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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

InnoVation Exploration Team (IVET)

Generic Animal Drug Alliance

April 21, 2011


New model for success
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


Innovation exploration team
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


Goals and objectives
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


Innovation exploration team1
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


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


Methods to achieve goals
Methods to Achieve Goals

  • Meet with sponsors

  • Adapt internal processes

  • Identify and utilize expertise within CVM

  • Develop Focus Groups and Tech Teams


Focus group roles
Focus Group Roles

  • Currently proposed Focus Groups:

    • Communications/Education

    • Surrogate Endpoints

    • Statistics

  • Discover tangible plans for their area


Tech team roles
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



Where do generics fit in
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.


Definition of innovation
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


Get involved
Get Involved

  • Sponsor feedback handout

  • Bring us your ideas and questions


Ivet group
IVET Group

Contact us at [email protected]


Questions, Comments, Recommendations??

Contact us at [email protected]


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