Re-engineering Clinical Trials - Speaker Bios May 12, 2015 at the Hyatt Regency, Washington D.C Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution. Kenneth Getz, MBA Director of Sponsored Research Programs & Research Associate Professor, Tufts CSDD Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch in 1994, Ken worked for over seven years in management consulting where he assisted biopharmaceutical companies develop and implement business strategies to improve clinical development performance. Robert M. Califf, MD, MACC, is Deputy Commissioner for Medical Products and Tobacco for the U.S. Food and Drug Administration. Appointed in February 2015, Dr. Califf provides executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. He also oversees the Office of Special Medical Programs and provides direction for cross-cutting clinical, scientific and regulatory initiatives, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system. Dr. Robert M. Califf, MD Deputy Commissioner for Medical Products & Tobacco, US Food and Drug Administration He attended Duke both as an undergraduate and for medical school, completing his residency at UCSF before returning to Duke for a cardiology fellowship. Dr. Califf served as the Donald F. Fortin, MD, Professor of Cardiology at Duke and most recently, Vice Chancellor for Clinical and Translational Research. An international leader in cardiovascular medicine, health outcomes, healthcare quality, and medical economics, he is recognized by the Institute for Scientific Information as one of the top 10 most cited medical authors, with more than 1,200 peer-reviewed publications. Dr. Califf co-chaired the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke and the FDA to identify and promote practices that will increase the quality and efficiency of clinical trials. He also served as co-principal investigator of Duke’s Clinical and Translational Science Award, funded by the NCATS; principal investigator for the coordinating center of the NIH Health Care Systems Research Collaboratory, a Common Fund program that develops, tests, and disseminates innovative methodologies for pragmatic clinical research; and co-principal investigator for the Baseline Study, a collaboration among Duke, Stanford, and Google that seeks new understandings of states of health and disease in humans. Re-engineering Clinical Trials - Speaker Bios May 12, 2015 at the Hyatt Regency, Washington D.C Professor Brendan Buckley is Chief Medical Officer and Executive Vice President of ICON plc a global clinical research organisation and leading provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. He is a co-founder of Firecrest Clinical, now an ICON company. He is Honorary Clinical Professor of Medicine and Pharmacology at the School of Medicine and Health, University College Cork, Ireland. A medical graduate of the National University of Ireland and doctoral graduate in Biochemistry of Oxford University, he has over 35 years experience in clinical research in collaboration with industry. He worked for over 35 years as a senior academic physician in internal medicine with a specialist expertise in Diabetes and Endocrinology and he also directed several large clinical biochemistry departments in a number of hospitals in the UK and Ireland during this time. Professor Brendan Buckley, MD, DPhil FRCPI Chief Medical Officer ICON plc Prior to joining ICON, he was a member of the Board of Directors of the Irish Medicines Board (now the Health Products Regulatory Authority), the national competent authority for Ireland, 2004-2011. He was a member of the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) from 2000-2003 and a member of the EMA Scientific Advisory Group on Diabetes and Metabolism until 2011. He has taught on a series of advanced courses for the FDA’s Office of Orphan Products Development (OOPD) and NIH’s Office of Rare Diseases Research (ORDR). He has been a coordinating Principal Investigator and member of steering committees for a number of very large trials in cardiology and metabolism. He chairs of a number of independent Data and Safety Monitoring Boards in large cardiometabolic and in complex orphan disease trials. Peter Schüler, MD, is board certified in Neurology and in Pharmaceutical Medicine (2001; Swiss Medical Association). He started is professional career in 1987 at the Medical Imaging Application Center of Siemens AG Medical Solutions. Later the same year he joined the Department of Experimental Neuropsychiatry of the Neurological University Hospital Erlangen, Germany. During the coming 8 years he was involved in basic and clinical CNS research. He held the position of Secretary General of the German section of the International League Against Epilepsy (ILAE; 1991-1995) and was awarded with the Alfred-Hauptman epilepsy prize and ILAE Young Investigator Award. In 1995 he joined Pharmacia as Head of Medical Affairs. In that period he also participated in the launch of two NCEs in the indications Parkinson’s and Major Depression. In October 2000 he moved into the CRO business, joining ICON in 2007, now in the function of Senior VP for Medical & Safety Services. He oversees all MDs, Safety and System Associates, and administrative support staff, in total over 350 people located in 12 offices across the globe. Dr. Peter Schüler, MD Senior VP Medical and Safety Services ICON plc He issued several publications on drug development and drug safety and authored an eBook about clinical trial design and conduct (Zenosis Ltd publisher). In 2015 his book “Re-engineering clinical trials” was published by Elsevier. He continues to lecture Pharmaceutical Medicine at the University of Duisburg-Essen as Head Lecturer and at the University of Aveiro, Portugal, as Invited Auxiliary Professor Re-engineering Clinical Trials - Speaker Bios May 12, 2015 at the Hyatt Regency, Washington D.C As vice president of product strategy, Michelle is responsible for product direction across the entire Medidata Clinical Cloud™. Michelle works with Medidata’s development team of over 200 people in creating new modules and capabilities within Medidata’s cloud-based platform, incorporating data-driven analytics and ensuring proper functionality and a better user experience. Michelle began her career in the UK in data management and technical standards at Glaxo Wellcome (now GlaxoSmithKline) and AstraZeneca. Drawing on over 15 years of experience in life sciences and software development, Michelle stands at the intersection of clinical trials and technology. Michelle is a passionate proponent of the role technology can play in improving clinical research, exploring how cloud-based platforms can improve clinical research and assessing the organizational requirements of an engineering culture to deliver such a platform. Michelle Marlborough Vice President, Product Strategy Medidata Solutions Worldwide Last year, Michelle was named by PharmaVOICE Magazine as one of the 100 most inspiring people in the life sciences industry and was honored as a 2014 Rising Star by the Healthcare Businesswomen’s Association (HBA). She holds a BS in biology and mathematics from Coventry University in the UK. Craig H. Lipset is Head of Clinical Innovation within Worldwide Research & Development at Pfizer. Craig’s team is responsible for impacting clinical research through digital tools, innovative research approaches and unprecedented collaborations. He serves on the Board of Directors for the Foundation for Sarcoidosis Research, the Board of Directors for the MedStar Health Research Institute, the Operations Committee for TransCelerate BioPharma, and as a Mentor at health tech accelerator Blueprint Health. Craig also serves on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig previously served as Venture Partner in Pfizer Venture Investments as well as Senior Director in Molecular Medicine within Pfizer R&D. Prior to Pfizer he served as Associate Vice President of Program Management at Adnexus Therapeutics (acquired by Bristol-Myers Squibb), and on the founding management team for Perceptive Informatics (now part of PAREXEL International). Craig Lipset Head of Clinical Innovation Pfizer, Inc.
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