Apply to PACT

The following documents provide information on the PACT services offered, a listing of major cell product manufacturing capabilities at PACT facilities.

• Overview of PACT Services and Capabilities
• Clinical Manufacturing and Regulatory Services Support - NEW
• Cell Product Manufacturing Capabilities at the PACT Facilities

The following documents provide information on the criteria that NHLBI will take into consideration when performing the initial scope review as well as evaluating the full RSA review (full review for Translational or Clinical RSAs only).

• PACT Application: Scope Criteria
• PACT Evaluation Criteria

You can reference the PACT Application System Users Guide for questions on how to complete initial registration and how to navigate within the application system. You may contact pactgroup@emmes.com for technical assistance with submitting your application.

Request for Services Applications (RSAs) for either translational development or clinical manufacturing will be accepted. Applications for clinical manufacturing or translational development services will undergo a two-part review process. A partical application (Scope) is initially submitted for program scope reivew, which NHLBI will conduct and either approve or not approve for a Full application submission. Full applications are reviewed in parallel by both NHLBI and an independent scientific review board.

Application Process Overview for Clinical and Translational RSAs

Requests for Regulatory Services will be accepted. These regulatory services are provided separately by the PACT Coordinating Center and are considered supplemental to regulatory services provided by the PACT CPF for approved combination RSA. Regulatory services-only requests will only undergo scope review by NHLBI. If approved, the PACT Coordinating Center will contact the applicant to discuss the regulatory services being requested prior to commencing services.

More information on PACT regulatory services provided can be found here: About PACT > PACT Services > PACT supported Regulatory Services.

Application Process Overview for Regulatory-only RSAs

Requests for regulatory services in combination with translational development or clinical manufacturing services requests will also be accepted. For combination RSAs (Clinical/Regulatory OR Translational/Regulatory RSAs), the translational or clinical component of the RSA will undergo the two-part review process described above in parallel with NHLBI's review of the regulatory component of the RSA. Both components of the combination RSA will be reviewed and will be individually approved or not approved.