Greg Koski, PhD, MD, CPI
Senior Scientist, Institute for Health Policy & Associate Professor of Anesthesia
Massachusetts General Hospital

Greg Koski  is currently Senior Scientist at the Institute for Health Policy and an Associate Professor in the Department of Anesthesiology and Critical Care of the Massachusetts General Hospital (MGH) at Harvard Medical School, having recently served for two and a half years as the first Director of the new Federal Office for Human Research Protections (OHRP) within the Office of the Secretary of the Department of Health and Human Services. Dr. Koski was recruited by former Secretary of Health and Human Services Donna Shalala to head the new office at a time of national upheaval in human research. Under Dr. Koski’s direction, the Department pursued a performance-focused systems approach to protection of human research participants; catalyzed the development of private, voluntary accreditation of human research protection programs; streamlined and simplified the federal assurance process; expanded education and outreach programs; and implemented continuous quality improvement methods to help entities engaged in human research evaluate and strengthen their programs. Koski also chaired the Human Subjects Research Subcommittee of the National Science and Technology Council's Committee on Science at the White House, and served as Executive Secretary of the National Human Research Protections Advisory Committee. In recognition of his contributions to human research, the AAPP awarded him an honorary lifetime membership in 2002.

Dr. Koski received his undergraduate education (A.B., '71), his Ph.D. in physiology ('77), and his M.D. ('78) from Harvard. A member of the first graduating class of the Harvard-Massachusetts Institute of Technology program in Health Sciences and Technology, he also did post-doctoral research at the National Institutes of Health as a Pharmacology Research Associate before joining the Harvard faculty at the MGH Department of Anesthesia in 1984. Dr. Koski also served as Director of Clinical Research Support and Development at the MGH, and was the Director of Human Research Affairs at the Partners HealthCare System before heading to Washington. Having now returned to Harvard, Dr. Koski is again practicing and teaching cardiac anesthesia, and will continue involvement in research ethics, responsible conduct and research integrity as a member of the Institute for Health Policy. Dr. Koski serves on the Board of Trustees of the Association of Clinical Research Professionals and chairs its Committee on Advocacy for Patients and the Profession. He also serves as vice-president for Ethics and Professional Conduct for the Academy of Pharmaceutical Physicians and Investigators.

Charles M. Alexander, MD, FACP, FACE, CPI (Hon)
Senior Director, Outcomes Research
Merck & Co, Inc

Charles M. Alexander is currently Senior Director, Outcomes Research at Merck. Dr. Alexander began working for Merck in 1992 and has been in Outcomes Research since 1996. Previously he co-chaired the APPI Academic Medicine Taskforce, served on the ACRP Board of Trustees as Ex-Officio, the Joint Task Force for the Affiliation Agreement and the APPI Negotiating Committee which successfully concluded in the affiliation agreement which was signed in 2005. He has served leadership roles in AAPP, APPI, and ACRP since 1998, has been a member of the AAPP/APPI Board of Trustees since 2001.  In 2008, he received an honorary certified physician investigator designation in recognition of his work helping to create the certification program.

Dr. Alexander received his medical degree and did postgraduate training from the University of Southern California and LAC/USC Medical Center, Los Angeles. Prior to joining Merck, he practiced diabetes, endocrinology and internal medicine in Los Angeles for ten years where he was also Clinical Professor of Medicine of the USC School of Medicine. Dr. Alexander is board certified in Internal Medicine and Endocrinology-Metabolism and is a Fellow of both the American College of Physicians and the American College of Endocrinology. He is the author of numerous scientific articles and presentations.

Peter Rheinstein MD, JD, MS
Consultant

Peter Rheinstein consults and speaks on drug issues. Previously, he was senior vice president for medical and clinical matters at a Johns Hopkins spinoff firm developing cancer diagnostics and therapeutics, publisher of the journal Discovery Medicine, and director of several offices for the U.S. Food and Drug Administration.

Rheinstein also has been a practicing physician, medical school faculty member, medical director for a national chain of extended care facilities, and president of the Drug Information Association (DIA). He has served APPI as its vice president for American Medical Association (AMA) Relations and delegate to the AMA House of Delegates, vice chair of the Policy Committee (and of ACRP’s Government Affairs Committee), and president of the Baltimore-Washington Chapter. He received the APPI President’s Outstanding Service Award in 2003.

Ihor W. Rak, MD
Vice President, Clinical, Neuroscience Therapy Area
AstraZeneca Pharmaceuticals LP

Ihor W. Rak joined AstraZeneca in 1996 within the Clinical Research organization providing medical and team leadership for a number of clinical projects, including SEROQUEL. In 2001, Dr. Rak took on the position of Global Product Director, Emerging Neuroscience. He successfully led the global neurologic, psychiatric and overactive bladder early development projects for AstraZeneca. Most recently (2005), Dr. Rak was appointed Vice President, Clinical Development for the Neuroscience Therapy Area. In his current role, he oversees the development and delivery of the Clinical contributions for both emerging products and established brands in the Neuroscience Therapy Area. He is also responsible for overseeing any Neuroscience-related Discovery Medicine activity.

Prior to joining AstraZeneca, Ihor was Founder and Medical Director of the Epilepsy Center and Co-Director of the Sleep Disorders Center at Sacred Heart Hospital, Allentown, Pennsylvania (USA). He also served as an Assistant Professor of Neurology and Research Associate at the University of Virginia, Charlottesville, Virginia, and Chief of Paediatric Neurology and Neurology Services in the U.S. Air Force Medical Corps, Wright-Patterson Air Force Base, in the State of Ohio.

Dr. Rak is a graduate of City University of New York and earned his medical degree at the College of Physicians and Surgeons at Columbia University, New York City. He completed his Internship, Residency and Fellowship at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia, and also participated in executive development programs at the University of Pennsylvania's prestigious Wharton School of Business. He has earned numerous medical board certifications and has been actively involved for a number of years with the American Academy of Pharmaceutical Physicians (AAPP) and the National Alliance for the Mentally Ill (NAMI), Delaware Chapter. Dr. Rak is also proud to serve as President-Elect of the Academy of Pharmaceutical Physicians and Investigators (APPI).

Richard G. Pellegrino, MD, PhD
President
Central Arkansas Research