Thursday, September, 2nd, 2010

7:30 to 8:15 am

Registration and Breakfast

8:15 to 8:45 am

Welcome and Opening Comments

8:45 to 10 am

Scientific Development and the Funding of Innovation

The advances in molecular medicine created opportunity for groundbreaking new medicines tailored to specific disease populations. However, many challenges remain in understanding disease biology and metabolism and the underlying mechanisms impacting disease subpopulations require for more effective diagnostics and therapeutics.

Innovation promises to create better technologies, enabling a smarter approach to drug approval.

This panel will address the financial, scientific and drug development challenges surrounding personalized medicine both in early stage start ups, and established bio/pharma companies.

10:15 to 11:30 am

Business and Market Challenges

It is often argued that personalized medicine will shrink markets because a tailored approach will circumscribe the number of patients eligible for therapy, resulting in reduced profits. On the other hand, with better validated biomarkers, drug development costs will decrease because better patient selection will produce smaller trials at reduced cost. All of this is predicated on new targeted therapies.

This panel will examine the strategic, economic, and market challenges of a constantly shifting landscape and how this will impact:

• Innovation and lifecycle management of both generics and branded drugs
• Market size and revenue
• The costs of prospective trials to adequately validate biomarkers

11:30 am to 12:30 pm

Lunch

12:30 to 1:45 pm

Overall Healthcare Challenges – Regulatory Approval, Reimbursement, and Healthcare Costs

Biomarker driven clinical trials coupled with the standing regulatory review process creates significant challenges in the current approval system.

Currently, in-vitro diagnostics and therapeutics are reviewed and approved under separate standards and separate divisions at the FDA.   A co-developed biomarker assay would require to satisfying both divisions’ hurdles, thus creating challenges around trial design.

On the issue of payment, the big question is who will pay for the test, and how will value be extracted? How will personalized medicine affect the overall cost of healthcare?

This panel will discuss issues facing regulatory approval and its impact on innovation, revenue generation and strategy, and costs to the payor system under the new healthcare plan.

2 to 3:15 pm

Legal and Investment Issues

Investment needs a legal environment that is stable and predictable.  One that allows a successful innovator in the personalized medicine space to realize excusive rights and profit margins sufficient to reward risk taking and success.

It is necessary in this context to give attention to U.S. and foreign patent systems. Those systems are currently under stress of challenges to patent eligibility as in the Myriad, Metabolite/Prometheus and Bilski cases.

Forced licensing or immunity can grow in various direct and indirect forms in revision of  Hatch-Waxman and Doha Declaration boundaries, university-company relationships, and government grant conditions.  Personalized medicine-affected changes in insurance, regulation, reporting, privacy and product and professional liability may also occur.

This panel will discuss these threats to personalized medicine development and critical steps needed to develop a new workable balance.