Donna W. Dorozinsky, RN, MSN, CCRC President
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Donna is a business consultant who has over 20 years of experience in clinical research with a strong focus in Phase I operations. Her energy and enthusiasm strikes a balance with her in depth knowledge of clinical research operations and Good Clinical Practice, and experience in project management. She began her career in clinical research at GlaxoSmithKline where she spent 15 years in Phase I Clinical Research Operations. In 2005 Donna founded DWD & Associates. In her capacity as President, she has led several large projects performing operational assessments and implementing process improvement initiatives for sponsors, CROs and clinical sites. She is an experienced auditor and has expertise in SOP development for both investigator and sponsor organizations. She has experience in Pre Approval Inspection readiness and has assisted organizations in developing and executing Corrective Action Preventative Action Plans in response to both regulatory inspections and sponsor audits. She has led the implementation of eSource systems in Phase I and has expertise in clinical validation of these systems. She has also assisted several organizations in developing and expanding their Phase I operations.
Donna has presented numerous training programs in topics of GCP compliance, Phase I Operations, and process standardization; and is a dynamic educator. She has served as adjunct faculty for Drexel University College of Medicine. Donna is currently President of the Association of Clinical Pharmacology Unit. Donna was a contributing author to Principles of Good Clinical Practice and the lead author on the recent revisions to the ACPU Guidelines and Recommendations for Conducting Phase I Studies. She has a Masters in Nursing from Widener University and is a Certified Clinical Research Coordinator.
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Angela Baker, MHA
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Angela C. Baker, has worked in various capacities of the early clinical research industry for more than 16 years and is Senior Director of Business Development for CRI Lifetree, a specialized research organization with clinical pharmacology units in Salt Lake City, UT, Philadelphia, PA and Marlton, NJ. She has a Master’s degree in Health Administration from the University of Southern Indiana. Prior to joining Lifetree, Angela was Senior Director for Business Development at Comprehensive Clinical Development (formerly Comprehensive Phase One®) in Miramar, FL for nearly six years and Senior Director for Business Development & Marketing at West Pharmaceutical Services GFI in Evansville, IN since 1996, where she was a member of the executive management team and directed recruitment and enrollment, budgets and contracts, information technology and marketing/business development for the company.
Angela led the ACPU Annual Meeting Planning Committee, held in October 2010 in Cincinnati, OH, and is currently leading the Programming Committee for 2012 Annual Meeting to be hosted by National Institutes of Health (NIH) Clinical Center in Bethesda in April 2012. Angela was a founding Member of the Initiative for Phase I Excellence in 2005 and worked with the core team to develop application to Drug Information Association (DIA) for Clinical Pharmacology/Phase I Special Interest Area Committee (SIAC) which was approved in October 2008. She currently serves on the Core Committee for the DIA Clinical Pharmacology/Phase I SIAC and is President-elect for ACPU.
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Howard E. Greenberg, MD, FCP
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Howard E. Greenberg, MD, FCP has been an investigator on over 130 early phase clinical trials, and coauthored over 40 peer-reviewed papers and 30 abstracts and presentations. He’s Adjunct Associate Professor, Department of Pharmacology & Experimental Therapeutics at Thomas Jefferson University in Philadelphia, PA. Dr. Greenberg served as Senior Medical Director of Clinilabs’s Clinical Research Unit, and Group Medical Director of the Bristol-Myers Squibb CRU. He has served on Institutional Review Boards, Data Safety Monitoring Boards, Pharmacy and Therapeutics committees; and held or holds leadership positions in several professional societies (ACCP, ACPU, ASCPT, DIA, USP) dealing with drug development and safety.
Dr. Greenberg received his B.S. in Chemical Engineering from Cornell University, M.S.E. in Chemical Engineering from the University of Pennsylvania, M.B.A. in Finance and Planning from Drexel University, and M.D. from Jefferson Medical College. He completed training in Internal Medicine at Lankenau Hospital and Clinical Pharmacology at Thomas Jefferson University prior to joining the faculty in 1997. He resides in Yardley, PA with his wife Joanne and dog Bosco. He is a Big Brother to 14 year old Spencer, and serves on the Board of Cornell Club of Greater Philadelphia as well as the Cornell Council, and the Board of Trustees of Men Mentoring Men.
