SOURCES SOUGHT
R -- Baseline and post-infusion assays of immunological responses to gene therapy agent for advanced Parkinson’s disease
- Notice Date
- 4/16/2014
- Notice Type
- Sources Sought
- 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
- HHS-NIH-NIDA(SSSA)-SS-14-164
- Archive Date
- 5/10/2014
- 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
- Description: This is a Sources Sought notice. This is NOT a solicitation, request for proposals (RFP), proposal abstracts, nor a request for quotations (RFQ). The purpose of this notice is to obtain information regarding the availability and capability to perform a potential requirement from ALL qualified sources that includes: (1) other than small businesses (large businesses, education institutions, non-profits, etc.); (2) small business sources; (3) HubZone small businesses; (4) service-disabled small businesses; (5) veteran-owned small businesses; (6) 8(a) small businesses; (7) veteran-owned small businesses; (8) woman-owned small businesses; (9) small disadvantaged businesses; and (10) private contractors and consultants, who can perform the requirements of the size classification relative to the North American Industry Classification System (NAICS) code as specified below. 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 quotations. 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. The 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 qualified companies technically capable of meeting the Government's requirement. ALL organizations with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice, NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE The NAICS applicable to this potential requirement is 541380, Testing Laboratories, with the associated small business size standard of $14.0 million. Background: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency mission 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) is a part of the National Institute of Health (NIH) supporting 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. The NINDS Surgical Neurology Branch (SNB) has an active research study, Protocol 12-N-0137, a Phase I clinical trial, which investigates the safety and effectiveness of infusion a gene therapy agent into the brain of patients with Parkinson's disease. The trial is FDA-approved under IND 14,996. Baseline and post-infusion assays of immunologic responses to the gene therapy agent and drug levels of the agent are required as safety and efficacy determinations. These assays will be instrumental in advancing research on Parkinson's disease. This is in line with the NINDS mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. Purpose and Objectives: The National Institute of Neurological Disorders and Stroke (NINDS) Surgical Neurology Branch (SNB) has a specific interest in advancing research on Parkinson's disease. Currently, the Surgical Neurology Branch (SNB) has a potential requirement to perform assays as required under Protocol #12-N-0137, which is a Phase I clinical trial that infuses a gene therapy agent into the brain of patients with Parkinson's disease. The trial is FDA-approved under IND 14,996. The purpose and essential requirement of this sources sought notice is to determine companies capable of prescreening PD subjects for Adeno-associated virus, serotype 2 vector (AAV2) antibody activity, and additional assessments for assays of serum for Glial cell line derived neurotrophic factor (GDNF) levels. These assays will be instrumental in advancing research on Parkinson's disease. Therefore, the procurement of assays required for the AAV2-GDNF research study is essential for continuing our study of Parkinson's disease. The research we are performing in this study may lead to new treatments for the disease. This is in line with the NINDS mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. Baseline and post-infusion assays of immunologic responses to the gene therapy agent and drug levels of the study agent are required as safety and efficacy determinations. Project requirements: Project requirements will include assays of immunologic responses to the gene therapy agent and drug levels of the study agent, which are required for safety and efficacy determinations. Assays will be obtained at the NIH Clinical Center and will be shipped to the contracting laboratory including anti-AAV2 antibody titer blood samples and three cerebrospinal fluid (CSF) samples. The assays will include detection of: 1) serum and CSF anti-AAV2 neutralizing antibody levels, 2) serum and CSF GDNF drug levels, and 3) serum and CSF anti-GDNF antibody levels. The anticipated period of performance is one (1) base year with an option to exercise four (4) additional 12-month option periods. Capability statements sought Respondents must provide a Capability Statement as part of their response that includes information on: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work (c) prior completed contractor support roles of similar nature, including any government contracts and/or contracts with commercial entities; and (d) experience and management capability as it relates to the functions described in this notice. Responses must include the respondents' DUNS number, company name, address, point of contact, and size and type of business pursuant to the NAICS code identified in this announcement. Other related information in the Capability Statement may include: Respondents' opinion as to the perceived difficulty and/or feasibility of this requirement or proposed acquisition; possible solutions and approaches that may currently exist in the marketplace; and information regarding innovative ideas or concepts as they relate to the development of a potential solicitation. Capability Statements shall be limited to 15 pages and submitted in response to this notice no later than the closing date specified in this announcement as an attached Adobe PDF or Microsoft Office file via email to hunter.tjugum@nih.gov. Respondents should include their technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. 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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