W911SR-24-S-CNATS RFI.pdf

15/May/2024 Development of Multi-Drug Autoinjector Technology

W911SR24SCNATS

REQUEST FOR INFORMATION AND INDUSTRY DAY ANNOUNCEMENT

DEVELOPMENT OF MULTI-DRUG AUTOINJECTOR TECHNOLOGY

Objective:

This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the United States Government (hereafter referred to as “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 (JPEO- CBRND), Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical (JPM CBRN Medical) is seeking solutions outlining approaches for development and U.S. Food and Drug Administration (FDA) approval of a multi-drug autoinjector as part of ongoing development and improvement of nerve agent countermeasures. This specific effort is aimed at consolidating several current therapies into a single platform, thereby reducing logistical burden and basic load for the warfighter, and increasing their survivability.

All parties submitting documentation are requested to participate in a virtual Industry Day and virtual presentation scheduled for 26 June 2024 to further explain their capability to meet the requirement.

Responses should include the respondent’s most up-to-date research and designs. Past responses and/or participation in any industry day related to the requirement should be updated and resubmitted.

This virtual Industry Day is an opportunity for industry partners to present their capabilities in one-on-one sessions with representatives from the Government agencies. Industry partners will update Government stakeholders on current efforts and capabilities.

Companies that wish to present at this virtual Industry Day must complete ALL the following steps:

1. Submit a white paper in response to the Request for Information (RFI) announcement the email addresses listed under Administration below.

2. Register at usarmy.detrick.dod-jpeo-cbrnd.mbx.industry-day@army.mil no later than 20 June 2024. Please include company name and the names of individuals that will be presenting.

Additional details on virtual location and time will be shared with registered participants.

3. Submit your unclassified PowerPoint presentations to usarmy.detrick.dod-jpeo-cbrnd.mbx.industry-day@army.mil no later than 20 June 2024. There will be approximately 30 minutes allocated for each presentation, with 20 minutes for the presentation and 10 minutes for Q&A. This approximate time allocated for presentations is subject to change based on the number of companies participating.

Presentations should align with white paper responses to the RFI and should include, at a minimum:

a. Company overview

b. Capabilities for a multi-drug autoinjector and reconstitution and/or coformulation abilities

c. Reactivator work currently in progress or planned

d. Quick overview of planned regulatory plan to FDA approval

Please ensure that presentations specifically address autoinjector development capabilities. Once presentations are evaluated as appropriate, presenters will be notified with further details and scheduling information.

Background:

The JPM CBRN Medical is interested in developing the Consolidated Nerve Agent Treatment System (CNATS), an integrated and modernized multi-drug autoinjector intended for use by the U.S. military and allies to counteract chemical warfare nerve agent threats. The components of the program include the integration of chemical warfare nerve agent medical countermeasures (MCMs), to include multiple drug constituents (an improved oxime, scopolamine, and atropine) in a modernized platform that is effective against current and emerging threats, to supplement or replace fielded MCMs, thereby unencumbering the warfighter. A modernized platform may incorporate wet and/or dry components that allows for incorporation in the manner that provides the most stable formulation and meets the program’s shelf-life requirements. An improved oxime is a broad-spectrum and/or centrally acting oxime that improves survivability. The intent of the CNATS program is to reduce the number of autoinjectors carried by the individual Service Member, while increasing survival. The JPM CBRN Medical is seeking development of a prototype CNATS, an MCM for nerve agent exposure. The performer will be the regulatory sponsor and is expected to take the prototype CNATS product to FDA approval.

Requirements:

DOD JPEO-CBRND, JPM CBRN Medical Chemical Defense Pharmaceuticals Joint Product Management Office is seeking responses from private or public entities (academic, non-profit, and commercial) outlining how they would approach a product development plan with planned milestones to develop and deliver a multi-drug autoinjector (an improved oxime, scopolamine, and atropine), using device manufacturing, preferably obtaining FDA approval within 120 months. Subject to responses and availability of funds, the product development plan is to execute an agreement that will cover two (2) years of device technical development work that will focus on the autoinjector, with remaining development subject to the development and availability of funds.

