Request for Information - Medical Countermeasure Testing Platforms

PRISM (Platforms for Rapid Integrated Solutions for Medical countermeasures) MEDICAL COUNTERMEASURE TESTING PLATFORMS Objective: 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 Platforms for Rapid Integrated Solutions for Medical countermeasures (PRISM) team at the Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) and the Joint Science and Technology Office (Vaccine and Therapeutics Division) is seeking information on the capabilities of non-Government entities (non-profit, academic and commercial) in the areas listed below. Background: Faced with the challenges of a constantly evolving chemical and biological threat environment, an unstable manufacturing base, and complex regulatory processes, traditional development methodologies have not enabled expeditious delivery of prophylactic Medical Countermeasures (MCMs) to the Warfighter. An innovative approach is being initiated, which will accelerate MCM delivery by leveraging platform technologies that can be applied to a broad range of threats, and that have the potential to significantly reduce risk in all stages of development. In this RFI, PRISM is seeking specific information on MCM testing platforms. Requirements: PRISM is seeking platform technologies that can accelerate development of MCMs, while reducing risk at all stages of development. In addition, PRISM has a significant interest in the ability of platform technologies to be implemented as a component of a - rapid response' capability which could provide candidate countermeasures to the Warfighter in a significantly shortened, and operationally relevant, timeframe. To accomplish this goal, PRISM is seeking standardized discovery, design, manufacturing, and testing platforms. Testing platforms, in particular, have the potential to significantly reduce the risk of product failure throughout development. PRISM defines testing platforms very broadly, including platforms that could, for example, improve, facilitate, and accelerate product in-process/release/other quality measurements, assess manufacturability, assess appropriate formulations, assess stability, facilitate non-clinical assessments, assess the potential for toxicity or adverse reactions prior to non-clinical and/or clinical studies, determine mechanisms of action, predict ADME/PK/PD, and others. The testing modality could be in silico, in vitro, or in vivo. Some examples include: - Platform assay methodologies that streamline product release by enabling multiple simultaneous quality measurements; - In silico assays that leverages database information and machine learning to assess candidates for manufacturability and stability issues. - Platform technologies that simulate or model organs/tissues and multi-organ environment, and that can be used to predict product behavior in vivo; - Computational modeling that predicts drug safety issues. Performance Objectives: The Government requests that respondents provide up to 3 pages containing a description of: 1) the testing platform technology and its potential for implementation in accelerating development of MCMs and reducing developmental risk; 2) the benefits of the platform in comparison with other known testing methodologies that accomplish the same or similar purpose; 3) the potential for the testing methodology to support a rapid-response capability; 4) the extent to which the methodology has been implemented in existing product development efforts, including qualification and validation status; 5) any interactions with the FDA regarding the acceptability of the platform, if pertinent; 6) the status of any Intellectual Property associated with the platform; 7) any unique equipment and/or specialized requirements of the testing platform; 8) the willingness/ability to transfer/implement platform technology at a DoD facility. 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 COB on 30 November 2017. Responses should be sent by e-mail to: contracts.mcdc@ati.org with Subject Line of Responding Organization and RFI Title (PRISM- MEDICAL COUNTERMEASURE TESTING PLATFORMS). Material that is advertisement only in nature is not desired. This RFI is being released to the general public via the Federal Business Opportunities web site for market research purposes only. All capable providers, particularly members of the Medical Countermeasures Defense Consortium are encouraged to respond. Respondents not already members of the consortium are encouraged to join at www.medcbrn.org.