SOLICITATION NOTICE
B -- Conduct of a Pre Clinical Non Human Primate Study for the Use of E-selectin in the Prevention of Secondary Stroke
- Notice Date
- 7/8/2010
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- 1671345
- Point of Contact
- Susan Nsangou, Phone: 3014432104
- E-Mail Address
-
nsangous@mail.nih.gov
(nsangous@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for a proposal. A solicitation document will not be issued and proposals will not be requested. National Institute on Drug Abuse, Office of Acquisitions- Neurosciences, Station Support/Simplified Acquisition on intends to negotiate on a sole source basis with the IIT Research Institute, 10 West 35th Street, Chicago, Illinois, for the study to conduct a pre-clinical non-human primate (NHP) study for the use of E-selectin in the prevention of secondary stroke. This is a part of the translational research within National Institute on Neurological Disorders and Stroke (NINDS), Stroke Research Branch, in Bethesda, Maryland. In the United States, stroke is the third leading cause of death and the leading cause of disability. Despite the use of antithrombotic drugs for the secondary prevention of stroke, 10% of patients who experience a cerebral ischemic event will go on to have a stroke within 90 days. The costs in medical treatment, lost productivity, and loss of quality of life are well documented. The development of new treatment strategies for the secondary prevention of stroke is a primary mission of the NINDS and an important issue for modern medicine. The NINDS has contracted for the engineering and manufacture of clinical grade recombinant human E-selectin within clinical good manufacturing practice (GMP) standards in sufficient volume for use in a stroke trial. The NINDS stroke trial will be the first human use trial, and the trial for which the initial investigational new drug (IND) application will be filed with the Food and Drug Administration (FDA.) IIT Research Institute has completed the toxicology tests, one in mice, and a pilot NHP study under a prior contract (now expired) with the National Cancer Institute. The NINDS is seeking continuity in the testing. FDA prefers continuity of test and manufacturing sites in providing data in support of human trials. Since IITRI performed two of three studies in the NINDS FDA-required toxicology studies, it is to the benefit of the government to sole source this contract due to the negative regulatory and costs implications in competing this work in the middle of toxicological testing for FDA approval. IITRI helped design the NHP toxicology study protocol. Therefore, as well as having performed the initial two studies, including the NHP pilot study in preparation for the full NHP toxicology study, the underlying assays and use of the delivery device, IITRI is solely qualified to finish the work on these regulatory tests. The latter is a critical component in that these devices have not been used with primates previously. Through the provisions of this agreement, the contractor will conduct a NHP preclinical toxicology study with E-Selection to support an IND application with the FDA for a Phase I clinical trial in humans. The anticipated period of performance is for a base period of 12 months. The acquisition is being conducted under simplified acquisition using FAR 12 procedures and is exempt from the requirements of FAR Part 6, Competition Requirement. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely with the discretion of the Government. Comments to this announcement, referencing synopsis number NOI1671345 may be submitted to the NIDA, Station Support/Simplified Acquisition Branch, 31 Center Drive, Bldg 31, Room 1B59, Bethesda, MD 20892-2080, and Attention: Susan A. Nsangou, Contracting Officer.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/1671345/listing.html)
- Place of Performance
- Address: Chicago, Illinois, United States
- Record
- SN02200368-W 20100710/100708235754-db04f2be41d71e6d14b0d5ab2986b08f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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