SOURCES SOUGHT
A -- NINDS Epilepsy Therapy Screening Program
- Notice Date
- 12/16/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, Maryland, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- SBSS-NIH-NINDS-16-02
- Archive Date
- 1/15/2016
- Point of Contact
- Jason S Williams, Phone: 3014965985, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
willjas@mail.nih.gov, kd17c@nih.gov
(willjas@mail.nih.gov, kd17c@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- NINDS EPILEPSY THERAPY SCREENING PROGRAM (ETSP) FULL TITLE: "The Identification and Differentiation of Therapeutics to Prevent, Modify and Treat Pharmacoresistant Epilepsy for the NINDS Epilepsy Therapy Screening Program (ETSP)" PURPOSE OF NOTICE: The purpose of this announcement is to identify and assess the availability of small business concerns with the requisite capabilities and qualifications to conduct multiple preclinical pharmacological evaluations of investigational compounds directed at identification of potential therapies to prevent, modify and treat epilepsy and related seizure disorders. On a limited basis the contractor may also perform model development and validation and conduct pharmacokinetic studies using normal or epileptic animals. The contract shall require the contractor to conduct studies in the following performance areas including, but not limited to: anti-seizure screening in acute and chronic seizure models, models of anti-epileptogeneis and disease modification, models of special epilepsy populations and genetic epilepsies, models and endpoints associated with recognized comorbidities of epilepsy and pharmacokinetic studies. Initial in vivo testing will routinely utilize male rodents but female rodents will also be required on specified candidate compounds. The envisioned contract award is a follow-on requirement to the current National Institute of Neurological Disorders and Stroke (NINDS) Anticonvulsant Screening Program (ASP) requirement currently being performed under NINDS contract HHSN271201100029C at the University of Utah, where the requirement has been performed since the inception of this program in 1975. The NINDS is seeking Small Business Capability Responses at this time in order to determine if this future follow-on requirement can be set-aside exclusively for small business concerns. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS, and if your business concern is NOT a small business concern, there is no need to respond to this announcement. Once a determination is made regarding the suitability of this future follow-on requirement for a small business set-aside (or an open competition to include both large and small businesses), a separate Pre-Solicitation Announcement will be issued in advance of the release of a Request for Proposals. BACKGROUND: The NINDS Epilepsy Therapy Screening Program (ETSP), until recently known as the Anticonvulsant Screening Program (ASP), was established in 1975 as part of a larger Antiepileptic Drug Development (ADD) program that included basic and clinical research, and extra- and intramural components. The ASP arm was added to address a critical need for new anti-seizure medications and to promote industry interest in their development, and it is the only remaining component of the original ADD program today. Since its inception, the program has been supported through a contract with the University of Utah, which NINDS initially awarded after open competitions in 1974, 1980 and 1984, and renewed thereafter on a sole-source basis. The screening process involves researchers from academia and industry in the U.S. and abroad ("ETSP participants") submitting compounds to the ETSP for investigation in a series of animal (rodent) seizure models. These tests are performed blinded by the contract laboratory and on a confidential basis through a written agreement between the NINDS and the ETSP participant at no cost to the ETSP participant. The NINDS reports test results to participants and provides advice on future steps for promising compounds, while protecting confidentiality and intellectual property. Over 32,000 compounds have been screened to date, and the ASP has contributed to bringing 10 antiseizure drugs to market since 1990, with a major role in some and a minor role in others. The ETSP was recently reviewed by Working Groups commissioned by the National Advisory Neurological Disorders and Stroke (NANDS) Council in 2011 and 2014. The Working Groups' recommendations were consistent in both reviews in favor of prioritizing the identification of treatments for drug refractory epilepsy, epileptogenesis, and disease modification over the identification of additional undifferentiated acute seizure drugs. The new name of the program is meant to emphasize that a major focus is going beyond the symptomatic treatment of seizures to identifying agents that have the potential to prevent their development. NAICS CODE and APPLICABLE SMALL BUSINESS QUALIFICATION: Based on the nature and type of compound screening and testing that will be required under the proposed project and considering the ultimate objective of this program to provide a full range of preclinical pharmacological screening and testing for investigational compounds using models of brain dysfunction designed to identify possible new therapeutics that could be further developed as possible treatments for seizure related disorders, this requirement is best denoted as a research and development project and is best classified by North American Industrial Classification System (NAICS) 541711, "Research and Development in Biotechnology". This is not a program management-type requirement, rather the contractor is expected to possess the expertise and resources to implement a broad range of applied preclinical pharmacological compound screening activity for epilepsy and related disorders. The small business size standard for NAICS Code 541711, "Research and Development in Biotechnology", is 500 or fewer employees. Furthermore, per FAR 19.001, a small business concern means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business in the United States or its outlying areas and that makes a significant contribution to the U.S. economy through payment of taxes and/or use of American products, material and/or labor, etc.. Small business concerns that meet the applicable NAICS code size standard and who believe that they have the capabilities, capacity, experience and qualifications to provide the full range of preclinical pharmacological investigational compound screening are asked to address each of the areas described in the Information Requested section below as part of a submitted Capability Statement. Please ensure that your response is complete and sufficiently detailed to assist in our evaluation as to whether or not this requirement could be set-aside for small business participation only. If your business is NOT a small business concern with regard to the aforementioned NAICS code, there is no need to respond to this announcement. If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns, the anticipated