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Royce Morrison, MD, CPI
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Royce Morrison, MD, CPI is Chief Medical Officer for Comprehensive Clinical Development. Sited at the Miramar, FL company’s Tacoma, WA CPU, he has served PI for early-phase studies since 2002. He led development of capabilities in cardiac safety and radiolabeled studies. With colleagues at Comprehensive’s three early-phase sites, he provides strategic and protocol design consultation.Dr. Morrison earned BS and MS degrees in electrical engineering, then MD, at Stanford University. He practiced consultative and primary care internal medicine in private practice and HMO settings, emphasizing geriatrics and HIV/AIDS care. For Group Health Cooperative, he participated in evidence review, guidelines development, formulary decisions and contractual coverage determinations. After cofounding a venture-financed consumer health information company, he joined Northwest Kinetics, which became a leader among single-site clinical pharmacology units and was acquired by Charles River, then Comprehensive Clinical Development.
A member of the ACPU Board since 2010 and contributor to recent Bylaws revision, Dr. Morrison also participates in ACCP, DIA and its Clinical Pharmacology SIAC Core Committee, ASCPT, American College of Physicians/American Society of Internal Medicine, Academy of Pharmaceutical Physicians and Investigators (Certified Physician Investigator), American Society of Clinical Oncology, and is Past President of the Northwest Association for Biomedical Research.
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Patrick Ayd, BSN, MBA
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Mr. Ayd has worked in the pharmaceutical industry for more than 13 years. Currently, Mr. Ayd is the President and Chief Operating Officer at SNBL-CPC a 96 inpatient bed Early Clinical Pharmacology center in Baltimore. Prior to joining SNBL-CPC, Mr. Ayd was president and CEO of ClinPharm Network, a clinical operations and quality assurance consulting firm, specializing in developing Continuous Quality Improvement (CQI) programs and working with small Pharma and Bio-Tech companies to help design their early phase clinical trials and to choose an appropriate facility to conduct those trials. Mr. Ayd is an accomplished GCP auditor and presenter that has conducted GCP ”mock FDA” audits both in the US and internationally.
Mr. Ayd joined the clinical pharmacology industry in 1998 as the Clinical Director of Pharmakinetics. In 2000, Mr. Ayd joined Parexel International where he designed and managed the company’s North American Phase I clinical research facility. In 2005, he designed and managed the construction of SNBL-CPC’s clinical facility, a 96-bed Phase I unit. From there, Mr. Ayd joined BASi, as Executive Director of Clinical Research he developed a program to conduct “First in Human” clinical trials. Mr. Ayd received his Bachelor’s degree in Nursing from University of Maryland, his MBA from Loyola University’s Selinger School of Business.
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Walter Kraft, MD
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Walter Kraft is Director of the Clinical Research Unit (CRU) located in Thomas Jefferson University Hospital. He holds Associate Professor appointments in the Departments of Pharmacology and Experimental Therapeutics, Medicine, and Surgery at Jefferson Medical College. Dr. Kraft has a research interest in early Phase 1 clinical trials in healthy volunteers and patient populations. He has served as investigator in industry or federally funded research protocols across a variety of therapeutic areas. He also leads a NIDA-funded clinical research effort in identifying novel treatments for the Neonatal Abstinence Syndrome. In addition to teaching responsibilities in the Medical and Graduate schools, he directs the Jefferson Program in Human Investigation. This is a comprehensive curriculum to train the physician scientists is clinical research methods. He is a trustee of the American Board of Clinical Pharmacology, an active member of the American Society of Clinical Pharmacology and Therapeutics, and serves as vice-chair of a Jefferson institutional review board. Dr. Kraft is a board certified internist and maintains a clinical practice that specializes in the treatment of complex venous thrombotic and vascular diseases.
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Randall Stoltz, MD
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Dr. Stoltz is the Medical Director for an 80 bed, state of the art, Covance phase 1 CRU in Evansville, Indiana. He has worked at the unit for over 20 years and has been an investigator in over 500 studies. He has been the chairman of the CPI ( Certified Physician Investigator) test development committee for ACRP-APPI for the past 4 years. He is Board Certified in Family Medicine. He provides medical/scientific consultation for clients in protocol design and safety for early stage clinical development. In addition he oversees the medical staff at the site and helps give direction in research at the site.
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William B. Smith, MD, FACC
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William B. Smith, MD, FACC, is currently a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. He is board certified in Nephrology, Internal Medicine and Cardiology with prior board certification in Critical Care Medicine.
Dr Smith is the President of New Orleans Center for Clinical Research and Volunteer Research Group located within the University of Tennessee Medical Center.Dr Smith has been involved as a Principal Investigator in over 1800 clinical research studies to include first-in-man, cardiac disease, renal/hepatic disease, healthy volunteers, diabetes, numerous vaccines, women’s health, HSDD, obesity, Parkinsons, Alzheimers, Multiple Sclerosis, and smoking cessation.
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