Leadership - Clinical Research Pathways

Clinical Research Pathways Leadership

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 public charity—and continue to advance high-quality, ethical research—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.

majorie-speers

Board of Directors

Peter F. Buckley, M.D.

Dean School of Medicine, Virginia Commonwealth University Executive Vice President, Medical Affairs Virginia Commonwealth University Health System

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Dr. Peter F. Buckley became Dean of the Virginia Commonwealth University (VCU) School of Medicine in January 2017. He also serves as VCU Health System Executive Vice President for Medical Affairs, overseeing the 600 physician-faculty group practice of the academic health sciences center. 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.

Anne B. Cropp, Pharm.D., BCAP

Founder and Chief Scientific Officer
Early Access Care

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Dr. Anne B. Cropp is founder and Chief Scientific Officer of Early Access Care, a healthcare firm that helps biopharmaceutical companies develop and implement programs for expanded access/compassionate use of investigational drugs. A globally recognized expert in early access/expanded access/compassionate use, Dr. Cropp collaborates with biopharmaceutical companies, global health authorities, and academic thought leaders on issues pertaining to adult and pediatric expanded access programs. She has presented at and chaired several international scientific symposia on early access and managed access.

Dr. Cropp has 25 years of experience in pharmaceutical and biopharmaceutical drug development, in a career distinguished by global leadership and achievements in innovation. Prior to founding Early Access Care, she was Vice President in the Global Product Development Group of Pfizer, Inc., where she also served as chair of the Pfizer Pediatric Council.

She has been responsible for the strategic planning, development, and execution of investigational drugs across a broad spectrum of diseases, including Alzheimer’s disease, heart failure, hypercholesterolemia, hypertension, and type 1 and type 2 diabetes mellitus. Dr. Cropp also has extensive expertise in drug development for pediatric and adult patients.

A pharmacist and board-certified clinical pharmacologist, Dr. Cropp earned a Bachelor of Science in pharmacy from Massachusetts College of Pharmacy and a Doctor of Pharmacy degree from Duquesne University. For her work on naloxone as a treatment for ischemic stroke, Dr. Cropp received the Roche Young Investigator Award. She completed a post-doctoral research fellowship in cardiovascular pharmacology at the Millard Fillmore Hospital in Buffalo, New York, and was an adjunct faculty member at the State University of New York at Buffalo. In addition, Dr. Cropp was a National Institutes of Health Fogarty Fellow at the National Heart, Lung, and Blood Institute.

Her decision to found Early Access Care is rooted in her experience as a longstanding member of the scientific research community and her desire to help patients and advance their care.

David Farber, J.D.

Partner, FDA/Life Sciences Practice King & Spalding

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David Farber brings together the best of King & Spalding’s knowledge, combining his experience in both litigation and public policy to solve client needs. Having been trained as a litigator, Mr. Farber maintains a strong, complex multiparty litigation practice, including serving as first chair in healthcare litigation, False Claims Act cases, and other commercial disputes. Mr. Farber also maintains a strong government advocacy practice before both the Congress and federal agencies, and has drafted and had passed legislation, as well as influenced and changed agency policies, principally in the healthcare and insurance fields. 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.

Angelike A. Giallourakis, Ph.D.

President Steven G. AYA Cancer Research Fund

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Dr. Angelike A. Giallourakis is President of the Steven G. AYA Cancer Research Fund, an advocacy organization supporting patients and research, and promoting the issues surrounding adolescent and young adult cancers. She is the Volunteer Coordinator for the AYA Cancer Advisory Council at Rainbow, Babies & Children’s Hospital of University Hospitals of Cleveland, a Parent Mentor, and a CAC2 (Coalition Against Childhood Cancer) Board Member. 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.

Andrew McFadyen

Founder and Executive Director
The Isaac Foundation
Equal Access for Rare Disorders

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Andrew McFadyen is the founder and Executive Director of two nonprofit organizations that help patients and families who are dealing with rare diseases.

The Isaac Foundation funds innovative research that seeks to find a cure for the mucopolysaccharidoses (MPS), a group of devastating, debilitating metabolic disorders. Mr. McFadyen’s oldest son, Isaac, has MPS VI. A second organization, Equal Access for Rare Disorders, works to ensure access to lifesaving treatments, both approved and in development, for patients with rare diseases. Both organizations are based in Campbellford, Ontario, Canada.

Mr. McFadyen has led advocacy efforts on behalf of patients throughout North America and has helped shape Canada’s public policy on providing government funding for cost-prohibitive treatments for children who are dying of rare diseases. A vocal opponent of “right to try laws” that weaken patient protections by bypassing the Food and Drug Administration, Mr. McFadyen has had articles published in Alaska’s online newspaper, Juneau Empire; on the U.S. political website, The Hill; and The Health Care Blog. He testified at a U.S. congressional hearing on right to try legislation.

Mr. McFadyen is a member of the NYU Langone Health Working Group on Compassionate Use and Pre-Approval Access (CUPA). He also is an associate fellow of the GE2P2 Global Foundation, which aims to advance scientific rigor and ethical research in evidence generation. He holds Bachelor of Arts and Bachelor of Education degrees from Queen’s University in Ontario.

Joanne Waldstreicher, M.D.

Chief Medical Officer Johnson & Johnson

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Dr. Joanne Waldstreicher is Chief Medical Officer, Johnson & Johnson. In this role, Dr. Waldstreicher has oversight across pharmaceuticals, devices, and consumer products for safety, epidemiology, clinical and regulatory operations, internal and external partnerships and collaborations supporting development of the ethical science, technology, and R&D policies, including those related to clinical trial transparency and compassionate access. Dr. Waldstreicher also chairs the Pharmaceuticals (Janssen) R&D Development Committee and supports the Device and Consumer Development Committees, which review late-stage development programs in the pipeline. Dr. Waldstreicher also holds an appointment as a faculty affiliate of the Division of Medical Ethics, Department of Population Health, New York University School of Medicine. 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.