Scra Pd Gwss Dec 2008 Public


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Scra Pd Gwss Dec 2008 Public

  1. 1. Kellye Eversole Eversole Associates Executive Director, SCRA 2008 Pierce’s Disease Research Symposium San Diego, California 16 December 2008
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 15. Kellye Eversole Eversole Associates Executive Director, SCRA