7th Annual Partnering with Central Labs, ECG and Imaging Core Labs

Advisory Board

Steve Asbury, Associate Clinical Diagnostic Services Consultant, ECG Coordinator, Eli Lilly & Company
Steve Asbury is employed by Eli Lilly & Company as the ECG Coordinator for the department of Clinical Diagnostic Services. Steve has worked in this department for the past eleven years. The first four years were dedicated to clinical laboratory support as the liaison between Lilly study teams and the central diagnostic service vendors, while the last seven years have been dedicated to the management of ECG data and vendors for Eli Lilly & Company. In the latter position his focus has been on implementing ECG processes at both Lilly and centralized ECG vendors while also growing the sponsor/ vendor relationship in an effort to gain a true partnership between the companies.

Solomon Babani, Director Outsource and Vendor Management, Celtic Pharmaceuticals

Tim Callahan, PhD, Chief Scientific Officer, Biomedical Systems
Dr. Timothy Callahan received his Ph.D. from Capella University in Interdisciplinary Studies with a concentration in Research Methodology. He has conducted research in Silent Myocardial Ischemia at the National Institutes of Health in Bethesda Maryland. Dr. Callahan has been in the research industry for approximately 21 years. An expert in diagnostic testing, he co-authored 2 patents in QT interval analysis and has authored many abstracts and publications. Dr. Callahan is a frequent speaker at Pharmaceutical Industry functions, including acting as the co-chair of the October, 2002 DIA "ECGs in Clinical Trials" meeting.

Gordon F Kapke, PhD, Senior Director, Biomarkers, COVANCE CENTRAL LABORATORY SERVICES
Dr. Kapke is Senior Director of Biomarker Services for Covance Central Laboratory Services (CCLS). Dr. Kapke joined Covance Central Laboratory Services in 1991 as a Laboratory Technical Director and has made key contributions including design and implementation of CCLS laboratories in Geneva, Sydney, Singapore and China. In China, Dr. Kapke also coached Huashon Hospital Clinical Laboratory in Shanghai to CAP accreditation.

Dr. Kapke’s scientific and laboratory operational experience has been instrumental in making Covance one of the world’s leading central laboratories. Dr. Kapke holds a B.S. degree in Chemistry from the University of Wisconsin and a Ph.D. in Chemistry from the University of Iowa. After graduate school, he accepted a position as a research scientist in the Department of Pharmacology, University of Iowa, followed by a clinical chemistry post-doctoral fellowship in the Department of Pathology, University of Iowa. Dr. Kapke is a Diplomat of the American Board of Clinical Chemistry and a Fellow, National Academy of Clinical Biochemistry.

Craig H. Lipset is Director of Molecular Medicine at Pfizer,
working from the company’s NY corporate headquarters. Craig’s 17 years of experience in drug development have included management positions within pharmaceutical, biotechnology, CRO, and technology companies. Prior to Pfizer, he served as Associate Vice President of Program Management at Adnexus Therapeutics. He brings extensive experience in applying creative strategies and appropriate technologies to clinical development.

Jeffrey Litwin, M.D. F.A.C.C, Chief Medical Officer Senior Vice President International Operations, eRESEARCHTECHNOLOGY
Dr. Litwin is a board certified Internist and Cardiologist. He is currently an Executive Vice President and the Chief Medical Officer for eResearchTechnology (eRT) which he joined in July, 2000. He is responsible for managing eRT’s cardiac safety operations and has provided consultative support to the Pharmaceutical Industry for the design and conduct of cardiac safety trials and to the Device Industry for the design of ECG and Holter technologies. Dr. Litwin left his cardiology practice in 1988 to serve as Director, Medical Affairs, Wyeth-Ayerst Laboratories. Prior to joining eRT, Dr. Litwin served as Executive Vice President and Chief Operating Officer of Executive Health Group, the nation’s leading provider of executive physical examinations. Dr. Litwin has also served as Deputy Medical Director of Nutri/System; and as a consultant to Schlumberger Ltd., and the American and National League of Professional Baseball Clubs.

James Paskavitz, MD, Medical Director, Perceptive Informatics
is a Behavioral Neurologist with functional neuroimaging expertise and 10 years of clinical and research experience. Prior to joining Perceptive, Dr. Paskavitz started laboratories for Human Brain Mapping at the University of Colorado and University of Massachusetts using functional MRI to study the physiologic underpinnings of human cognitive and motor control. His imaging research extended into studying the compensatory physiology of disease states, including Alzheimer's disease, multiple sclerosis, stroke, and amyotrophic lateral sclerosis. He has published his Alzheimer’s and imaging research in peer reviewed journals and has presented at many national and international meetings including the upcoming International Conference On Alzheimer’s Disease 2008 in Chicago this July and Human Brain Mapping 2008 in Australia this June.

As a practicing neurologist, his clinical expertise was concentrated in Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and movement disorders. He had one of the largest dementia and movement disorder practices in the northeastern United States. Dr. Paskavitz has done clinical and imaging consultative work with several of the world's largest pharmaceutical companies. He received his MD from the University of Massachusetts Medical School then completed a Neurology residency and Behavioral Neurology fellowship at the University of Colorado before returning as faculty to University of Massachusetts Memorial Healthcare in Worcester, MA. He is a member of the American Academy of Neurology (AAN), a member of the Organization for Human Brain Mapping (OHBM) and board certified by American Board of Psychiatry and Neurology (ABPN).

Rajani Prasad, PhD, Vice President, Clinical Research, Clinical Reference Laboratory Global Services
Rajani Prasad, PhD, Vice President of Clinical Reference Laboratory Global Services. Established the clinical trial division in 1991 with previous experience in clinical trial management and analytical laboratory set-up. Dr. Prasad received her Master’s in Organic Chemistry from S.U.N.Y., New York followed by her Ph.D. in Biochemistry from the University of Kansas Medical Center, and has been published in numerous scientific publications over the years.

