SOURCES SOUGHT
A -- Therapeutics for Rare and Neglected Disease (TRND) Program
- Notice Date
- 6/30/2010
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NIH-NHLBI-HG-11-27
- Archive Date
- 9/30/2011
- Point of Contact
- Kelli T Broda, Phone: 301-435-0332
- E-Mail Address
-
brodak@mail.nih.gov
(brodak@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), on behalf of the National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH) is conducting a market survey to assess the availability and technical capability of small business firms to perform small molecule (e.g. not monoclonal antibody, protein or vaccine) drug discovery and preclinical development services for the NIH Therapeutics for Rare and Neglected Disease (TRND) Program. The applicable NAICS Code is 541712 and the size standard is 500 employees. It is anticipated that one or more awards will be made by September 2011 for a period of two years, with options for additional services within each year. The goal of the TRND initiative is to bridge the wide gap in time and resources that often exists between basic research and human testing of new drugs. The effort is grounded in, but aims to improve and build upon, existing processes for drug development in the pharmaceutical industry. TRND will strive to move candidate compounds forward in the drug development pipeline until they meet Food and Drug Administration (FDA) requirements for an Investigational New Drug (IND) application. The TRND initiative is housed in the NIH Center for Translational Therapeutics (NCTT). NCTT through its TRND program will establish collaborations with biomedical and drug development researchers at universities and in industry to enable and implement drug discovery programs, from Hit Validation through IND approval. This contract will be used to perform pre-clinical drug discovery and development activities. It will not be used to perform human clinical studies. In addition to the development of new candidate drugs for rare and neglected diseases, the TRND initiative will seek to advance the field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial pre-clinical stage of development. The services required for this contract include full service capabilities in small molecule drug discovery and drug development capabilities, from the confirmation of hits to IND enabling studies, an animal vivarium and the capability to develop novel animal disease models for rare diseases, IND regulatory strategy, and preparation of the IND. The studies to be performed will be grouped according to the following drug development segments: (1) Hit to Lead (Confirmation of Hits), (2) Lead Optimization (Selection of Optimized Leads from Chemical Leads), (3) Efficacy/Biomarker Assays – which requires the ability to identify the best drug mechanism of action and biomarker assays for each particular drug project, (4) Animal Pharmacology Studies – which requires the ability to identify the best animal disease model resources for each drug project, and having a sufficient animal testing facility and vivarium to support this project, (5) Selection of Drug Candidate, (6) Investigational New Drug (IND)-Enabling Studies – which will be standard 12-15 month programs involving GLP testing of whether the drug has an acceptable preclinical drug safety profile, and developing an acceptable clinical dosage form, (7) Chemistry Manufacturing and Controls (CMC) Development; and (8) Regulatory Strategy and Assembly of IND. Contract requirements will also include project oversight services to manage and ensure the efficient implementation and timely completion of several drug projects from TRND simultaneously. This includes providing an infrastructure with responsibility for daily project management, communications, and reporting on project status, recommending modifications to project requirements and timelines, and managing any projects undertaken by subcontractors. The Contractor will also be required to develop, implement and maintain data management systems to support all assigned studies and drug projects. This includes providing secure in-house data management capabilities and equipment to submit, compile, store, collate, analyze, track and retrieve data, structures, results, specimens, reagents, biological agents, drug products produced and released, documents generated in product development, and data received from other compound screening activities performed by third parties. Small business firms having demonstrated experience in performing the above requirements are invited to submit capability statements. Capability statements must provide evidence of ability to perform and experience in performing the requirements described above and will be reviewed based on the following: 1) evidence of the firm’s status as a small business under NAICS code 541712 with a size standard of 500 employees; 2) ability to coordinate and manage a contract of this large scope and direct experience in performing projects of a similar nature; 3) ability to perform and experience in performing the requirements described above 4) qualifications and availability of personnel with experience in conducting the range of required drug development services, including experience in drug development studies and services and applicable Food & Drug Administration (FDA) regulatory requirements 5) availability of facilities, all needed types of animals including dogs and non-human primates, an animal vivarium, ability to develop drug efficacy biomarker assays and rare disease animal models, equipment, and resources necessary for the performance of the requirements identified above. This includes the appropriate licenses and inspections to carry out FDA regulated drug development studies and the following required certifications: GMP, GLP, and AAALAC accreditation. It is recognized that some contract requirements may need to be provided by subcontractors. Any portion of the work that the small business would require a subcontractor to perform should be identified, and the capability and experience of the subcontractor must be described. Any proposed subcontractors that will perform GLP drug safety testing studies must have already been audited. In addition, the small business should describe any previous working relationship with the subcontractor and provide documentation of the subcontractor’s commitment to perform the needed requirements under a subcontract with the small business. Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. This is NOT a Request for Proposals (RFP), and responses should NOT include budgetary information. Firms responding to this notice shall provide capability statements (original and three copies) no later than 3:30pm EST on the fifteenth (15th) calendar day from the date of this announcement to the following address: National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions, Rockledge II – Room 6102, 6701 Rockledge Drive – MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Kelli Broda, Contract Specialist. Capability statements may also be emailed (as a Word document or PDF): to Kelli Broda at: brodak@nhlbi.nih.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NIH-NHLBI-HG-11-27/listing.html)
- Record
- SN02193359-W 20100702/100630235537-d7a371a16397ce149c29b9af166d147c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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