MODIFICATION
A -- Surviving Blood Loss Program-Research and Development
- Notice Date
- 1/16/2015
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-15-R-SBLP
- Response Due
- 1/21/2015
- Archive Date
- 3/17/2015
- Point of Contact
- Shawn Haubner, 508-233-6167
- E-Mail Address
-
ACC-APG - Natick (SPS)
(shawn.p.haubner.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Request for Information (RFI) Surviving Blood Loss (SBL) Program SYNOPSIS This is a Request for Information (RFI) for planning purposes only, as defined in Federal Acquisition Regulation (FAR) 15.201e. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Government will NOT pay for information and materials received in response to this RFI and is no way obligated by the information received. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified performer sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; small disadvantaged businesses; and universities and educational institutions, (3) their size classification relative to the North American Industry Classification System (NAICS) Code for the proposed acquisition. The applicable NAICS Code is 541712 - Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology). Your responses to the information requested will assist the Government in determining the appropriate acquisition method to conduct clinical trials for the development of an FDA-approved, infusion therapy to treat patients with severe hemorrhage as experienced during combat. In accordance with current FDA recommendations, early clinical trials should: study the safety profile of the therapeutic; study the optimal starting dose and dosing schedule for the product; and identify and study the potential biological activities to provide scientific data on which to base further product development. BACKGROUND Severe hemorrhage continues to be the leading cause of US deaths in combat. In collaboration with the Defense Advanced Research Projects Agency (DARPA) and the US Army Medical Research and Materiel Command (USAMRMC), the Defense Health Program Joint Program Committee Six (JPC-6) has a requirement to develop novel strategies to radically extend the time that an injured warfighter can survive critical blood loss on the battlefield before surgery. Whereas conventional resuscitation methods require a significant amount of blood and plasma products that are typically unavailable at the battlefield point-of-injury (with standard intravenous fluids being an inadequate blood substitute that worsen a patient's condition), DARPA and JPC-6 researchers have identified a low-volume, water soluble model - 17 -ethynylestradiol-3-sulfate, sodium salt (EE-3-SO4) - which may help to mitigate the effects of hemorrhage at the cellular level and prevent or reverse the onset of hemorrhagic shock, thereby exponentially increasing the survivability of the patient. The concept moving forward is that EE-3-SO4 may be deployed as a field expedient solution that can be administered to severely injured warfighters in the prehospital environment. JPC-6 therefore seeks full solution clinical research support to guide EE-3-SO4 through FDA IND submission and GCP compliant Phase 1 and 2a clinical trials for an indication as a viable infusion therapy for the treatment of critical patients with significant blood loss. Support may also be required to conduct additional preclinical work as required to facilitate either the Phase 1 or Phase 2a clinical trials. The anticipated period of performance is 36 months, although this is subject to change given the variable nature of FDA submissions. OBJECTIVES The objective of issuing this RFI is to gather information that will assist in the determination of a suitable acquisition solution for conducting a clinical trial for patients with significant blood loss as experienced in combat. In accordance with current FDA recommendations, the clinical trials supported through this acquisition should study the safety profile of the therapeutic; study the optimal starting dose and dosing schedule for the product; and identify and study the potential biological activities to provide scientific data on which to base further product development. Interested parties should provide detailed responses and/or materials related to their capabilities to fulfill ANY OR ALL of the inquiries listed below: 1.Description of your organization's experience with the program management of technically complex efforts, to include existing capabilities to manage pharmaceutical product development efforts through FDA approval including assuming product sponsorship. a.Product(s) taken to FDA licensure/approval, including product type. b.Current products under development expected to achieve FDA licensure. Include explanation of product type and current stage of development. c.Experience conducting clinical trials and animal studies in accordance with US Army IRB and IACUC guidelines, Department of the Army HRPP guidance, and 21 CFR 314 Subpart I or 601 Subpart H (i.e., the Animal Rule) protocols. d.Experience conducting the following types of research and development studies: efficacy studies; genetic and reproduction toxicology studies; short-term and long-term toxicology studies; range-finding toxicology, toxicokinetic/pharmacokinetic studies; absorption, distribution, metabolism and excretion (ADME) studies; safety pharmacology analysis; mechanism of action studies. e.Experience in conducting studies in accordance with Good Laboratory Practice (GLP) requirements. 