Getting Real About Real World Evidence - Webinar Recording/Transcript

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Getting Real About Real World Evidence: Practical Next Steps for Drug and Device Manufacturers

Real world evidence — “RWE,” so-called — is making its way into your world.

FDA regulation and inspections are being affected in ways large and small. Meanwhile, some bold drug and device makers are finding ways to take business advantage of the opportunities RWE offers, while others hang back, worried about risks and unforeseen consequences.

In other words, it’s kind of a mess.

Or, put more kindly, a rapidly developing situation with both regulatory and profit impact that’s certain to affect ... you.

FDAnews has reached out to Sonali P. Gunawardhana Esq., one of the sharpest legal minds to emerge from the FDA in recent years, and Dr. Mary Jo Lamberti, a faculty member at Tufts CSDD. They will walk you through the fast-moving RWE changes currently affecting the agency and business decisions alike. In this fast-paced 60-minute session, you’ll discover:

  • Ways drugmakers are using RWE to support promotional claims
  • Ways devicemakers are using RWE to support premarket applications
  • Why some manufacturers hesitate to use RWE for promotional claims, fearing charges of unsubstantiated claims, increased legal liability, and increased government surveillance
  • Impact of recent FDA statements: How the agency may want RWE data included in approval and clearance applications, and as a basis for drug and device promotional claims
  • Interpreting FDA guidances: How the agency may use data collected outside of the traditional clinical-trial context to support regulatory decision-making; how RWE “could constitute valid scientific evidence that could be used in some FDA regulatory contexts”
  • The 21st Century Cures Act: How it seeks to speed drug and device approval by shifting certain evidentiary requirements from clinical trials to post-market—in other words, to “the real world.”
  • And much more!

RWE is real and it’s here to stay. Going forward, you can expect it to move the FDA in new directions, and to affect your business decisions in unanticipated ways. Now is the time to learn what you need to know to stay compliant ... and competitive.

Real world evidence (RWE) affects FDA health regulation across the board – devicemakers, drugmakers, biotech, and consultants to these industries that conduct studies or analyses with RWE. This learning session will be of particular interest to:

  • Regulatory specialists
  • Quality specialists
  • Strategic planners
  • Clinical trial developers
  • Data Analysts

Meet Your Presenters

Sonali P. Gunawardhana Esq., Of Counsel at Shook, Hardy & Bacon L.L.P., draws on early 10 years’ experience as an FDA lawyer to offer clients practical, forward-looking guidance on avoiding and resolving FDA regulatory challenges. At the FDA she worked closely with district-office investigators inspecting devicemakers, IRBs, clinical investigators and CROs. Her civilian practice expertise includes current Good Manufacturing Practices (cGMP); clinical trial compliance strategies; and programs that FDA field investigators use during inspections.

Mary Jo Lamberti, PhD, Professor and Associate Director of Sponsored Research at Tufts Center for the Study of Drug Development, leads multi-sponsored and grant funded research projects at the Tufts Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine. She has extensive experience conducting research on pharmaceutical and biotechnology industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at industry conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts, Dr. Lamberti was director of market research at CenterWatch.