SOURCES SOUGHT
A -- Medicinal Chemistry Services for Neurotherapeutics
- Notice Date
- 8/24/2009
- 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-SS-09-03
- Archive Date
- 10/8/2009
- Point of Contact
- Annette Carter, Phone: (301) 496-5916
- E-Mail Address
-
cartera@nida.nih.gov
(cartera@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- MEDICINAL CHEMISTRY SERVICES FOR NEUROTHERAPEUTICS SOURCES SOUGHT - NINDS-SS-09-03 PURPOSE: The National Institute of Neurological Disorders and Stroke (NINDS) is interested in identifying sources with the requisite capabilities and qualifications to provide 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 NINDS MCNP would support collaborations between a medicinal chemistry facility (Contractor) and academic or industry researchers (Contributors) with bioactive small molecule compounds and bioactivity assays to develop lead compounds with sufficient potency, efficacy, and drug-likeness to begin the preclinical pharmacology and safety (ADMET) studies required for an investigational new drug (IND) application. The NINDS anticipates initiating 8-10 exploratory chemistry and 2-5 chemical optimization projects per year, over a five-year period. Since chemical optimization projects may span more than a year, the NINDS will require the capacity to support up to ten (10) chemical optimization projects concurrently. Please note that the MCNP has been expanded beyond that previously described in the Small Business Sources Sought Notice NINDS-SS-09-01, in terms of the number of exploratory chemistry and chemical optimization studies that are anticipated each year. Again, the new estimates are for initiating 8-10 exploratory chemistry and 2-5 chemical optimizations projects each year, with up to ten chemical optimization projects underway at one time. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. 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: High-throughput screens and basic research studies have led to the discovery of many small molecule compounds with activity in models of nervous system diseases. Some of these compounds might be transformed into drugs, with chemical modifications to improve their potency and pharmacological properties. However, biotechnology and pharmaceutical companies are hesitant to invest in the early development of compounds for rare diseases or new targets, given concerns about profitability and risk. Academic researchers who have identified a promising compound rarely have access to medicinal chemistry services. The NINDS is considering a medicinal chemistry program to overcome these barriers to drug development. This program is envisioned as a collaborative effort between a medicinal chemistry service facility (Contractor) and researchers with bioassays that model neurological disorders and a bioactive small molecule compound (Contributors). The Contractor would provide: • Medicinal chemistry design and synthesis for chemical optimization studies • In vitro and in vivo assays appropriate for characterizing and optimizing the pharmacological activities of compounds. These may include assays for solubility, metabolic and chemical stability, membrane permeability, inhibition of major metabolic enzymes, and mutagenicity. This program will not include IND-enabling ADMET studies. • A data management system that can be accessed by the Contributors and NINDS staff The Contributors would provide: • Primary in vitro disease assay that is sufficiently robust and reproducible to reliably detect subtle differences in bioactivity among similar compounds and that is amenable to rapid screening • Secondary disease assay(s) sufficient to confirm the bioactivity detected in the primary assay and to provide sufficient proof of concept to justify clinical testing. • Small molecule compound(s) that show(s) activity in the assays described above and serve(s) as a starting point for optimization • Laboratory staff and other resources to test analog compounds in the disease assays, in the home laboratory, on a routine schedule. Potential Contributors could apply to NINDS for access to these medicinal chemistry services. Applications would be reviewed with rapid turn-around. The Contractor would assist Contributors with exploratory chemistry studies to determine if the starting compound is amenable to chemical optimization. For the most promising compounds, the Contractor would initiate chemical optimization, involving dozens of rapid, iterative rounds of analog synthesis and testing in close collaboration with the Contributor. Typically, analog compounds would be tested on a weekly or biweekly schedule, with results of the primary screening informing the subsequent analog design and synthesis by the Contractor. This work must be done confidentially. Contributors would conduct all of the tests involving disease-specific assays and models in their own laboratories. The NINDS is seeking a Declaration of Exceptional Circumstances (DEC) to enable the Contributor to receive the intellectual property rights to the analog compounds. The NINDS anticipates initiating 8-10 exploratory chemistry projects and 2-5 chemical optimization projects per year over the 5-year contract period. Since chemical optimization projects may span more than one year, the Contractor will need to be able to support up to ten (10) chemical optimization projects concurrently. 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 and in vivo assays if it becomes necessary to explore the Structure-Activity Relationship around a particular pharmacological or toxicological property, 4) Provide data and material management, and 5) Rapidly scale chemistry capacity (including dedicated chemistry staff) up or down in order to support anywhere from two to ten chemical optimization projects at any given time, based on the needs of NINDS. The Capability Statement should indicate how many chemists and other staff that your business would be able to dedicate to such a contract, and which of those would be available in-house. (The NINDS anticipates initiating 8-10 exploratory chemistry projects and 2-5 chemical optimization projects per year over the 5-year contract period. Since chemical optimization projects may span more than one year, the Contractor will need to be able to support up to ten (10) chemical optimization projects concurrently.) If you previously responded to the NINDS Small Business Sources Sought Notice NINDS-SS-09-01, please address item 5) only, indicating how your organization would staff the contract to complete the increased number of projects. 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 September 23, 2009. In lieu of hard copies, 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 must specifically address each of the requirement specific 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., Large Business, Educational Institution, Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a). If submitting hard copies, please send to: 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.
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