SOURCES SOUGHT
A -- Diazepam Autoinjector Drug Delivery Device
- Notice Date
- 10/23/2017
- 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), BLDG 1 KANSAS ST, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-18-S-0002
- Archive Date
- 11/23/2017
- 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
- This Request For Information (RFI) is posted to conduct market research for a capability from potential sources for development of an autoinjector drug- delivery device(s), or an already FDA-approved (cleared to market) drug delivery device that will deliver therapies useful for the treatment of seizures resulting from nerve agent poisionng. MCS is seeking industry interest to manufacture this antidote individually, in self-contained delivery devices designed for automatic self- or buddy-intramuscular administration by military Service Members. This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201(e). This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. 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. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback. The Joint Product Manager - Medical Countermeasure Systems-Chemical Defense Pharmaceuticals (JPdM-MCS-CDP) is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, radiological and nuclear threats. Currently, MCS-CDP is seeking capabilities from potential sources for development of an autoinjector drug-delivery device(s), or an already FDA- approved (cleared to market) drug delivery device that will deliver this treatment as follows: Diazepam, as a component of the Convulsant Antidote for Nerve Agents (CANA). Each autoinjector contains 10 mg of diazepam in 2.0 mL. 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 CANA is a self-contained unit for diazepam injection. The U.S. Army Office of The Surgeon General (OTSG) sponsors the CANA New Drug Application (NDA), NDA 20-124, approved in December 1990. The National Stock Number for the CANA product is NSN 6505-01-274- 0951. 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. As such, MCS-CDP is seeking information on 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 drug delivery platform 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 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. (2) Description of company's experience with FDA regulatory activities leading to product approval/licensure, to include: a. 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. b. Engaging in meetings with the FDA and preparation of pre-meeting information packets. c. Comparative bioavailability and bioequivalence studies d. Stability testing at controlled room temperature and identification of temperature excursion limits. (3) Submit Draft Development Plan Outline describing, proposed preclinical, clinical studies, and CDRH device studies/protocols envisioned to be necessary to manufacture the above drugs in a drug delivery device suitable for FDA approval. (4) Provide an estimated cost and schedule for a diazepam autoinjector taken through development to manufacturing through an Emergency Use Authorization (EUA). (5) Provide an estimated cost and schedule for a diazepam autoinjector taken through development to manufacturing through full FDA licensure. SUBMISSION INSTRUCTIONS: All written responses must be received within fifteen (15) days of issuance of this RFI. Submissions should: (1) Use Microsoft Word or Adobe Portable Document Format (PDF); (2) Be sent to the POC identified below by email only; (3) Be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (4) Include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(s); and (5) Not exceed 10 single sided pages in total (not including cover page and cover letter). Material that is advertisement only in nature is not desired. Please address responses to this notice to the Government Contracting Officer, Richard Totten: richard.w.totten2.civ@mail.mil. Please designate a company point of contact (telephone, address, and email). All questions regarding this RFI must be in writing and emailed. No telephone inquiries will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/8e67fb2929a4927826fbb20f2fc7e707)
- Record
- SN04720234-W 20171025/171023230834-8e67fb2929a4927826fbb20f2fc7e707 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |