CBRN Defense Network and Clinical Capability Development

A REQUEST FOR INFORMATION (RFI) ONLY – This RFI is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Solicitations are not available at this time. Requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government (USG) to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. It is the responsibility of the potential offerors to monitor Sam.gov for additional information pertaining to this requirement. Within the Department of War (DoW), the CPE-CBRND-ET develops, manufactures and delivers safe and effective Medical Countermeasures (MCMs) for preparedness, prevention, protection, response, and recovery from CBRN threats. Today’s chemical and biological threat landscape is diverse, dynamic, and regionally distinct. Agile and flexible defense systems are required to provide Combatant Commands (CCMDs) and other stakeholders throughout the Chemical and Biological Defense Program (CBDP) with safe and effective MCMs at the speed of relevance, especially if those MCMs are early in development. The CBRN Advance Defense Enabling Network and Clinical Capability (CADENCC) program is a Medical Architecture Accelerator designed to rapidly develop, test, and evaluate MCMs. Specifically, CADENCC seeks to strengthen a clinical site network to generate safety and potentially efficacy data that enables CBRN defense readiness. For example, CADENCC could streamline the execution of advanced development activities by establishing disease-agnostic Master Protocols (e.g., for “respiratory illness”) or sub-protocols (e.g., initial screening protocols), providing access to clinical trial networks, and integrating novel technologies. The network should be prepared to handle studies involving healthy volunteers and patient populations, potentially under demanding and rapid response timelines. CADENCC will likely identify an “Integrator” to serve as a central coordinating entity to perform necessary actions or subcontract as needed to performers to achieve Government-directed

objectives. In this approach, the Integrator would identify and establish subcontracts with appropriate performers to complete typical activities associated with supporting a clinical trial network, as well as address or subcontract additional services to support unexpected

requirements with appropriate advance notice. CPE-CBRND-ET has identified

objectives listed below to enhance the CADENCC program's core assets. CADENCC is seeking information on capabilities and experience in the following areas (but not limited to). STRENGTHEN AND EXPAND CLINICAL SITE NETWORK INCLUDING WIDER GEOGRAPHIC COVERAGE AND LEVERAGE EXISTING PRE-POSITIONED CLINICAL SITES/ASSETS 1. Experience in managing clinical trial networks or large-scale multi-site trials for clinical trials up to phase 2 completion, compliant with Food and Drug Administration (FDA) regulations. 2. Ability to perform multiple/concurrent clinical trials. Include estimated time typically required to initiate a clinical trial and how those time projections may be impacted if multiple concurrent trials are running. 3. Establishing or leveraging existing clinical trial sites in the Continental United States (CONUS) (priority) and Outside the Continental United States (OCONUS) (option). 4. Accessing and/or developing a clinical trial network or consortium, including a description of the proposed model for the clinical trial network. Detail the governance structure, administrative oversight, and how a geographically diverse collection of sites would be managed. 5. Summarize coordination capabilities across a diverse group of sites which may include federal, state, public health, military, academic and private facilities. FACILITATION OF ACCELERATED CLINICAL TRIAL INITIATION 1. Detail the network’s collective experience with both Phase 1 and Phase 2 clinical trials. Specify experience in clinical trials such as first-in-human studies, SAD/MAD, dose-ranging, and preliminary efficacy studies. 2. Discuss innovative approaches and strategies that would be employed to accelerate study start-up, execution, and close-out of clinical studies to significantly compress the traditional trial timeline, while still satisfying safety and rigor

requirements of regulatory authorities. Include the following: a. Standardized Informed Consent Forms (ICFs) or other techniques. b. Screening protocols and/or streamlined participant identification and recruitment techniques and engagement. For example, identify methods to pre-position subjects by soliciting interest/ engagement in advance of study execution, and identify corresponding level of agency(s) approval necessary to engage methods and any potential schedule reduction. c. Standardized or existing regulatory processes and experience including early involvement with regulatory bodies and review boards in both CONUS and OCONUS settings; for example, Institutional Review Boards (IRBs), Ethics Committees (ECs), US Army Medical Research and Development Command (OHRO), and others. d. Experience in streamlining communication with FDA to facilitate protocol review, INDs, etc. e. Experience in collaborating with government agencies such as the FDA and the DoW in the planning and execution of clinical trials. 3. Approaches to, and experience in, the development of master protocols, including adaptive platform trials, umbrella trial protocols, basket trial protocols, or other protocols capable of evaluating multiple products. a. Experience in approaches such as built-in down-select, interim analysis, and clinical

objective/endpoint shifts. b. Experience or ability to use master protocols to conduct phase 1, phase 2 and pharmacokinetic studies. 4. Summarize strategies to identify, enroll and maintain subjects such as expediting subject enrollment and/or mitigating slow enrollment ENABLE DECENTRALIZED DATA COLLECTION USING DIGITAL HEALTH TECHNOLOGIES 1. Provide information on leveraging AI, technologies (including health technologies) and innovation to clinical trials, including recruitment/achieving enrollment targets, data collection, data quality and assurance, and more. 2. Provide information on developing a remote/decentralized approach to conducting clinical trials, including data collection, safety data, and participant monitoring. ACCELERATE CLINICAL EVALUATION OF MCMs 1. Provide information on abilities to conduct clinical trials on varying product modalities including level of participant support (inpatient vs. outpatient vs. human challenge) (for example, but not limited to): a. Biologics (including antibodies), small molecules, vaccines b. Devices/diagnostics c. Varying administration routes including, but not limited to: oral, Subcutaneous, nasal, nebulized, intramuscular 2. Discuss innovative approaches and strategies that would be employed to accelerate study start-up, execution, and close-out of clinical studies to significantly compress the traditional trial timeline, while still satisfying safety and rigor