Central Labs 2007 Advisory Board

Biographies are listed below in alphabetical order.

Solomon Babani
Director, Contracts and Vendor Management
Celtic Pharma Development Services

Solomon has recently joined the Private Equity firm, Celtic Pharma as Director of Contracts and Vendor Management. In this capacity, Solomon is responsible for implementing and overseeing the entire outsourcing process and strategy for all functional and therapeutic areas at Celtic. Solomon began his career performing molecular biology experimentation as a Research Technician at the Albert Einstein School of Medicine (Bronx, NY). He made his way into industry, when he joined the biotechnology company Regeneron Pharmaceuticals (Tarrytown, NY), as a Research Associate. While at Regeneron, he transitioned out of the labs and into Clinical Research where he became the Manager of Clinical Finance. Solomon then made his move into Big Pharma, when he joined Pfizer, Inc. as Manager, Contracts and Outsourcing, where he supported Phase IIIB and IV clinical trials. Most recently, Solomon worked at Novartis Pharmaceuticals (East Hanover, NJ), as an Associate Director in the CRO Management group, where he managed the outsourcing of global Phase II – IV clinical studies in a variety of therapeutic areas. In addition, Solomon was responsible for the general oversight and strategy related to the outsourcing of centralized reading and collection of ECG data. Solomon holds a BA in Biology from Yeshiva University and an MBA in Finance and Management from New York University's Stern School of Business.

Annette Balog, BS, MBA
Vice President, Global Product and Account Management
QUINTILES LABORATORIES

Annette Balog has 20 years of experience in the healthcare industry. She began her career in sales with Stuart Pharmaceuticals, now AstraZeneca. She progressed through the organization in positions' that included sales management, product management, new product development, marketing, institutional sales and marketing and disease management. In 1998, Annette joined Quintiles Laboratories. She is currently the Sr. Director, Global Product and Account Management. In this role, she is responsible for global business development including strategic planning, sales, marketing, proposal development and contracting. Annette has a BS in Business Administration from California State Polytechnic University and an MBA from the University of Delaware.

Terri Binder, MS, DMD, PhD
Senior Scientist
AMGEN

Terri Binder, MS, DMD, PhD has been at Amgen Inc. since December 1997. She created her previous position of Medical Imaging Services Manager in May 2002. She is the primary technical liaison between Clinical Study Teams and Medical Imaging Service Providers, and was the primary coordinating author of an Amgen SOP and Technical Manual on Evaluation, Qualification, Selection, and Management of Technical Service Providers. Prior to May 2002, Dr. Binder was a Clinical Study Manager for trials that utilized medical imaging endpoints, and wrote an Amgen internal Guide to Managing Clinical Trials with Imaging Components. Before joining Amgen, Dr. Binder was a Clinical Manager at Block Drug Company, where she was responsible for clinical trials using digital subtraction radiography to assess oral bone loss. Terri received her BS from Cornell University, MS from Harvard School of Public Health, DMD from Harvard School of Dental Medicine, PhD in Immunology from University of Connecticut, and a Certificate of Periodontics from Columbia University School of Dental and Oral Surgery. Before her pharmaceutical industry career, she was an Assistant Professor at Columbia University School of Dental and Oral Surgery for four years, combining teaching and research, and practicing Periodontics in a private dental office one day a week. Terri is a member of DIA as well as several professional dental organizations

Agostino Fede, PhD, MBA
PPD

Agostino Fede, Ph.D., joined PPD in 2005 as senior vice president of global central labs. PPD's global central labs provide highly standardized efficacy and safety testing services with customized lab results databases for built-in flexibility for biopharmaceutical companies engaged in clinical drug development. With international experience in the biopharmaceuticals, diagnostics and medical device industries, Fede had previously served as vice president of operations and sales director for Covance Central Laboratories in Europe. He most recently served as chief executive officer and founder of vizyo s.a., a drug development informatics venture in Geneva, Switzerland, and has held management roles with C.R. Bard and the diagnostics division of Abbott Laboratories. Fede holds a master's and doctorate in molecular biology and biophysics from the Swiss Federal Institute of Technology and a master's in business administration from Ashridge.

