Science & Technology Directorate

Transcription

1 Science & Technology Directorate National Center for Zoonotic & Animal Disease Defense (ZADD) - CEEZAD COE S&T Review October 2013 Dr. Juergen Richt CEEZAD Director Washington, D.C.

2 ZADD Overview COE Description DHS Policy: Homeland Security Act of 2002 and HSPD-9 call for a center for homeland security addressing biological and chemical countermeasures, animal and plant health and diagnostics, and defense of the agriculture and food system. Center Mission Statement: To protect the nation s agriculture and public health sectors against high consequence foreign animal, emerging, and/or zoonotic disease by conducting research, developing technology, training a specialized workforce, and communicating the results of this research to federal and state first responders, the agricultural industries, and scientific community. Research Theme Areas FAZD Focus: Decision support systems Operational livestock sampling and screening tools CEEZAD Focus: Developing novel vaccine candidates, adjuvants and diagnostic technologies (known and unknown) supporting the Differentiating Infected from Vaccinated Animals (DIVA) Shared ZADD Mission Space: Developing integrated programs to train foreign animal, emerging, and zoonotic disease professionals ZADD will develop, validate and transition screening and information analysis tools for high priority animal diseases. Customers DHS S&T Agriculture Defense Branch DHS Plum Island Animal Disease Center DHS OHA Food, Agriculture and Veterinary Defense Branch DHS National Protection and Programs Directorate Office of Infrastructure Protection USDA Animal and Plant Health Inspection Service CDC National Center for Emerging and Zoonotic Infectious Diseases State and Local Veterinarians and Animal Health Officials Livestock and Presenter s Poultry Producers Name and June Associations 17,

3 RVFV Vaccine Development Overview Challenge Statement: Develop safe, efficacious DIVA compatible vaccine for RVFV Committed HSE End User: USDA, Biologics industry Project Goal and Benefit to the End User(s): Development of new technical capability against RVFV Safe and efficacious DIVA compatible vaccine candidates for RVFV Companion DIVA tests (indirect ELISA) Subunity and vectored vaccine platforms have potential for U.S. licensure and manufacturing Alternative to conventional inactivated and modified live virus RVFV vaccines Discovery POC Pre- Development Full Development Market Research partners Industry partner Value Chain Category: Prevent Detect Mitigate Respond Recover Type of Final Product and End User: Internal (DHS) External Product Type Software Technology Analysis or Report Data Trained Staff Project Phase: Technology concept Proof of concept Validation in Lab Validation in environment Systems prototype in environment Category Applied Research Technology Development Technology Demonstration Systems prototype in System operational Presenter s environment Name Development June 17,

4 Project Team and Roles Project Performers and Partners Lead Performer: Kansas State University Performer(s): Mount Sinai School of Medicine Performer(s): South Dakota State University Partners: USDA ABADRU; NewLink Inc., Medgene Labs Project Role Project management, research on vaccine and DIVA test development, animal studies at BSL-3Ag containment, training Development and initial characterization of NDV-based RVFV vaccine candidates Development of diagnostic assays, immunogenicity testing of vaccine candidates and adjuvants Collaborate on vaccine development studies End User(s) Commitment End User: USDA Agricultural Research Service, DHS S&T Plum Island Animal Disease Center End User: USDA Center for Veterinary Biologics Project Role Advanced development and testing of the product and licensure Providing requirements for licensure End User: USDA National Veterinary Stockpile Providing requirements for inclusion in emergency planning and stockpile Transition Partner(s) Partner(s): Biologics industry (including Ceva Biomune, Avimex, Boehringer Ingelheim Vetmedica) Project Role Development of the product after Proof of Concept (POC) studies completed, licensure Presenter s Name June 17,

5 Test & Evaluation Research Plan Transition point: Successful proof-of-concept study with a small vaccine trials in host (<10 animals) Completed Milestones Milestone 1: Development/selection of the vaccine candidates Output: Gn, Gc and N proteins of RVFV expressed and characterized in vitro, subunit and NDV-based vaccine candidates created and tested in vitro Milestone 2: Immunogenicity testing of the vaccine candidates Output: Good serologic responses in sheep after single vaccination for subunit and VLP vaccine Milestone 3: Prototype DIVA test development Output: ELISA tests for DIVA concept to detect antibodies to Gn, Gc and N proteins of RVFV Planned Milestones Milestone 1: Efficacy studies in sheep Output: Efficacious RVFV vaccine for use in sheep as POC Status: Planned for early 2014 Milestone 2: Efficacy studies in cattle Output: Efficacious RVFV vaccine for use in cattle as POC Status: Planned for early 2015 Milestone 3: Technology transfer to commercial partner (Master cells, Master virus stocks) Output: Fully licensed RVFV vaccine Status: Planned for late 2015 early 2016 Fiscal Year (FY) FY12 FY13 FY14 FY15 FY16 Project Period of Performance Total Funding $504,551 $516,551* $445,000* $500,000* Planned Milestones Represents COE Biennial Reviews held by OUP *Proposed pending availability of funds Presenter s Name June 17,

6 Next Steps Discussion What information or assistance does the Center need from DHS? Financial and regulatory mechanisms for accelerated supplementary research funds for the validation and deployment of new vaccine and diagnostic technologies DHS requirements for stockpile vaccines, specifically RVFV vaccine (market within the US) Facilities and funding for performing respective studies under BSL-3Ag conditions to move products toward transition to animal pharmaceutical industry (For example, costs for animal and laboratory space is approximately $1,000 per day at the KSU Biosecurity Research Institute.) Assistance with testing of vaccine and diagnostic tools outside of the US in endemic areas What information does DHS need from the Center to utilize the research outputs? Presenter s Name June 17,

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