ORA Science Strategic Plan by mgm78489

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									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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