Medicinal Chemistry Support Program for Therapeutic Development (MCSP)

Added: Jun 30, 2017 10:13 am PRE-SOLICITATION NOTICE FOR FEDBIZOPPS

SUBJECT: Medicinal Chemistry Support Program for Therapeutic Development (MCSP)

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NO. NIH-NINDS-17-01, ENTITLED: "MEDICINAL CHEMISTRY SUPPORT PROGRAM FOR THERAPEUTIC DEVELOPMENT (MCSP)" WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT JULY 17, 2017.
The National Institute on Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm have established a virtual pharma network of contract service providers and consultants with extensive industry experience to enable small molecule, peptide and biologic therapeutics discovery and development in the National Institutes of Health (NIH) community. NINDS and the BPN have a need to recompete its full service, turn-key medicinal chemistry operations for the development of therapeutics within the mission of NINDS, BPN and other NIH Institutes and Centers (ICs). This full-service facility and staff would support a range of medicinal chemistry services including structure activity relationship (SAR) analysis and design, synthesis, in vitro absorption, distribution, metabolism, excretion and toxicology (ADMET), computational chemistry/Computer Aided Drug Discovery (CADD) and compound logistics of storage and shipping. The BPN, and other NINDS and NIH programs offer researchers access to a range of industry-standard services and expertise including full service medicinal chemistry services, pharmacokinetics/toxicology, drug manufacturing and formulation and Phase I clinical testing.
The term neurotherapeutics includes therapies targeted to indications due to disorders of the central and/or peripheral nervous system, and shall include novel agents developed by the NIH and its grantees (henceforth known as the "Contributor (s)") and provided to the NINDS for collaborative development as well as investigational agents supported through the NINDS including the BPN and other Institutes or Centers (ICs). Although the NINDS focus is on neurotherapeutics it is envisioned the other ICs may on occasion access this contract for small molecule therapeutics other than neurotherapeutics. The data generated from this contract will be used by NINDS, contributors or sponsored investigators in support of Investigational New Drug (IND) Application directed preclinical activities. The results of the efforts of this contract will be the basis to advance preclinical candidate compounds for further development i.e., advanced PK and toxicological evaluation in preparation of IND filings.
The ultimate goal of the NIH programs served by this contract and of individual projects is to bring new drugs to market.
The scope of this MCSP contract shall be medicinal chemistry services including project management and reporting, compound logistics, synthesis, computational chemistry and in vitro ADMET studies in support of preclinical drug discovery efforts supported by NIH, NINDS and its contributors. The work may include any individual service or combinations of services described (e.g. Synthesis, CADD, ADMET individually or in combination).
Any resultant Contractor must have the capacity to conduct from 1-10 projects simultaneously in the three phases (exploratory, hit-to-lead, lead optimization). The Contractor shall also have available sufficient professional and technical personnel, facilities and the capability to rapidly scale up or down the number of staff dedicated to the MCSP contract, depending on the number of projects underway at any given time
The NINDS may make multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) type contracts under this program. It is also anticipated that any resultant ID/IQ award(s) will be made in the first quarter of Fiscal Year 2018.

This is NOT a Request for Proposals (RFP). This is a Pre-solicitation Notice only. Request for Proposals (RFP) No. NIH-NINDS-17-01 entitled: "Medicinal Chemistry Support Program for Therapeutic Development (MCSP)" will be available electronically on or about July 17, 2017 and accessed only through the FedBizOpps website (URL: http://www.fedbizopps.gov). 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.