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Analyzing Health Reform, Comparative Effectiveness and Reimbursement Trends in the Pharma/Biotech Market to Demonstrate Improved Value

The WHCC Pharmaceutical, Biotech and Medical Device Executive 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.

Chair:
Robert E. Henry
Editor-in-Chief
American Health & Drug Benefits
Engage Healthcare Communications, LLC


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Monday, April 12, 2010
1:35 pm -
2:25 pm
Comparative Effectiveness—Methodologies, Implications and Coverage Policies
  • Exploring new directions in comparative effectiveness methodologies and future coverage implications
  • Value-Based Pricing – How pharma and medical device pricing will need to evolve based on comparative effectiveness studies
  • Understanding the linkage between CER study results and policy development
  • Overcoming challenges for coverage recommendations when there is limited research
Michael Rawlins - Speaker Photo Sir Michael Rawlins, MD
Chairman
National Institute for Health and Clinical Excellence
United Kingdom


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Jean Slutsky - Speaker Photo Jean Slutsky, AHRQ
Director, Center for Outcomes and Evidence
Agency for Healthcare Research and Quality

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2:30 pm -
3:20 pm
The New Era of Demonstrating Value and Cost Effectiveness for Patient-Centered Care
  • Review of the Recovery Act and the spending plan including data infrastructure, dissemination and translation, and priority populations
  • FDA data infrastructure -- How to make CMS data available to both public and private sectors to improve effectiveness for certain populations
  • The use of patient registries and distributed networks of EMRs for clinical trials and research
Patrick Conway, MD
Chief Medical Officer, Office of the Assistant Secretary for Planning and Evaluation, DHHS;
Executive Director, Federal Coordinating Council on Comparative Effectiveness Research

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James M. Corrigan
Senior Vice President and General Manager, GE Healthcare IT
GE Healthcare

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Tuesday, April 13, 2010
10:20 am -
11:10 am
FDA Update on Innovation in 21st Century Product Development
  • Upcoming changes in the FDA structure and new focus areas- regulatory science
  • FDA and the regulation of diagnostics
  • Companion Diagnostics – Insight into the co-development of diagnostics and drug treatment
Vicki Seyfert-Margolis, Ph.D
Senior Advisor, Science Innovation and Policy
Office of the Chief Scientist
Office of the Commissioner
Food and Drug Administration

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Patrick Soon-Shiong - Speaker Photo Patrick Soon-Shiong, MD
Executive Chairman and CEO
Abraxis BioScience

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11:15 am -
12:05 pm
The Biosimilars Market and the Future of the Generics Industry
  • Identifying divergent purchasing groups and pricing strategies for biosimilars
  • Addressing payer strategies and incentives used in promoting generics
  • Growth trends and the implications of value-based health care assessment
David Simmons
President and General Manager, Established Products Business Unit
Pfizer

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Business Case Forum 8: Convergence of Medical Devices and Drugs/Biologics
2:25 pm -
3:10 pm
The Explosion in the Vaccine Market—Addressing Unmet Needs in Infectious Disease
  • Innovations in vaccine development and deployment
  • Emerging models for delivery of needed vaccines
Dr. Theodore Tsai
Senior Vice President, Scientific Affairs
Novartis Vaccines and Diagnostics

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3:15 pm -
4:15 pm
Expediting the FDA Process for New Medical Technologies
  • Developing pragmatic clinical trials that support post-marketing decisions
  • New trends in FDA review and approval of emerging medical devices
Richard E. Kuntz, MD, MSc
Senior Vice President and Chief Scientific, Clinical and Regulatory Officer
Medtronic, Inc.

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Jonathan Sackner-Bernstein, MD
Associate Center Director, Post Market Operations
Center for Devices and Radiological Health, FDA
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