2.Ability to manage and conduct clinical study activities, Phase 1 dose escalation/pharmacokinetic studies and Phase 2 expanded safety/drug-drug interaction studies, in accordance with FDA regulations and Good Clinical Practices (GCP) guidelines. a.Experience designing GCP-compliant clinical protocols, informed consent forms, and case report forms sufficient for submission to the Human Subjects Research Review Board (HSRRB). b.Experience managing day-to-day clinical study operations, to include study drug and study supplies inventory management, severe adverse event management, and safety monitoring board management. c.Experience with clinical study data management, archiving and final study report generation. d.Experience with the design and conduct of the bioanalytical and pharmacokinetic (BA/PK) aspects of human clinical trials as well as with the analysis and evaluation of BA/PK data from human clinical trials. e.Experience with statistical planning and analysis should include developing a detailed statistical analysis plan, developing a subject randomization scheme, conducting interim and final analyses, and preparing a final statistical report. f.Experience in designing clinical protocols to evaluate a multi-drug prophylactic regimen (i.e., evaluate drug-drug interactions for concomitantly administered pharmaceuticals). 3.Ability to evaluate and incorporate enabling technologies critical to enhance and/or prolong the drug product shelf life. a.Individual unique identification (IUID) and visual temperature to time indicator (TTI) product labeling, other than syringe and needle administration, and stabilizing technologies to ensure stability across a wide range of temperatures. 4.Description of your company's experience with FDA regulatory interactions leading to product approval/licensure, to include: a.Ability to manage activities related to the development of an IND application and New Drug Application (NDA)/Biologics License Application (BLA) submissions. Describe experience with submissions in an electronic Common Technical Document (eCTD) format. b.Engaging in meetings, Types A, B and C, with the FDA and preparation of pre-meeting information packets. c.Preparation and submission of Special Protocol Assessments. 5.Performance of the following specific tasks related to Phase 1 and/or Phase 2a trials: a.Prepare study protocols, informed consent forms, appendices, source documents, study specific procedures, and any other supporting documents required for the study. b.Prepare final clinical study reports in eCTD format (Sponsor provided format), inclusive of study results and analytical supportive data sufficient to be included in the eventual product indication package and filing with the FDA for licensure. c.Conduct study site selection. The Sponsor will review and approve study site selection if site is not submitted as part of original proposal. d.Convene and support planning and regulatory meetings as deemed necessary to support the EE-3-SO4 clinical trials program. e.Prepare for and attend Government Interim Progress Reviews (IPRs). f.Prepare and participate in regulatory site visits. g.Notify the Government immediately of any serious adverse events (SAE). h.Prepare and update Investigator's Brochure as needed. i.Literature reviews and preparation of technical documents. j.Prepare, edit, and format necessary documents for IND/NDA applications (21 CFR 312,314), IND/NDA amendments, annual reports, in eCTD format, for review and submission by the Sponsor. k.Prepare an annotated Phase 3 clinical trial outline. i.Perform all clinical trial monitoring responsibilities, per 21 CFR 312 and ICH E6 GCP guidance, to include but limited to the following: ii.Conduct site qualification and/or pre-study monitoring visits. iii.Develop Clinical Monitoring Plan, to be jointly agreed upon by Sponsor. iv.Conduct Initial, Interim, and Close-Out monitoring visits. Offeror will provide draft monitoring reports within 10 days of visit and final monitoring reports within 30 days of visit. v.Provide final study data and site essential study documents to Sponsor for inclusion in Trial Master File at completion of study. l.Perform full data management services to include, but not limited to, the following: i.Use an electronic data capture (EDC) method using an FDA 21 CFR Part 11 compliant Clinical Data Management System to collect and manage study data. ii.Perform study database set-up, testing, and validation and provide the testing and validation documentation. iii.Perform study database maintenance, modifications and change control management. iv.Develop and provide end user guidelines, training, and end user technical support. v.Store records at Contractor's facility in compliance with the SOPs in place at the close of the study. vi.Develop and coordinate the review and approval of the study Data Management Plan (DMP) and its supporting appendices. vii.Develop and coordinate the review