FDA Regulatory Outlook 2018 and Beyond: Real World Evidence - Navigating the Years Ahead

Presented by New England Healthcare Executive Network


Foley Hoag LLP

Seaport West
155 Seaport Boulevard
Boston, MA 02210-2600

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April 2, 2018 7:30AM–10:00AM


Real world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions. FDA uses RWD and RWE to monitor post-market safety and adverse events to make regulatory decisions. FDA is now recognizing the value of RWD and patient input to determine the risk/benefit profile and quality of life (QOL) value of breakthrough devices and novel technologies in support of regulatory decision making in premarket submissions.

What steps can your company take to stay ahead of FDA requirements and improve your regulatory compliance program? How can your firm capitalize on the patient perspective and use RWD and RWE to support the clinical performance of your product?

Come join this timely, lively, keynote presentation and blue-ribbon panel discussion. Ask questions and contribute your insights during the audience interactive segment. Identify and consider how to best use real-world evidence to ensure product safety and effectiveness.

Keynote Speaker

  • Ellen DiResta, Patient Engagement, Strategy Consultant
    Ellen is a frequent lecturer and curriculum advisor (Strategy and Innovation) at Boston University, Tufts, MIT, Philadelphia University, Becker College.

Program Moderator

  • Giacomo Basadonna, M.D., Ph.D., Managing Director, Global Medical Affairs, Alira Healthcare, Inc., CEO and Founder, enlightenVue, Inc., Professor of Surgery at the University of Massachusetts Medical School
    Dr. Basadonna is a member of 23 national committees, 3 hospital committees and 14 professional societies. His previous hospital appointments include UC Davis Medical Center, Yale New Haven Hospital, and UMass Memorial Hospital.


  • Nancy Johansen, Director of Regulatory Affairs at Orchard Therapeutics, Ltd.
    A biologist by training, Nancy has over 26 years of regulatory experience for novel therapies.
  • Mary McNamara-Cullinane, Partner, Alira Healthcare, Inc.
    Strategic regulatory consultant to the medical device and biotech industry with varied expertise including the regulation of radiology, urology, physical medicine, orthopedic, neurological, wound care, digital health, IVD's, dental medical devices and combination products.
  • Cynthia Nolte, Ph.D., RAC, Senior Director Regulatory Affairs, ICON plc
    Regulatory affairs professional with 20+ years of RA, QA and clinical experience in medical device products.

Topics for Discussion

  • The role of the FDA and their focus on patient engagement
  • Translating desired behavioral attributes to product and features
  • Evaluating new products and novel technologies to engage patients, and how it differs from preference tests
  • Current FDA thinking using RWE/RDE in support of Premarket Submissions
  • Best practices for generation of RWD to advance product development and adoption