SOURCES SOUGHT
A -- Phase I Clinical Trials Facility for Development of Neurotherapeutics
- Notice Date
- 1/13/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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
- SB-SS-NIH-NINDS-15-01
- Point of Contact
- Annette Carter, Phone: (301) 496-1813, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
cartera@mail.nih.gov, kd17c@nih.gov
(cartera@mail.nih.gov, kd17c@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Small Business Sources Sought Notice NIH-NINDS-15-01 Phase I Clinical Trials Facility for Development of Neurotherapeutics The National Institute of Neurological Disorders and Stroke (NINDS) is interested in identifying Small Business organizations with requisite qualifications and capabilities to provide a full service, turn-key Phase I Clinical Trials Facility in support of the development of novel neurotherapeutic agents. This full service facility is to perform a full range of services from protocol development through submission of clinical study reports to be used by the NINDS, sponsored Investigators or Contributors in support of Investigative New Drug (IND) applications. The emphasis of this Phase I Clinical Trials Facility will be to perform Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Phase I clinical trials utilizing NINDS-supplied novel agents developed by NINDS, sponsored Investigators or Contributors with an emphasis on first in human testing to determine the tolerated dose range, the dosing regimen, the safety profile and pharmacokinetic (PK) parameters. Assigned Phase I Clinical Trials may also include pharmacodynamics (PD), and evaluation of biological effects and early signs of efficacy. The data generated from these trials will be used by NINDS, its Contributors or sponsored Investigators in support of IND applications and ultimately serve as the basis to advance candidate compounds for further clinical development. It is anticipated that one to two Phase I Clinical Trials will be performed per year for the duration of the contract, and that multiple Phase I Clinical Trials will likely need to be conducted concurrently at the Phase I Clinical Trials Facility. The applicable North American Industry Classification System (NAICS) code for this requirement is 541712. Therefore, the small business size standard for this announcement is 500 or fewer employees. Please note that in order to qualify as an eligible small business for purposes of a small business set-aside (where large businesses would be excluded from competing), at least 50% of the direct labor cost must be "in-house". Specifically, FAR 52.219-14, "Limitations on Subcontracting," states that "at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern." Responses to this announcement must address how your business meets the applicable size standard. Small businesses that meet the applicable size standard above and who believe that they have the experience and possess the requisite qualifications and capabilities to provide a full service, turn-key Phase 1 Clinical Trial Facility, are asked to address each of the following capabilities and submit a response. a) Ownership/control of a clinical trial facility with capabilities for housing research subjects and performing Phase 1 clinical trials; b) Experience conducting both SAD and MAD Phase I studies, first in human, in healthy volunteers and patients in compliance with FDA regulations and ICH GCP guidelines; c) Capacity to perform multiple Phase 1 SAD and/or MAD clinical trials concurrently per year; d) Ability to perform timed sample collection including blood, urine, CSF and other bodily fluids/tissues; e) Ability to recruit and retain the trial subjects; f) Established relationships and capabilities to provide specialized imaging for assessment and/or performing specific safety evaluations, e.g. CT, MRI, PET, EMG, EEG and ERG; g) Availability of an onsite investigational pharmacy including drug storage facility and limited cGMP capability; h) Availability of a certified laboratory for conducting hematology, chemistry and sample testing including on-site specimen storage facility at room temperature, 4, -20 and -70 degrees Celsius; i) Established quality control and assurance procedures; and j) Experience, expertise, and availability of in-house and/or on-staff personnel necessary to perform inpatient Phase 1 clinical trials, including first in man trials, to include, but not limited to: 1) Licensed physicians 2) Research nurses 3) clinical pharmacologist with expertise in analysis and reporting of PK and pharmacodynamics (PD) data from Phase 1 clinical trials 4) medical specialists to perform safety assessments (e.g., ophthalmologists or neurologists) and PD measures 5) study coordinators and clinical research assistants/associates 6) pharmacovigilance 7) protocol development 8) data management/IT resources 9) statistical analyses 10) medical writing 11) suitable regulatory affairs including preparing submissions to the FDA 12) technical and administrative management infrastructure to ensure the efficient planning, implementation, communication, oversight and completion of all clinical operation services Responses must address each of the capabilities stated above. Generic marketing brochures or capability statements are not wanted nor will they be reviewed. Please submit one (1) electronic copy of your response to the following e-mail address: Ms. Annette Carter, Contracting Officer, cartera@mail.nih.gov. All responses to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to Ms. Annette Carter, Contracting Officer, at cartera@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SB-SS-NIH-NINDS-15-01. ALL RESPONSES ARE DUE NO LATER THAN 5:00 PM EASTERN STANDARD TIME ON JANUARY 28, 2015. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS, and if your business concern is NOT a small business, 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 subsequent Request for Proposals will be set-aside for small businesses only and a future Pre-Solicitation Notice for this requirement would indicate this determination. 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. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this Small Business Sources Sought announcement or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. 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/SB-SS-NIH-NINDS-15-01/listing.html)
- Place of Performance
- Address: Contractor's facility., United States
- Record
- SN03615404-W 20150115/150113235154-bc43d57159634b5ccb32d18448e7670a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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