Bruno Gagnon, B.Pharm., M.Sc.,
Senior Consultant
Biologics Consulting Group

Bruno Gagnon is a Senior Consultant with the Biologics Consulting Group, Inc. He creates powerful partnerships that enable his clients to optimize the way they execute their clinical trials. Through harmonization of best practices, standardization and process improvement, he builds an environment allowing project teams to successfully meet and exceed their goals. At Chiron Corporation (now Novartis), Bruno had leadership responsibility for five global functional areas within the BioPharma Development organization: Outsourcing and Contracts, SOPs & Training, Clinical Supply Chain Management, Medical Writing, Clinical Systems. Bruno has over 12 years of experience in Clinical Operations. He held positions of increasing responsibilities in the Big Pharma, CRO and Biotech sectors.

Gordon Kapke, PhD
Vice President Global Technical Affairs
COVANCE CENTRAL LABORATORY SERVICES

Dr. Kapke is Vice President of Global Technical Affairs and Chief Scientific Officer for Covance Central Laboratory Services. He has 14 years of experience in centralized clinical laboratory services in support of clinical trials. He has been a direct participant in launching and operating all Covance Central Laboratory global sites (Geneva, Sydney, and Singapore) and works closely with Covance Virtual Central Laboratory located in Zeist, Netherlands. He was conferred with an academic a ppointment as a visiting professor at Huashan Hospital, Fudan University, Shanghai, China in May 2006. Prior to accepting a position at Covance, Dr. Kapke spent 10 years at Orlando Regional Medical Center, Orlando, FL in technical and administrative positions. He 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 and 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
Associate Vice President, Program Management
ADNEXUS THERAPEUTICS

Craig H. Lipset brings over 13 years experience in the global development of biopharmaceutical products. He currently serves as Associate Vice President, Program Management at Adnexus Therapeutics, with responsibility for leading the company's novel protein therapeutics from the bench to the clinic, including all aspects of program management and partnerships. Mr. Lipset also serves as President of Critical Path Imaging, a consulting firm dedicated to improving the value and decreases the risk of medical imaging in drug development for pharmaceutical and biotechnology companies. He brings extensive experience in applying creative strategies and technologies towards accelerating clinical development.

David S. Lester, PhD
World Wide Clinical Technology
PGRD PFIZER

Dr. Lester is New York Site head of WorldWide Clinical Technology at PGRD. He received his BSc (Hons) from the University of New South Wales, Sydney, Australia, in 1977; an MSc from Hebrew University of Jerusalem, Israel, in 1979; and a PhD in Biological Sciences from Northwestern University in 1984. From 1983 to 1985, he completed a postdoctoral fellowship in Pharmacology from Harvard University Medical School. He then joined the faculty in 1985 of the Dept. of Membrane Research at the Weizmann Institute of Science in Israel. In 1990, he moved to the US and was a Visiting Scientist at the National Institute of Neurological Disorders and Stroke, National Institutes of Health. In 1993, he moved to the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration, where he held numerous positions until his departure in 2001. His final position at CDER was as the Associate Director and Senior Science Advisor of Office of Pharmaceutical Sciences. In 2001, he was appointed as Director of Clinical Technologies at Pharmacia Corp., until May 2003, where upon the acquisition of Pharmacia by Pfizer, he transferred to his present position. Research interests have included the incorporation of innovative technologies into clinical trials for the use of biomarkers or surrogate endpoints. Dr. Lester has an extensive publication record included five edited volumes. He is active in numerous professional societies and has a strong record in public science policy activities.