Performance Objectives:

1) Designed for military use, and capable of being administered by self, medical, and non-medical personnel in clinical and non-clinical (i.e., austere operational environment) settings, and the device will maintain full functionality after prolonged exposure to an austere environment.

2) Product Performance Requirements:

a) The multi-drug autoinjector should be designed for military use in accordance with

Military Standard (MIL STD) 810H.

b) The delivery device and drug should be stable at operationally-relevant temperatures to include temperature extremes experienced by service members in the field.

c) The desired operating temperature for this joint service member-carried autoinjector is

0°C to 40°C (32°F to 104°F).

d) Protection from environmental factors (e.g., humidity, oxygen ingress), which can affect product stability and performance.

e) In addition, the shelf life, at controlled room temperature, should achieve an initial shelf life of two years, with a longer target of up to the longer period observed through the Shelf-Life Extension Program (SLEP).

f) It is recommended the performer use design-outcome predictive frameworks and methods like Design for Six Sigma (DFSS) and Critical Parameter Development & Management (CPD&M) methods to develop a highly reliable device as required by the FDA.

g) Device will need to meet FDA’s reliability requirements.

3) A multi-drug autoinjector prototype should be able to:

a) Deliver three drug constituents via an intramuscular route through Mission Oriented Protective Posture (MOPP) Level 4 Individual Protective Equipment and Army Combat Uniform.

i) A wearable device, such as a patch, does not meet the intent of the program.

b) Delivery may be achieved through a combination of mechanisms including, but not limited to:

i) Delivery of a combination of dry (lyophilized, spray dry, or combination) drug constituents and aqueous drug constituents via an intramuscular route through MOPP Level 4 Individual Protective Equipment and Army Combat Uniform.

ii) Delivery of a combination of drug constituents via coformulation and/or aqueous drug constituents and/or dry drug constituents via an intramuscular route through MOPP Level 4 Individual Protective Equipment and Army Combat Uniform.

4) The multi-drug autoinjector operation should be consistent with the operation of other fielded military autoinjectors. A device with reconstitution capability should rapidly and fully reconstitute the drug prior to administration, and not require additional user steps (such as shaking) to reconstitute.

5) The multi-drug autoinjector should allow a warfighter wearing MOPP Level 4 Individual Protective Equipment and Army Combat Uniform to identify this device (tactile differentiation) from other current/developmental autoinjectors in use by the military and be self-administered during periods of reduced visibility/dexterity, while minimizing the risk of inadvertent administration.

6) Program Elements of the RFI response:

a) The respondent should demonstrate capabilities to confirm expected shelf life and conduct or manage stability programs to support the development of the autoinjector. The respondent will include plans to perform stability testing on the drug product and integrity of the device.

b) The response should demonstrate how, as the multi-drug autoinjector program evolves through the phases toward licensure with the FDA, the respondent’s capabilities to manufacture at scales necessary for the specific phases of the program and at commercial scale production meet market requirements. Responses should include discussion on how the manufacturing processes are validated.

c) The respondent should describe a plan to develop and deliver to the DOD prototypes of the CNATS multi-drug autoinjector.

d) The respondent shall describe a plan to develop a regulatory pathway to FDA approval including all required studies.

e) The respondent acknowledges that, in the event of a future award, the awarded performer shall serve as the regulatory sponsor for FDA correspondence and submissions of data packages to obtain FDA approval.

f) The respondent acknowledges that, in the event of a future award, the awarded performer shall comply with Institution Animal Care & Use Committee (IACUC) review and U.S.

Army Animal Care and Use Review Office (ACURO) review, approvals from the U.S.

Army Medical Research and Development Command (USAMRDC) Human Research Protections Office (HRPO) and the study's central Institutional Review Board (IRB), if required.

g) Preferred: Skilled in Design for Six Sigma design framework.

i) Can demonstrate use of Critical Parameter Development and Management design methods.

