Meet our speakers
Executive Partner, ,
HealthCare Global (Oncology) Enterprises Inc & Triesta Sciences, Bangalore
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Director Outsourcing & Vendor Management,
Celtic Pharma
Solomon joined Celtic Pharma Development Services (CPDS) in August, 2006 as Director of Outsourcing and Vendor Management. In this capacity, Solomon is responsible for implementing and overseeing the entire outsourcing process and strategy for all functions (pre-clinical, clinical, regulatory, manufacturing, etc.) within CPDS. In addition, Solomon is responsible for continuing to cultivate and build relationships with all of the vendors working with CPDS. Solomon began his career as a Research Technician at the Albert Einstein School of Medicine. He made his way into industry, when he joined the biotechnology company Regeneron Pharmaceuticals, 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, as Manager, Contracts and Outsourcing, where he supported Phase IIIB and IV clinical trials. Prior to his current position, Solomon worked at Novartis Pharmaceuticals, 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. 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.
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R&D QA Unit Manager,
AstraZeneca
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Director Global Clinical Outsourcing,
AstraZeneca
Janet is responsible for Global Clinical Outsourcing in AstraZeneca, which involves setting the strategy, defining new operating models for outsourcing and ensuring operational delivery for all outsourced clinical work. Janet joined AstraZeneca in 2001, initially as Clinical Development Director for Emerging Oncology Clinical Project Teams and then as line manager of the clinical project leaders within AP clinical. Prior to AstraZeneca, she worked in several pharmaceutical companies and a CRO in a variety of project leadership and project and line management roles. Following her MBA, Janet worked as a management consultant delivering innovative business solutions on numerous projects along the pharmaceutical value chain to several Pharma clients. In addition to the MBA, she has a Batchelor of Science degree and is also a Chartered Member of CIPD.
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Executive Director Clinical Research Operations US,
Merck
Dr. Mark Evans is Executive Director of Global Trial Execution, Clinical Research Operations, Merck Research Laboratories. In this role he is responsible for the conduct of Merck's global clinical research studies and is business owner of associated clinical trial management systems and technology. Dr. Evans joined Merck's Australian subsidiary in 1983 as a Clinical Research Associate. In a career that has spanned 25 years with the company he has held various positions of increasing responsibility in Merck's Research Laboratories including Associate Director, Clinical Research Operations, Middle East, Africa, Asia Pacific and Canada; Senior Director, Clinical Research Operations US; Executive Director, Clinical Research Operations US and Latin America; and Regional Medical Director, Mid European Region. Throughout his career at Merck Dr. Evans has been involved in numerous process improvement and optimization initiatives. Most recently he was co-lead of the clinical study site management workstream of Merck's late clinical development transformation initiative. Currently, Dr. Evans is leading the Global Resource Alignment Project that is defining and implementing a clinical research resource optimization strategy for company's global medical organization.
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President and CEO,
Research Point
John Farinacci is well-known and well-respected throughout the pharmaceutical, biotech and CRO industries, with a proven record of start-up, turnaround and enduring business successes. Prior to founding ResearchPoint, Farinacci served as Executive Vice President of Quintiles Transnational Corporation, where he provided key leadership in acquisitions and integrations, helping Quintiles to become the CRO industry's market leader. Previously, Farinacci served as President and Chief Operating Officer and held various other senior executive positions at Pharmaco (currently PPD). During his tenure there, Farinacci played a pivotal role in moving Pharmaco to the second largest CRO in the industry. Farinacci also worked with Sterling Drug earlier on in his career. He earned his degree in Biology/Chemistry at New York's Russell Sage College.
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Director Merck Kforce Alliance,
Kforce
Michele Ingram graduated from University of California, Santa Barbara with a bachelor's in Communication Studies in 1991. In 1993, Michele became involved in clinical research. Over the years, she has held positions as a Clinical Research Associate, Regional CRA Manager, and Associate Director. In early 2003, Michele began working on the Merck-Kforce Alliance. Currently, Michele is the Director of the Merck-Kforce Alliance, a team of 100 clinical research professionals. She has responsibility for oversight of the management team as well as for the overall success of the Alliance. Michele serves as the key business contact with Merck.
Michele resides in Phoenix, Arizona, where she lives with her husband and three children.
