ORA Science Strategic Plan Carl J. Sciacchitano Director, Division of Field Science Food and Drug Administration Office of Regulatory Affairs Development of SSP Pro-Active advance processes Response to Changing Global Environment – Science Board Reports – Business Process Improvement (McKinsey) Report – Need for Environmental Samples Peanut Corporation of America (PCA) Ensure Laboratory Efficiencies Target investments in laboratories SSP Key Initiatives Strengthen collaborative partnerships with Centers, States, and Foreign partners Increase ORA laboratory capacity Enhance ORA laboratory capabilities Enhance ORA laboratory IT systems Increase Capacity More: – Inspections Inspections with environmental sampling – Imported products Field exams – Analytical screening tools used in the field PREDICT predicting – Outbreaks/Emergency response – Proactive surveillance …ORA labs will have the capacity to analyze 2X/3X/5X as many samples – anticipating more opportunities to collect meaningful, targeted samples – by 2015. Increase Capacity How? – In-flow of samples is foundational to success – Implement specific business process improvements identified in McKinsey study or otherwise (e.g. workflow, methods, IT, instrumentation, operational hours, reporting, coordination, expertise, program optimization) – New methods – e.g. “outbreak methods” – Expand the high throughput models – Expand mobile lab deployments; screening stations – Use of FERN labs to support analytical needs – Infrastructure: people, facilities, instrumentation Enhance Capability New: – Threats – Technology – Methodology – Instrumentation – Inspection support – Collaboration/Leveraging …ORA’s scientific and analytical capability will meet current needs and is anticipating future needs. ORA National Laboratory Resource Mission Statement ORA’s laboratory network provides diverse scientific expertise, leadership, and responsive quality analytical services to safe guard public health in a global 200K environment Workforce 2013 Equipment Specialty ALM-4 2012 Equipment Lab Units Refresh Lab Samples Analyzed Fiscal Year Ending New Emerging Investigatory Programs ALM-3 BBP-4 Lab Initiative/ 2011 Implementation 1stQ: 15.5K ORA Workforce FERN HTDL-1 2010 To Date: 22K ML OSIP Centers Assessment/ Program ALM-2 HTEL-1 BBP-3 Excellence Equipment Support 66K Challenge HTML-2,3 Program FERN Initiatives QMS-2 ALM-1 2009 BBP-2 HTCL-1 Optimization Program 40K Mobile BBP-1 Lab Mgrs Mtg HTML-1 QMS-1 FERN 2008 Labs FOUNDATION Accountability/Service Sample Collection/Flow Productivity, Efficiency, Quality Risk Assessment, Coordination Optimization of Laboratory Capabilities and Capacity High Throughput Laboratory (HTL) Analytical Tools Initiative (ATI) Best Business Practices (BBP) Lab Operational Workflow Automated Lab Management (ALM) IT System Challenges Sample Preparation Enrichment Screening Confirmation Rapid Results (across matrices and analytes) Methods Development Detection difficulties, new technologies and novel approaches to age-old problems Detection Difficulties/Challenges: Traditional bacteriological methods can be time consuming and not conducive to high throughput High-infectious dose pathogens/low pathogen numbers/high microbial background necessitating large sample sizes/volumes Matrix difficulties (e.g. fresh produce, background issues) Examples of new technologies: LFDs, ELISA, IMS Real-time PCR applications Microarrays-genotypic, phenotypic BioPlex Formats Federal/State and International Laboratory Operations National Harmonization of Food Testing Methods – Compiled from input of federal, state, local, international labs – Provides analytical confidence in method performance Compendium of Microbiological Protocols and Chemical Tests (COMPACT) Collaboration with States Food Emergency Response Network (FERN) Electronic Laboratory Exchange Network (eLEXNET) Harmonization in federal/state laboratory operations – transparency in program support, standards, sharing analytical findings Integrated Food Safety System Food Emergency Response Network (FERN) Mission: Integrate the nation’s multilevel food-testing laboratories to detect, identify, respond to and recover from a bioterrorism or public health emergency/outbreaks involving the food supply. FERN Members: 157 Laboratories representing 50 US States and Puerto Rico have satisfactorily completed FERN Laboratory Qualification Checklists – Affiliations: 35 Federal; 111 State; 11 Local – Disciplines:120 Microbiological; 105 Chemistry; 35 Radiological Fund 14 Chemistry & 5 Radiological Agreements – Total of approximately $14 million in loaned equipment and approximately $6 million in cooperative agreement funds annually FERN’s Integration with Other Networks Food Plants FERN NPDN Environmental Animal eLRN NAHLN Human Health LRN eLEXNET eLEXNET – > 1.65M sample test records are contained in eLEXNET (and building) – > 114,500 samples are imports from 185 countries – 124 Labs submit data to eLEXNET – Data can be used to develop trends and ascertain what other similar incidents International Collaborations International Meeting (Global Food Safety Working Together) – 1st International Analytical Methods Conference (Oct 2009) – 15 Countries and World Organizations Invited – Sharing of methods, analytical capabilities and common standards FY09 Accomplishments: Capacity High Throughput Laboratories – 3 Micro (NRL, PRL-SW, DEN-DO) – 1 Chem (ARL) – 1 Drug (PHI-DO) – 1 Environmental (DET-DO) BBP – Lab Operations – Standardization of methods (troubleshooting, method transfer, training, etc) – Dedicated equipment/staff for complex areas of investigation – Comprehensive certifications for PFGE analytes – Rapid serological screening – Rapid PFGE analysis 2day qPCR method (Salmonella / E. coli) VIDAS for rapid Salmonella identification (↓24hrs) FY09 Accomplishments: Capabilities New Virology Method to detect Norovirus and rapid PFGE methods Tobacco analysis lab CDRH/Academic Community collaboration expanding post-market analytical device Hand-held devices rapid detection in dietary supplements, APIs, excipients and finished dosage forms. – Raman Spectroscopy, XRF, Ion Mobility Spectrometry and NIR technologies XRF rapid screening tool for investigators/laboratories examining food. Regulatory applications for Asian patent medicines and supplements, food, food contact surfaces, devices, drugs, and cosmetics. DART, rapid detection of chemical contamination on produce and other food commodities Summary of Challenges Continued support and investment in infrastructure – need FTEs/facilities/equipment Increased Environmental sampling – Establish global ORA Science platform to extend regulatory expertise Summary of Challenges (cont.) Screening and Responsiveness to trade – Screening Stations Screening for Unknowns Third Party Laboratories Moving Forward Engage academia/industry Communication/transparency Federal/State and International Collaborations Creating a non-static environment FDA Science Board Input Risk assessment/ Sampling schemes for food testing Identification of new technologies, portable and hand held devices for application in food and/or drug testing more discriminating analysis Food processing technology and risk International Collaboration Questions?
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