FDAnews Announces — Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies: DAIA Will be a Game-Changer Webinar, Dec. 5, 2018

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DAIA, in one form or another, is around the corner. What impact will it have on LDTs, in vitro diagnostics, targeted drugs & biologics?

FDAnews

FDAnews

Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies:
DAIA Will be a Game-Changer
**An FDAnews Webinar**
Dec. 5, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/ldtsivdgt    

For the first time ever, FDA and Congress agree on what the future of LDTs should look like. If passed in the next session of Congress, the current draft of the Diagnostic Accuracy Innovation Act (DAIA) will impact FDA regulation of laboratory developed tests (LDTs), in vitro companion diagnostic devices, and targeted drug and biologic therapies in dramatic and nuanced ways.

Based on FDA’s and industry reaction, and the expectation that the new Congress will try to resolve this issue next year,it’s likely there will be a significant change in the regulation of LDTs, companion diagnostics and targeted therapies.

It’s not too late to influence the bill that’s expected to be re-introduced in the next session of Congress, and it’s definitely not too soon to start preparing for the future. Don’t miss this opportunity to be heard on this groundbreaking issue, and to hear two of the most knowledgeable experts explain what’s in store for those in this space.

In 90 fast-paced minutes, attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights regarding how under DAIA, the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. Attendees will learn the following:

  • Current regulatory landscape for LDTs and in vitro companion diagnostics
  • Breakdown of the DAIA — how the legislation would change FDA’s oversight of in vitro diagnostic products, and would affect pre-and post-market requirements
  • How the DAIA defines low-risk and high-risk test and how it affects the regulatory burden
  • Under what circumstances an existing product will need to seek marketing approval from FDA
  • What enforcement powers will FDA be granted — such as the ability to demand a product recall
  • The implications for targeted drug and biologic therapies — such as when an in vitro companion diagnostic must be approved by FDA before it will approve the targeted therapy

Register today to understand what manufacturers should be doing to prepare for these coming changes, including identifying products that may fall under DAIA and planning to obtain the data needed to support a marketing application.

Meet the Presenters:
Mike Druckman, Partner, Hogan Lovells US LLP
Mike Druckman is a partner in the FDA pharmaceutical group at Hogan Lovells US LLP. He previously served as Associate Chief Counsel for Biologics and for Enforcement at FDA. He works closely with lawyers in the firm’s FDA medical device group in advising clients who are developing targeted therapies, including gene therapies, on designing their clinical programs appropriately to accommodate diagnostics.

Blake Wilson, Senior Associate, Hogan Lovells US LLP
Blake Wilson is a senior associate in the FDA medical device group at Hogan Lovells US LLP. Blake’s practice focuses on premarket approval of medical devices, and he regularly advises on LDTs.

Who Will Benefit:
Quality and regulatory professionals in drugs, biologics, lab testing, companion diagnostics, and gene therapies.

Webinar Details:
Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies:
DAIA Will be a Game-Changer
**An FDAnews Webinar**
Dec. 5, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/ldtsivdgt    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/ldtsivdgt                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michell Butler
FDAnews
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