Agenda

• Go beyond clinical trials - how pharma can improve access to medicines that work by demonstrating relative effectiveness
• Why it’s no longer enough to lower prices – explore how strategic partnerships between key stakeholders can increase access to effective medicines
• Assess the impact of the healthcare budget on patient access, HTA’s, payers, and quality.

Tehseen Salimi, Vice President - Global Evidence & Value Development, Sanofi

• Understand the volume-to-value evolution in healthcare delivery and how payers and providers are facing new requirements for improving care while containing costs
• How pharma should learn to collaborate and innovate with organized customers throughout development and commercialization to:
  • Shape development programs based on real-world evidence
  • Demonstrate the clinical, humanistic and economic value of new products
  • Develop enhanced, scalable and patient-focused care interventions
  David S. Memel, MD, MS, MBA, Executive Director, HEOR, Boehringer Ingelheim

• Ensure strategic alignment: Align senior leadership on the value at stake in associated brands, assets, and projects, and create a clear articulation of the enterprise approach to RWD
• Evolve current HEOR capabilities and operating model: How to balance the benefits of centralization with the need for local knowledge and agility
• Determine asset-level RWD strategies: Review the product portfolio for key decision points and commercial milestones, and the role that RWD can play in safety, efficacy, or cost-effectiveness
• Assume a seat at the table to shape industry standards and policies: Pharma leadership teams need to engage in industry dialogue to determine standards

  Steve Savas, Partner, McKinsey & Company

This session will address implications of the choice of study design on payer decision making and clinical guideline development, as well as on the communication of evidence and incentives for innovation.

• Examine how payers and clinical guideline organizations are considering observational data in decision making
• Identify steps to increase the appropriate use and acceptance of real-world evidence
• Evaluate the impact of various types of evidence in the ability to communicate and share results

Jennifer Graff, Director - Comparative Effectiveness Research, National Pharmaceutical Council

The drive for more collaboration in healthcare will impact your business model as customers become more demanding and complex.  In this session a payer veteran that his witnessed this transformation will give you strategies on;

• How consolidation and accountable care organizations (ACOs) are changing the medical landscape
• How patient reported data is a reflection of activity throughout the healthcare utilization journey
• What the Affordable Care Act means for your business and how delivery systems should evolve for appropriate cost effectiveness

Charles Shasky, Head - Aetna Pharmacoeconomic CER (APCER), Aetna

Real-world evidence is now a critical element of the clinical and health economic research agenda. Going forward, real-world data will increasingly be ‘table stakes’ for market access. 

This panel will deliver you a strategy for building:

• The kinds of evidence that influence payers and providers
• The tools, platforms, and organizational capabilities you’ll need to collect this data and shape a compelling value story for these key stakeholders
• The framework for relationships you need to have with payers and providers to make the most of your evidence

Jill Sackman, Senior Consultant, Numerof & Associates
Panelists are being added from leading payer organizations - TBC

• How the release of Medicare and Medicaid claims data will increase transparency on health care performance and outcomes
• What the legislative history and regulatory actions mean for a company’s ability to commercialize claims data
• Why your path to market will benefit from more robust data on outcomes, cost of care and burden of disease

  Stephanie Carlton, Health Policy Advisor, United States Senate - Health Committee 

• How the Affordable Care Act is structured to create a premium on real-world evidence, how Johnson & Johnson is responding – and how you should too!

