MODIFICATION
65 -- MCS-CDP REQUEST FOR INFORMATION
- Notice Date
- 9/27/2013
- Notice Type
- Modification/Amendment
- 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
- W911QY13R0018
- Archive Date
- 12/26/2013
- 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
- SYNOPSIS: The purpose of this Request For Information (RFI) is to conduct market research for potential candidates with the capability to participate, in whole or in part, with the advanced development of an Improved Nerve Agent Treatment System (INATS) effort requiring the delivery of a U.S. Food and Drug Administration (FDA)-approved system. This RFI is being reissued to establish a pool of candidates and update market research for planning purposes only, as defined in Federal Acquisition Regulation (FAR) 15.201. This is not a solicitation or request for competitive 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. In January 2013, MCS-CDP issued a Draft Request for Proposal with a subsequent Pre-Solicitation Conference held in February 2013 to gain industry feedback and gauge industry interest. The Government has interest in sources with the potential therapeutic and drug delivery platforms as well as suggested contract strategies for the advanced development, FDA-approval, manufacture, and production of initial and full operational capability quantities of INATS. Request previous respondents and attendees respond to this RFI to restate their interest and capabilities in the development of this product. Respondents are invited to provide materials related to their capabilities to fulfill ALL or ANY of the requirements listed below. Respondents should provide whether their level of interest and current capability is 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 candidates are interested in teaming with other sources, please include in your response authorization to release your company's name, area of interest, and POC information to be made available on a public website. All proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. BACKGROUND: Therapeutic pharmaceuticals 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 Department of Defense (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. CURRENT REQUIREMENT: Currently, MCS-CDP is seeking capabilities from potential sources for the advanced development of the INATS, a new and improved regimen to treat nerve agent-induced toxicity. To address capability gaps, the MCS-CDP is developing the INATS, to be used in conjunction with the pretreatment pyridostigmine bromide (PB) and an anticonvulsant to provide increased survival over current (i.e., atropine, 2-PAM and diazepam) and future (i.e., atropine, oxime and midazolam) treatment regimens. System requirements include a drug delivery platform containing an improved oxime formulation and atropine to replace the current Antidote Treatment - Nerve Agent Autoinjector (ATNAA), containing the drugs atropine and 2-PAM. The therapeutic and delivery device platform must be a post-exposure treatment effective against a broad spectrum of nerve agents, to include emerging threats, and must be stable at operationally relevant temperatures to include temperature extremes experienced by Service Members in the field. The Service Member-carried INATS should be administrable by self- and buddy-aid in Mission Oriented Protective Posture 4 (MOPP-4) over-garments and mask, to a casualty in MOPP-4. The INATS will be compatible with fielded and future medical countermeasures in the nerve agent family of systems, to include pyridostigmine bromide (PB), atropine and anticonvulsants. This advanced development effort may include but not be limited to the following activities: formulation, stability and compatibility studies; non-clinical and clinical studies; manufacturing process development; large-scale manufacturing; the preparation and successful submission of a New Drug Application (NDA), and manufacture and delivery of required quantities. Respondents are invited to provide materials related to their capabilities to fulfill ALL or ANY of the requirements specified above. Respondents should provide whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. As such, MCS-CDP is seeking information on current industry capabilities from interested entities with potential to meet ANY of the following criteria, IN WHOLE OR IN PART: (1) Description of your company's candidate therapeutic, to include: General background information, pertinent research efforts, indication(s), and human dose and route of administration. Specifically, identify the therapeutics' ability to fulfill the treatment requirement specified above in the Purpose and Objectives section. Status of in vitro and/or animal model development (i.e., small animal species, large animal species, route of exposure). Include any proprietary information and limitations, if any, on sharing of animal models or testing paradigms with the government and its contractors. Summary of any pertinent data resulting from efficacy studies (i.e., route of challenge, animal model); genetic and reproduction toxicology studies; short-term and long-term toxicology studies; range-finding toxicology, toxicokinetic/pharmacokinetic studies; absorption, distribution, metabolism and excretion (ADME) studies; safety pharmacology analysis; mechanism of action studies. Formulation development efforts, the candidate therapeutics' formulation and any relevant chemical, physical, and immunological characteristics. Summarize any efforts related to manufacturing process development, to include assay qualification and validation, production qualification and validation, and process scale-up. Provide any available information on the therapeutics' stability, shelf-life and storage conditions. Assessment of the therapeutic's maturity, stage of development using the Quantitative Technological Readiness Levels (Q-TRLs) for Medical Product Development Appendix A. Any intellectual property concerns/restrictions to include your company's rights and willingness to sell or license any intellectual property. Proprietary information should be