SPECIAL NOTICE
A -- Phase 1 Clinical Trial Services for Neurotherapeutics
- Notice Date
- 5/30/2014
- Notice Type
- Special Notice
- 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
- HHS-NIH-NINDS-RFI-14-004
- Archive Date
- 7/31/2014
- Point of Contact
- Annette Carter, Phone: (301) 496-5916, 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
- Phase 1 Clinical Trial Services for Neurotherapeutics: Request for Information (HHS-NIH-NINDS-RFI-14-004) Purpose The National Institute of Neurological Disorders and Stroke (NINDS), NIH is considering establishing a Phase 1 clinical trials contract program to support advancement of neurotherapeutics. The services provided under this contract program will support that part of NINDS's mission for the development of neurotherapeutics. The design, study population and procedures to be performed will vary from project to project; therefore NINDS would like to determine whether it is possible for a single vendor to provide the full range of services potentially required. NINDS is seeking feedback from potential sources regarding interest, availability, and costs for the desired resources and services. This announcement is a REQUEST FOR INFORMATION (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes. Background The proposed clinical trial services contract is envisioned as offering a mechanism to support Phase 1 clinical trials for neurotherapeutics, as well as other drugs of direct interest to NINDS. The term neurotherapeutics includes therapies targeted to indications due to dysfunction of the central and/or peripheral nervous system, which fall within the mission of NINDS or the Institutes and Centers that are part of the NIH Blueprint Neurotherapeutics Network (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). Compounds to be assessed may include small molecules, peptides, proteins or oligonucleotides provided by Contributors (e.g. NINDS grantees) to the program. Phase 1 studies denote clinical trials performed for characterization of safety, pharmacokinetics (PK) and pharmacodynamics (PD), although exploratory efficacy data may be collected in some instances. Pharmacodynamics (PD) is used here to encompass measures to assess target engagement, modulation of biological processes subsequent to target engagement, and modulated processes relevant to disease pathogenesis. It is anticipated that these will all be first-in-human clinical trials. Depending on the project, study populations may be healthy volunteers, demographic subsets of healthy volunteers, or patients with conditions of interest, typically mild forms of the proposed disease indication. NINDS will maintain frequent, close communication and contact in monitoring and providing oversight of the Phase 1 trials contract. In addition, under such a program the NINDS will provide the Phase 1 clinical trial unit contractor(s) with the following: • A detailed clinical trial synopsis or full protocol; • IND for the project (held by NIH or Contributor Institution); • cGMP manufactured investigational therapeutic for the clinical trial; • Access to design and performance of PK and PD assays used in preclinical development; • Expertise on the compound and indication under study. The extent of services provided by the Phase 1 clinical trial unit contractor(s) will vary somewhat depending on the specific requirement of each project, though are generally anticipated to be full service from finalization of the clinical protocol through writing of a complete study report. Technical Requirements The following are the requirements envisioned for the Phase 1 clinical trial unit contractor(s): • A track record of successful recruitment of healthy volunteer and patient populations, including capability for creating recruitment plans; • A clinical research unit with facilities and equipment for housing subjects, performing routine safety evaluations (e.g., vital signs, ECG), precisely timed phlebotomy and urine collection for PK/PD studies and processing of PK and PD samples ; o On-site sample storage facilities at room temperature, 4, -20 and -70 degrees Celsius; o CLIA (Clinical Laboratory Improvement Amendments) certified laboratory for performance of routine chemistry, hematology and urine safety tests; • Collection of cerebrospinal fluid (CSF) via lumbar puncture or with a temporary in-dwelling catheter; • Performance of and experience with cognitive testing, using paper or computer based systems; • Performance of PK and specialty PD assays on plasma, blood, or CSF; • Design and validation of PK and PD assays; • Regulatory support for writing of IND annual reports; • Data management capabilities/facilities necessary for the conduct/performance of a Phase 1 clinical trial, such as CRF design, data base compliant with Good Clinical Practice (GCP) guidelines; • On-site resuscitation equipment and a definitive plan for management of life-threatening adverse events; • Access to equipment required for diagnosis or special safety evaluations, including computerized tomography (CT), magnetic resonance imaging (MRI), proton emission tomography (PET), electromyography (EMG), electroencephalography (EEG) and electroretinography (ERG); o Note: Please describe access plan if located off-site. • Drug storage facility and shipment capability if study requires more than one site; • On-site and on-staff physicians with established experience in performance of Phase 1 clinical trials; • On-site study coordinators and staff to conduct study and perform site regulatory tasks; • Support as required from the following disciplines: o Medical writing to assist with finalization of protocol, investigators brochure and composition of complete study report; o Statisticians and programmers to assist with finalization of protocol, statistical analysis plan and data analysis; o Clinical research associates for study monitoring. • An investigational pharmacist with established experience in performance of Phase 1 clinical trials and an on-site investigational pharmacy with double locked access and storage capabilities at room temperature, 4, -20 and -70 degrees Celsius; • Limited cGMP capability in the investigational pharmacy for manipulations such as over encapsulation; • Pharmacovigilance capabilities for composition of serious adverse event reports and narratives; • A clinical pharmacologist with established experience in analysis of PK and PD from Phase 1 clinical trials and writing of pharmacology reports; • Access to clinical specialists for additional safety assessments that may be required on some studies, such as ophthalmology exam or detailed neurologic examination. Information Requested If your organization would be interested in providing services under such a contract program, please address your interest, qualifications, experience, and capabilities by responding to the following five areas outlined below. It would be appreciated if responses were limited to no more than ten (10) pages. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Generic marketing brochures are not wanted nor will they be considered. 1. Technical Requirements • Please address each of the bulleted requirements above. Please identify which requirements can be performed in your organization's facility and which would require subcontracting. 2. Experience • Provide the total number of Phase 1 studies conducted in the last 3 years in healthy volunteers and in patient populations relevant to neurotherapeutic development and stratified by small molecule, protein therapeutics or oligonucleotides. 3. Quality • Please describe your organization's internal quality control processes; • How many times has the facility been audited by FDA? Please summarize any Form 483 citations and remediation. 4. Costs • Please provide an estimate of the typical costs for the each of the bulleted Technical Requirements described above. o Please comment on cost of a typical healthy volunteer single ascending dose trial alone, a multiple ascending dose trial alone, and a combined single and multiple ascending dose trial. 5. Business and Organization Information • The Government does not intend to provide liability insurance nor indemnify any contractor under this program. Given that, how would your organization handle this, e.g., via obtaining your own Clinical Trial Insurance, a certificate of insurance or indemnification from the Contributor (IND holder), etc...? Please address. • A list of current and/or prior federal contracts directly with the Government or as a subcontractor to another organization for services called for in this notice; • Type and size of your business organization, e.g., Large Business, Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization. Responses Please submit 3 copies of your response to the attention of Annette Carter, Contracting Officer, National Institutes of Health, NINDS R&D CMB, 6001 Executive Blvd., Suite 3287, Bethesda, MD 20892-9531 or via courier to Rockville, MD 20852 by 4:00 PM Local Time on Friday, June 27, 2014. Electronic submittal will also be accepted at cartera@mail.nih.gov (please format for printing). This Request for Information (RFI) 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. Acknowledgement 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 request for information 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. 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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