Drug Manufacturing and Formulation Program (DMFP)

Added: Jan 16, 2015 10:22 am The National Institute of Neurological Diseases and Stroke (NINDS), National Institute of Health (NIH), has made multiple Indefinite Delivery/Indefinite Quantity (IDIQ) contract awards under RFP No. NIH-NINDS-14-02. IDIQ contracts have been awarded to Albany Molecular Research, Inc. (AMRI), Albany, New York, Contract No. HHSN271201500005i and MRIGlobal, Kansas City, Missouri, Contract No. HHSN271201500006i, on January 15, 2015. These contracts will cover acquisition of services to conduct studies that will support the development and manufacture of dosage forms of small molecule drug candidates suitable for administration in preclinical and clinical studies of neurological disease/disorders. Services to be provided include: manufacture the active pharmaceutical ingredient (API), formulate the API, package, label, store, and distribute completed drug product.

Both IDIQ contracts have been awarded with a ten (10) year ordering period of January 15, 2015 through January 14, 2025. The minimum award amount for AMRI is $20,000 and $25,000 for MRIGlobal; maximum award estimates are $37,393,571 for AMRI and $53,563,068 for MRIGlobal. Also, each organization has been awarded a funded task order with the parent IDIQ contract. The initial task order will cover performance of technical support activities under both contracts for the first 12 months of the IDIQ order period, January 15, 2015 through January 14, 2016. The initial task order award to AMRI was for $22, 211 and $49,282 to MRIGlobal. The initial task order awards also contain nine (9) additional 12-month term options as follows:

AMRI:
Option No. 1 - Technical support for Year 02 (12 months) 01/15/16- 01/14/17 - $22,819
Option No. 2 - Technical support for Year 03 (12 months) 01/15/17- 01/14/18 - $23,445
Option No. 3 - Technical support for Year 04 (12 months) 01/15/18- 01/14/19 - $24,091
Option No. 4 - Technical support for Year 05 (12 months) 01/15/19- 01/14/20 - $24,756
Option No. 5 - Technical support for Year 06 (12 months) 01/15/20- 01/14/21 - $25,440
Option No. 6 - Technical support for Year 07 (12 months) 01/15/21- 01/14/22 - $26,146
Option No. 7 - Technical support for Year 08 (12 months) 01/15/22- 01/14/23 - $26,872
Option No. 8 - Technical support for Year 09 (12 months) 01/15/23- 01/14/24 - $27,620
Option No. 9 - Technical support for Year 10 (12 months) 01/15/24- 01/14/25 - $28,391

Separate and distinct from the annual technical support activities, the NINDS will compete and award future Task Orders between these two contractors for all compound studies covered under the contract. Award of compound studies will be made through issuance of competitive Task Order Request for Proposals (TORFPs) as the need arises. It is anticipated that the resultant Task Order awards will be cost-reimbursement, completion-type orders and each will have variable periods of performance. The NINDS anticipates issuing two (2) to three (3) TORFPs for compound studies during each year of the IDIQ order period.

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