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Dr. Kaitin is the Director of the Tufts Center for the Study of Drug Development, an academic drug policy research group providing strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of the drug development process. He is also Professor of Medicine at Tufts University School of Medicine, and he serves on the faculty of the European Center for Pharmaceutical Medicine at the University of Basel. Dr. Kaitin publishes extensively on the factors that contribute to the slow pace and high cost of pharmaceutical R&D, and he has provided public testimony before the U.S. Congress on drug development, regulation, and policy issues. Dr. Kaitin is an internationally recognized expert on the science of drug development, and he is frequently quoted in the business and trade press on R&D trends in the research-based pharmaceutical and biotechnology industries. Dr. Kaitin is a former President of the Drug Information Association and Editor-in-Chief of the Drug Information Journal, and he serves on the editorial boards of the American Journal of Therapeutics, Clinical Research and Regulatory Affairs, Drug Information Journal, Drug Discovery and Development, and the Food and Drug Letter. Dr. Kaitin also serves on the Boards of Directors of two publicly held companies, Curis Pharmaceuticals, Inc. and Phase Forward, Inc., and the privately held company Bio-Tree Systems, Inc. Dr. Kaitin received a B.S. from Cornell University and an M.S. and Ph.D. in pharmacology from the University of Rochester.
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Vice President Global Clinical Strategic Resourcing,
Wyeth
Dianne Kikta received her PhD in Medical Sciences, with an emphasis in Physiology and Pharmacology, from the University of South Florida, College of Medicine, in 1979. She completed a National Institutes of Health-funded post-doctoral fellowship at the University of Florida, College of Medicine, in Cardiovascular and Endocrine Physiology, in 1983 and then continued her academic career as a Research Scientist at the Bockus Research Institute, at the Graduate Hospital of the University of Pennsylvania. Dr. Kikta was also an Adjunct Assistant Professor in the Department of Physiology at the University of Pennsylvania, College of Medicine. In 2000, Dr. Kikta obtained an MBA from Villanova University, College of Commerce and Finance. In 1988, Dr. Kikta left academia and joined Wyeth Research as a Clinical Writer. She has held positions of increasing responsibility, and is currently Vice President, Global Clinical Strategic Resourcing at Wyeth. In this capacity, she is responsible for providing strategic oversight of opportunities for flexible resourcing for the clinical organization to meet objectives efficiently, especially through offshoring and outsourcing. Throughout her professional career, Dr. Kikta has been involved in innovation and change initiatives. At Wyeth, specifically, she has been involved in some capacity with most change initiatives within the clinical research organization over the past 10+ years—most recently as the sponsor for an initiative to determine how to work more effectively 24/7. Through this initiative, a novel approach to expanding into India, allowing the clinical organization to achieve more in a 24-hour period and thus eliminating significant bottlenecks in the clinical development process was implemented through a successful partnership.
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Contractor in Clinical Operations,
Idenix
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Director, Cardiovascular & Metabolics Global Development & Medical Affairs,
Bristol Myers Squibb, Asia-Pacific Region
Vinod K Mattoo
Director Cardiovascular & Metabolics
Global Development and Medical Affairs
Bristol-Myers Squibb Company
Asia-Pacific Region
Singapore
B I O G R A P H Y
Dr. Mattoo completed his MB (medical graduation) from Medical College, Srinagar, India. He did post-graduate fellowship in internal medicine at Postgraduate Institute of Medical Sciences, Chandigarh and also received his post-doctoral fellowship in endocrinology and metabolism at the same university.
Previously, he was with the Faculty of Medicine and Endocrinology, Institute of Medical Sciences, Srinagar, India (1983-1990) as Associate Professor of Medicine and Endocrinology. From 1990 to 1993, he was Medical Advisor at Wockhardt Pharmaceuticals at Bombay, India with responsibility for clinical research in diabetes, metabolism and nutrition.
Dr Mattoo joined Eli Lilly and Company as Medical Director of India in 1993 to start Lilly Clinical Research department at New Delhi. He also was the Lilly Clinical Research Physician (Diabetes) for Asia Pacific Region.
In 2002, Dr Mattoo moved to the corporate center of Eli Lilly and Company at Indianapolis, USA as Senior Clinical Research Physician and Medical Advisor, Global Diabetes Care, Eli Lilly and Company with responsibility for outside US countries primarily Asia and Eastern Europe. He returned to India in July 2005 as Chief Scientific Officer, India to head the medical function at Eli Lilly & Company, India where his primary responsibility has been expansion of Lilly Clinical Research activities in India across therapeutic areas of diabetes, bone, growth, oncology and intensive care.
Currently, Dr. Mattoo is Director, cardiovascular and metabolic products for Bristol-Myers Squibb for their Asia-Pacific Region based at Singapore. He has published over 30 papers on diabetes and endocrinology and has been an invited speaker at several international conferences on endocrinology and on clinical research opportunities in Asia.
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Practical Leader, Product Development and Commercialization,
Quintiles Consulting
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National Director, AWARE for All,
Center for Information & Study on Clinical Research Participation (CISCRP)
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Assoc. Dir. Clinical Study Planning & Resourcing Global Clinical Program and Resource Management,
Bayer Healthcare Pharmaceuticals
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Senior Strategic Sourcing Director,
Shire Pharmaceuticals
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Global Strategic Sourcing Leader,
Pricewaterhouse Cooper
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Global Head CQA External Alliances,
F. Hoffman La Roche Ltd
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Vice President, Clinical Operations,
ARIAD Pharmaceuticals, Inc.
