Release Criteria Initiative

Release Criteria Initiative 

On December 12, 2023, The Society for Immunotherapy of Cancer (SITC) convened cellular therapy experts with representation from major academic centers, industry, and the regulatory agencies to dive deeper into the topic of release criteria for cellular therapies, and provide recommendations to the field on their application, usefulness, and role in the regulatory process.

Overview

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. 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 meeting report. 

READ THE SUMMARY REPORT

Outcomes & Next Steps

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:

COMMENT

Commentary papers and meetings on future/past FDA guidance documents related to release criteria specifications

  • SITC has provided comment on the recently released FDA guidance on potency in January of 2024. The comments provided reflected the outcomes and discussions held at the summit

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CONVENE

Future consensus meetings to address the hurdles specifically stated within the summit report

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PUBLISH

Development of future manuscripts:

  • Addressing and defining the relevance/necessity of potency assays and release criteria
  • Commenting on existing FDA guidance related to, cellular therapy development, potency assays and release criteria

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AMPLIFY

Leverage the SITC annual meeting and other national scientific meetings to amplify these efforts for fieldwide adoption

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COLLABORATE

Collaborate with other like-minded societies including:

  • Future collaborative meetings with FDA to share results from summit

Organizers

Chantale Bernatchez, PhD

Chantale Bernatchez, PhD
The Cell Therapy Manufacturing Center

Patrick Hanley, PhD

Patrick Hanley, PhD
Children's National Hospital

Michael Kalos, PhD

Michael Kalos, PhD
Next Pillar Consulting

Raj Puri, MD, PhD

Raj Puri, MD, PhD
Iovance

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