SOURCES SOUGHT
R -- Contractor support on clinical trial of Exendin-4 treatment for Alzheimers
- Notice Date
- 4/15/2016
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SS-2016-325
- Archive Date
- 5/17/2016
- Point of Contact
- Hunter A. Tjugum, Phone: 301 435 8780
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a "Sources Sought" notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method, including whether a small business social-economic set-aside, competitive or non-competitive method is possible, and to determine the availability of all qualified companies technically capable of meeting the Government's requirement. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE The NAICS code applicable to this requirement is 541990 All Other Professional, Scientific and Technical Services with associated small business size standard $15.0 million. Background The National Institute of Aging (NIA), one of the 27 Institutes and Centers of the National Institutes of Health, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. The Laboratory of Neurosciences (LNS) in the Intramural Research Program (IRP) at the NIA seeks to understand, at the molecular and cellular levels, the events that occur in the nervous system during aging and the mechanisms responsible for aging of the nervous system and age-related neurodegenerative disorders such as Alzheimer's, Parkinson's and Huntington's diseases, and stroke. A broad array of experimental models and cutting-edge genetic, molecular and biochemical technologies are being applied to accomplish this goal. Knowledge gained in such basic research is being applied in preclinical studies to develop approaches (diet, drugs and cell therapy) for preventing and treating these disorders. To determine the safety and tolerability, as well as to acquire preliminary evidence for the effectiveness of twice daily administration of Exendin-4 as a treatment for early-stage Alzheimer s disease or mild cognitive impairment, NIA has lauched into a Pilot Study of Exendin-4 in Alzheimer s Disease. Exendin-4 (or Exenatide) is a medication currently used to treat diabetes, but it has shown promising results in tests of its effectiveness in protecting neurons from damaging processes associated with Alzheimer s disease. It is possible that Exendin-4 may be a treatment for Alzheimer s disease, which involves the gradual deterioration and death of neurons. Researchers are interested in studying the safety and comparing the effects of Exendin-4 with placebo to on congestive performance, overall clinical progression, various chemicals measured in blood and cerebrospinal fluid, and brain MRI, in individuals with early-stage Alzheimer's disease or mild cognitive impairment. (protocol #10-AG-0423 clinicalstudies.info.nih.gov) Purpose and Objectives This Small Business Sources Sought notice seeks to determine eligible sources with the capability to provide the required services stated herein. LNS has a potential requirement to obtain contractor support services to provide laboratory support for the NIA Protocol 10-AG-0423 ("A pilot clinical study of Exendin-4 in Alzheimer's disease"), in regards to the measurement of CSF and plasma biomarkers of Alzheimer's disease. The pilot clinical study of Exendin-4 in Alzheimer's disease describes a Phase II double-blinded placebo-controlled randomized clinical trial of Exendin-4 in patients with early Alzheimer's disease. Up to 120 participants will undergo screening procedures so that 40 participants will meet eligibility criteria and be enrolled into treatment with Exendin-4 or placebo for 18 months. Screening includes a blood draw to provide plasma and a lumbar puncture to provide cerebrospinal fluid (CSF). Eligibility, among other criteria, is based on the results of cognitive testing and levels of a CSF biomarker of Alzheimer's disease [amyloid beta peptide (Ab1-42)]. Enrolled participants will be followed over a course of 18 months and will return periodically for study visits. Specifically, enrolled participants will return for follow up at 6, 12, and 18 months after treatment initiation. Returning participants will provide plasma in each of the above visits and (optionally) CSF at the final 18 month visit. Project Requirements The Government will provide to the contractor de-identified CSF and plasma samples from study participants. Each sample will be marked by a study identification number, a study visit number the type of biofluid contained (plasma vs. CSF) and the date of acquisition. The contractor will obtain and report results of measurements performed on samples obtained according to the schedule below. These measurements will be performed according to established laboratory standards for quality control to ensure validity and accuracy of the results. Specifically, contractor shall be responsible to perform the following levels of analysis. A. Screening visit (Up to 120 participants) - CSF samples (5 ml) i. Measurement of the levels of the amyloid beta peptide (Ab1-42) ii. Measurement of the levels of the total tau protein (t-tau) iii. Measurement of the levels of the tau protein phosphorylated on threonine 181 (pTau181) - Plasma samples (5 ml) i. Measurement of the levels of the amyloid beta peptide (Ab1-42) and the amyloid beta peptide (Ab1-40) and of the ratio (Ab1-42/ Ab1-40) B. Six (6), and 12 month study visits (Up to 40 participants) - Plasma samples (5 ml) i. Measurement of the levels of the amyloid beta peptide (Ab1-42) and the amyloid beta peptide (Ab1-40) and of the ratio (Ab1-42/ Ab1-40) C. 18 month study visit (Up to 40 participants) - CSF samples (5 ml) i. Measurement of the levels of the amyloid beta peptide (Ab1-42) ii. Measurement of the levels of the total tau protein (t-tau) iii. Measurement of the levels of the tau protein phosphorylated on threonine 181 (pTau181) -Plasma samples (5 ml) i. Measurement of the levels of the amyloid beta peptide (Ab1-42) and the amyloid beta peptide (Ab1-40) and of the ratio (Ab1-42/ Ab1-40) The contractor shall retain any unused portion of the samples and return it to the NIA at a reimubursable cost. The contractor shall provide a written report of the analysis of CSF samples within 30 days from their receipt. The contractor shall provide a written report of the analysis of plasma samples every 6 months. The report will include the subject's study identification number, a study visit number, the type of biofluid contained (plasma vs. CSF) and the date of acquisition. Period of Performance: The anticipated period of performance of this potential requirement is 12 months from June 2, 2016 through June 1, 2017 with an option of four (4) subsequent option years. CAPABILITY STATEMENT / INFORMATION SOUGHT Interested parties are expected to review this notice to familiarize itself with the requirements of this product or service. Failure to do so will be at your firm's own risk. Respondents must provide clear and convincing evidence of any published manuscripts of research conducted in the subject area as part of their responses, such as analysis of biomarkers of plasma and CSF samples for the standardization of biomarkers for Alzheimer's disease. Respondents must also include documented experience in the preparation and interpretation of changes in biomarkers associated with treatment of Alzheimer's disease. Respondents should provide a general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. Page limit is not inclusive of cover letter or resumes or CV's. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist identified in this announcement. Facsimile responses will NOT be accepted. Respondents must reference announcement number HHS-NIH-NIDA-SSSA-SS-2016-325 on all correspondence related to this announcement. The response must be submitted to Hunter Tjugum, at hunter.tjugum@nih.gov prior to the closing date specified in this announcement. The response must be received on or before the closing date specified in this announcement. Facsimile responses will not be accepted. CONCLUDING STATEMENTS Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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