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.