SOURCES SOUGHT
A -- Medicinal Chemistry Services for Neurotherapeutics
- Notice Date
- 4/19/2010
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, Maryland, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- NINDS-SB-SS-10-02
- Archive Date
- 5/19/2010
- Point of Contact
- Annette Carter, Phone: (301) 496-5916
- E-Mail Address
-
cartera@mail.nih.gov
(cartera@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- MEDICINAL CHEMISTRY SERVICES FOR NEUROTHERAPEUTICS (MCNP) SMALL BUSINESS SOURCES SOUGHT - NINDS-SB-SS-10-02 PURPOSE: The National Institute of Neurological Disorders and Stroke (NINDS) has a requirement 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. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS, and if your business concern is NOT a small business, there is no need to respond to this announcement. Once a determination is made regarding the suitability of this future requirement for a small business set-aside or an open competition to include both large and small business, a separate Pre-Solicitation Announcement will be issued in advance of the release of a Request for Proposals. The applicable North American Industry Classification System (NAICS) code for this requirement is 541711. Therefore, the small business size standard for this announcement is 500 or fewer employees. Please note that in order to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the direct labor cost must be in-house. Specifically, FAR 52-219-14 - Limitations on Subcontracting states that at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern. Submitted Capability Statements must address how the business meets the applicable size standard designated for this project. BACKGROUND: 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 include the following components, which will interact as indicated: • 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). • Medicinal chemistry consultants. The NIH will hire consultants to assist the COTR in reviewing proposals, reports, and data produced by the Contractor and Contributors. • 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. The goal of the Blueprint 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. Medicinal chemistry for Blueprint projects will be supported through the base award and first option item of this contract award. For drug development projects that are not a part of the Blueprint program, the NIH will acquire medicinal chemistry on a project-by-project basis through the exercise of option items under this contract. 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 sought a Declaration of Exceptional Circumstances (DEC) to the Federal Acquisition Regulations (FAR) for this contract. The DEC enables the Contributors to retain control of the intellectual property for compounds created through the MCNP. INFORMATION REQUESTED: Your response should demonstrate your ability and related experience in a requirement-specific Capability Statement to: 1) Develop and implement strategies for medicinal chemistry optimization; 2) Provide milligram-scale and scale-up synthesis of chemical analogs; 3) Provide appropriate in vitro assays if it becomes necessary to explore the Structure-Activity Relationship around a particular pharmacological or toxicological property; 4) Provide compound management and registration services; 5) Rapidly scale chemistry capacity (including dedicated chemistry staff) up or down in order to support the anticipated workload. The Capability Statement should indicate how many chemists and other staff that the small business would be able to dedicate to such a contract, and which of those would be available in-house. Please submit 3 copies of your response to the attention of Annette Carter, Contracting Officer at the address provided by 4:00 PM Local Time on Tuesday May 4, 2010. Electronic submittal will also be accepted at cartera@mail.nih.gov (please format for printing). You are encouraged to limit you response to fewer than 15 pages and your response must specifically address each of the requirement specific information requested items stated above. Generic marketing brochures will not be considered further. This Announcement is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this announcement or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. All respondents are asked to indicate the type and size of your business organization, e.g., Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, or 8(a). Annette Carter, Contracting Officer, National Institutes of Health, NINDS R&D CMB, 6001 Executive Blvd., Suite 3287, Bethesda, MD 20892-9531 or via courier to Rockville, MD 20852.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/NINDS-SB-SS-10-02/listing.html)
- Record
- SN02126081-W 20100421/100419235041-36174de94d1c6fc98130141bc4812223 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |