Preparing Your Company for Diagnostics Reform and the VALID Act: Key Issues and the Road Ahead

Monday, September 27, 2021

10:05 AM – 10:55 AM ET

Location: Washington, D.C. - Capital Hilton (Presidential Ballroom)

In-person D.C. Moderator(s)

Nathan A. Brown, JD

Partner
Akin Gump Strauss Hauer & Feld LLP

In-person D.C. Speaker(s)

Jeff D. Allen, PhD

President and CEO
Friends of Cancer Research

Virtual Speaker(s)

EH

Elizabeth Hillebrenner, MSE

Associate Director for Scientific & Regulatory Programs, CDRH
FDA

In-person D.C. Speaker(s)

Lauren Silvis, J.D.

Senior Vice President, External Affairs
Tempus, Inc.

Virtual Speaker(s)

April Veoukas, JD

Director, Regulatory Affairs
Abbott

Key stakeholders are increasingly recognizing the need for diagnostics regulatory reform that establishes a unique, modernized regulatory framework for all diagnostics, including Laboratory Developed Tests. The COVID-19 public health emergency has highlighted the importance of in vitro diagnostics to the health care system, and the need for well understood regulatory requirements. With the introduction of the VALID Act 2021 and the upcoming legislative vehicle opportunity presented by the must-pass user fee reauthorization next year, now is the time to begin preparing your company for potential changes to diagnostics regulations, either via legislation or changes in FDA policy. Panelists will discuss potential legislative and regulatory reforms to IVD regulation, likely timing and transition steps, and the impact for large and start-up diagnostic developers as well as providers and patients.