several venture-funded technology start-up companies, including head of global marketing and development for First Genetic Trust, Inc., which developed software for large-scale, collaborative genetic research and personalized medicine. During a 16- year career at IBM, he co-led the corporate strategy team that guided IBMâs formation of its Life Sciences industry organization. Mr. Wholley
114 FINANCIAL INCENTIVES holds an M.Phil. from Rutgers University and a Certificate in Business Administration from the Stern School of Business at New York University. Janet Woodcock, M.D., is director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). Dr. Woodcock first joined CDER in 1994 and FDA in 1986. From 2005 until 2008, she served as FDAâs commissioner, holding several positions, in- cluding deputy commissioner and chief medical officer, deputy commis- sioner for operations, and chief operating officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations. Before joining CDER, Dr. Woodcock served as director, Of- fice of Therapeutics Research and Review, and acting deputy director in FDAâs Center for Biologics Evaluation and Research. Dr. Woodcock received her M.D. from Northwestern University Feinberg School of Medicine and completed further training and held teaching appointments at the Pennsylvania State University and the University of California, San Francisco.