marked as Company Proprietary (2) Description of your company's candidate drug delivery platform, to include: General background information, product name and description, as well as pertinent development efforts. Specifically, identify the drug delivery platform's ability to fulfill the treatment requirement specified in the above Purpose and Objectives section. Assessment of appropriateness of the drug delivery platform for military field-use, including: a.Portability of the drug delivery platform by the Warfighter and combat medic b.Ease of self- or buddy administration by personnel in MOPP-4 protective ensemble c.Ability of the 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.Compatibility of known pharmaceutical products in the drug delivery platform, as well as its components, under long-term storage conditions Summary of existing manufacturing capabilities, annual and surge capacity, and place of manufacture. Assessment of drug delivery platform's maturity, stage of development using the Quantitative Technological Readiness Levels (Q-TRLs) for Medical Product Development. (3) Description of your company's experience with the program management of technically complex efforts, to include: Existing capabilities to manage pharmaceutical product development efforts through FDA approval, to include assuming product sponsorship. a.Product(s) taken to FDA licensure/approval, including product type. Examples include small molecule therapeutics, large molecule therapeutics, vaccine, etc. b.Current products under development expected to achieve FDA licensure. Include explanation of product type and current stage of development. Examples include small molecule therapeutics, large molecule therapeutics, vaccine, etc. c.Experience with product development under 21 CFR 314 Subpart I or 601 Subpart H (i.e., the Animal Rule). Include any animal subject concerns. (4) Description of your company's technical expertise in pharmaceutical product development, to include: Ability to design and conduct non-Good Laboratory Practices (GLP) as well as GLP-compliant testing. a.Experience conducting the following types of research and development studies: efficacy studies; drug-drug interaction studies; genetic and reproduction toxicology studies; short-term and long-term toxicology studies; range-finding toxicology, toxicokinetic/pharmacokinetic studies; ADME studies; safety pharmacology analysis; mechanism of action studies. b.Experience with designing and developing well characterized animal models. Ability to manufacture current Good Manufacturing Practices (cGMP)-compliant clinical material to support 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.Estimate of small and/or large-scale cGMP-compliant manufacturing capability. 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 pharmaceutical with the delivery device. Ability to manage and conduct clinical study activities, Phase 1 dose escalation/pharmacokinetic studies and Phase 2 expanded safety/drug-drug interaction studies, in accordance with FDA regulations and Good Clinical Practices (GCP) guidelines. a.Experience designing GCP-compliant clinical protocols, informed consent forms, and case report forms sufficient for submission to the U.S. Army Human Research Protection Office (HRPO). b.Experience managing day-to-day clinical study operations, to include study drug and study supplies inventory management, severe adverse event management, and safety monitoring board management. Experience with clinical study data management, archiving and final study report generation. c.Experience with the design and conduct of the bioanalytical and pharmacokinetic (BA/PK) aspects of human clinical trials as well as with the analysis and evaluation of BA/PK data from human clinical trials. d.Experience with statistical planning and analysis including development of detailed statistical analysis plans, development of subject randomization schemes, conduct of interim and final analyses, and preparation of final statistical report. e.Experience in designing clinical protocols to evaluate a multi-drug treatment regimen. (i.e., evaluate drug-drug interactions for concomitantly administered pharmaceuticals) Ability to evaluate and incorporate enabling technologies critical to enhance and/or prolong the drug product shelf life across a wide range of temperatures. (5) Description of your company's experience with FDA regulatory interactions leading to product approval/licensure, to include: a.Ability to manage activities related to the development of regulatory submissions, to include Investigational New Drug (IND) application and New Drug Application (NDA) submissions. Describe experience with submissions in an electronic Common Technical Document (eCTD) format. b.Engaging in meetings, Types A, B and C, with the FDA and preparation of pre-meeting information packets. c.Preparation and submission of Special Protocol Assessments. SUBMISSION INSTRUCTIONS: All 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; (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(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 the Government Contract Specialist, Richard Totten: richard.w.totten2.civ@mail.mil. Please designate a company point of contact (telephone, address, and email). 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. Responders must identify their 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 ensure that your registration in the System for Award Management (SAM) is up to date prior to submission of your response. Further information and registration information may be found at the following website: https://www.sam.gov/portal/public/SAM/ Contracting Office Address: US Army, Army Contracting Command, Natick Contracting Division, Fort Detrick, ATTN: Richard Totten 1564 Freedman Drive, Fort Detrick, Maryland 21702. Point of Contact: richard.w.totten2.civ@mail.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/a0a37e9b58fdd71af745ecaf1b8c19af)
- Record
- SN03205184-W 20130929/130927234820-a0a37e9b58fdd71af745ecaf1b8c19af (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 |