Synthetic Molecular Binding Agents (SYMBA)

REQUEST FOR INFORMATION Synthetic Molecular Binding Agents (SYMBA) 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) and the Joint Science and Technology Office are seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) in the areas listed below. Background: The Joint Science and Technology Office (JSTO) in support of the Detection and Diagnostics Division (RD-CBA) is seeking information from interested contractors on the development of a prototype methodology to produce fully synthetic molecular binding agents (SYMBAs) for the detection and identification of viral and bacterial pathogens and toxins. A streamlined wet-chemistry process to produce large quantities of antigen-specific binding molecules to provide consistency is currently a capability gap for the Department of Defense (DoD) in the development of an affinity based diagnostic platform. The current process is labor intensive and lacks in cost and time effectiveness as it relies on immunological responses from animals and involves sample isolation, culture, screening, cloning, characterization, and specific storage constraints. Furthermore, the final products often vary in yield, shelf-life, specificity, and sensitivity. The ideal methodology would be amenable to production through an abiotic synthetic process under a Quality Manufacturing system. Additionally, controlling yield and optimizing shelf-life, specificity, sensitivity, and binding affinity should be important factors in the resulting solution. The synthetic components should contain a binding moiety able to bind a solid substrate such as nitrocellulose or microbeads and a reporting moiety capable of optical detection by methods such as electrochemiluminescence or fluorescence. The binding/reporting molecule(s) could function as a pair (one binding, one reporting) or as a single presumably somewhat larger molecule. The ideal outcome for this project is achieving a streamlined process for developing SYMBAs that would enhance therapeutic and diagnostic support for the warfighter. Requirements: The purpose of this RFI is to solicit information on the availability or status of an approach for developing a prototype methodology for producing SYMBAs capable of detecting and identifying viral and bacterial pathogens and toxins that are a threat to the warfighter. The proposed solution should result in a detailed protocol which would outline the technical approach, required equipment and materials, and any other pertinent information that would be necessary for successful execution of the process. Performance Objectives: a. Fewer than 10 pages (single-sided; not including cover page and cover letter). b. Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number, and e-mail of designated point of contact of the responder. c. Any relevant past performance (i.e. knowledge of imprinted polymers/protein crystallization/rational design/antibody-antigen binding and biomarker identification). d. Relevant past performance information that illustrates experience working in the field of synthetic biology. e. Associated intellectual property (IP) rights or patent coverage. f. Facility security level clearance. g. Willingness to enter into agreements with the DoD utilizing the medical countermeasures Other Transaction Authority (OTA) via membership in the Medical CBRN (Chemical Biological Radiological Nuclear) Defense Consortium (MCDC) (www.medcbrn.org) RFI Format: The Respondents shall provide the following in response to this this RFI: 1. Organization Description - Provide a brief company description and history, program management practices, and include any experience developing similar products. - Discuss any anticipated data rights assertions. - Does your facility have a Secret level clearance (or higher) or have the ability to achieve a clearance if required? - Number of cleared personnel working at the company with a current Secret level (or higher) clearance? - Would you anticipate any foreign nationals working on the project? 2. Methodology Description - A brief description of the key method(s) proposed - Visual representation of the end state prototype methodology concept - Anticipated requirement for Government Furnished Property or Materials 3. Schedule - Approximate milestone based timeline/schedule to develop prototype methodology and related technical documentation (technical drawings, description of materials, etc.). See Attachment A for a suggested format for schedule development. 4. Cost - Provide the Rough Order of Magnitude (ROM) cost estimate of each milestone for developing the prototype methodology. See Attachment A for a suggested format for cost development. 