TAS::75 0872::TAS SMARTT (11-8470187)

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Participation as a member of the SMARTT Steering Committee (SC) and subcommittees as necessary to provide input to the overall SMARTT program. (Section 3.0) Contribution to the creation of a cGMP- and GLP-grade manual of procedures (MOP) with updates as necessary during the production phase (SMARTT Phase II). (Section 2.3.1) Development and implementation of Material Transfer Agreements (MTA) with input from NHLBI and the CC. (Section 2.3.2.1) Contribution to developing procedures for evaluating, prioritizing and processing Request for Services Applications (RSAs). (Section 2.3.2.2) These procedures will then be utilized in the production phase to evaluate each RSA, including completion of a Feasibility Assessment (FA). (Section 2.3.2.3) Contribution to the design and content of the Coordinating Center's (CC) customer satisfaction survey (Section 2.3.2.5), marketing plan (Section 2.3.4), public and private websites (Section 2.3.3), and the electronic database for tracking all biologics and data throughout the production process. ABL's computer system capabilities are also described. (Section 4.2) . Provision of services as a US FDA-defined cGMP production faculty for biological therapy products. Processing, analyzing (Section 2.3 .5), storing, and shipping products (Section 4.1.2) produced. Provision of translational support or manufacturing services to Investigators with requested biological therapy products. (Section 2.3.5) Provision of semi-annual production reports to the NHLBI PO and CO (Section 2.3.2.4), while constantly maintaining all required certifications and requirements to manufacture both nonclinical and clinical products; all data is available for the yearly site visits by the CC. Design and implementation of monitoring plans for products, including production and compliance with regulatory requirements. (Section 2.3.6) Maintenance of quality control and quality assurance plans for all biologics products. (Section 2.3.6) For each manufactured product, provision of complete protocol information, including quality control and quality assurance procedures, in accordance with the MOP, and preparation of archival samples from each lot manufactured. (Section 2.3.6) Provision of orderly closeout and termination of service agreements during the final months of the contract. (Section 2.3.2.6)