Objectives –

2. 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 Objectives –

3. “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 Definition of Terms –

4. 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 Definition of Terms (Cont’d) –

5. “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 Definition of Terms (Cont’d) –

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

7. Biosafety Curricula Training Biosafety Associations, Professional Competency and Credentialing Individual Mentoring and Organizational Twinning Challenges: Low Resource Countries –

8. Challenges: Funding Organizations – “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. 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. Recipients overwhelmed by the contracting process. Large defense contractors, complicated contracts, personnel turnover

9. 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 Recommendations –

10. 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 Recommendations –

11. 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 Recommendations –

12. 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 Recommendations –

13. 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 Recommendations –

14. 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 An Approach to Sustainability – Capacity building can’t be effective without self-sufficiency because no one’s resources are infinite

15. 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 An Approach to Sustainability (Cont’d) –

16. 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 An Approach to Sustainability (Cont’d) –

17. 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 THANK YOU –

18. INSPIRION BIOSCIENCES J. Craig Reed, Ph.D., RBP InspirionBiosciences@hotmail.com