On 14 July 2016, the US Food and Drug Administration (FDA) issued the long-awaited draft guidance on the co-development of a therapeutic product and diagnostic. This guidance is intended to serve as a practical guide to assist therapeutic product sponsors and IVD sponsors in developing a therapeutic product and an accompanying diagnostic. It follows FDA’s August 2014 In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff.
Offered in collaboration with the Combination Products Coalition (CPC), this program offers the unique opportunity to examine the draft guidance’s contents with FDA representatives and industry peers. You will hear directly from FDA experts and industry representatives regarding what the draft guidance includes as well as how the draft guidance may affect you and your company. In addition to Pamela Bradley, PhD of CDRH, FDA representatives include Pat Keegan, PhD, director of the Division of Oncology Products, Reena Philip, PhD, Donna Roscoe, PhD, Michael Pacanowski, PharmD, MPH and Christopher Leptak, MD, PhD.
This program will include an explanation from FDA regarding the considerations for drafting the guidance. Additionally, a panel of industry representatives will be given an opportunity to discuss how the draft guidance will impact drug and diagnostic development. The workshop then will be opened to the public and the audience for questions directed to FDA as part of a “roundtable” discussion. You will benefit from the interactive dialog between FDA and industry representatives, and have the opportunity to provide feedback directly to the FDA experts responsible for developing the draft guidance, highlighting ambiguities or challenges you might face in implementing the guidance.
In addition to the opportunity to provide feedback directly to FDA experts during the program, RAPS and CPC will collaborate to compile the major themes emerging from the program regarding implementation and submit them as comments FDA will consider when developing its final guidance. Don’t miss your opportunity to provide your input on this pivotal topic, important for advancing personalized/precision medicine.
Learning Objectives
At the conclusion of this program, participants should be able to:
- Explain key FDA expectations for the design of studies enabling co-development and other fundamentals applicable to co-development
- Describe the impact on their business and operations
- Identify guidance opportunities and limitations
- Clarify FDA expectations in a live setting
- Provide feedback on the draft guidance for consideration in developing final FDA guidance
Who Should Attend?
This program is intended for regulatory professionals (drug and diagnostic manufacturers), statisticians, project management, legal counsel and quality personnel at all professional levels.
* Questions for FDA and industry representatives will be collected in advance. Registrants (for both the in-person workshop and webcast) will be notified approximately two weeks prior to the workshop to submit their questions.