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NVCA’s Medical Industry Group (MIG) & MedIC Scorecard

NVCA’s Medical Industry Group (MIG) & MedIC Scorecard . David Douglass, Delphi Ventures Ross Jaffe, Versant Ventures, Incoming Chair Jack Lasersohn , The Vertical Group Jonathan Leff , Deerfield Management, Outgoing Chair Terry McGuire, Polaris Ventures Jonathan Root, USVP.

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NVCA’s Medical Industry Group (MIG) & MedIC Scorecard

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  1. NVCA’s Medical Industry Group (MIG)& MedIC Scorecard David Douglass, Delphi Ventures Ross Jaffe, Versant Ventures, Incoming Chair Jack Lasersohn, The Vertical Group Jonathan Leff, Deerfield Management, Outgoing Chair Terry McGuire, Polaris Ventures Jonathan Root, USVP

  2. NVCA Medical Industry Group’s Purpose • Be a leading voice the medical innovation ecosystem • Shape new laws and polices that enhance investment in innovative medical products

  3. How? • Engage!!! • Draft thoughtful legislation and comments to regulatory guidances • Provide credible data to shape debate (i.e., LS Investment Survey) • Build important relationships in D.C. • Provide proactive solutions • Become part of the conversation by participating in stakeholder meetings and congressional meetings and briefings

  4. Examples of Our Successes in Shaping Policy • FDA/CDRH adoption of Innovation Pathway for medical devices • CMS release of “Innovators Guide” and adoption of Coverage with Evidence Development • 2008 PCAST Report on Personalized Medicine • 12 years of data exclusivity for biologics • Patent reform • FDA/CDRH Benefit / Risk Framework Guidance • Expansion and codifcation of Accelerated Approval pathway • Creation of Breakthrough Therapies designation • 2011 PCAST Jobs & Competitiveness Report • 2012 PCAST report on Accelerating New Drug Innovation • SBIR grant program open to VC-backed companies • New CMS framework for payment for advanced diagnostic tests • Patient Centered Benefit Risk framework for regulatory decision making

  5. 2014 Public Policy Priorities • FDA regulation • Continue to drive culture change at FDA • MDIC Patient Centered Benefit Risk Project • Advance a limited use pathway for new therapies • Advance expedited access program for medical devices • Review of FDA’s Special Protocol Assessment (SPA) process • Reimbursement/Payment • Develop a set of principals on how to evaluate the value of innovative medical technologies • Promote coverage and payment policies that recognize the value of innovative products • Tax Incentives • Promote tax reform and tax policies that encourage investment in emerging companies and medical innovation • Advocate for a small company phase-in from the medical device tax  • Patent Litigation Reform • Maintain strong patent protection for innovative small companies

  6. NVCA needs your investment in our future! Your leadership and commitment matters! Contact: Kelly Slone, Vice President, Life Science Policy kslone@nvca.org 703-778-9291

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