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Drug Manufacturing and Formulation Program (DMFP)

Solicitation Number: NIH-NINDS-14-02
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Neurological Disorders and Stroke
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NIH-NINDS-14-02
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Presolicitation
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Added: Apr 17, 2014 4:44 pm
THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NO. NIH-NINDS-14-02, ENTITLED: "DRUG MANUFACTURING AND FORMULATION PROGRAM (DMFP)," WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT MAY 1, 2014.

The NIH established the Blueprint Neurotherapeutics Network (BPN) to bridge the gap in drug development between basic researchers and biopharmaceutical companies (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm).
The Network offers neuroscience researchers a "virtual pharma" to develop promising hit compounds from chemical optimization through Phase I human clinical testing. The BPN supports, through grants and contracts, every step of the drug development process from validated hits to Phase I human clinical trials.


This proposed contract initiative, under the auspices of the NIH, National Institute of Neurological Disorders and Stroke (NINDS), and as part of the BPN, will support the development and manufacture of dosage forms (e.g., including and not limited to parenteral, oral solutions, tablets, capsules, and ocular delivery systems) of small molecule drug candidates suitable for administration in preclinical efficacy studies, Investigational new drug (IND) enabling studies, and clinical trials. Work under the proposed contract will include process development and preparation of active pharmaceutical ingredients (API), pre-formulation and formulation studies, physical and chemical characterizations, analytical method development and validation, stability studies, drug product manufacturing, packaging, storage, quality control, regulatory documentation, and distribution of the drug products. All work will be conducted in accordance with Current Good Manufacturing Practices regulations (cGMPs) and, as appropriate, Good Laboratory Practice (GLP) regulations.


The NINDS anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contracts that, together, will constitute the DMFP.


The ultimate goal of the Blueprint program and the individual manufacturing projects is to bring new drugs to market. To this end, the NIH has received approval for a Determination of Exceptional Circumstances (DEC) and has obtained authorized deviations from the Federal Acquisition Regulations Clause at 52.227-11, "Patent Rights," and 52.227-14, "Rights in Data" that will be applicable to any resultant contract awarded under this program. Prospective offerors are advised that agreement to the terms of these FAR clause deviations will be a condition for contract award. Deviations from the standard FAR Clauses mentioned above will enable the BPN program compound Contributors to retain control of the intellectual property for compounds created through the DMFP.


Request for Proposals (RFP) No. NIH-NINDS-14-02 will be available at the FedBizOpps website on or about May, 1, 2014. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE FEDBIZOPPS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.


Sincerely,
Laurie Leonard
Contracting Officer
NINDS R&D Contracts Management Branch
National Institute on Drug Abuse, NIH

:
6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531
Bethesda, Maryland 20892-9531
:
Laurie A Leonard,
Contracting Officer
Phone: 301 496-1813
Fax: 301 402-4225
:
Annette Carter,
Contracting Officer
Phone: (301) 496-1813
Fax: 301-402-4225