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. Hal Mann, Head, Global Central Laboratory Outsourcing, GLAXOSMITHKLINE Hal has been involved in Pharmaceutical Clinical Development field for more than 16 years with the last 14 of them with GlaxoSmithKline. Following a brief period as a Study Coordinator and then a CRS for a CRO Hal entered the GI Clinical Group in Glaxo's R&D organization. In 1998 Hal combined his clinical trials experience and his BS in Medical Technology to join the Global Resourcing, Grants and Contracts group at GSK to head up the outsourcing of Central Laboratory services and management of the relationships with related key suppliers. Hal has established formal supplier evaluations and various levels of relationship governance processes, practices and models for central laboratory suppliers and for the past 4 years, he has been involved in significant strategic and operational advancements in developing the partnership GSK and their primary central laboratory supplier, Quest Diagnostics Clinical Trials.

Hal Mann
Global Resourcing, Grants and Contracts
GLAXOSMITHKLINE

Scott Neff
Global Business Development
CORESEARCH

Scott Neff is responsible for Global Business Development at COResearch, the ECG Core Lab at Duke University. Scott has 18 years experience in the Pharmaceutical industry helping develop marketing and study execution programs for sponsors surrounding clinical drug development. Scotts experience has enabled multiple CRO's as well as Pharmaceutical and Biotech companies understand regulatory requirements, their application, and has helped plan strategies that have resulted in accelerating clinical drug development programs. Karen Petrie, Lab Data Manager, GENENTECH Karen Petrie is a Senior Laboratory Data Manager at Genentech. She has over 20 years experience in the pharmaceutical and biotechnology industries. With her education in the field of genetics, she began her career working as a molecular biologist at Syntex. After several years working in a laboratory, she then moved on to the field of clinical data management, where she now has over 10 years experience specializing in the area of laboratory data management for companies such as, Genentech, Roche and Syntex. Karen has been liaising with central laboratories since the early 1990's. During this time, she has developed various data processing and reporting systems to facilitate the management of both central and local laboratory data. Karen chaired the Oracle Clinical User Group, "Laboratory Data Handling Focus Group" for 4 ?_ years, and still remains an active member of that, and other Oracle Clinical Focus Groups.

Karen Petrie
Lab Data Manager
GENENTECH

Rajani Prasad
Vice President
CRL.MEDINET

Rajani Prasad, PhD, Vice President of CRL.Medinet Inc. 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.

Donald Rosen, MD
Founder, Chief Strategy Officer
RADPHARM

Dr. Rosen has practiced as a diagnostic radiologist in Princeton, N.J. since 1990. Prior to that he was in private practice in Orange County, CA. As a member of Princeton Radiology Associates he cofounded RadPharm in 1998. He has lectured at many Pharmaceutical and Oncology meetings about the uses of diagnostic imaging in Oncology clinical trials. He is on the board of the American Cancer Society and the Breast Cancer Resource Center in Princeton. He received his B.A. from the University of Pennsylvania and his M.D. from the University of Cincinnati. Anthony Santicerma, MS Director of Strategic Alliance and Global Marketing, Quest Diagnostics Anthony J. Santicerma, M.S., Director of Strategic Alliance and Global Marketing, Quest Diagnostics Clinical Trials. Tony has over 20 years of experience in the pharmaceutical and development services industries. He held positions in pre-clinical research, sales and marketing with Johnson & Johnson and in business development with Clinical Research Organizations (CROs). Tony holds an M.S. from Fairleigh Dickinson University and a B.A from East Stroudsburg University.

Lawrence Satin, MD
Chief Medical Officer
CARDIOCORE

Following his residency in internal medicine at Mount Sinai Hospital, New York, and a cardiology fellowship at Georgetown University, he founded the Washington Heart Institute in 1970 where he practiced clinical and nuclear cardiology for over 30 years. He has been active in pharmaceutical research since 1985 where he became the Director of Medical Affairs for the National Clinical Research Centers, Inc. In 1992 he founded Central Cardiac Testing one of the earliest core labs, and the first to employ ECGs by modem and 12-lead Holter recordings in clinical trials. In March, 2003, in response to the new FDA guidelines for cardiac safety, Dr. Satin created Cardiocore Lab, where he serves as Chairman of the Board and Chief Medical Officer. He chaired the 2005 DIA Conference session on Cardiac Safety and Definitive QT studies.

