SOLICITATION NOTICE
A -- Drug Discovery & Preclinical Development Services for the NIH Therapeutics for Rare and Neglected Disease (TRND) Program
- Notice Date
- 9/8/2010
- Notice Type
- Presolicitation
- 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
- NHLBI-HG-11-27
- Archive Date
- 9/30/2011
- Point of Contact
- Kelli T Broda, Phone: 301-435-0332, Lynn M Furtaw, Phone: 301-435-0357
- E-Mail Address
-
brodak@mail.nih.gov, lynn.furtaw@nih.gov
(brodak@mail.nih.gov, lynn.furtaw@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 interested in soliciting proposals from all interested organizations 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. This acquisition will be competed under full and open competition. 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 the two year period. 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. NHGRI intends to seek deviations from FAR clause 52.227-11, Patent Rights-Retention by the Contractor (Short Form) (June 1989) and FAR clause 52.227-14, Rights in Data-General (December 2007). More information on the content of the deviations will be provided in the solicitation. Potential offerors will be afforded an opportunity to comment on the proposed deviations and to identify the impact these deviations may have on their conduct of work should they be awarded a contract. The due date for comments will be specified in the solicitation. Thereafter, NHGRI will consider this input and determine whether alternative courses of action may be appropriate. The solicitation will be made available electronically on or about 15 calendar days after the date of this notice. No paper copies will be available. Proposals will be due on or about November 22, 2010. Offerors are responsible for downloading their own copy of the solicitation and for routinely checking the internet site for any possible solicitation amendments that may be issued by the Government. This advertisement does not commit the Government to award a contract. Original Point of Contact Lynn Furtaw, Contracting Officer, Phone (301) 435-0357, Fax (301) 480-3432, E-mail furtawl@nhlbi.nih.gov or Kelli Broda, Contract Specialist, Phone (301) 435-0332, Fax (301) 480-3432, E-mail brodak@mail.nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HG-11-27/listing.html)
- Record
- SN02272825-W 20100910/100908235537-c393b1d548c42522bacfcbfdbed6ad65 (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 |