Cooperative Research & Development Agreement (CRADA) for the Development of Molecular Foot-and-Mouth Disease Vaccines

DEPARTMENT OF HOMELAND SECURITY Cooperative Research and Development Agreement (CRADA) Opportunity with the Department of Homeland Security for the Development of Molecular Foot-and-Mouth Disease Vaccines. AGENCY: Science and Technology Directorate, DHS. ACTION: Notice of intent. SUMMARY: The Department of Homeland Security Science and Technology Directorate (DHS S&T), through its Plum Island Animal Disease Center (PIADC), is seeking industry collaborators to aid DHS S&T in developing foot-and-mouth disease (FMD) molecular vaccine technologies with the goal of producing commercially available FMD vaccines. DHS S&T requests that vaccine manufacturers submit a white paper describing their capabilities and experience with various molecular vaccine platforms. Selected applicants will be required to enter into a Limited Purpose (LP)-CRADA that will define the conditions of the partnership, including intellectual property rights and licensing conditions associated with DHS S&T technologies. Specifically, DHS S&T is interested in the use of a FMD virus (FMDV) 3C protease mutant (see Journal of Virology, Foot-and-mouth disease virus 3C protease mutant: Implications for FMD vaccine development, (doi:10.1128/JVI.00924-17), shown by DHS to significantly enhance FMDV capsid expression compared to wildtype (wt) 3C. DHS S&T has successfully evaluated and demonstrated feasibility of the 3C mutant in the following expression platforms: baculovirus, mammalian cell culture, and E. coli culture. Details will be disclosed to partners who are selected to participate. The role of the industry collaborator(s) for this LP-CRADA collaboration will be to develop and evaluate the use of the 3C protease mutant in production of molecular FMD vaccine candidates in collaboration with DHS S&T at PIADC. Upon successful completion, the commercial partner will submit an FMD vaccine product license application and product development plan to the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics (CVB) (see Title 9 of the Code of Federal Regulations (9 CFR) section 102.6 and related USDA APHIS Veterinary Services memoranda). The FMD vaccine candidate(s) must also have the capability to differentiate infected from vaccinated animals using commercially available test kits. DHS S&T is seeking collaborators who own or have access to the technological components for, have the technological expertise in, and have proven track records of success in the fields of transboundary animal disease vaccine research, development, and the attainment of USDA vaccine product licenses. LP-CRADA collaborators must indicate if they are currently or may be funded by the Federal government for any related efforts, and if yes, they must include a discussion of how proposed LP-CRADA work and Federal government-funded work would not be duplicative. The proposed term of the LP-CRADA can be up to thirty-six (36) months. ADDRESSES: Mail comments and requests to participate to Dr. John Neilan (ATTN: John Neilan, PIADC, P.O. Box 848, Greenport, NY 11944). Submit electronic comments and other data to John.Neilan@st.dhs.gov. FOR FURTHER INFORMATION CONTACT: For information on DHS CRADAs, contact: Dr. Lesley Blancas, Technology Transfer and Commercialization Program Lead, DHS S&T, Lesley.Blancas@hq.dhs.gov; (202) 254-6926. Science Lead, DHS S&T, John.Neilan@st.dhs.gov; 631-323-3025. SUPPLEMENTARY INFORMATION: I. FMD Vaccine Requirements 1. The FMD vaccine will be manufactured in the United States, preferably. 2. The ideal FMD vaccine will have the following characteristics: a. Efficacy in established DHS S&T PIADC FMDV large animal challenge models exceeding 85%. b. Safety in large animals after administration. 3. The final FMD vaccine product will meet the following CVB safety requirements: a. No residues in meat or milk, b. No transmission to other animals, c. No reversion to virulence, and d. Safe in target animal species under typical production conditions. 4. The final FMD vaccine product will meet CVB efficacy requirements. 5. The FMD vaccine also must meet testing requirements outlined by the OIE (World Organisation for Animal Health). II. DHS S&T Role DHS S&T's role includes but is not limited to: 1. Coordination of testing and evaluation of FMD vaccines in cattle and/or swine infected with FMDV. 2. Coordination of testing and evaluation of samples collected from the testing and evaluation of the FMD vaccine in cattle and/or swine, such as serum virus neutralization titers, and detection of FMDV and FMDV nucleic acid in plasma, serum, or nasal secretions. 3. Preparation of laboratory and animal study reports. III. Period of Performance If CRADA collaborator(s) is (are) selected, the period of performance will be 36 months from the award date. Upon successful completion of the work, a comprehensive data package to obtain a USDA license for the FMD vaccine for use in cattle or swine should be submitted to USDA APHIS CVB within 60 months of the CRADA award date. The submission must adhere to the requirements of the USDA APHIS CVB Veterinary Services and other applicable CVB 9 CFR requirements for FMD vaccines. IV. Selection Criteria The Plum Island Animal Disease Center (PIADC) reserves the right to select CRADA collaborators for all, some, or none of the proposals in response to this notice. PIADC will provide no funding for reimbursement of proposal development costs. Proposals (or any other material) submitted in response to this notice will not be returned. Proposals submitted are expected to be unclassified. DHS S&T PIADC will select proposals at its sole discretion on the basis of: 1. How well the proposal communicates the collaborators' understanding of and ability to meet the CRADA's goals and proposed timeline, specifically the technical merit, feasibility, scalability, production capacity, and expertise. a. Partners should have expertise in the production, extraction, and optimization in bacterial, plant, mammalian, or insect cells. Other commercially viable vaccine platforms not specifically mentioned will be considered. However, additional information about the platform may be requested by DHS S&T in order to make a thorough evaluation. 2. How well the proposal addresses the following criteria: a. Capability of the collaborator to provide FMD vaccines and materials for proposed testing. b. Capability of the collaborator to meet the requirements for development, validation testing and analysis, and submission of supporting data and documents fulfilling the CVB requirements for product licensure in the U.S. c. Preliminary data or results that support the assay requirements outlined above. DHS S&T will notify selected participants via an emailed invitation to the original submitter. No review outcomes or selection criteria will be made available to submitters. Special Notice: While only federal employees will participate in the final selection process, government support contractors may review and provide support during the application evaluation process. All participants involved in the evaluation process, including those in support roles, will sign a Non-Disclosure Agreement prior to such involvement. Submission in response to this solicitation constitutes approval to release the application package to the evaluation team that may include government support contractors. Participation in this CRADA does not imply the future purchase of any materials, equipment, or services from the collaborating entities, and non-Federal CRADA participants will not be excluded from any future PIADC procurements based solely on their participation in this CRADA. Authority: CRADAs are authorized by the Federal Technology Transfer Act of 1986, as amended and codified by 15 U.S.C. 3710a. DHS, as an executive agency under 5 U.S.C.105, is a Federal agency for the purposes of 15 U.S.C. 3710a and may enter into a CRADA. DHS delegated the authority to conduct CRADAs to the Science and Technology Directorate and its laboratories.