SOLICITATION NOTICE
R -- Investigating mechanism of action of DAC HYP in the treatment of Multiple Sclerosis(MS)
- Notice Date
- 4/23/2010
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- 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
- 1569785
- Archive Date
- 5/15/2010
- Point of Contact
- Jasmine D Snoddy, Phone: 301 594 1571
- E-Mail Address
-
snoddyj@mail.nih.gov
(snoddyj@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. The National Institute on Drug Abuse (NIDA) Station Support/Simplified Acquisition (SS/SA) Branch, on behalf of the National Institute of Neurological Disorders and Stroke (NINDS) intends to negotiate and award a sole source purchase order to Laboratory Corporation of America, to investigate the mechanism of action (MOA) of CD25-blocking therapies in high inflammatory multiple sclerosis (HI-MS). The secondary goal of this study is to assess long-term safety and efficacy of CD25-blocking therapies in HI-MS. The purpose of these send-out research labs is to link the more limited research data (collected through these shared send-out research labs) performed on large number of patients in multicented trials with more extensive MOA research data generated by NIB investigators. The hope is that this clinical will: 1) define and subsequently validate biomarkers predictive of clinical efficacy of CD25-blocking agents in MS disease activity and disability, 2) define biomarkers predictive of side effects (and thus will help to select out patients who may be at high risks of side-effects) and 3) define entire MOA of CD25-blocking agents on the human immune system. Because of the entire purpose for the send-out research tests to be acquired under NIB protocol T-N1335 is to assure compatibility with the send-out research tests acquired under multicentric ongoing and planned Phase II/III trails sponsored by Biogen/Facet, NIB has to utilize the identical pre-specified laboratory (i.e. Esoterix) as Biogen/Facet utilizes for all DAC HY P clinical trials. This is the only known source to provide current research data. The period of performance will be April 30, 2010-May 31, 2013. The acquisition is being conducted under simplified acquisition using FAR 12 procedures and is exempt from the requirement 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 1569785 may be submitted to the NIDA, Station Support/Simplified Acquisition Branch, 31 Center Drive, Bldg. 31, Room 1B59, Bethesda, Maryland 20892-2080 and Attention: Jasmine Snoddy, Contract Specialist.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/1569785/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02130772-W 20100425/100423235333-37d6e42d559dbf018fe147666ac5d48b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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