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Medicinal Chemistry for Neurotherapeutics Program (MCNP)

Solicitation Number: NIH-NINDS-10-01
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-10-01
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Solicitation
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Added: Jun 09, 2010 1:24 pm
The National Institute of Neurological Disorders and Stroke (NINDS), NIH has a requirement in support of a program that will require provision for medicinal chemistry services. The NINDS envisions awarding a contract for medicinal chemistry services as part of a new Medicinal Chemistry for Neurotherapeutics Program (MCNP), which is designed to help overcome barriers to drug development for diseases that affect the nervous system. The MCNP is part of an overall NIH Blueprint Network program initiative.

The design of the MCNP is to provide neuroscientists with medicinal chemistry services to develop preclinical drug candidates-optimized drug leads that are ready for Investigational New Drug (IND)-enabling pharmacology and toxicology studies. The MCNP will involve the following components, which will interact as follows:
• A medicinal chemistry facility (Contractor). The Contractor will provide compound design, synthesis, and management services, as well as in vitro pharmacology and toxicology assays for the purposes of improving the drug-like qualities of compounds.
• Neuroscience researchers (Contributors) with bioactive small molecule compounds and bioactivity assays. The Contributors' compounds will serve as starting points for medicinal chemistry. The Contributors, using their own bioactivity assays, will test compounds provided by the medicinal chemistry Contractor.
• NIH staff. The NIH Contracting Officer (CO) and Contracting Officer Technical Representative (COTR) will oversee the medicinal chemistry contract. The COTR will offer suggestions and provide feedback to the Contractor on medicinal chemistry strategies and project design, in consultation with the Contributors and NIH-hired medicinal chemistry consultants (see below).
• Information Technology (IT) system. The NIH will establish a database and user-friendly interface for entering, searching, downloading, and visualizing medicinal chemistry data. The medicinal chemistry Contractor and Contributors will be responsible for entering the data that they generate into this database. All MCNP participants will receive training on how to use the IT system and technical support.

The MCNP will serve as part of the NIH Blueprint Neurotherapeutics Network and provide medicinal chemistry for drug development projects independent of the Blueprint Network. The Blueprint Network offers neuroscience researchers access to a full range of industry-style drug development services and expertise, including medicinal chemistry, IND - enabling studies, and phase I clinical trial infrastructure. A goal of the Blueprint Network is to advance compounds successfully from chemical optimization through phase I clinical testing, at which point the compounds will be more attractive for private sector investment and commercial development.
Preclinical drug candidates generated from these projects will undergo further development and testing through other NIH programs or within the academic or commercial sector.


The work of the Contractor will be divided into projects. In general, each project will involve a different Contributor. Projects will include any or all of the following stages: (1) Exploratory Chemistry, (2) Hit-to-Lead Chemistry, and (3) Lead Optimization. The goal of Exploratory Chemistry is to gather sufficient data to determine whether the starting compound(s) and primary bioactivity assay provided by the Contributor are suitable for pursuing Hit-to-Lead Chemistry. Exploratory Chemistry will generally include obtaining commercially available compounds that are structurally similar to the starting compound(s) ("SAR by catalog") and limited chemical synthesis of custom-designed analogs. The goal of Hit-to-Lead Chemistry is to develop one or more chemical series that demonstrate a mature SAR, successful outcomes in preliminary absorption, distribution, metabolism and excretion (ADME) assays, IC50/EC50 < 100 nM in the primary bioactivity assay (potency in a cellular assay is desirable) and, if the Contributor has in vivo models, in vivo activity. For Lead Optimization, the goal is to develop a preclinical drug candidate with optimized ADME properties and minimal predicted toxicity. The Contractor must have sufficient capacity to support a workload comparable to any of the following combinations of projects: (1) 6 projects in Lead Optimization, concurrently; (2) 10 projects in Hit-to-Lead Chemistry, concurrently; and (3) 3 projects in Lead Optimization and 5 projects in Hit-to-Lead Chemistry, concurrently.


The Contractor shall provide the following services during the contract: (1) project planning; (2) project management; (3) design, procurement, and milligram-scale synthesis of chemical analogs; (4) multi-gram and scale-up synthesis for testing in animal models; (5) in vitro pharmacology and toxicology testing for lead optimization; (6) compound registration and data entry; and (7) compound management.


The ultimate goal of the Blueprint program and of individual medicinal chemistry projects is to bring new drugs to market. To this end, the NIH has received approval for a Determination of Exceptional Circumstances (DEC) and deviation to the standard FAR Clauses associated with patent rights and rights-in-data. The FAR clause deviations will be made a part of any resultant contract, and will allow Contributors to retain control of the intellectual property for compounds tested, evaluated and/or created through the MCNP.


It is anticipated that one (1) cost-reimbursement completion type contract with line item options, will be made from this solicitation and that award may be made on or about April 15, 2011, and will cover a five-year period of performance. This is NOT a Request for Proposals (RFP). Request for Proposals (RFP) No. NIH-NINDS-10-01 will be available electronically and may be accessed through the FedBizOpps (URL: http://www.fedbizopps.gov) 15 or more calendar days after the issuance of this synopsis. THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. 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.

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Solicitation 1

Type:
Solicitation
Posted Date:
June 30, 2010
Description: RFP Cover Letter and RFP NINDS-10-01
Description: RFP PDF Attachments 1-14
Description: RFP PDF Attachments 15-24

Amendment 1

Type:
Mod/Amendment
Posted Date:
June 30, 2010
Description: Attachment #1 has been modified to reflect a corrected due date for receipt of proposals.

Amendment 2

Type:
Mod/Amendment
Posted Date:
August 2, 2010
Description: Amendment #2 to RFP NIH-NINDS-10-01 has been issued to amend certain portions of the soliciation based on questions received.
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6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531
Bethesda, Maryland 20892-9531
:
Annette Carter,
Contracting Officer
Phone: (301) 496-1813
Fax: (301) 402-4225
:
Kirkland L. Davis,
Chief, Contracts Management Branch
Phone: (301) 496-1813
Fax: (301) 402-4225