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 no later than 5:00 PM Eastern Standard Time (EST) on 15 JANUARY 2019. Any questions regarding this RFI should be submitted in writing by email to the Agreement Officer Representative (AOR), Dr. Diane Dutt at contact@example.gov. Final responses should be sent by e-mail to: contact@example.gov, 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 CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at contact@example.gov. ? ATTACHMENT A Estimated Schedule and Cost Table EQUEST FOR INFORMATION Synthetic Molecular Binding Agents (SYMBA) 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) and the Joint Science and Technology Office are seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) in the areas listed below. Background: The Joint Science and Technology Office (JSTO) in support of the Detection and Diagnostics Division (RD-CBA) is seeking information from interested contractors on the development of a prototype methodology to produce fully synthetic molecular binding agents (SYMBAs) for the detection and identification of viral and bacterial pathogens and toxins. A streamlined wet-chemistry process to produce large quantities of antigen-specific binding molecules to provide consistency is currently a capability gap for the Department of Defense (DoD) in the development of an affinity based diagnostic platform. The current process is labor intensive and lacks in cost and time effectiveness as it relies on immunological responses from animals and involves sample isolation, culture, screening, cloning, characterization, and specific storage constraints. Furthermore, the final products often vary in yield, shelf-life, specificity, and sensitivity. The ideal methodology would be amenable to production through an abiotic synthetic process under a Quality Manufacturing system. Additionally, controlling yield and optimizing shelf-life, specificity, sensitivity, and binding affinity should be important factors in the resulting solution. The synthetic components should contain a binding moiety able to bind a solid substrate, such as nitrocellulose, and a reporting moiety capable of optical detection. The binding/reporting molecule(s) could function as a pair (one binding, one reporting) or as a single presumably somewhat larger molecule. The ideal outcome for this project is achieving a streamlined process for developing SYMBAs that would enhance therapeutic and diagnostic support for the warfighter. Requirements: The purpose of this RFI is to solicit information on the availability or status of an approach for developing a prototype methodology for producing SYMBAs capable of detecting and identifying viral and bacterial pathogens and toxins that are a threat to the warfighter. The proposed solution should result in a detailed protocol which would outline the technical approach, required equipment and materials, and any other pertinent information that would be necessary for successful execution of the process. Performance Objectives: a. Fewer than 10 pages (single-sided; not including cover page and cover letter). b. Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number, and e-mail of designated point of contact of the responder. c. Any relevant past performance (i.e. knowledge of imprinted polymers/protein crystallization/rational design/antibody-antigen binding and biomarker identification). d. Relevant past performance information that illustrates experience working in the field of synthetic biology. e. Associated intellectual property (IP) rights or patent coverage. f. Facility security level clearance. g. Willingness to enter into agreements with the DoD utilizing the medical countermeasures Other Transaction Authority (OTA) via membership in the Medical CBRN (Chemical Biological Radiological Nuclear) Defense Consortium (MCDC) (www.medcbrn.org) RFI Format: The Respondents shall provide the following in response to this this RFI: 1. Organization Description - Provide a brief company description and history, program management practices, and include any experience developing similar products. - Discuss any anticipated data rights assertions. - Does your facility have a Secret level clearance (or higher) or have the ability to achieve a clearance if required? - Number of cleared personnel working at the company with a current Secret level (or higher) clearance? - Would you anticipate any foreign nationals working on the project? 2. Methodology Description - A brief description of the key method(s) proposed - Visual representation of the end state prototype methodology concept - Anticipated requirement for Government Furnished Property or Materials 3. Schedule - Approximate milestone based timeline/schedule to develop prototype methodology and related technical documentation (technical drawings, description of materials, etc.). See Attachment A for a suggested format for schedule development. 4. Cost - Provide the Rough Order of Magnitude (ROM) cost estimate of each milestone for developing the prototype methodology. See Attachment A for a suggested format for cost development. 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 no later than 5:00 PM Eastern Standard Time (EST) on 15 JANUARY 2019. Any questions regarding this RFI should be submitted in writing by email to the Agreement Officer Representative (AOR), Dr. Diane Dutt at contact@example.gov. Final responses should be sent by e-mail to: contact@example.gov, 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 CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at contact@example.gov. ? ATTACHMENT A