In the summer of 2022, SITC convened cellular therapy experts from academia, government, and industry to identify significant regulatory hurdles facing cellular therapies as they relate to the Investigational New Drug Application (IND) and Biological License Application (BLA) regulatory review. These hurdles and potential solutions were detailed within an initial Cellular Therapy Regulatory Summit EXECUTIVE SUMMARY. While many hurdles were identified, the topic concerning potency assays and release criteria specifications was selected as the most critical hurdle. In order to address this, SITC reconvened experts in 2023 to focus specifically on release criteria and the role of potency. Summit attendees were divided into three expert panels each addressing a significant hurdle identified by the summit organizers:
Panel 1: Release criteria for current commercial products
Panel 2: Potency as a release criterion
Panel 3: Future development of ideal release criteria
These panels worked to identify key hurdles and propose potential solutions across these topics. The results from the summit can be found within the Release Criteria EXECUTIVE SUMMARY.
Summit attendees formalized possible solutions towards addressing the hurdles associated with release criteria throughout the program. At the conclusion of the meeting, SITC was provided with five key efforts that would create momentum in this arena:
Commentary papers and meetings on future/past FDA guidance documents related to release criteria specifications
Future consensus meetings to address the hurdles specifically stated within the summit report
Development of future manuscripts:
Leverage the SITC annual meeting and other national scientific meetings to amplify these efforts for fieldwide adoption
Collaborate with other like-minded societies including:
The number of cellular and gene therapy-based oncology treatments being developed by the field has grown exponentially over the past ten years. As a result of this rapid advancement, many hurdles exist in the field that are causing delays in development and regulatory review of these important products. To help address this, the Society for Immunotherapy of Cancer (SITC) convened a Cellular Therapy Strategic Taskforce in 2021. The purpose of this taskforce was to formulate a strategic plan for the society aimed at increasing SITC’s overall impact in advancing the most promising cellular therapies to improve oncology patient care.
The strategic plan consisted of three key pillars including groundbreaking science, balanced educational content, and regulatory consensus. As a first step in facilitating regulatory consensus, SITC hosted the Cellular Therapy Regulatory Summit. This summit consisted of cellular therapy experts from academia, industry, and government meeting hybridly to further the goals of the SITC cellular therapy strategic plan.
The main goal of the SITC Cellular Therapy Regulatory Summit was to identity the most significant hurdles facing cellular therapy researchers throughout the Investigational New Drug (IND) Application process. In order to facilitate this process, the attendees participated in a pre-summit survey asking them to assign a ranking of 1-5 for each hurdle, 5 meaning the hurdle is most important to address and 1 being of least importance. The identified hurdles included:
Commentary papers and meetings on future/past FDA guidance documents related to cellular therapies
Future consensus meetings to address the hurdles specifically stated within this report
Development of future manuscripts addressing:
Leverage the SITC annual meeting and other national scientific meetings to amplify these efforts for field wide adoption
T