Regulatory Objectives:

1) FDA Compliance: The CNATS multi-drug autoinjector and studies conducted for its development must meet or exceed the FDA’s quality standards established by current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and FDA and/or, when appropriate, International Council for Harmonisation (ICH) and International Organization for Standardization (ISO) standards, during the course of development.

2) FDA Approval:

a) Assume regulatory sponsorship of the CNATS prototype.

b) Take the CNATS prototype through all required non-clinical and clinical trials required by the FDA to achieve approval and/or clearance.

c) Ensure the device meets FDA reliability requirements, and all other chemistry, manufacturing, and controls requirements.

d) Develop and maintain a regulatory pathway to FDA approval and/or clearance including all required studies, as well as strategies for pre-Investigational New Drug (IND), IND, New Drug Application (NDA), and other submissions required by the FDA.

e) ISO standards, during the course of development.

f) Comply with IACUC review and U.S. Army ACURO review, approvals from the U.S.

USAMRDC Office of Human and Animal Research Oversight (OHARO) Office of Human Research Oversight (OHRO), and the study's central IRB, if required.

g) Demonstrate capabilities to develop and manufacture the autoinjector under cGMP guidelines to meet the needs of each clinical phase of the program and eventual commercial market(s).

h) The performer (sponsor) will analyze the data obtained during the study using FDA and ICH-compliant statistical methods to support regulatory filings. In addition, the results and analysis will be reported/provided in a form that allows the sponsor to submit the documents to the FDA.

i) Provide authorization pursuant to Public Law 115-92 for the DOD to engage with the FDA regarding the regulatory submissions, if it is or becomes a DOD medical priority product.

RFI Response:

Respondents should include the following in their response to this RFI. Responses should, not exceed a maximum of seven (7) pages.

1) Company Description, Background and Data Rights (Two (2) page maximum).

a) Provide a brief description of company history, alliances, and funding, emphasizing experience in device manufacturing.

b) Provide a background of any product taken through FDA approval process or demonstrate how they would do so as regulatory sponsor.

c) Discuss any data rights assertions anticipated for the autoinjector development (freedom to operate, patent application status, issued or licensed intellectual property).

2) Multi-Drug Autoinjector Technology Device Manufacturing Capability Description (Five (5) page maximum). Please provide the following information for ALL configuration options presented.

a) Multi-drug constituents, which may include reconstitution technology for the broad-spectrum oxime or coformulation of the drug components.

b) Description and discussion of any or all the capabilities described in the Performance Objectives section. Innovative approaches that address the overarching program goals that do not precisely match the above Performance Objectives can be included:

i) Provide a description of the design framework and design methods to be used in this effort.

ii) Discussion of the maturity of the proposed approaches, including previous demonstrated use, and any relevant FDA regulatory exposure.

iii) Provide a high-level development schedule.

iv) Provide a Rough Order of Magnitude cost for multi-drug autoinjector development.

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 1600 on 17 June 2024, with Industry Day registration and Industry Day PowerPoint presentation submissions by 20 June 2024. RFI Responses ONLY should be sent by e-mail to All the recipients listed below:

usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil

Bianca Batista: bianca.g.batista.civ@army.mil

Joseph Mccaffery: joseph.w.mccaffery2.civ@army.mil

Responses must include the 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 an Other Transaction Agreement (OTA) issued either under the Medical CBRN Defense Consortium (MCDC) or the Chemical, Biological, Radiological and Nuclear Defense (CBRND) Broad Agency Announcement (BAA) 22-01. Respondents interested in the MCDC can obtain information at www.medcbrn.org.

Respondents may also inquire about the Medical Countermeasures Broad Agency Announcement (BAA) in SAM.gov, keywords CBRND- 22-01. For questions related to this RFI, please e-mail questions to:

usarmy.detrick.dod-jpeo-cbrnd.mbx.baa@army.mil

Bianca Batista: bianca.g.batista.civ@army.mil

Joseph Mccaffery: Joseph.w.mccaffery2.civ@army.mil