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The 8<sup>th</sup> Annual Pharmaceutical, Biotech and Medical Device Summit

The WHCC 8th Annual Pharmaceutical, Biotech and Medical Device Summit convenes over 150 CEO and senior executives focused on creating strategies to demonstrate clinical and cost effectiveness, evidence based and personalized medicine, and the implications of health reform, comparative effectiveness and reimbursement changes. CEOs, Chief Medical Officers, Strategy, Innovation and Marketing Officers are in attendance, as well as Vice Presidents and Directors of Evidence-Based Medicine, Branding, Licensing, Business Development, Medication Safety and Product Managers from Pharmaceutical, Biotech and Medical Device organizations.

Monday, April 4, 2011
2:00 pm -
2:55 pm
Modernizing the FDA—Accelerating Innovation and Approval Processes
  • The changing FDA structure - Promoting and incentivizing innovation for drug and device manufacturers
  • Advances in communicating with the public and transparency within the Agency
  • Initiatives to create efficiencies in the Agency, promote innovation and streamline application and approval processes
Garry Neil, MD
Corporate Vice President, Corporate Office of Science and Technology
Johnson & Johnson
 View Biography
Vicki L. Seyfert-Margolis, PhD
Chief Scientific Officer, Immune Tolerance Network
Federal Drug Administration (FDA)
 View Biography
3:00 pm -
4:00 pm
Comparative Effectiveness—New Models to Compete and Succeed in a Value-Driven Market
  • Evolving pre- and post-approval strategies to demonstrate comparative value
  • New directions in demonstrating product value through pharmacoeconomic and health outcomes research
  • Outlining strategies to define value by multiple stakeholders and their respective comparative models
  • Identifying the product pipeline decision-making changes will need to occur and at what stages of development
Jane Barlow, MD, MPH, MBA
Vice President, Medical Strategy & Precision Health Solutions
Medco Health Solutions
Joshua J. Ofman Joshua J. Ofman, MD, MSHS
VP, Global Coverage & Reimbursement, Global Government Affairs; VP, Global Health Economics and Global Development
Amgen
 View Biography
Tuesday, April 5, 2011
10:40 am -
11:35 am
The Interface between Comparative Effectiveness and Evidence Based Medicine
  • Experts discuss evidence-based care—from EBM policy implementation to business models to improve health outcomes
  • Examine what the future holds as we enter a new era of evidence based practice and comparative effectiveness
Ravinder Dhawan, PhD
Senior Director, World Wide Market Access
Johnson & Johnson Pharmaceutical Services
Sharon Levine, MD
Associate Executive Medical Director, The Permanente Medical Group;
Board Member, Patient Center Outcomes Research Institute
 View Biography
11:40 am -
12:35 pm
The Cost-Effective Consumer—Exploring Generic Alternatives and Cost Savings from Expensive Brand Drugs
  • Financial incentives for plans and consumers for generic utilization without compromising value and outcomes
  • Details on patent expiration and emerging opportunities in generics for pharmaceutical, biotech and generic manufacturers
  • Strategies to make affordable treatments available to patients and consumers
  • Addressing payer strategies and incentives used in promoting generics to cut reimbursement costs associated with expensive drugs
Jeff George
Global Head, Sandoz;
Member of the Executive Committee, Novartis
 View Biography
Thomas M. Moriarty
General Counsel, Secretary and Senior Vice President, Pharmaceutical Strategies and Solutions
Medco
 View Biography
2:50 pm -
3:45 pm
Fostering Innovation in Medical Device Technology
  • Interagency collaboration - Insights in to Government’s joint efforts to promote public health and provide timely access to medical innovations
  • FDA/CMS Parallel Review Considerations – Strategies to reduce the time between FDA marketing approval and CMS national coverage decisions
  • The evolving role of the FDA 501k approval process – New methods to strengthen process, improve consistency and accelerate consumer access
William A. Hawkins
Chairman and Chief Executive Officer
Medtronic
 View Biography
Jeffrey E. Shuren Jeffrey E. Shuren, M.D., J.D
Director, Center for Devices and Radiological Health
U.S. Food and Drug Administration
 View Biography
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