Apply to PACT

>>>Please note PACT will be closing out the system for regulatory service applications on Friday, December 4, 2020.<<<

PACT will no longer accept applications for clinical and translational service requests after May 1, 2020. Scope applications must be submitted by April 27, 2020 to allow time for NHLBI scope review and applicant submission of the full application. Please note that applications for regulatory services will continue to be accepted in the online application system.

The current NHLBI PACT program is funded through June 30, 2021. Therefore, the PACT program will only accept applications for services that can be completed by this date.

 

Registration is required to access the online application system. Once you have registered you can submit a PACT Request for Service Application (RSA) at any time.

Click here to register and apply:

Apply Here

 

Please contact the PACT Coordinating Center, The Emmes Corporation, at pactgroup@emmes.com if you need assistance with your online application or have any additional questions.

If you are interested in applying for PACT services, please review the PACT FAQs and information and materials in the tabs below to get started.

 

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

PACT Application Materials
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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).

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.

Translational Development or Clinical Services Requests
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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 partial application (Scope) is initially submitted for program scope review, 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

 

Regulatory Service Requests
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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

Combination Service Requests
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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.