Project Facilitate: Enhancing the Single Patient IND Process for Oncology

May 16, 2019   |   1:00 PM to 3:30 PM
FDA White Oak Campus Building 31, Room 1503 - Great Room
10903 New Hampshire Avenue, Silver Spring, MD 20993
 

To further our common commitment to improving patient access to investigational therapies, the Foundation is pleased to join FDA for Project Facilitate: Enhancing the Single Patient IND Process for Oncology Health Care Providers. This public workshop brings all stakeholders together to discuss FDA’s Project Facilitate and the Expanded Access Navigator. Project Facilitate, a pilot program developed under the Oncology Center of Excellence (OCE), is planned as a call center to facilitate the Single Patient IND request process for oncologists treating patients with cancer. This pilot may create a model to ultimately extend across disease states.  

Workshop Objectives

  • Obtain input from multiple stakeholders on gaps in patient and healthcare provider knowledge of the current system for Single Patient IND requests, challenges with the current system for requesting Single Patient INDs, and suggestions for improving the current system.
  • Discuss updates to Reagan-Udall Foundation’s Expanded Access Navigator.
  • Obtain feedback on Project Facilitate, a planned pilot call center to facilitate the Single Patient IND request process for oncologists treating patients with cancer

 

Draft Agenda

Topic

Speaker

Opening Remarks

Norman "Ned" Sharpless, MD

Acting Commissioner of Food and Drugs

FDA

Welcome

Richard Pazdur 
Director, OCE 
Ellen Sigal, PhD
Board Chair

Reagan-Udall Foundation for the FDA  

Reagan-Udall EA Navigator 

  • Overview of Updates 
  • Live Demonstration of Website 

Amar Bhat, PhD
Interim Executive Director

Reagan-Udall Foundation for the FDA 

FDA’s Current Oncology Single Patient IND Process and Plan for Project Facilitate Pilot

Jessica Boehmer 
Regulatory Scientist, 
Office of Hematology and Oncology Products 

Panel Discussion 
Panelists: 

  • Monica Epstein, Oncology Nurse, NIH/NCI 
  • Elena Gerasimov, Director of Programs, Compassionate Use Navigator, Kids v Cancer 
  • Chul Kim, Oncologist, MedStar Georgetown University Hospital 
  • Michael Menefee, FDA Oncologist 
  • Michele Russell-Einhorn, Chief Compliance Officer and Institutional Official, Advarra 

Discussion Topics: 

  • Identify gaps in patient and healthcare provider knowledge of the current system for SPI requests 
  • Identify challenges with the current system for SPI requests 

Moderator:
Rea Blakey
Associate Director, 
External Outreach and Engagement, OCE

Audience Participation

  

Concluding Remarks

Gideon Blumenthal 
Deputy Director, OCE

Learn more about this workshop.