Inactive

Description: This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain inform... Description: This is a Research and Development (R&D) 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 R&D 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. Background: The mission of the National Institute of Neurological Disorders and Stroke (NINDS) is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. Purpose/Objective: The NINDS is interested in identifying 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 final clinical study reports to be used by the NINDS and sponsored Investigators/Collaborators. 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 the NINDS and sponsored Investigators/Collaborators and ultimately serve as the basis to advance candidate compounds for further clinical development if appropriate. It is anticipated that up to three to five 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. Project Requirements: Organizations 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 in their response. Ownership/control of a clinical trial facility with capabilities for housing research subjects and performing Phase 1 clinical trials; Immediate access to supportive care in the event of a serious adverse event; Experience conducting both first in human SAD and MAD Phase I studies, in healthy volunteers in compliance with NIH and FDA regulations and ICH GCP guidelines; Capacity to perform multiple Phase 1 SAD and/or MAD clinical trials concurrently per year; Ability to perform timed sample collection including blood, urine, CSF and other bodily fluids/tissues; Ability to recruit and retain the trial subjects; access to neurology patients if required via existing relationships; Established relationships and/or in-house capabilities to provide specialized imaging for assessment and/or performing specific safety evaluations, e.g. CT, MRI, PET, EMG, EEG and ERG; Availability of an onsite investigational pharmacy including drug storage facility and limited cGMP capability for compounding and manipulations. Have current accreditation and certification for the performance of pharmacy services; Ability to work with a range of investigational products such as small molecule and/or peptide and/or antibody and/or protein products; 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; Ability to do bioanalysis including but not limited to PK, anti-drug antibody testing, and biomarker measurements; Established relationships and/or in-house capabilities to do exploratory efficacy measurements for a variety of neurological outcomes; Established quality control and assurance procedures; Ability to develop and maintain clinical trial databases; 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: Project managers Licensed physicians Research nurses Clinical pharmacologist with expertise in analysis and reporting of PK and pharmacodynamics (PD) data from Phase 1 clinical trials Medical specialists to perform safety assessments (e.g., ophthalmologists or neurologists) and PD measures Study coordinators and clinical research assistants/associates Pharmacovigilance Protocol development and oversight Data management/IT resources Statistical analyses Medical writing Suitable regulatory affairs including preparing submissions to the FDA Technical and administrative management infrastructure to ensure the efficient planning, implementation, communication, oversight and completion of all clinical operation services Capability statement /information sought. Respondents must provide clear and convincing documentation of their capability of providing the required services specified in this notice. Respondents 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. Respondents must submit their response 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 in an 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. Responses are limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested. Responses must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses must be submitted to Evan Feely, Contract Specialist, via e-mail at evan.feely@nih.gov. Facsimile responses are NOT accepted. All responses must be received on or before the closing date of this notice and reference notice number: 75N95023R00008. 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 SAM. 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).”