SOURCES SOUGHT
A -- Medical Countermeasures (MCM) against Radio-logical and Nuclear (Rad/Nuc) Threats
- Notice Date
- 11/8/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), 10 General Green Avenue, Building 1, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-19-S-0002
- Archive Date
- 12/22/2018
- Point of Contact
- Scott Ivan Hoffman, Phone: 3016198148, Richard Totten, Phone: 3016192446
- E-Mail Address
-
scott.i.hoffman2.civ@mail.mil, richard.w.totten2.civ@mail.mil
(scott.i.hoffman2.civ@mail.mil, richard.w.totten2.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR INFORMATION Medical Countermeasures (MCM) against Radiological and Nuclear (Rad/Nuc) Threats Purpose: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, Medical Countermeasure Systems (JPEO-CBRND-MCS) is seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) for development of prophylactic medical countermeasures (MCM) to combat Rad/Nuc threats, specifically those leading to Acute Radiation Syndrome (ARS) The Offeror will serve as the Food and Drug Administration (FDA) sponsor for this Rad/Nuc MCM and would be responsible for product development, manufacturing, and regulatory requirements needed for FDA approval and compliance. Background: JPEO-CBRND-MCS is tasked with protecting the warfighter against chemical, biological, radiological, and nuclear (CBRN) threats. Chemical Defense Pharmaceuticals (CDP) within MCS has been charged to develop prophylactic and therapeutic capability against CRN threats Currently, MCS-CDP is specifically seeking capabilities from more than one potential source for development of prophylactic (radioprotectant) MCM to counteract the effects of ARS. ARS encompasses a spectrum of pathophysiologic changes caused by exposure to high doses of penetrating radiation in a relatively short time period. Injuries sustained depend on the dose and extent of radiation exposure (e.g., whole- or partial-body). Radiation exposures exceeding 2 Gray (Gy) in adults can result in the depletion of hematopoietic stem cells and cellular progenitors in the bone marrow, which may lead to severe neutropenia, thrombocytopenia and death from infection or hemorrhage. Higher radiation doses can cause gastrointestinal (GI) complications, including mucosal barrier breakdown, bacterial translocation, and loss of GI structural integrity, which can lead to rapid death. Individuals who survive ARS may suffer from the delayed effects of acute radiation exposure (DEARE), which can include pulmonary, renal, cardiovascular, immunological and cutaneous complications occurring weeks to months after radiation exposure. Project Requirements: MCS-CDP is committed to addressing the need for Rad/Nuc MCMs, specifically those that will protect the warfighter and enable him or her to finish the mission in a radiological and nuclear environment. For the purposes of this RFI, the terms "MCM(s)" and "drug(s)" will include drugs, biologics and cellular therapies. The objective of a prophylactic MCM is to reduce the likelihood of developing severe adverse health effects associated with ARS to increase survival. The prophylactic MCM must work in concert with other medical products to lessen performance degradation and increase survival for an individual contributing to a higher level of unit readiness. A prophylactic MCM will need to be given pre-exposure, pre-symptomatic and be administered at the lowest echelon of heath care possible to the Joint Force (age range of 18 - 62 years) prior to operating in a known, high risk irradiated environment. To this effect the method of administration must be tailored to optimize ease of administration in an operational environment. Performance Objectives: When responding to this RFI, please limit responses to no more than 5 pages. Responses should include current industry capabilities from interested entities in the following areas: 1.General background information, product name and description to include: a.Anticipated route of administration b.Anticipated duration of protection c.Anticipated time to protection 2.Pertinent development efforts needed to obtain FDA approval under the animal rule for a prophylactic MCM with an ARS indication to include: a.Summary of clinical data to show protection against radiation damage and injury b.Summary of animal data to show protection against radiation damage and injury c.Summary of existing manufacturing capabilities and place of manufacture, to include experience with compliance with current Good Manufacturing Practices (cGMP) and corresponding ICH guidelines. d.Any intellectual property concerns to include your company's rights and ability to sell or license any intellectual property as well as your company's interest in selling or licensing the intellectual property. Proprietary information should be marked accordingly. e.Description of company's experience with FDA regulatory activities leading to product approval/Licensure to include: 3.Provide an estimated cost and schedule for taking this candidate drug to be used under an early access scenario (EUA, IND Contingency Protocol, etc.) and to Full FDA approval/Licensure 4.Provide a summary of your commercialization plan or market strategy. Company Information 5.Provide a brief company description and history, emphasizing experience developing similar products, company size, and Traditional or Non-Traditional Defense contractor status. 6.Discuss any data rights assertions anticipated for the project/products Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by Close of Business on 7 December 2018. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI the first choice for an acquisition vehicle, if appropriate, will be the Medical Countermeasures Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at mcdc@ati.org.
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