Executive Director Marjorie A. Speers, Ph.D.
Marjorie A. Speers, Ph.D., is a global leader in human research protections. Most recently, she was founding president and CEO of the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), retiring in 2013.
Dr. Speers views the opportunity to lead this one-of-a-kind foundation—and continue to contribute to research protections and public well-being worldwide—as the natural progression in an exemplary career of public service. Before establishing AAHRPP in 2001, she served as acting executive director of the National Bioethics Advisory Commission. At the Centers for Disease Control and Prevention, she oversaw research protections for all domestic and international research.
Dr. Speers is a graduate of Dickinson College, where she serves on the Board of Trustees and established a scholarship that has benefited numerous international students. She also holds doctoral degrees in psychology and epidemiology from Yale University.
Board of Trustees
Anita L. Allen, JD, PhD
Vice Provost for Faculty
Henry R. Silverman Professor of Law
Professor of Philosophy
University of Pennsylvania
Dr. Anita L. Allen is Vice Provost for Faculty and the Henry R. Silverman Professor of Law and professor of philosophy at the University of Pennsylvania. In 2010 she was appointed by President Obama to the Presidential Commission for the Study of Bioethical Issues.
Dr. Allen is an expert on privacy and data protection law, bioethics, and contemporary values. In June 2014, she received a Lifetime Achievement Award from the Electronic Privacy Information Center in Washington, D.C., for her pioneering privacy scholarship and advocacy.
Her books include Unpopular Privacy: What Must We Hide? (Oxford, 2011); Privacy Law and Society (Thomson/West, 2011); The New Ethics: A Guided Tour of the 21st Century Moral Landscape (Miramax/Hyperion, 2004); Why Privacy Isn’t Everything: Feminist Reflections on Personal Accountability (Rowman and Littlefield, 2003); and Uneasy Access: Privacy for Women in a Free Society (Rowman and Littlefield, 1988). She co-edited (with Milton Regan) Debating Democracy’s Discontent (Oxford, 1998).
Dr. Allen, who has written more than a 100 scholarly articles, has also contributed to popular magazines and blogs, and has frequently appeared on nationally broadcast television and radio programs. Dr. Allen has served on numerous editorial and advisory boards, and on the boards of a number of local and national non-profits and professional associations, including the Association of American Law Schools, the Association for Practical and Professional Ethics, the Hastings Center, and the Bazelon Center for Mental Health Law.
Peter F. Buckley, MD
School of Medicine, Virginia Commonwealth University
Executive Vice President, Medical Affairs
Virginia Commonwealth University Health System
Dr. Buckley was Dean of the Medical College of Georgia at Augusta University (AU) from 2011 to 2016. A psychiatrist and expert in schizophrenia, Dr. Buckley was also a professor of psychiatry, pharmacology, and radiology. He served as Interim Executive Vice President for Health Affairs for AU and Interim Chief Executive Officer for AU Medical Center and AU Medical Associates.
Dr. Buckley joined the faculty of the state’s public medical school in 2000 as Chair of the Department of Psychiatry and Health Behavior. From 2007 to 2010, he also served as Associate Dean and then as Senior Associate Dean for Leadership Development in the medical school. His previous academic appointments include serving as professor and Vice Chair of the Department of Psychiatry at Case Western Reserve University, School of Medicine, Cleveland. In 1994, Dr. Buckley also became Medical Director of Western Reserve Psychiatric Hospital, a role that expanded over time to include serving as Medical Director for Northcoast Behavioral Healthcare System, which included three state inpatient psychiatric facilities in Cleveland and Toledo, Ohio. Dr. Buckley also served as Co-Director of the statewide community service product line for the Ohio Department of Mental Health.
Dr. Buckley serves as a member of the Council of Deans (CODs) with the Association of American Medical Colleges (AAMC). Dr. Buckley is on the COD Administration Board and chairs the COD Fellowship Program. He is a Distinguished Fellow of the American Psychiatric Association and served on the association’s Workgroup on the Role of Psychiatry in Healthcare Reform. He is also a Fellow of the Royal College of Psychiatrists and served as Chair of the PanAmerican Division. Dr. Buckley is a past President of the American Association of Chairs of Departments of Psychiatry. He serves as a member of the Data Safety & Monitoring Board of the National Institute of Mental Health (NIMH). He is former Chair of the NIMH Interventions Committee for Disorders Related to Schizophrenia, Late Life, or Personality, and regularly serves as chair for various special emphasis panels. Dr. Buckley also serves on the Maintenance of Certification Committee for the American Board of Psychiatry and Neurology. He has served as a reviewer for the Liaison Committee on Medical Education (LCME) and as a reviewer/panel participant for the National Academy of Medicine (NAM). He is a member of the Executive Committee of the International Congress of Schizophrenia Research.
