On November 13, 2020, Friends of Cancer Research (Friends) held the first of two virtual sessions of the Friends Annual Meeting. Day 1 covered Modernizing Expedited Development Programs, which focused on the current framework of FDA expedited development pathways and proposed ways to improve on the existing system.
The meeting opened with a keynote address from FDA Commissioner Stephen Hahn. Hahn discussed the ongoing fight against COVID-19 and how the agency has been aided by the work of organizations like Friends. He also discussed the FDA’s continued cancer-related work, including studying outcomes for those with cancer and COVID-19, as well as continued drug approvals.
Stephen Hahn: “We continue full-speed ahead on our non-COVID cancer-related work, including important drug approvals.”
Hahn’s address was followed by a conversation between Friends Chair & Founder, Ellen Sigal, and the director of the FDA’s Oncology Center of Excellence (OCE), Richard Pazdur. They discussed a variety of topics, ranging from the COVID-19 pandemic to the diverse pilot programs in the OCE. They also discussed the OCE’s Beyond Breakthrough project, the main impetus behind the Modernizing Expedited Development Programs working group. The primary focus of the Beyond Breakthrough project was to critically look at what happens after the designations are given, to make sure the programs are being used effectively. Finally, they looked at what is still missing in the fight against cancer, including further collaboration and cooperation between stakeholders.
Richard Pazdur: “We really wanted to make a concerted effort to make sure that patients with cancer do not feel forgotten in this pandemic.”
During the Day 1 event, Friends President and CEO, Jeff Allen, highlighted the launch of the new Friends Drug Development Dashboard, which has data of drug approvals dating back to 2013. The dashboard was an offshoot of the data analyzed by the Modernizing Expedited Development Programs working group.
The meeting culminated in a panel discussion around the working group’s white paper findings. The panel consisted of working group members Anne-Virginie Eggimann of Bluebird Bio, Scott Korn of Merck, Bea Lavery of Genentech, Paul Melmeyer from the Muscular Dystrophy Association, Harpreet Singh of the FDA, and was moderated by Amy McKee of Parexel. The panel opened with a brief introductory presentation from Amy overviewing some key findings and proposals outlined in the white paper. They then discussed the current expedited approval system, including how programs enable more dialogue and exchange between the FDA and sponsors allowing for real-time problem solving and the need for a codification of best practices. The panel closed with a few comments from Pazdur, who emphasized the need to look at the big picture when considering the approval pathways.
Day 1 of the Friends Annual Meeting concluded with a few words from Jeff Allen, looking ahead to Day 2 of the Annual Meeting focusing on Optimizing the Use of Accelerated Approval. Links to the white paper on Modernizing Expedited Development Pathways can be found here, and the recap of Day 2 can be found here.