and approval of the Case Report Forms (CRFs). viii.Develop and coordinate the review of the Study Database Design Specifications including CRF Annotation, Edit Check list, and Data listing/report. ix.Develop external data transfer handling and validation plan to and coordinate external data transfers from other data sources, including but are not limited, laboratory data, to appropriate parties. x.Perform data entry and management activities. xi.Perform data discrepancy management activities. xii.Perform Serious Adverse Events data reconciliation with Sponsor. xiii.Perform medical coding using MedDRA and WHO-DD, and coordinate review and approval of the coded data. m.Provide full biostatistical support to include, but not limited to, the following: i.Prepare/conduct sample-size calculation in conjunction with clinical subject matter experts. ii.Prepare/conduct statistical power calculation and prepare statistics section of protocol. iii.Prepare and coordinate the review and approval of the Statistical Analysis Plan. iv.Prepare and coordinate the review and approval of the statistical programming validation plan. v.Prepare and coordinate the review and approval of the Data Display Shells (Mock Table, Listing, and Figures [TLFs]). vi.Prepare and coordinate the review and approval of the populated draft TLFs/final TLFs. vii.Provide all components for the submission of data to FDA in the FDA-required format. n.Coordinate with Sponsor for approval of membership and charter, and manage any required Data Monitoring Committee. o.Submission of study protocol and associated documentation to the study site (or affiliated) Institutional Review Board (IRB) and the US Army Human Research Protection Office (HRPO). The Contractor is responsible for amending protocols if necessary, and tracking any additional review and approval issues to resolution. p.Provide support in all correspondence and document preparation for all interactions with FDA in eCTD format (Sponsor provided templates). q.Preparation for and attend all meetings with FDA. r.Make all study documentation available to the Government. s.Track all regulatory issues and actions to resolution/completion. t.Provide regulatory and technical support and consultation for validating and documenting Good Manufacturing Practices (GMP) process(es). u.Provide technical and clinical consultation for design and execution of clinical studies. v.Provide writing and technical support for the preparation of any additional regulatory documents required for the clinical development effort. w.Participate in sessions in which the Sponsor team rehearses for the FDA meeting(s). x.Participate in strategy/advice meetings with the Government product development team to discuss the strategy/approach for the FDA meeting(s). 6.There may be a preference for the offeror to serve as regulatory sponsor for the FDA IND submission. Indicate the extent to which your organization would be willing and/or is capable/experienced to serve in this capacity (please note that lack of capability in this aspect is not necessarily detrimental to the overall technical capability review). Respondents are invited to provide materials related to their capabilities to fulfill ANY OR ALL of the inquiries listed above. Respondents should provide responses whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. SUBMISSION INSTRUCTIONS All written responses must be received by January 21, 2015 at 3:00 PM EST. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to Shawn Haubner at shawn.p.haubner.civ@mail.mil ; (3) be minimum 11 font on 8.5 quote mark X 11 quote mark paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single organization point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 15 single sided pages in total (not including cover page and cover letter). Material that is advertisement only in nature is not desired. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary and will be protected if appropriately marked. Do not use Government Security classification markings. Responses should include patent rights and/or licensure information for any data, product or technology that may be used to accomplish a proposed solution. Please indicate preference as to whether or not any future development rights would be shared with the Government if a partnership were to develop. Questions regarding this RFI should be submitted to Shawn Haubner at shawn.p.haubner.civ@mail.mil no later than 24 hours prior to the end date. DISCLAIMER AND IMPORTANT NOTES The Government will not pay for any information submitted in response hereto. Responders are solely responsible for all expenses associated with responding to this RFI. This notice does not obligate the Government to issue a solicitation or to award a contract. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. 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 the 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 which may be published in the future. POINT OF CONTACT Mr. Shawn Haubner Contract Specialist Army Contracting Command-Aberdeen Proving Ground-Natick Contracting Division 100 Medway Rd, Milford, MA 01757 shawn.p.haubner.civ@mail.mil
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