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Counsel,,
Pillsbury Winthrop Shaw Pittman LLP
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Vice President, Medical Safety - Global Medical Affairs & Pharmacovigilance,
Bristol-Myers Squibb
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Director, Clinical Research and Operations,
Maxygen, Inc.
Dr. Ruskin has developed over 50 clinical protocols ranging from first-in-human studies to global Phase III and IV trials in a wide array of therapeutic areas such as vaccines, oncologic and cardiovascular medications, orphan drugs, MRSA antibiotics, neonatal medical devices, and many others. Budgets have ranged from $100,000 for start-up ventures to many well over $20M. As a global lead from both the sponsor company and the large CRO perspective, as well as working with many smaller vendors, he has the unique perspective of partnering needs from both sides and from various sized companies. Dr. Ruskin received his veterinary medicine degree from Kansas State University and went on to a combined MPH/PhD program in Epidemiology from Emory. He worked at the CDC restructuring the National Reportable Infectious Disease database, worked on some of the early stage HIV trials, was appointed to an FDA Advisory Committee for radiologic health, and is a leading industry speaker in the areas of sound, efficient, and cost effective study design methodologies. He has worked closely with many partner companies throughout the years to assist them in providing solutions for sponsor company needs.
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Global Head of Sourcing Management,
Grunenthal
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Vice Preseident Enterprise Transformation Unit,
Quintiles
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Sourcing Group Manager,,
GLAXOSMITHKLINE
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Managing Director - Healthcare Equity Research,
Jefferies & Company, Inc.
Dave Windley is a managing director in the Equity Research Group of Jefferies & Company. He was a founding member of Jefferies’ Healthcare Research team in August 2000. Dave follows companies in the pharmaceutical services and specialty pharmaceutical sectors. Prior to joining Jefferies, Dave was a senior analyst at J.C. Bradford & Co. from 1998 to 2000, and a member of the healthcare industry team at Coopers & Lybrand, LLP from 1992-1995.
Mr. Windley earned his MBA from the Owen School at Vanderbilt University, and his BA from Transylvania University. Dave is a chartered financial analyst, certified public accountant and a four-time Wall Street Journal Best on the Street selection.
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Leader, Emerging Markets and Services,
BBK Worldwide
Linda drives the development of emerging markets and services for BBK Worldwide in support of the firm’s leadership position in global patient recruitment. She spearheads the expansion of the BBK Worldwide Alliance, a network of industry-leading service companies that support BBK’s patient recruitment and retention capabilities worldwide. She identifies, trains, and maintains relationships with these key strategic partners to ensure enrollment excellence for BBK’s clients conducting critical and complex multi-country, multicenter clinical trials.
Linda has been instrumental in developing other BBK innovations, including Good Recruitment Practice (GRP) and BBK’s cultural adaptation services. An engaging trainer and speaker, she also leads workshops at investigator meetings and represents BBK at leading industry conferences, including those sponsored by the Drug Information Association (DIA) and the Center for Business Intelligence, at which she interprets the latest knowledge from BBK for colleagues worldwide. She has also been published in trade publications such as DTC Perspectives and Good Clinical Practice Journal (GCPj).
Linda has eight years of experience in patient recruitment, and 17 years of experience in the healthcare, communications, and environmental science fields. Previously at BBK, Linda led account teams as a senior campaign manager, ensuring that client business and enrollment objectives were met on time and on budget. She also served as a senior communications consultant, directing messaging and content for client patient recruitment campaigns. Before joining BBK, she worked in both the corporate and nonprofit arenas as a writer, editor, and project manager. Linda has a bachelor’s degree in environmental studies from the University of Maine at Fort Kent, and a master’s degree in technical and science communication from Drexel University.
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Head of In- and Outsourcing,
Orion Pharma Clinical R&D
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President and Author of Pharmaceutical Metrics,
Customized Improvement Strategies
Dave Zuckerman is president of Customized Improvement Strategies LLC, a consulting firm that supports clients in teambuilding, process-streamlining and organizational change. He holds engineering degrees from Princeton and Washington Universities and has 25 years experience helping organizations find new ways to tackle difficult problems.
Dave is working with a number of pharmaceutical and CRO clients to help them measure, streamline and optimize pharma-CRO partnering. He has authored multiple articles on clinical operations, protocol optimization, metrics, and CRO partnering and is the author of the book "Pharmaceutical Metrics" from Gower Press.
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Reserve an exhibition stand at the Clinical Outsourcing World Americas exhibition - book early to ensure optimum stand placement!
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