Dr. Buckley has published 500 original articles, book chapters, and abstracts. He is senior author of a postgraduate textbook of psychiatry. Dr. Buckley has also authored or edited 16 books on schizophrenia and related topics. He is editor of the journal Clinical Schizophrenia & Related Psychoses and was the inaugural editor of the Journal of Dual Diagnosis. He also is associate editor of the Journal of Nervous and Mental Diseases, a member of the editorial boards of 10 other psychiatric journals, and has served as a reviewer for over 60 journals. Dr. Buckley’s research predominantly focuses on the neurobiology and treatment of schizophrenia, including current studies on the genetics of schizophrenia and on the psychopharmacology of schizophrenia. He has also conducted research on patient- and family-centered care and on the development of academic leadership.
Donald A. Deieso, PhD
Chairman & CEO
Operating Partner & Co-Head of the Healthcare Group
Arsenal Capital Partners
Donald A. Deieso became Executive Chairman of the WIRB-Copernicus Group in 2012, immediately following the acquisition by Arsenal Capital Partners. He assumed the additional role of CEO in October of 2013. Since 2011, Dr. Deieso serves as an Operating Partner and Co-Head of the Healthcare Group within Arsenal Capital Partners. Before assuming these positions, Dr. Deieso served as CEO in a number of publicly-traded and privately-held companies in the healthcare, life science, technology, and engineering industries. Additionally, Dr. Deieso has held senior positions in federal and state regulatory agencies. He has led successful transformations of a number of companies in the healthcare and life science sectors gaining the recognition of leading a Deloitte Fast 500 Company for three consecutive years and being named an Ernst &Young Entrepreneur of the Year Finalist in 2010.
Dr. Deieso serves as the Chairman of the Board of Directors of several heathcare companies including; Certara, BioIVT, and TractManager. Previously, he served on the Board of Directors of Sentrx, Breckenridge Financial Services, and IMDS. He is a former Board of Trustee of the Kenan Institute of the University of North Carolina and the NJ Symphony Orchestra.
Dr. Deieso received a B.S.M.E. in mechanical engineering from Manhattan College, and an M.S. and Ph.D. from Rutgers University, where he served on the faculty. He lectures and writes frequently on compliance matters related to clinical research and compliance within the life science industry.
David Farber, JD
Partner, FDA/Life Sciences Practice
King & Spalding
In his litigation practice, Mr. Farber began his career working on environmental and health and safety cases, including complex insurance coverage and trade secret matters. He has tried over 20 cases, ranging from expedited administrative law judge trials to a recent five-day broker malpractice case. He has also litigated False Claims Act and Trade Secret litigations. Mr. Farber has recently been involved in several international disputes, including international arbitrations and related litigation.
On the advocacy side, Mr. Farber’s work focuses on the healthcare and insurance industries. Clients often turn to him as the primary strategist and policy architect for a broad range of matters. Working with the Congress, the Executive (with particular focus on the Centers for Medicare & Medicaid Services and Food and Drug Administration) and academia, he has successfully guided clients through the legislative enactment and the regulatory promulgation processes. He drafted, and had enacted, the SMART Act of 2012, which was the first major reform of the Medicare Secondary Payer system in over 30 years.
Mr. Farber excels at combining innovative legislative advocacy, regulatory change, and litigation to help clients achieve solutions. His clients often comment on the unexpected and quick manner in which Mr. Farber is able to resolve disputes and obtain outcomes, using a combination of skills usually found across multiple specialists.
Finally, Mr. Farber has worked on a broad range of other client needs, ranging from representation of an international agricultural biotech foundation that has received the largest Gates grant given to an African entity, to his service as personal counsel to Secretary Jack Kemp from 1992 through his passing in 2009.
Kenneth A. Getz, MBA
Center for Information and Study on Clinical Research Participation
Director, Sponsored Research & Associate Professor
Tufts Center for the Study of Drug Development
A well-known speaker at conferences, symposia, universities, investor meetings, and corporations, Mr. Getz has published extensively in peer-review journals, books, and in the trade press. He is the author of two nationally recognized books for patients and their advocates—Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation—and the recipient of several awards for innovation and scholarship. Mr. Getz has held a number of board appointments in the private and public sectors, including serving on the Institute of Medicine’s Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative. He is on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science, writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials, and has twice been nominated for a Distinguished Faculty Award at Tufts University.
