Science Moving TowArds Research Translation and Therapy (SMARTT) - Biologics Production Facility

The National Heart, Lung, and Blood Institute is seeking a biologics Production Facility (PF) for a new six-year program, Science Moving TowArds Research Translation and Therapy (SMARTT).



The purpose of the SMARTT program is to assist translation to the clinic of novel synthetic, natural, or biologic therapeutic interventions arising in the scientific community for the treatment of heart, lung, and blood diseases. SMARTT will provide resources in the areas of preclinical and clinical-grade production and testing for biologics, non-biologics and small molecules in accordance with Good Manufacturing Practices (GMP), and in the conduct of pharmacology/toxicology studies. In addition, SMARTT will provide regulatory assistance to investigators wishing to conduct early stage clinical trials. SMARTT will consist of a Production Facility (PF) for biologics; a PF for non-biologics and small molecules; a Pharmacology/Toxicology Center (PTC); and a Coordinating Center (CC). SMARTT will provide consulting, manufacturing, pharmacology and toxicology testing, preclinical and early phase clinical study design support, and administrative and regulatory expertise. The CC will monitor and coordinate organizational and regulatory aspects of the SMARTT program.



One award is anticipated under a Request for Proposal (RFP). The biologics PF will 1) participate in the Steering Committee (SC), subcommittees, and teleconferences, 2) provide, maintain, and update a Manual of Procedures (MOP), 3) contribute to the design and content of the CCs customer satisfaction survey for investigators to evaluate the quality, acceptability, and timeliness of the product and service provided, 4) contribute to the design and content of the CCs public and private web sites and provide updates to the CC as needed, 5) produce scalable clinical and/or research grade biological therapeutic products, in accordance with Good Manufacturing Practices (GMP), as defined by the US Food and Drug Administration (FDA), and applicable Federal and State regulations, for use by investigators studying a heart, lung or blood topic, 6) prepare and ship products, in accordance with the MOP and Federal and State guidelines, upon completion of GMP production and testing, 7) maintain product-related inventories in a secure and confidential manner, 8) monitor facilities to ensure quality control of product production and accuracy and completeness of production data, and maintain and make available for review, as necessary, records of monitoring activities, and 9) prepare materials for and participate in site visits to the contractors facilities and ensure that up-to-date versions of all required certifications, inspections, and assurances are available for review during site visits.



This is not a request for proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. It is anticipated that the RFP will be available on FedBizOpps on or about August 28, 2009. This advertisement does not commit the Government to award a contract.