Request for Proposals may be set-aside for small business concern participation only and a future Pre-Solicitation Notice for this requirement would indicate this determination. Responses to this announcement must address how your business meets the applicable NAICS code size standard and must include the respondents' DUNS number; organization name; organization address; point of contact, including title, address, telephone, and e-mail address; and your current small business size status (e.g. small, small disadvantaged business, HUBZone small business, woman-owned small business, 8(a), etc.) pursuant to the applicable NAICS code specified above (NAICS 541711). INFORMATION REQUESTED: Small business concerns that meet the applicable NAICS code size standard and who believe that they have the expertise, experience and capacity to perform the compound screening studies described are asked to address each of the following items in your response to this Small Business Sources Sought Announcement as part of your submitted Capability Response: 1) Demonstrate evidence of proficiency in conducting studies with different rodent species by various routes of administration [oral gavage (p.o.), intraperitoneal (i.p.), subcutaneous (s.c.), and intracerebroventricular injection (i.c.v.)] performed in acute and chronic seizure models as follows. These include electrical stimulation models (maximal electroshock mouse and rat, mouse 6 Hz seizure test, mouse corneal kindled seizure test and rat pharmacoresistant amygdala kindled seizure test) and chemoconvulsant models (metrazol-, pilocarpine-, focal- and systemic kainic acid-) induced seizures. a. Provide data tables demonstrating quantitative pharmacological profiles for at least 10 clinically approved anti-seizure drugs (ASDs) by i.p. route of administration. The profiles require the following: ED50s & TD50s determinations, 95% confidence intervals, quantitative calculations must include at minimum eight rats or mice per test dose. Quantitation must be provided for both mouse and rat maximal electroshock tests, mouse 6 Hz seizure test and mouse corneal kindled seizure test. TD50 values (TD= "toxic dose") must be based on assessment of motor impairment in mice (rotarod test) and rats (assessment of minimal motor impairment). b. Provide data table demonstrating quantitative pharmacological profiles for at least 6 clinically approved anti-seizure drugs (ASDs) by i.p. route of administration. The profiles require ED50s determinations in a pharmacoresistant amygdala kindled seizure test and a chronic mouse model of mesial temporal epilepsy (mTLE) induced by focal administration of a chemoconvulsive agent. 2) Demonstrate capacity to perform annually the following quantitative screening of novel investigational compounds. Include technical staff, laboratory, animal and surgical facilities and equipment to handle concurrent testing requirements. a. At minimum 200 compounds in the mouse and rat maximal electroshock tests, mouse 6 Hz seizure test and mouse corneal kindled seizure test. b. At minimum 20 compounds in a rat model of pharmacoresistant amygdala kindled seizures and a mouse model of mesial temporal lobe epilepsy. c. At minimum 5 compounds screened in post-status epilepticus epileptic rats measuring spontaneous recurrent seizures chronically by video-EEG monitoring. This must include the capability of administering test compounds in food via an automated feeder system. d. Capability to screen a minimum of 20 investigational compounds in acute or cultured rodent hippocampal slice preparation determining concentration response activity against spontaneous bursting. e. At minimum 15 compounds evaluated in a rodent model of drug refractory status epilepticus. f. A minimum of 5 compounds evaluated for anti-epileptogenic effects in a status epilepticus-induced chronically epileptic rat by assessing the development of spontaneous recurrent seizures recorded by video-EEG monitoring. g. Demonstrate capability to perform pharmacokinetic studies on approximately 10 compounds. 3) Demonstrate experience in setting-up and validating new models in-house for screening investigational compounds for the treatment of pharmacoresistant epilepsy, disease modification and epileptogenesis. 4) Demonstrate capabilities to receive and store hundreds of investigational small and large molecules including Drug Enforcement Agency (DEA) Scheduled compounds (must possess DEA license for schedule I-V drugs). Capability to prepare dosing formulations and properly dispose of investigational compounds. Obtain, adequately house and maintain hundreds of mice and rats for periods of weeks to months between and during test cycles providing evidence of meeting all IACUC and PHS animal certification requirements, accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and approved Animal Welfare Assurance for the Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW), Office of the Director, NIH as required by Section 1-43-30 of the PHS Policy on Humane Care and Use of Laboratory Animals. Report-writing, data collection capabilities and record storage for up to ten years. Provide evidence of capabilities for IT security, and networking support for managing data and interface with NIH network. 5) Provide evidence of scientific expertise of the principle investigator in the evaluation of investigational compounds in models of epilepsy, the development and validation of rodent seizure models (demonstrated by peer reviewed scientific publications and invited speaker invitations) and broad knowledge in the epilepsy research field. Provide profile of company management team and their experience in management of epilepsy therapy screening business. Responses to this announcement should be limited to no more than 15 pages and must specifically address each of the items contained in the Information Requested section of this announcement. A generic marketing brochure would not suffice for purposes of determining a small business to be capable for this requirement and generic marketing brochures will not be evaluated. Please submit one (1) electronic copy of your response via e-mail to Mr. Jason Williams, Contract Specialist, at willjas@nida.nih.gov and one copy to Mr. Kirkland L. Davis, Contracting Officer, at kd17c@nih.gov in MS Word (.doc, docx) or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS-NIH-NINDS-16-02. As previously stated, you are encouraged to limit your response to no more than 15 pages. ALL RESPONSES ARE DUE BY 3:30 PM EASTERN STANDARD TIME ON JANUARY 7, 2016. This Small Business Sources Sought Announcement is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. Responses will be held in a confidential manner. Any proprietary information should be so marked.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/SBSS-NIH-NINDS-16-02/listing.html)
- Place of Performance
- Address: Contractor's facility, United States
- Record
- SN03971065-W 20151218/151216234417-28c2fd7d2e3f26734dd1df2fb7837751 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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