SOURCES SOUGHT
Q -- AAV2-GDNF for Parkinson’s Disease (PD)
- Notice Date
- 5/20/2014
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
- ZIP Code
- 20892-5480
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-2014-222
- Archive Date
- 6/21/2014
- Point of Contact
- Brian J. Lind, Phone: 301-402-1635, ,
- E-Mail Address
-
LindBJ@nida.nih.gov,
(LindBJ@nida.nih.gov, /div)
- Small Business Set-Aside
- N/A
- Description
- Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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. Background: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) Surgical Neurology Branch (SNB) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. In 2013 a Purchase Order was awarded to perform assays for Protocol 12-N-0137, a Phase I clinical trial which infuses a gene therapy agent into the brain of patients with Parkinson's disease. The trial is FDA-approved under IND 14,996. FDA and IRB approval of the protocol require assays of serum and cerebrospinal fluid for Anti-AAV2 antibody titers, GDNF protein levels, and anti-GDNF antibody levels. These assays are performed at baseline and at intervals up to five years following the gene therapy infusion, for a total of 10 time points per subject in 24 subjects. Purpose and Objectives: SNB has a requirement to procure assays for the AAV2- Glial cell-derived neurotrophic factor (GDNF). Baseline and post-infusion assays of immunologic responses to the gene therapy agent are required as safety and efficacy determinations. These assays will be instrumental in advancing research on Parkinson's Disease. Project requirements: The specific tasks required under this requirement are but not limited to the following: 1. Description of Tasks and Associated Deliverables: Prescreening Subjects for Anti-AAV2 Antibody Activity and Additional Assessment Serum and/or CSF samples will be stored at -20ºC or lower and shipped to Southern Research on dry ice. Samples for initial screening will be assayed within approximately two weeks from receipt for their anti-AAV2 neutralizing antibody titers using a cell-based assay. Additional samples collected during the clinical trial will be stored at -70ºC or lower and assayed at the conclusion of the various cohorts or as directed by the project officer. The assay to be used will be a cell-based anti-AAV2 neutralizing antibody (nAb) assay. Briefly, 293A cells will be plated in 96-well microtiter plates at 1 x 104 cells/well in 100 µL of culture medium and incubated overnight at 37ºC in 5% CO2. The following day, serum samples will be incubated at 56ºC for 45 minutes to inactivate complement and diluted 1:40 in culture medium, followed by seven 2-fold dilutions. A mouse anti-AAV monoclonal antibody (mAb), designated A20 (Fitzgerald Industries, Concord, MA), will be used as a positive control; it will also be diluted to various concentrations. Equal volumes of subject serum or A20 mAb dilutions will be mixed with a constant amount of AAV2 conjugated to green fluorescent protein (AAV2-GFP) and incubated at 37ºC in 5% CO2 for 1 hour. 100 µL of medium, medium plus AAV2-GFP, or serum/mAb samples that had been incubated with AAV2-GFP will be added to the plated 293A cells in duplicate. Plates will be incubated for an additional 2 days at 37ºC in 5% CO2. At the end of this incubation period, medium will be decanted, the plates blotted, and phosphate buffered saline (PBS) will be added (100 µL/well). Plates will then be read on a Synergy 4 plate reader and the percent inhibition of AAV2-GFP transfection caused by the serum samples will be assessed to determine the titer of nAb in the sample. Titer will be defined as the inverse of the lowest dilution where the relative fluorescent units (RFU) of the diluted sample is still above 50% of the assay maximum signal. 2. Assay of Serum and CNS Samples for GDNF Levels Human glial cell line-derived neurotrophic factor (GDNF) protein levels will be determined using an enzyme-linked immunosorbent assay (ELISA). Serum and/or CNS samples will be stored at -20ºC or lower and shipped to Southern Research on dry ice. The ELISA will be performed as an indirect ‘sandwich' assay as briefly described below, utilizing the GDNF Emax ImmunoAssay System (Promega, Madison, WI). Plates are coated overnight at 4ºC with an anti-GDNF mAb, washed, blocked for 1 hour at room temperature (RT) without shaking, and washed. A GDNF standard curve is performed in duplicate on each plate, as well as various dilutions of each test sample in duplicate. The plates are incubated at RT for 5 hours with shaking and washed. An anti-human GDNF polyclonal antibody (pAb) is added to the wells and plates are incubated overnight at 4ºC without shaking and washed. A horseradish peroxidase-conjugated chicken IgY anti-human IgG pAb (HRP-CαHuIgG) is added to each well and plates are incubated at RT for 2 hours with shaking and washed. GDNF levels are ultimately detected by adding a chemiluminescent HRP substrate and reading the relative light units (RLUs) on a Synergy 4 plate reader. GDNF levels are determined from the RLUs, using the GDNF standard curve. 3. Assay of Serum and CSF Samples for Anti-GDNF Antibody Levels Antibody activity in serum or CSF samples will be measured using an indirect ELISA. Serum and/or CSF samples will be stored at -20ºC or lower and shipped to Southern Research on dry ice. Briefly, plates will be coated overnight at 4ºC with an anti-GDNF capture antibody, washed, blocked at RT for 1 hour without shaking, and washed. A constant amount of GDNF is added and the plates are incubated at RT for 5 hours with shaking and washed. Various dilutions of serum, CSF, and/or an anti-GDNF control Ab (to generate a standard curve) are added in duplicate and plates are incubated overnight at 4ºC without shaking and washed. A biotinylated-detection pAb is added and plates are incubated at RT with shaking and washed. Next, a streptavidin-HRP conjugate is added to the wells; plates are incubated at RT for 20 minutes with shaking and washed. Anti-GDNF levels are ultimately detected by adding a chemiluminescent HRP substrate and reading the relative RLUs on a Synergy 4 plate reader. The amount of anti-GDNF Ab in the samples is determined from the RLUs, using the anti-GDNF standard curve. Anticipated period of performance: The anticipated period of performance if requirement moves forward is as follows: Base Year - September 1, 2014 through August 30, 2015 Option Year One - September 1, 2015 through August 30, 2016 Option Year Two - September 1, 2016 through August 30, 2017 Option Year Three - September 1, 2017 through August 30, 2018 Option Year Four - September 1, 2018 through August 30, 2019   Capability statement /information sought. The respondent response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the specialized requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted, to this market survey extensive experience with and the ability to perform all of the specialized requirements elsewhere described. 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. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (15) page limit. The 15-page limit does not include the cover page, executive summary, or references, if requested. 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 (facsimile responses are NOT accepted ) to: Brian J. Lind Contract Specialist NIH\NIDA\SSSA lindbj@nida.nih.gov The response must be received on or before June 6, 2014, 10:00 AM (EST). 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 presolicitation 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/HHS-NIH-NIDA-SSSA-SBSS-2014-222/listing.html)
- Place of Performance
- Address: National Institutes of Health, National Institute of Nuerological Disorders and Stroke, 10 Center Drive, Building 10, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03371272-W 20140522/140520234943-7bbb67d0ae7dea3543dfc821e224914c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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