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InnoVation Exploration Team (IVET)

InnoVation Exploration Team (IVET). Generic Animal Drug Alliance April 21, 2011. New Model for Success. Our old business model for animal drug evaluation is not sufficient. ONADE is tasked with new challenges and opportunities beyond drug evaluation

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InnoVation Exploration Team (IVET)

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  1. InnoVation Exploration Team (IVET) Generic Animal Drug Alliance April 21, 2011

  2. New Model for Success • Our old business model for animal drug evaluation is not sufficient. • ONADE is tasked with new challenges and opportunities beyond drug evaluation • ONADE needs to be agile and able to succeed in a dynamic environment

  3. Innovation Exploration Team • Be a think tank group to: • Embrace innovation, new concepts and ideas from sponsors • Interact with Office Leadership Team and ONADE reviewers to develop new ways of approaching our evaluation of new products

  4. Goals and Objectives • Overall Goal: facilitate introduction of innovative products and processes to ONADE • Objective 1: increase certainty of regulatory path • Objective 2: increase awareness of potential safety, effectiveness, and quality issues • Objective 3: increase scientific and technical knowledge among reviewers

  5. Innovation Exploration Team • What’s happening now? • Setting up a charter, infrastructure and system of operation and recruitment • Identifying areas and issues that need to be addressed • Setting up a system of communication with the Office Leadership Team and ONADE • Engaging ONADE members to work on critical issues • Meeting with drug sponsors to collect feedback

  6. Our role is NOTto Review submissions Make decisions Change things that work well Change our safety, effectiveness, or quality standards Focus on specific products Our role ISto Propose ideas to the Office Leadership Team (OLT) for novel ways of approaching the review process Work with OLT and ONADE reviewers to develop ways to increase our efficiency Facilitate efficient learning and communication Focus on process and culture

  7. Methods to Achieve Goals • Meet with sponsors • Adapt internal processes • Identify and utilize expertise within CVM • Develop Focus Groups and Tech Teams

  8. Focus Group Roles • Currently proposed Focus Groups: • Communications/Education • Surrogate Endpoints • Statistics • Discover tangible plans for their area

  9. Tech Team Roles • Develop potential review methods to handle novel products that may not fit under our current guidance • Informally meet with sponsors in advance to establishing a INAD • Three “tech teams” established

  10. The Cycle of Innovation

  11. Where Do Generics Fit In? • IVET Goal: Facilitate introduction of innovative products and processes to ONADE. • Generic sponsors are already thinking outside of the box.

  12. Definition of Innovation • No single definition works… • Potential Guidelines: • Something for which our current guidance documents are insufficient • Product fulfills an unmet need • Novel API or first in class • Novel claim • Novel manufacturing process • Novel delivery system

  13. Get Involved • Sponsor feedback handout • Bring us your ideas and questions

  14. IVET Group Contact us at IVET@fda.hhs.gov

  15. Questions, Comments, Recommendations?? Contact us at IVET@fda.hhs.gov

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