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Bethesda North Marriott Hotel and Conference Center

Mar 03, 2016 7:30 AM - Mar 04, 2016 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Marketing Pharmaceuticals 2016

Discuss the complexity of marketing and how to promote pharmaceuticals, biologics, and medical devices in an effective yet compliant manner in an evolving environment.

Session 7B: Advocacy Groups: When and How Should They be Engaged?

Session Chair(s)

James  Valentine, JD, MHS

James Valentine, JD, MHS

Director

Hyman, Phelps & McNamara, PC, United States

There is an open question amongst the drug development industry about how and when to best interact with patient groups regarding clinical trials. This knowledge gap has the potential to delay the start of meaningful clinical trials or lead to the conduct of less efficient trials by not tapping into the patient resource. Complex legal, ethical and regulatory issues, and ill-defined expectations can lead to unproductive relationships and disparate or unanticipated outcomes. While key stakeholders have moved to create a more effective model for engagement between research sponsors, investigators, and patient groups, leading to better clinical trials, guidelines for best practices have not been shared across the industry. This session will explore opportunities for drug developers to engage with patient advocacy groups, provide an overview of the regulatory framework through which such engagement should be moderated, and explore case studies that highlight best practices for industry interactions and partnerships with these groups.

Speaker(s)

James  Valentine, JD, MHS

Speaker

James Valentine, JD, MHS

Hyman, Phelps & McNamara, PC, United States

Director

Rebecca  Prince

Speaker

Rebecca Prince

Bristol-Myers Squibb, United States

Senior Corporate Counsel

Dara S. Katcher Levy, JD

Dara S. Katcher Levy, JD

Hyman Phelps & McNamara P.C., United States

Director

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