1. INSPIRION BIOSCIENCES US National Academies of Science workshop Anticipating Biosecurity Challenges of the Global Expansion of High Containment Biological Laboratories July 11-13, 2011 Istanbul, Turkey Global Biosafety & Biosecurity Challenges: Options for Nations with Limited Resources J. Craig Reed, Ph.D., RBP 1

2. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 2 Objectives – Define “Limited Resources” Define “Low Resource Country” Identify challenges to implementation Propose options Define “Sustainability” Propose a broadly applicable approach to sustainable solutions from the perspective of recipient and funding community

3. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 3 Definition of Terms – “Limited Resources” –No resources are infinite, therefore all are “limited” –All members of the international funding community have limited resources –Some have greater limitations than others

4. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 4 Definition of Terms (Cont’d) – Examples of “Limited Resources” –$ –Laboratory capacity (equipment, reagents, staff) –Infrastructure, engineering, utilities –Education (institutions, teachers, textbooks) –Access to formal training –Federal regulatory framework with guidelines and/ or standards

5. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 5 Definition of Terms (Cont’d) – “Low Resource” countries <0.85 on UN Human Development Index in 2009 UN Human Development Report http://hdr.undp.org/en/reports/global/hdr2009/ Gross National Income < $10,000 per capita (World Bank) http://data.worldbank.org/indicator/NY.GNP.PCAP.CD/countries/latest?display=default

6. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 6 Challenges: Low Resource Countries – Country-/Region-specific Regulatory Framework, Guidelines and/or Standards Biosafety and Biosecurity Awareness Infrastructure Equipment, Reagents, Services Management Processes and Administrative Controls

7. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 7 Challenges: Low Resource Countries – Biosafety Curricula Training Biosafety Associations, Professional Competency and Credentialing Individual Mentoring and Organizational Twinning

8. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 8 Challenges: Funding Organizations – One size does not necessarily fit all. Solutions that work in one location may not work somewhere else. Technology isn’t the only answer. And it may not always be the BEST answer. “The rules follow the money.” Existing donor-specific regulations not likely to be accepted carte blanch. But likely a good model and a good starting point. This is good – encourages ownership for the approach and solution. Recipients overwhelmed by the contracting process. Large defense contractors, complicated contracts, personnel turnover

9. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 9 Recommendations – Country-/Region-specific regulatory framework, guidelines and/or standards –Establish and implement a national regulatory framework –Use CWA 15793:2007 to create national guidelines OR –Tailor existing guidelines (WHO LBM, US BMBL, Canada LBG) OR –Adopt existing guidelines Biosafety and Biosecurity Awareness –Target awareness raising efforts toward elected officials, Ministers, senior laboratory management –Request technical information, translate it, distribute through Regional BSA, IFBA or Ministry

10. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 10 Recommendations – Infrastructure –National level Beyond our scope –Institutional level Develop your own laboratory design standards modeled after others OR Translate and adopt existing design standards from other countries Ensure local national staff work side-by-side with expatriate staff to gain expertise Awareness raising activities should increase budget allocations for improvement and maintenance

11. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 11 Recommendations – Equipment, Reagents, Services –Emphasize use of local materials from local economy –Support local/regional capacity to construct, produce and distribute these materials –Identify individuals for training and accreditation (BSCs) –Support local/regional capacity to re-engineer safety equipment Management Processes and Administrative Controls –Use CWA 15793:2007 to ensure all roles/responsibilities are accounted for and formalized within the organization –Ensure biosafety implementation is integrated across the organization

12. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 12 Recommendations – Biosafety Curricula –Universities and Regional/National biosafety assocn’s should create and instruct formal biosafety curricula –Collaborate with organizations that have already developed formal course work Training –Reference free training available at websites of IFBA, ABSA, others –Int’l funders should consolidate and distribute through Regional/National biosafety assocn’s

13. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 13 Recommendations – Biosafety associations, professional competency and credentialing –Funders: Endorse creation by communication with gov’t officials –Participate in the CEN BSP Competency Workshop –Regional biosafety assocn’s develop their own credentialing schemes that are relevant, germane and cost-effective for their members. Individual mentoring and Organizational Twinning –Contact IFBA or Regional/National association and request a mentor –Mentors should be assigned with cultural and geographical consideration –Regional:Regional (APBA:BACAC) and Regional:National (APBA:PhBBA) assoc’n pairings are demonstrated to work

14. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 14 An Approach to Sustainability – What is “Sustainability”? –“The ability of the recipient to independently manage and maintain the processes, equipment, consumables, staff and all costs needed to continue accomplishing the objectives of the program.” –Without incurring indebtedness! “Sustainability” = Self-Sufficiency Capacity building can’t be effective without self-sufficiency because no one’s resources are infinite

15. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 15 An Approach to Sustainability (Cont’d) – Two transition plans must be developed and agreed upon by funding and recipient partners: –Financial –Management Accurate measures of sustainability must be identified, agreed upon and measured. Pairing of funding partner project mgmt staff and Local Nationals allows technical and mgmt responsibilities to be learned and transferred

16. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 16 An Approach to Sustainability (Cont’d) – Recipients: Formulate a national level Implementation Plan –Establish priorities based upon disease prevalence –Consolidate rather than expand –Collaborate –Gather financial support from elected officials –Create your own guidelines/standards –Work with IFBA and your regional biosafety assoc’n –Establish local and national professional biosafety assoc’ns –Establish regional biosafety training centers

17. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 17 THANK YOU – Maureen Ellis Co-Chair, International Federation of Biosafety Associations Felix Gmuender Basler & Hofmann Pte Ltd, Singapore Rob Heckert Robert Heckert Consulting, LLC Willy Tonui President, AfBSA Kenya Medical Research Institute, Nairobi

18. INSPIRION BIOSCIENCES Science and Safety Spanning the Globe 18 INSPIRION BIOSCIENCES J. Craig Reed, Ph.D., RBP InspirionBiosciences@hotmail.com