SPECIAL NOTICE
A -- W911QY-15-S-0007
- Notice Date
- 3/25/2015
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY15S0007
- Archive Date
- 3/24/2016
- Point of Contact
- Richard Totten, 301-619-2446
- E-Mail Address
-
ACC-APG - Natick (SPS)
(richard.totten1@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR INFORMATION SYNOPSIS: The purpose of this Request For Information (RFI) is to conduct market research for manufacturing capabilities for the nerve agent antidote scopolamine. The Department of Defense (DoD) is seeking industry interest to manufacture the drug product/substance scopolamine for intramuscular administration by military Service Members. Respondents are invited to submit information on their capability to fulfill ALL or ANY of the requirements listed below. Respondents should indicate their intent to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. If interested in teaming with other firms, please indicate your willingness to release your information on a public website by indicating your authorization to release your company's name, area of interest, and POC information. All proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. BACKGROUND: Therapeutic pharmaceutical treatments against chemical, biological, radiological and nuclear (CBRN) warfare agents are required to support the Joint Forces across a range of military operations. As such, the DoD has a need for developing and fielding systems that provide treatment for exposure to CBRN agents. The Medical Countermeasure Systems-Chemical Defense Pharmaceuticals (MCS-CDP) Joint Product Management Office is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, radiological and nuclear threats. The current MCS-CDP portfolio includes nerve agent therapeutics, pretreatments and prophylactics at varying stages of clinical development, including FDA-approved drugs. OBJECTIVE: Currently, MCS-CDP is seeking capabilities from interested parties for the advanced development of the centrally-acting therapeutic scopolamine for intramuscular administration by military Service Members for use as an adjunct in conjunction with the pretreatment pyridostigmine bromide (PB) as well as the oxime/atropine and anticonvulsant therapies. This RFI is being released to identify existing sources for the active pharmaceutical ingredient scopolamine hydrobromide, and identify expertise for the development and/or manufacture of the drug product/ substance for FDA approval. As such, MCS-CDP is seeking information on current industry capabilities from interested entities in any of the following areas: (1) Description of your company's technical expertise in pharmaceutical product development, to include: Ability to manufacture current Good Manufacturing Practices (cGMP)-compliant clinical material to support nonclinical and Phase 1 and/or Phase 2 clinical studies. a.Experience with performing chemistry, manufacturing, and controls (CMC) studies and activities to include: standard characterization; assay development and validation; process development and validation; process scale-up assessments; preparation of technology transfer packages; formulation preparation and analysis; clinical trial formulation development; clinical dose delivery; container closure/extractables/leachables/compatability and sterilization. b.Summary of existing manufacturing capabilities, to include estimate of small and/or large-scale cGMP-compliant manufacturing capability as well as annual, surge capacity and place of manufacturer. c.Experience implementing International Conference of Harmonization (ICH) stability test programs to establish product shelf life, storage conditions and stability; experience conducting stability and compatibility testing of the scopolamine with the delivery device. (2) Description of company's experience with FDA regulatory activities leading to product approval/licensure, to include: Ability to manage activities related to the development of an IND application and NDA submissions and supplements. Describe experience with submissions in an electronic Common Technical Document (eCTD) format. Engaging in meetings with the FDA and preparation of pre-meeting information packets. Product development under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. Comparative bioavailability and bioequivalence studies (3) Description of drug development plan recommendations for scopolamine hydrobromide for injection (USP), to include: Proposed plan that provides for Chemistry, Manufacturing and Controls (CMC) studies envisioned to be necessary to manufacture scopolamine for FDA approval, including: a.Selection/auditing of vendors for API supply and clinical trial materials b.cGMP manufacture of SCP, to include cGMP manufacture of clinical placebo and active lots c.ICH stability method development/validation d.Formulation development e.Manufacture of non-GMP/cGMP placebo, active engineering lots for stability studies f.Development/validation of bioanalytical methods SUBMISSION INSTRUCTIONS: Request all responses be sent within fifteen (15) days of issuance of this RFI. Submissions should: (1) Use Microsoft Word or Adobe Portable Document Format (PDF); (2) Be sent by email to the POC identified below; (3) Be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (4) Include a company point of contact with name, title, address, telephone and fax numbers, and e-mail address (es); 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 Contract Specialist, Richard Totten: richard.w.totten2.civ@mail.mil. All questions regarding this RFI must be in writing and emailed to the Government POC. No telephone inquiries will be accepted. The North American Industry Classification Systems (NAICS) for this notice is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) with a size standard of 500 employees. Please identify your company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please indicate if you are registered in the System for Award Management (SAM), and provide your CAGE Code and or your DUNS number in your response to this RFI. SAM registration information may be found at the following website: https://www.sam.gov/portal/public/SAM/ 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 to respondents with respect to any information submitted. Contracting Office Address: US Army, Army Contracting Command, Natick Contracting Division, Fort Detrick, ATTN: Richard Totten 110 Thomas Johnson Drive, Frederick, Maryland 21702. Point of Contact: richard.w.totten2.civ@mail.mil
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