Planning Committees

ACRP 2010 Global Conference Planning Committee
APPI Program Working Group
Pharmaceutical Medicine Working Group

ACRP 2010 Global Conference Planning Committee

Chair Donna Edgerton, BSN, RN, CCRC Millennium Pharmaceuticals   Vice Chair Glenda Guest, CCRA Norwich Clinical Research   Member Shay Brill, MT(ASCP), CCRA Pharmaceutical Research Associates, Inc.   Member Joseph Kwentus, MD Precise Research Centers   Member Susan Odum, MEd, CCRC OrthoCarolina Research Institute   Member Peter Rheinstein, MD, JD, MS Severn Health Solutions

Member Susan Rockwell, MEd Medical Device Consultants   Member Deb Rosenfelder, CCRC Paragon Biomedical, Inc.   Member Heike Schoen, MS, MBA CSG Germany   Member Yafit Stark, PhD Teva Innovative R&D   Member Lynn VanDermark, RN, BSN, MBA, RAC, CCRA MedTrials, Inc.   Member Stephen Zalewski, PharmD, CCRC ZeeCRO

 

 

Donna Edgerton, BSN, RN, CCRC, is currently Senior Director of Clinical Quality Standards, Quality Assurance for Millennium Pharmaceuticals: The Takeda Oncology Company where she is responsible for the development and implementation of the GCP and pharmacovigilance compliance strategies. Prior to joining Millennium, Donna was Director of Clinical Operations for Sonus Pharmaceuticals and Director of Clinical Quality Assurance for Corixa.

 

Donna left emergency nursing for clinical research in 1990 when she became a research nurse coordinator at the University of Washington. Subsequently she managed a clinical research center, and developed clinical operations and quality programs for a research services organization. From 2003-2008, before moving to Cambridge for her current position, Donna held an instructor appointment at the University of Washington, teaching in the Clinical Trial Certificate program.

 

Donna has been active in ACRP for over ten years. She achieved certification in 1998, served as Pacific Northwest Chapter chair for more than five years, and was appointed to Global Conference Planning Committee in 2006 where she is currently serving as chair for the 2010 Conference.

 

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Glenda Guest, CCRA, is Vice President of Norwich Clinical Research Associates Ltd. (NCRA). She has been involved in regulated research since 1997 and specializes in medical device monitoring and project management, GCP and third party auditing as well as training on US regulated research and Good Clinical Practice.

 

She is the immediate past chair of the ACRP’s Medical Device Forum and remains an active member of the Device Forum Steering Committee. She is Vice Chair of the ACRP 2009 Global Conference Planning and remains actively involved with the ACRP Central New York chapter. She has been an ACRP Certified Clinical Research Associate since April 2002.

 

She has also been recognized by the Society of Quality Assurance as RQAP-GCP, which is a Registered Quality Assurance Professional – Good Clinical Practices, having successfully passed the first exam for this designation offered by SQA in April 2007.

 

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Shay Brill, MT(ASCP), CCRA, has been involved with clinical research for over fourteen years. While at PRA International, Inc., Shay has developed a broad experience in clinical operations, working first as a CRA, then as Lead CRA, and a functional manager. In October 1999, Shay became a member of the Staff Development team and has been involved with developing and training global clinical programs across PRA International. Most recently, Shay has returned to Business Solutions as a director to manage new solutions, processes and systems, across the organization.

 

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Joseph Kwentus, MD, is the President of Precise Research Centers, a private clinical trials center outside Jackson, Mississippi.  Dr. Kwentus is a board certified psychiatrist who has been a physician investigator on clinical trials since 1986.  The areas of medical interest that Dr. Kwentus primarily investigates include: alcohol dependence, Alzheimer’s disease, bipolar disorder, pain, major depressive disorder, schizophrenia and sleep disorders.  Dr. Kwentus is board certified in psychiatry and neurology, with added qualifications in seven other subspecialties.  He has authored numerous medical publications and has spoken at symposia around the globe.

 

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Susan Odum, MEd, CCRC, manages Outcomes and Scientific Studies at the OrthoCarolina Research Institute in Charlotte, N.C. Ms. Odum has over 10 years worth of research experience, consults for industry sponsors and hospitals, and has co-authored over 20 peer-reviewed publications and over 40 presentations worldwide. Ms. Odum served as secretary for the Charlotte, N.C., ACRP chapter in 2006 and is currently President Elect. Ms. Odum holds a BSED in Exercise Science, a MEd in Exercise Science (Biomechanics) and a MEd in Developmental Kinesiology (Motor Learning). Ms. Odum is an ACRP Certified Clinical Research Coordinator (CCRC).

 

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Peter Rheinstein, MD, JD, MS, is a consultant on drug regulatory and liability issues at Severn Health Solutions in Maryland.

 

Previously, he was Senior Vice President at a biotech firm developing cancer diagnostics and therapeutics on license from Johns Hopkins University. He spent more than 25 years in management positions at the Food and Drug Administration (FDA) and served twice as President of the Drug Information Association (DIA). Dr. Rheinstein represents APPI in the AMA House of Delegates.

 

He is a graduate of the Johns Hopkins University School of Medicine and the University of Maryland School of Law. He is board certified in family practice and geriatric medicine. His biography appears in Who’s Who in America and Who’s Who in the World.

 

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Susan Rockwell, MEd, Manager, Clinical Trials and Business Development, has over twenty years of experience in clinical and healthcare research. Since joining MDCI in 1988, she held positions of CRA, Senior CRA, CRA Manager, Project Manager, and Clinical Trials Manager. Prior to joining MDCI, she coordinated cardiovascular drug trials at Boston University Medical Center and managed healthcare programs at the American Heart Association, Massachusetts Affiliate.
 

