Scra Pd Gwss Dec 2008 Public

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  • 1. Kellye Eversole Eversole Associates Executive Director, SCRA 2008 Pierce’s Disease Research Symposium San Diego, California 16 December 2008
  • 2. Regulatory Barriers to Biotech Specialty Crops Costs of meeting regulatory requirements and data generation studies are the same regardless of whether the • Market potential is large or small or the potential return on investment is low or non- existent • Developer is a grower organization, small company, governmental research laboratory, or a large company • Product will enhance food safety, improve the diet of humans or animals, or save an industry • Trait has been developed with significant public research funding
  • 3. • Concept of an independent entity was developed in 2004 and 2005 through several national meetings with USDA support • Formerly known as the Specialty Crop Regulatory Initiative (SCRI) • USDA seed money in 2006-2008 has allowed hiring of Eversole Associates to develop mission/vision, transitional and long-term structure, project evaluation process, and initial project goals
  • 4. The SCRA is an independent, non-profit entity that serves as a critical catalyst to the commercialization of diverse crops and biotechnology-derived traits for the specialty crop industry by • Focusing on ensuring that consumers have access to a safe, varied, high quality supply of food and fiber • Helping public and private-sector crop developers meet the complex US regulatory requirements • Fostering creative and innovative public-private collaborations for the public good
  • 5. Our Vision Enhanced public good through biotechnology: Increased diversity of specialty crops, traits, and crop developers Our Mission Facilitating regulatory clearance for biotechnology-derived specialty crops
  • 6. • Modeled after successful public-private programs (FDA’s Orphan Drug and USDA’s IR-4 programs) • Works within the existing regulatory framework • As a trusted third party, regulators, industry, academia, growers, consumers, and research agencies have a forum to work together for the public good
  • 7. Transition Structural Organization Goals 2009 Activate Stakeholder Liaison SCRA Board of Stakeholder Group Directors Pending Receipt of (Comprised of SCRI Liaison Funding Steering Committee) Group EC Members: Batkin, Eversole, Gutterson, Hood, McHughen Executive Committee EC Agency Liaisons: Blalock, Goldner, McCammon, & Thro Hire part-time Executive Director & technology Staff officer Eversole, Mustell, & Leach
  • 8. Long-Term Structure Stakeholder SCRA Board of Liaison Group Directors Board Affairs and Program Executive Governance Development & Committee Committee Marketing Committee Executive Executive Director Director Technology Financial Officer Officer
  • 9. Pillars of Activity • Advice & Education about regulatory requirements • Knowledge Generation through funding or co-funding • Navigation assistance with sample guidelines, content lists, and dossier templates to ease registration process • Facilitation – interface between developers and regulatory agencies, public and private-sector stakeholders
  • 10. Tools • Delineation of regulatory requirements for biotechnology-derived specialty crops • Guidance for navigating through the regulatory process • Assistance in compiling regulatory application dossiers • Funding or co-funding the development of data for regulatory requirements
  • 11. Status • Seeking pilot projects with funding for assistance to further refine toolbox • Proposal is under development for the SCRA to become a USDA National Research Support Program (NRSP) – 5-year core funding to formalize non-profit, ramp up staff time and hire part-time technology officer – Fund/co-fund several projects per year – Implement Stakeholder Liaison Group – Host national workshops – Develop guidance information
  • 12. Project Evaluation Process (PEP) • A clear, transparent, objective process for selecting projects - pilot PEP approved 2008 • Ultimate goals for the PEP – Project addresses the SCRA vision and mission – Includes a marketable trait for a specialty crop • Initially, we would like to see projects that have a high impact • Critical elements that must be addressed – Scientific and technical plan – Business plan – Regulatory plan
  • 13. Bottom Line : What we can do with you • Enhance understanding of regulatory requirements and reduce overall costs and time • Standardize quality and stewardship programs • Reduce time to market • Reduce regulatory risks and uncertainties
  • 14. How you can help • Enter into a partnership with the SCRA now by supporting a pilot program for the PD/GWSS research community • Help us determine the best short-term deliverables • Provide support for the SCRA’s NRSP application
  • 15. www.specialtycropassistance.org Kellye Eversole Eversole Associates Executive Director, SCRA eversole@eversoleassociates.com