Making the CDCRN A Reality Industry View Larry

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Making the CDCRN A Reality: Industry View Larry L Wood Corporate Vice President &

Making the CDCRN A Reality: Industry View Larry L Wood Corporate Vice President & General Manager, Transcatheter Heart Valves - Edwards Lifesciences

Disclosures Affiliation/Financial Relationship • Salary and Equity Company • Edwards Lifesciences

Disclosures Affiliation/Financial Relationship • Salary and Equity Company • Edwards Lifesciences

The Innovators Dilemma The Thrill of Victory The Agony of Defeat The challenge is

The Innovators Dilemma The Thrill of Victory The Agony of Defeat The challenge is you don’t know which is which until after the study! Hundreds of millions spent and $0 resulting revenue Builds the basis for future clinical success

The Early TAVR Procedure Proved to be Technically Challenging and Very Complex Nobody was

The Early TAVR Procedure Proved to be Technically Challenging and Very Complex Nobody was optimistic about this being a mainstream therapy! 10

TAVR Trials Now Represent the Largest and Most Rigorous Comparative Body of Evidence in

TAVR Trials Now Represent the Largest and Most Rigorous Comparative Body of Evidence in the History of AVR Today, TAVR trials represent the largest and most rigorous comparative body of evidence in the history of AVR with 20, 000+ patients studied

The TVTR is Robust and Complementary to High Quality Pre-Market Studies The TVTR infrastructure

The TVTR is Robust and Complementary to High Quality Pre-Market Studies The TVTR infrastructure has been successfully leveraged for post-market studies and approval of niche indications Can this infrastructure be used to reduce the cost of innovation and clinical trials?

The Current Pre-Market Clinical Trial Model Presents Pros and Cons for the Sponsor Pros:

The Current Pre-Market Clinical Trial Model Presents Pros and Cons for the Sponsor Pros: • 100% oversight of data integrity, accuracy, and analysis • 95%+ data compliance • Sponsor has real-time access to databases for ad-hoc analysis and reporting • Rapid technology and procedural learnings Cons: • Data collection, monitoring, and long-term follow-up is expensive • Follow-up is expensive and burdensome on research centers and hospital infrastructure 7

If Cost Was the Only Factor, the Proposed CDCRN Model Would Be Embraced By

If Cost Was the Only Factor, the Proposed CDCRN Model Would Be Embraced By All

There is More To The Equation Than Just Cost… Risk/Benefit

There is More To The Equation Than Just Cost… Risk/Benefit

Pre-Market Clinical Trial Expenses Example: Sponsor Expense Breakdown for Pre-Market Clinical Trial [CATEGORY NAME]:

Pre-Market Clinical Trial Expenses Example: Sponsor Expense Breakdown for Pre-Market Clinical Trial [CATEGORY NAME]: [VALUE] Site Payments; Patient Reimbursement; Vendor Coordination, 40% [CATEGORY NAME]: [VALUE] • Majority of trial costs will likely remain fixed Clinical Monitoring: [VALUE] • Opportunities exist to reduce the cost burden of database development and clinical monitoring

There are Significant Risks that Need Thoughtful Consideration Execution & Speed Rapid Learning Confidentiality

There are Significant Risks that Need Thoughtful Consideration Execution & Speed Rapid Learning Confidentiality Data Queries Data Quality Customization

International Regulators and Payers Must Also Embrace the Model • Today, industry leverages large

International Regulators and Payers Must Also Embrace the Model • Today, industry leverages large clinical trials for international regulators and payers • Appropriate coverage and payment has become a bigger issue for industry than regulatory approval

For the CDRCN Model to Work, each Partner Must be Willing to Compromise

For the CDRCN Model to Work, each Partner Must be Willing to Compromise

The CDRCN Model Must be a True Partnership between Societies and Sponsors Accept different

The CDRCN Model Must be a True Partnership between Societies and Sponsors Accept different evidence/quality standards What we would get is an integrated, cost. Accept more risk efficient, sustainable, total life-cycle infrastructure that supports product development, approval, payment and surveillance Accept less independence Accept different evidence/quality standards

Summary • The TVTR infrastructure has been successfully leveraged for streamlining post-market studies •

Summary • The TVTR infrastructure has been successfully leveraged for streamlining post-market studies • Under a true partnership model, it is possible that the CDCRN model could be implemented for TAVR in the premarket setting • Key challenges remain 15