Scott Sawicki, MA
Associate Director, Global CRO Management
NOVARTIS PHARMACEUTICALS CORPORATION

Scott has over 12 years of clinical research and development experience across multiple therapeutic areas in several disciplines. Scott is currently an Associate Director in the Global CRO Management Group at Novartis Pharmaceuticals Corporation located in East Hanover, New Jersey managing phase I through IV master services agreements and developing and maintaining preferred provider relationships for central laboratory outsourced activities. Prior to joining Novartis, Scott was a Manager for 3.5 years in 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 working as a Clinical Supplies Liaison. Scott attended York College of Pennsylvania where he earned a B.A. in Speech Communications. Scott then completed his graduate studies at Temple University and earned a M.A. in Applied Communications. His graduate work focused on the study of human communication in personal and professional contexts (including negotiation, mediation, and alternative dispute resolution conflict processes) and 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 learning's in working closely with clinical teams and external service providers to cultivate business collaborations and ensure positive working relationships in the pharmaceutical industry.

Anthony Santicerma, MS
Director of Strategic Alliance and Global Marketing
QUEST DIAGNOSTICS

Cindi Schmittlein
Global Account Manager - ECG Suppliers
ASTRAZENECA

Cindi Schmittlein has over 10 years experience in the healthcare industry. This experience includes over 7 years on the supplier side at a management level and over 4 years on the sponsor side of clinical research and development. Cindi has been the Global Account Manager for ECG Suppliers at AstraZeneca Pharmaceuticals since 2003 and has been working in the ECG industry since 1999. As the Global Account Manager, Cindi is responsible for managing the ECG supplier relationships across AstraZeneca's business and developing strategic and technical solutions that support clinical trial work across all clinical functions. Cindi also represents Global Outsourcing on AstraZeneca's Global QT Review Committee. This committee is a multifunctional team that has experience, expertise, and interest in drug-induced effects on ventricular repolarization, the QT interval, and druginduced arrhythmias. Cindi has a BA from Mary Washington College in Fredericksburg, VA.

Susan T. Steen MT (ASCP)
Manager, External Data Coordination
BRISTOL-MYERS SQUIBB

Susan Steen is currently the Site Manager for the External Data Operation group for Bristol-Myers Squibb at their Hopewell, New Jersey facility. She has been with Bristol-Myers Squibb for 18 years. As a Data Manager for 14 years, she happily specialized in the review and editing of clinical laboratory data, volunteering to use her experience in clinical laboratory science to provide clean laboratory data in the support of DNA fillings. In recent years, she has managed an External Data group which is responsible for interacting with vendors of laboratory data, imaging data and every other sort of electronic data. The Electronic Data group provides participates in selection of vendors, provides specifications for transfer of data, received and loads the data and then is responsible for review and editing of all loaded electronic data.

Roberto Vaccaro
AMGEN

Current categories include Central Laboratories, ECG, Imaging, and IVRS Services. Roberto facilitates and leads cross-functional and cross-organizational sourcing initiatives in collaboration with other functional business units. He develops and implements sourcing strategies and negotiates strategic contracts. Prior to joining Merck in March, 2005, he worked at Wyeth Pharmaceuticals. Other previous employers include Rockwell Automation and Bayer. Roberto has an MBA from The American Graduate School of International Management, Thunderbird.

Nancy Widener
Global Director, Outsourcing Management
BRISTOL-MYERS SQUIBB

Nancy received her B.S and M.S. degrees from Michigan State University in Microbiology and Public Health and Clinical Laboratory Sciences. She has been involved in clinical research for over 20 years, first as a study coordinator at a busy infectious disease academic site and then in various positions within the pharmaceutical industry. Nancy started her pharma career at the Upjohn company in 1993 and was part of the Pharmacia & Upjohn, Pharmacia and Pfizer companies before joining Bristol-Myers Squibb. Nancy has been involved in outsourcing for 10 years and joined Bristol-Myers Squibb in early 2004 as Global Director of the Investigator Contracts and Outsourcing Management groups.