Bridge the Gap /
Proving the Value of Healthcare Innovation
November 17, 2009 | Washington, DC

Agenda /

8:00 am-3:30 pm / Registration

8:00-8:30 am / Networking Breakfast

8:30-9:00 am / Welcome, Introduction, and Framework for the Day

Manufacturers spend billions of dollars each year on research and development, clinical trials, and marketing of new healthcare products.  But reforms on the horizon – including more than $500 billion in payment cuts and a new focus on comparative effectiveness research – have the potential to change how we define, value, and encourage innovation in healthcare.  How do experts define innovation in healthcare technology?  What might health reform mean for innovation? And how will today’s discussions improve our understanding of the relationship between innovation and health policy?

9:00-9:45 am / International Perspectives on Measuring Innovation

Countries around the world have grappled with the issue of providing healthcare to all citizens using a finite set of resources.  Policymakers decide upon the appropriate value of innovation, either directly or indirectly, in making decisions about how to allocate healthcare resources.  Nations vary considerably in their approaches, however.  The National Institutes for Clinical Excellence (NICE) in the United Kingdom makes recommendations that affect access to therapies for millions of patients treated by the National Health Service.   In France, the government bases reimbursement for new medical products on how they rate on a multi-parameter scale; innovation is one of the most significant factors in that rating.  Explore how other developed countries assess the value of innovation and discuss how the U.S. can learn from their example. 

9:45-10:45 am / Domestic Policy Roundtable on Healthcare Innovation

How are policymakers incorporating innovation into their legislative agendas?  Will short-term demands to reduce healthcare costs limit the ability to encourage risk-taking and innovation?  How will new payment models provide incentives to physicians and manufacturers to explore new treatments and technologies?  An expert panel of key agency leaders will discuss the Obama Administration’s plans for policies that will impact innovation, including a pathway for follow-on biologics, increased funding for comparative effectiveness research, and payment cuts to providers and health plans.  Hear how policymakers are balancing patients’ demands for new technologies with increased scrutiny of overall cost effectiveness, and what information is most helpful to them in shaping future policy.    

10:45-11:00 am / Networking Break

11:00-11:45 am / Financing Healthcare Innovation in a Global Economy

Some observers maintain that the U.S. market supports innovations in healthcare technology that benefit patients across the globe.  But more than ever, domestic healthcare technology companies must justify their investment decisions to their shareholders.  As the U.S. healthcare system enters a new era of reform, will global companies have access to the capital they need to continue to innovate?  What factors are driving Wall Street’s investment decisions?  How will healthcare reform affect the balance of international trade?  Learn from the investment community and a leading U.S. policy official in international trade about how U.S. companies should be thinking about their positioning. 

11:45 am-12:30 pm / Presentation of Avalere Health Research on CER and Innovation

Sponsored by the National Pharmaceutical Council

12:30-1:30 pm / Networking Lunch

1:30-2:15 pm / Keynote: The Future of Innovation 

Is the pace of innovation slowing down?  How will the pressures of cost controls and demands for more evidence impact investments in basic science and clinical research?  Is it time to consider other funding models for innovation, in the United States or across the globe?  Hear from an industry leader who is working to preserve incentives for innovation while competing in a challenging global economy.

2:15-3:15 pm / Assessing the Impact of REMS on Innovation

The Food and Drug Administration can now require applicants for certain new drug approvals to develop and implement Risk Evaluation and Mitigation Strategies (REMS).  The FDA intends for REMS to address specific drug safety issues around patient monitoring, dispensing, and settings of use, thereby allowing patient access.  Though few of the current REMS involve extensive requirements, all REMS necessitate additional work from patients, providers and manufacturers; as the complexity of REMS continues to evolve, the associated stakeholder burdens can be expected to increase.  This new authority can be seen to increase the potential cost of marketing a drug or biologic; alternately, REMS can also be seen as enabling the approval of some products, given the new risk monitoring processes.  The session will feature an overview of REMS, and a case study of a recent product whose market entry was shaped by REMS.   Patient and innovator perspectives will help illuminate the two-edged nature of REMS with respect to incentive for innovation.

3:15-3:30 pm / Concluding Remarks