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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 14, 2018 FBO #5927
SOURCES SOUGHT

A -- Diazepam Autoinjector

Notice Date
2/12/2018
 
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-18-S-0004
 
Archive Date
3/10/2018
 
Point of Contact
Richard Totten, Phone: 3016192446
 
E-Mail Address
richard.w.totten2.civ@mail.mil
(richard.w.totten2.civ@mail.mil)
 
Small Business Set-Aside
N/A
 
Description
REQUEST FOR INFORMATION Diazepam Autoinjector 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 Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) is seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) for development of a diazepam autoinjector with an anticonvulsant indication against organophosphate poisoning. The government is considering two options, 1) a development option and 2) a change in manufacturer option: 1) The Offeror will serve as the Food and Drug Administration (FDA) sponsor for a diazepam autoinjector and would be responsible for product development, manufacturing, and regulatory requirements needed for FDA approval and compliance. 2) The government is currently the NDA holder for Diazepam Auto-Injector, (NDA #20-124), Convulsant Antidote for Nerve Agents (CANA) and is interested in retaining sponsorship. The government is seeking a manufacturing partner; a tech transfer will be arranged between the current manufacturer and the partner. In addition to cGMP production, the partner will be responsible for product recall and Adverse Event reporting and all post-marketing activities. Background: Currently, MCS-CDP is seeking capabilities from more than one potential source for development of an autoinjector drug-delivery device(s), or a previously FDA-approved (cleared to market) drug delivery device (combination product) that can be self-administered or buddy aid and will deliver the following treatment: Diazepam autoinjector. Each autoinjector contains 10 mg of diazepam in 2.0 mL total volume. Under the current diazepam autoinjector NDA, each mL contains 5 mg diazepam compounded with 40% propylene glycol, 10% ethyl alcohol, 5% sodium benzoate and benzoic acid as buffers, and 1.5% benzyl alcohol as preservative. The partner will be provided access (via letter of authorization to cross-reference) to the current diazepam NDA, NDA #20-124, Diazepam Auto-Injector, approved in December 1990, with 0129 submission up to and including the current year (2018) and a tech transfer protocol (if applicable to the proposal) from the current manufacturer to assure as complete manufacturing process transfer as possible. Requirements. The Service Member-carried device must be administrable by personnel in Mission Oriented Protective Posture 4 (MOPP-4) over-garments and mask, to a casualty in MOPP-4. The delivery device platform and drug must be stable at operationally relevant temperatures to include temperature extremes experienced by Service Members in the field. The desired storage conditions for the antidote in its drug delivery device is USP Controlled Room Temperature (i.e., stored at 25 C [77 F], excursions permitted to 15-30 C [59-86 F]; Keep from Freezing, Protect from light), or be such as to provide reduced logistical burden than the currently fielded antidotes. In addition, the shelf life should eventually achieve 5 years at controlled room temperature. Performance Objectives: When responding to this RFI, please provide responses for both proposed development options listed above and limit responses to 3-5 pages for each development option. Responses should include current industry capabilities from interested entities in the following areas: 1. Description of company's proposed drug delivery platform, to include: General background information, product name and description, as well as pertinent development efforts needed to encompass delivery of a single drug (diazepam) in a single autoinjector. Appropriateness of proposed drug delivery device for military field-use, including: a. Portability of the proposed diazepam autoinjector by the Warfighter and combat medic. b. Ease of self- or buddy administration by personnel in Mission Oriented Protective Posture (MOPP) 4 protective ensemble. c. Ability of the proposed diazepam autoinjector drug delivery platform to administer drug product through MOPP-4. d. Suitability for use across a wide range of temperature and operationally relevant environmental conditions. e. Suitability for long term storage at controlled room temperature. f. Compatibility of known pharmaceutical products in the proposed drug delivery platform, as well as its components, under long-term storage conditions. g. Summary of existing manufacturing capabilities, annual and surge capacity, and place of manufacture, to include experience with compliance with current Good Manufacturing Practices (cGMP) and corresponding ICH guidelines. h. 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. I. Description of company's experience with FDA regulatory activities leading to drug-device combination product approval/licensure, to include: 1) Ability to manage activities related to the development of an IND application and New Drug Application (NDA) submissions and supplements. Describe experience with submissions in an electronic Common Technical Document (eCTD) format. 2) Engaging in meetings with the FDA and preparation of pre-meeting information packets. 3) Comparative bioavailability and bioequivalence studies 4) Stability testing at controlled room temperature and identification of temperature excursion limits. j. Provide an estimated cost and schedule for a diazepam autoinjector taken through development to manufacturing through an Emergency Use Authorization (EUA). k. Provide an estimated cost and schedule for a diazepam autoinjector taken through development to manufacturing through full FDA licensure. l. (optional) Provide a high level summary of your commercialization plan or market strategy. 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 4:00 pm on 9 March 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.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/notices/6e9914e977694007e2a80d9a7a86a342)
 
Record
SN04820324-W 20180214/180212231721-6e9914e977694007e2a80d9a7a86a342 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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