  Robert Donnelly, Senior Director – Health Policy, Johnson & Johnson 

• How HIPAA laws will affect your ability to collect patient supplied data
• HITECH Act amendments to rulemaking that are being implemented in 2013
• How the Genetic Information Non-Discrimination Act (GENA) affects the transfer of genetic information

Maya Bernstein, Privacy Advocate, HHS-ASPE

If you are like many other companies today then you are part of a global strategy for growth and have partners in emerging markets to support your strategy.  But is you organization developing RWE capabilities in these markets?  What is the political, economic, scientific, and technological landscape?  We will ask those that know the road with direct experience in these markets and you need to hear their perspectives on:

• What the future policies are in these markets and how your business will be impacted
• How cost effective evidence will be taken into consideration in pricing and reimbursement decisions
• How to implement real-world data based on first-hand experience
• Navigating the real-world data landscape in China, Asia Pacific, and other emerging markets

  Xianchen Liu, Global Head of HEOR, Pfizer
  Danyi Zhang, President & Chief Medical Officer, VitalStrategic Research Institute

• Centralize data-sets:  Hear how Pfizer have centralized the acquisition of real-world data sets through the creation of a ‘Data Mart’ to facilitate access to this evidence across the enterprise
• Collaborate with data partners: Understand Pfizer’s strategy with Medco (Express Scripts), Humana, and Humedica and how these partnerships will improve patient outcomes
• Target drug development: Find out how real-world evidence helps Pfizer better target what drugs to develop and how to develop them
• Go-to-Market:Discuss how to bring therapies to market in a precision medicine framework

  Marc L. Berger, Vice President - Real World Data and Analytics, Pfizer

• Familiarize yourself with the new generation of analysis methods to deal with massive EMR datasets
• Define your psycho-social variables to allow you to capture usable wisdom more rapidly
• How you can develop a useful harmonization strategy around the capture of this information
• Ways to determine and communicate your medicine’s impact on health outcomes/costs for payers - for the next generation of research

  Robert Kaplan, Director - Office of Behavioral and Social Sciences Research (OBSSR), National Institutes of Health

• Extract more value from data partners: articulating what data is needed for the decision matrix and defining your research question for HTA needs
• Feasibility checks on the quality of data to ensure valuable results
• Set up key relationships/contracts to gain appropriate access to data
• Navigate the barrage of data sources on the market to avoid gaps and biases

  Craig Richardson, Head of Access to External Data, Johnson & Johnson

• Find out what Penn has learned from its massive data warehouse on 4.5 million patients collected over 12 years
• Understand the security challenges and development of data mapping standards for provider EMR systems
• The future of commercializing provider data – important lessons learned from the payoff of Penn’s data warehousing investments

Brian Wells, AVP of Health Technology & Academic Computing, University of Pennsylvania Health System

• Real-World Populations:  An analysis for you to understand managing data on multiple chronic conditions or multiple concurrent interventions
• Establish evidence where it doesn’t exist for translation into practice
• Business impact of new payment directions:
• Medical Homes
• Accountable Care Organizations (ACOs)
• Health Insurance Exchanges (HIEs)
• Public Reporting of Outcome Metrics

John Lynch, Executive Director, Connecticut Center for Primary Care

Take a front seat to the leading statistical minds in healthcare:

• Experts in methods such as causal inference and Bayesian statistics can transform your organizational capacity for handling large quantities of data integration
• Learn the best practices involved with handling ‘missing-data’ which is often cited as a leading problem among data scientists in healthcare for effective data management

Speakers include elite statisticians with decades of experience such as:

Donald Rubin, Professor of Statistics, Harvard
Pravin Jadhav, Director – Simulation & Modeling, Merck
Diane Mould, President, Projections Research

• How to use CMS claims data to figure out the total number of disease combinations
• Learn the implications of a complex disease environment
• Use algorithms based on a CMS-Hierarchical Conditions Categories (HCC) claims model

James Sorace, Senior Medical Officer, ASPE – Office of Science & Data Policy

• Digitize epidemiology in your organization with news, social networks, and computer monitoring to create predictive analytic tools for improved health outcomes
• Monitor social networks to intercept data and create algorithms of behavioral diseases to understand containment
• Case study results of cross-functional and international projects that use web platforms for the capture real-time data like FluNearMe ™

Alessandro Vespignani, Sternberg Family Distinguished Professor, Northeastern University