Anthony J. Santicerma, MS, Director of Global Marketing, Quest Diagnostics Clinical Trials
Anthony J. Santicerma, M.S., Director of Global Marketing, Quest Diagnostics Clinical Trials. Tony has over 25 years of experience in the pharmaceutical and diagnostics industries, primarily with Johnson & Johnson, Clinical Research Organizations (CROs) and Quest Diagnostics. His functional responsibilities ranged from research scientist in pre-clinical pharmacology and toxicology to sales & marketing management roles encompassing all phases of clinical research & development (Phase I to Phase IV). Tony's current role is to lead global strategic marketing initiatives for Quest Diagnostics Clinical Trials. He holds an M.S. from Fairleigh Dickinson University and a B.A from East Stroudsburg University.

Lawrence Satin, MD, Chief Medical Officer, CARDIOCORE
With 40 years of distinguished experience, Lawrence Satin is one of the world’s leading research cardiologists. He is an internationally recognized thought leader and consultant for cardiac safety testing in clinical trials. Early in his career, Dr. Satin worked with Dr. Norman Holter (inventor of the Holter monitor) analyzing NASA astronauts’ cardiac responses. In 1992, he helped pioneer the cardiac testing industry, founding one of the first cardiac core labs. He was first to deploy digital 12-lead Holters in clinical trials, first to record hi-fidelity Holter data in a Thorough QT (TQT) study, first to apply cardiograph barcode scanning, and first to provide a GCP-complaint method for the digital transfer of Holter data. In the 1980s, Dr. Satin was Director of Medical Affairs for National Clinical Research Centers, and served as principal investigator for complex cardiovascular studies. He also founded the Washington Heart Institute, a preeminent cardiac diagnostic center, and he served as Chief of Cardiology at two Washington area hospitals. Today, Dr. Satin is the Chief Medical Officer of Cardiocore, a premier provider of ECG, Holter and echocardiography services in clinical trials.”

Scott Sawicki, MA, Section Head, Central Laboratory & Diagnostic Services, CRO Management, Novartis Pharmaceuticals Corporation
Scott has over 14 years of clinical development and outsourcing experience across several disciplines in multiple therapeutic areas. Scott currently serves as the Section Head of Central Laboratory & Diagnostic Services in the Global CRO Management Group at Novartis Pharmaceuticals Corporation in East Hanover, New Jersey. Scott manages the partnerships and outsourcing strategy with central laboratory and diagnostic service providers (which include Cardiac Safety and Imaging services). Prior to joining Novartis, Scott was a Contract Manager for 3.5 years in the Outsourcing Management group at Aventis and worked an additional 2.5 years with Aventis’ predecessor company, Rhone-Poulenc Rorer in the Global Pharmaceutical Development group as a Clinical Supplies Liaison. Scott has a Bachelor of Arts in Speech Communications from York College of Pennsylvania and a Master of Arts in Applied Communications from Temple University. His graduate work focused on the study of human communication in personal and professional contexts, including negotiation, mediation, and alternative dispute resolution conflict methods.

His studies also included the functional nature of communication and the way that communication can be problematic in social, professional, group, and organizational settings. Scott has been able to apply his skills working closely with clinical teams and external service providers to cultivate business collaborations and ensure the development of positive working relationships in the pharmaceutical industry Research Laboratories Division as a Program Coordinator conducting vaccine clinical trials. Diane moved on to a sourcing role occupying positions, developing/ negotiating/managing: contracts with laboratories, diagnostics and CROs, master service agreements, academic agreements, the sourcing of centralized services for laboratory, diagnostic and imaging vendors. She currently leads a group of sourcing managers who chair multidisciplined, expert teams who manage scientific/ operational issues with vendors, change control and the ongoing oversight of outsource relationships for centralized laboratory, diagnostic and imaging vendors for the Merck Research Laboratories Division. The group also serves as liasons between clinical research and procurement developing program and study specific specifications for responsible for facilitating the development of the business requirements and strategy execution for all outsourcing of scientific based work.

Diane L. Stinson, Associate Director, Development Outsourcing, Merck & Co., Inc.
Diane is an Associate Director of Outsourcing in the External Services department of Merck& Co., Inc. supporting the sourcing of services for multiple phases of clinical trial development. Experience includes 10 years of practical experience in a clinical hospital laboratory and 16 years in the pharmaceutical industry. Prior to joining Merck &Co. Inc., Diane managed the Clinical Chemistry, Immunology and Serology departments at Graduate Hospital in Philadelphia, PA. She holds a Bachelor of Science Degree in Microbiology, certification as a Medical Technologist, ASCP, and an MBA in Financial Management. She began her career at Merck & Co., Inc. as a Quality Control Inspector then as an Auditor in the Manufacturing Division, moving then to the Merck

Stephanie Talbott, Vice President Global Business Development, ICON Central Laboratories Stephanie joined ICON Central Laboratories
in 2001 where she served as Director of Business Development and Vice President of North American Sales before assuming her current global executive responsibilities in early 2006. Prior to joining ICON, she was Director of Clinical Sales for North America at Covance Inc., where she also held the position of Director of Sales for Specialty Services. In addition, Ms. Talbott served as Associate Director of Research and Regulatory Services at Premier Research Worldwide, Director of Business Development for NDA Clinical Trial Services and General Manager for Pharmaceutical Laboratory Services, Inc., where she also served as the Director of Corporate Accounts. She holds a Bachelor of Science degree in Medical Technology from the University of Cincinnati and is MT(ASCP) certified.

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