Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders   2

Amendment 2: Q&A part 2 and revised Section M posted

Amendment 1: Q&A part 1 posted and proposal due date extended

The National Institute of Neurological Disorders and Stroke (NINDS) has a need for current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical (preclinical) support services to support translational development of therapeutic biotechnology products (Biologics) for NIH drug discovery and development programs. To that end, several NIH programs are being launched or expanded to provide support for investigators developing medical interventions for neurological disorders, including the NIH Blueprint Neurotherapeutics (BPN) network, the NINDS Ultra-Rare Gene Therapy (URGenT) program, and the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP).

Contractors must provide support for both Biologics cGMP manufacturing and GLP nonclinical services, including execution of the studies and completion of study reports and documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs. These services may be provided through a combination of internally executed studies and subcontracted work. All work in support of NIH biologics programs will be awarded through issuance of task orders against indefinite delivery, indefinite quantity (IDIQ) contracts.

Please see the RFP and attachments for more information and review all instructions carefully. All proposals must be submitted through NIH's electronic Contract Proposal Submission (eCPS) and contain all required information/documentation. Additonally, all offerors must have an active SAM registration at the time of proposal submission to be considered for award.