A--Advanced Development of a Prophylactic Bioscavenger as a Nerve Agent Countermeasure

Sources Sought Notice SSN Number: W911QY-11-S-0004 Advanced Development of a Prophylactic Bioscavenger as a Nerve Agent Countermeasure SYNOPSIS: This is a Sources Sought Notice (SSN) for planning purposes only, as defined in Federal Acquisition Register (FAR) 15.201e. This is a Qualified/Capable Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified business sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The North American Industry Classification System (NAICS) Code(s) is/are 541711. Your responses to the information requested will assist the Government in determining the appropriate acquisition method for an Advanced Development of a Prophylactic Bioscavenger as a Nerve Agent Countermeasure. (Note: this RFI is separate from the previously released Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures SSN, W911QY-10-S-0003. Responses are requested regardless of whether a response to the previous RFI was submitted). BACKGROUND: The Chemical Biological Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) Joint Project Management Office (JPMO) is responsible for the development, procurement, fielding, and sustaining of medical treatment and prophylactic capabilities against chemical, biological, radiological and nuclear agents. The current CBMS-MITS portfolio includes therapeutics, pretreatments and prophylactics at varying stages of clinical development, including FDA-approved drugs. PURPOSE AND OBJECTIVES: The Department of Defense has a requirement for a prophylactic nerve agent Bioscavenger capability. The Bioscavenger program will pursue the development and of a suitable prophylactic candidate that will provide broad-spectrum protection against nerve agents, and work in concert with existing pretreatments and therapeutic countermeasures to offer optimal protection to the Warfighter. The objective of issuing this SSN is to gather information that will assist in the determination of a suitable contract solution for the advanced development, manufacture, FDA-approval, and production of the Bioscavenger product. CBMS MITS is in the process of assessing suitable technologies to meet DoD requirements (see RFI # W911QY-11-RFI-0001). As such, CBMS-MITS 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 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, vaccines, 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, vaccines, 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. (2) 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 sufficient to support the filing of an Investigational New Drug (IND) application for clinical testing in humans. a. Experience conducting the following types of research and development studies: efficacy studies; 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. 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 Human Subjects Research Review Board (HSRRB). 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 should include developing a detailed statistical analysis plan, developing a subject randomization scheme, conducting interim and final analyses, and preparing a final statistical report. e. Experience in designing clinical protocols to evaluate a multi-drug prophylactic 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. a. Individual unique identification (IUID) and visual temperature to time indicator (TTI) product labeling, other than syringe and needle administration, and stabilizing technologies to ensure stability across a wide range of temperatures. (3) 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 an IND application and New Drug Application (NDA)/Biologics License Application (BLA) 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. Respondents are invited to provide materials related to their capabilities to fulfill ANY OR ALL of the requirements specified above. Respondents should provide responses 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. The Government will retain comments and information received in response to this SSN. Proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. Questions regarding this SSN should be forwarded to the CBMS e-mail address listed below within ten (10) days after SSN release. SUBMISSION INSTRUCTIONS: All written responses must be received by Friday April 1, 2011. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to Mr. Drake Russell, EMAIL ADDRESS: contact@example.gov; (3) be minimum 11 font on 8.5" X 11" paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this SSN; (5) include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 15 single sided pages in total (not including cover page and cover letter). Other media types (i.e. CD, printed technical information) that meet the submission criteria above will be accepted and should be sent to the address below. Material that is advertisement only in nature is not desired. DISCLAIMER AND IMPORTANT NOTES: The Government will not pay for any information submitted in response hereto. This notice does not obligate the Government to issue a solicitation or to award a contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to the respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation which may be published in the future. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. CONTACTING OFFICE ADDRESS: JPEO - CBMS - MITS Natick, RDE - COM Contracting Office 64 Thomas Johnson Drive Frederick, MD 21702 Point of Contact: Mr. Drake Russell, Contract Specialists, JPEO CBD, email address: contact@example.gov