Ms. Rockwell is an active member of the Association of Clinical Research Professionals, where she currently serves on the Global Conference Planning Committee and the Device Forum Steering Committee. She is a past member of the Board of Trustees, a past chair of the Editorial Advisory Board, and a past chair of the Device Forum. Ms. Rockwell holds a MEd degree in Health Education from Boston University and a BA degree in Biology from the University of Virginia.

 

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Deborah Rosenfelder, CCRC is a certified clinical research coordinator with more than ten years experience in clinical research. Ms. Rosenfelder currently oversees the interventional cardiology research at the University of Pittsburgh Medical Center. She has acquired a broad range of experience in cardiovascular research in both drug and device arenas. She has been responsible for managing all aspects of clinical trials including internal, multicenter and international trials.

 

Ms. Rosenfelder lectures on reimbursement issues related to trial, device trials and other research related topics. Ms. Rosenfelder began her career as a critical care nurse where she has sixteen years of experience, ten of which are in the field of cardiology.

 

She has been a member of ACRP for over nine years and is actively involved with the device forum and Global Conference Planning Committee of ACRP.

 

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Heike Schoen, MS, MBA, holds the position of Managing Director at CSG mbH, a Germany-based contract research organization for the health care, pharmaceutical, biotech and medical device industries.

 

Heike gained more than 13 years experience in globally -operating Contract Research Organizations. She held various management positions in clinical research, medical marketing and business development within Europe. Before joining CSG she worked as an executive recruiter, consultant and trainer in the life sciences industry. She holds a Master of Science in Psychology and a Master of Business Administration.

 

Since joining ACRP in 2001, she has been involved in chapter activities throughout Germany, and co-chaired ACRP European Conferences. Since January 2005, Heike has been a member of the global ABOT Team and Chair of the German Chapter.

 

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Yafit Stark, PhD, has been an ACRP member since 1998. Dr. Stark joined Teva in 1987. From 1991 to 1994 she was based in the United States, where she established the Innovative R&D Division of Teva USA. Dr. Stark then established and managed the Innovative R&D Division’s global clinical research and clinical development of all innovative products at Teva. Today she holds the position of Chief Clinical Officer, Innovative R&D Division and is in charge of the clinical development strategy and implementation of new methodologies in both innovative and biogeneric product development.

 

Dr. Stark holds a PhD degree in Pathology from the Sackler School of Medicine, Tel Aviv University, and a Post-Doctorate in Immuno-Histopathology from Tel Aviv University and the Weizmann Institute of Science. She served as a member of the academic staff of the Sackler School of Medicine and continues to lecture on Pathology and Oncology Drug Development in the School of Medicine’s College for Advanced Degrees.

 

Dr. Stark served as a member of the Nominating Committee of the Association of Clinical Research Professionals (ACRP) in 2007, and is an active member of “Tnufa”, the Project Funding Evaluation Committee of the Chief Scientist’s Office at the Israeli Ministry of Industry, Trade and Labor. She serves on the Board of Directors of the Israeli Research Association for Eye Health and Blindness Prevention and the International Association for Fighting Best Disease, and on the Advisory Forum of Xenia Venture Capital, an investment company operating a technological incubator in support of high-technology startup companies in Israel. She previously served on the ACRP European Conference Planning Committee and is currently a member of both the ACRP Education Committee and Global Conference Planning Committee.

 

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Lynn VanDermark, RN, BSN, MBA, RAC, CCRA, CEO and one of the founding partners of MedTrials, Inc., has a BS in Nursing from the University of Virginia and an MBA from Baylor University. She has held previous roles as a Senior Research Nurse, Clinical Research Associate and Consultant. Lynn is a registered nurse in the state of Texas, a Certified Clinical Research Associate, and is Regulatory Affairs Certified.

 

Lynn serves as adjunct faculty for the University of North Texas Health Science Center, is a member of the Association of Clinical Research Professionals, and is a past president of the North Texas chapter of ACRP. Lynn currently serves on the ACRP Education and Global Conference Planning Committees.

 

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Stephen Zalewski, PharmD, CCRC, is originally from Pennsylvania. He graduated from the Philadelphia College of Pharmacy (University of the Sciences at Philadelphia) with a Bachelor of Sciences in Pharmacy (1984). He later earned his Doctorate in Pharmacy from Nova Southeastern University (2000).

 

Dr. Zalewski has been a pharmacist for almost twenty-five years with fifteen years in clinical research. He has worked on Phase I-IV trials in academic, institutional and CRO settings. His pharmacy experience includes large and small hospital settings, retail settings, long-term care facilities and home infusion.

 

Dr. Zalewski has been a member of ACRP for several years and received his CCRC certification in 2002.

 

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APPI Program Working Group

Chair
Peter Rheinstein, MD, JD, MS,
President-Elect, Academy of Pharmaceutical Physicians and Investigators (APPI),
Consultant on drug regulatory and liability issues at Severn Health Solutions

 

Joseph Kwentus, MD,
President, Precise Research Centers

 

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

 

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Pharmaceutical Medicine Working Group

Chair
John Irvin, MD, PhD,
Physician Scientist/Healthcare Consultant

 

Co-Chair
Peter Stonier, PhD, FRCP, FRCPE, FFPM,
Director of Education & Training, Faculty of Pharmaceutical Medicine, Royal College of Physicians

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

 

Chris Allen, MD, FRCA, FFPM,
Merck & Co, Inc.

 

Prof. Fritz Bϋhler, MD,
Director, European Center for Pharmaceutical Medicine

 

Dina Jose, MD, CPI (HON),
Associate Dean, School of Clinical Research, American University of Health Sciences

 

Honorio Silva, MD,
President, Inter American Foundation for Clinical Research (IAFCR)

 

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