Mr. Getz holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch in 1994, Mr. Getz worked for over seven years in management consulting, where he assisted biopharmaceutical companies in developing and implementing business strategies to improve clinical development performance
Angelike A. Giallourakis, Ph.D
Steven G. AYA Cancer Research Fund
Dr. Giallourakis began her career in the field of rehabilitation counseling. She worked as a rehabilitation counselor for the Cleveland Society for the Blind and then as a program coordinator for services for independent living.
She received a Ph.D. in special education from Kent State University, specializing in the collaborative interactions between families and professionals within the educational environment.
Dr. Giallourakis is a former college professor in special education at Cleveland State University. She stepped down from this position upon her son’s diagnoses in 2006 to be his caregiver. She credits her professional training with the skills to educate others about the issues surround AYA cancer, supporting families, and addressing oncology professionals.
Alan Lefkowitz, JD
Chief Legal Officer & Chief Commercial Officer
Prior to being the Chief Legal Officer and Chief Commercial Officer for WIRB-Copernicus Group, he served in senior executive legal positions within the healthcare, technology, software, medical devices, and insurance sectors. His legal specialties include corporate, commercial, intellectual property, compliance, securities, mergers and acquisitions, governance, and software licensing.
Stephen M. McLean
Arsenal Capital Partners
Mr. McLean has also been an active personal investor/board member of private companies in the healthcare industry at the integration of life sciences and information services. Mr. McLean helped to found and served as a director of Agencourt Bioscience Corporation and Agencourt Personal Genomics. He has previously been an investor and member of the Board of Directors of Packard Bioscience, Cure DM, RS Medical Corporation, Obagi Medical, and EduNeering. Mr. McLean currently serves on the Board of Directors of the WIRB-Copernicus Group, Certara, TractManager, BioreclamationIVT, Courtagen Life Sciences, and CentriHealth.
Mr. McLean is the Chairman of the International Biomedical Research Alliance, (the “Alliance”). The Alliance is a private sector foundation formed to support an advanced biomedical Ph.D. program, the NIH Oxford Cambridge Scholars Program, (the “Program”). The Program was established in 2000 by Dr. Michael Lenardo of NIH to accelerate the training of American and British biomedical Ph.D.’s. It is the only academic program in the world to be an affiliate of the Rhodes Scholarship. In addition to providing financial support to scholars enrolled in the Program, the Alliance actively provides strategic guidance to NIH Program administrators regarding student recruitment, Program management, private sector priorities and scholar placement.
Mr. McLean holds an MBA with distinction from the Wharton School (1980) and a B.S. in Economics summa cum laude from the University of Pennsylvania (1979). He has been an occasional lecturer at Wharton for the Wharton Department of Business Ethics.
Lindsay McNair, MD, MPH, MSBioethics
Chief Medical Officer
Dr. McNair graduated from the University of Connecticut School of Medicine and trained in general surgery at Boston University Medical Center. She completed her Master of Public Health at Boston University, concentrating in biostatistics/epidemiology, and her Master of Science in Bioethics at Union Graduate College, concentrating in research ethics. She was a member of the IRB at Boston University Medical Center, and founded and chaired the Human Subject Protection Committee at Vertex Pharmaceuticals. She was a site visitor for the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Dr. McNair serves on committees including the Multi-Regional Clinical Trials Center at Harvard, and is an associate editor of the Journal of Empirical Research on Human Research Ethics.
Joanne Waldstreicher, MD
Chief Medical Officer
Johnson & Johnson
Among her prior roles in Janssen, the pharmaceutical sector of Johnson & Johnson, Dr. Waldstreicher was responsible for late-stage development spanning the areas of neuroscience, cardiovascular, and metabolism including Invokana®, Xarelto®, Invega Sustenna®, and Invega Trinza®. Before joining Johnson & Johnson in 2002, Dr. Waldstreicher was head of the endocrinology and metabolism clinical research group at Merck Research Laboratories, and responsible for overseeing clinical development of Mevacor®, Zocor®, Proscar®, and Propecia®, and for clinical development programs in atherosclerosis, obesity, diabetes, urology, and dermatology. During that time, she received numerous awards and distinctions, including the Merck Research Laboratory Key Innovator Award.
Dr. Waldstreicher received both the Jonas Salk and Belle Zeller scholarships from the City University of New York and graduated Summa Cum Laude from Brooklyn College. She graduated Cum Laude from Harvard Medical School in 1987, and completed her internship and residency at Beth Israel Hospital and her endocrinology fellowship at Massachusetts General Hospital. She has won numerous awards and scholarships, and has authored numerous papers and abstracts. Dr. Waldstreicher combines broad experience in science and medicine with a passion for advancing transparency and ethics.