SPECIAL NOTICE
A -- Drug Manufacturing and Formulation Services for Neurotherapeutics
- Notice Date
- 3/21/2013
- Notice Type
- Special Notice
- 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-RFI-NS-13-001
- Point of Contact
- Laurie A Leonard, Phone: 301 496-1813, Annette Carter, Phone: (301) 496-5916
- E-Mail Address
-
ll44s@nih.gov, cartera@mail.nih.gov
(ll44s@nih.gov, cartera@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PURPOSE The Blueprint Neurotherapeutics Network (BPN) through the National Institute of Neurological Disorders and Stroke (NINDS) is considering developing a drug product development program for the manufacture and formulation of dosage forms suitable for administration in preclinical and clinical studies. The goal of the product development program is to manufacture the active pharmaceutical ingredient (API), formulate the API, package, label, store, and distribute completed drug product to preclinical and clinical trial sites. The NINDS envisions awarding a contract for drug manufacturing and formulation services. The Institute is conducting market research to help determine how best to structure contract(s) for this work. BACKGROUND The NIH Blueprint established the Neurotherapeutics Network (BPN) to enable drug discovery by the neuroscience community. The BPN offers neuroscience researchers a "virtual pharma" network of contract service providers and consultants with extensive industry experience to develop promising hit compounds from chemical optimization through Phase I human clinical testing. A long term goal is to produce effective medication for a disorder of the nervous system that is currently poorly treated or untreatable. BPN will provide early chemistry knowledge and assist in technology transfer from discovery labs to the product development service provider. Services described below are important next steps for BPN contributors and quality service facilities are needed to develop and prepare drug products for human testing. For additional information on the Neurotherapeutics Network, please visit http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm. The NINDS is considering a drug product development program to assist our BPN contributors. This program is envisioned as a collaborative effort between a service facility and contributors with compounds ready to manufacture. The service facility shall provide: • Chemistry scale up and process development • Manufacture of active pharmaceutical ingredients • Receipt and storage of API • Preformulation & Formulation of API o Analytic method development o Stability studies • Fill and finish of formulations suitable for clinical trial • Packaging, labeling, and storage • Distribution to clinical trial sites The service facility shall be responsible for overseeing the program and providing guidance on individual projects. The service facility shall assist BPN contributors with shipment requirements. The service facility shall complete the work in a timely fashion. Service facility shall provide data and reports in a format suitable for inclusion in IND applications and shall assist in the development of the applications. INFORMATION REQUESTED This Request for Information (RFI) seeks input on the design of this program from potential service contractors with staffing and equipment for drug product development studies and GMP manufacturing through Phase I and/or Phase II clinical trials. Please respond to the section below. If you would be interested in competing for a contract to provide services to the NINDS and the BPN contributors, please provide the following information in no more than five (5) pages: • Brief summary of your background and past commercialization success applicable to this program. Please do not provide your generic capabilities statement. • Indicate the type and size of your business organization, e.g., Large Business, Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization. • Brief summary of your manufacturing and formulation capabilities, resources, and typical costs for the formulation and GMP scaling services described above. Please indicate what can be done in-house and what would/may require subcontracts • Brief description of the dosage forms that your service primarily manufactures and processes in place to manufacture and test forms outside your capabilities • Brief description of your transfer out process • Brief description of how your company typically handles intellectual property generated in the course of performing manufacturing and formulation development work for clients. For example, do you operate primarily as a fee-for-service organization? • Other comments and suggestions regarding the proposed program RESPONSES This Request for Information (RFI) 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. Acknowledgement 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 request for information 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. Responses should be identified with NINDS RFI NS-13-001 and are due by April 22, 2013. Please submit your responses to the attention of Laurie Leonard, Contracting Officer at the following email address: leonardl@mail.nih.gov by 4:00 PM Local Time on April 22, 2013. Electronic submissions will be accepted only.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/NINDS-RFI-NS-13-001/listing.html)
- Record
- SN03017748-W 20130323/130321234643-18443dffc5e2bc336a07b21974914a6f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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