SOURCE: Tufts Center for the Study of Drug Development

Tufts Center for the Study of Drug Development

April 21, 2015 09:00 ET

Biopharma Summit Set for May 12 on Re-Engineering Clinical Trials to Improve Drug Development and Performance

FDA Deputy Commissioner Robert Califf to Present Overview of Supportive Regulatory Strategies

BOSTON, MA--(Marketwired - Apr 21, 2015) - Responding to the mounting challenges of highly inefficient and costly clinical trials, which have stymied R&D productivity, the Tufts Center for the Study of Drug Development and ICON plc will host a one-day Biopharma Summit May 12 in Washington, DC, to outline innovative approaches and insights to "fixing the clinical trial conundrum."

"There is widespread agreement across the pharmaceutical and biotech industry that the clinical trial process needs to be fundamentally improved," said Kenneth Getz, director of sponsored programs and research associate professor at Tufts CSDD. "Nearly every aspect of clinical trial activity -- from protocol design to study start-up, from patient recruitment to study conclusion -- needs to be streamlined and optimized."

"Fixing the clinical trial conundrum requires more than technology solutions, new practices. and working harder. It means re-thinking the way clinical trials are designed and executed in order to fundamentally transform clinical trial performance."

The Summit, to be held at the Hyatt Regency Washington, DC, is intended for senior pharmaceutical, biotech, medical device, and contract research organization executives, clinical research professionals, bioethicists, funders, policy makers, and regulators.

Robert Califf, recently appointed deputy commissioner for medical products and tobacco at the U.S. Food and Drug Administration (FDA), will present his agency's assessment of major opportunities for improving R&D quality and efficiency, as well as changes the FDA is considering adopting to better accommodate the evolving R&D environment.

Califf, who joined the FDA in February, is responsible for providing 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, and oversees the Office of Special Medical Programs.

Also speaking will be:

  • Ken Getz, on reasons the traditional clinical trial paradigm is failing.
  • Brendan Buckley, ICON's chief medical officer, on how to engage sites and patients to optimize drug development
  • Peter Schüler, ICON's senior vice president for medical and safety services, on new directions in protocol design
  • Michelle Marlborough, vice president, product strategy at Medidata Solutions Worldwide, on the role of big data and advanced analytics in clinical trial re-engineering
  • Craig Lipset, head of clinical innovation at Pfizer, Inc., on managing organizational change

"Even though the pharma industry depends heavily on the discovery of innovative products, it is conservative in the manner in which it conducts clinical trials," Buckley said. "We are delighted to partner with Tufts CSDD on this event where delegates will learn about a variety of options to enhance drug development, and we look forward to some lively debate around this topic."

Attendees at the one-day Summit will receive a complimentary copy of "Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process" (Elsevier B.V.), published earlier this month, edited and co-authored by Brendan Buckley and Peter Schüler, which includes leading experts' factual reviews of critical reforms.

For more information and to register, visit http://csdd.tufts.edu/courses/special_events or contact Rachel Stanton at Rachel.Stanton@tufts.edu.

ABOUT ICON PLC
ICON plc (http://www.iconplc.com) is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management, and analysis of programs that support clinical development -- from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 10,600 employees.

ABOUT THE TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.

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