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September 19 – 21, 2017
Boston, USA

Day One
Wednesday September 20, 2017

Day Two
Thursday September 21, 2017

08.45
Chair’s Opening Remarks

  • Tehseen Salimi Head of Medical Affairs for Primary Care & Women’s Health, Merck

Leveraging the RWE Strategy Across the Drug Development Process to Achieve Commercial Success – Part One

09.00
Opening Keynote Panel Discussion: Defining the Value of RWE Through Advanced Analytics across the Continuum of Drug Development

  • Christoph Koenen VP Development Lead , Bristol-Myers Squibb
  • Frank Zhang VP Market Access - Global Strategy & US, Alnylam Pharmaceuticals
  • Julie Locklear VP & Head, Health Economics & Outcomes Research, EMD Serono
  • Kitty Rajagopalan VP & Head Global Health Economics & Outcomes Research & Market Access, Sunovion Pharmaceuticals

Synopsis

  • What is RWE? – Clearly defining the hierarchy and classification of RWE
  • How far is the industry willing to integrate RWE into the drug development plan?
  • Defining at which point should real-world analytics be integrated in the development process – the benefits of early RWE generation for assuring a successful launch and reimbursement pursuit vs. after launch RWA
  • Exploring how RWA is being adopted across the whole continuum of drug development
  • Discussing the future of RWE in pharmaceutical decision-making

09.45
Keynote Session: Real-World Analytics & Value Generation – Successfully Bringing to Market & Commercializing Drugs

  • Tehseen Salimi Head of Medical Affairs for Primary Care & Women’s Health, Merck

Synopsis

  • Assessing the barriers to and potential when fully accepting RWE to inform decisions in the late stages of drug development
  • Exploring the role of RWE in clinical development decision making and mitigation of post-launch risk
  • Establishing a framework for using real world analytics to link proof of value during proof of concept (maximizing returns)

10.15
The Data Driven Shift to Value Based, Personalized Healthcare

  • Brett Davis General Manager, ConvergeHEALTH by Deloitte

Synopsis

  • Analyzing how the health care ecosystem is in a period of unprecedented change, with technology, data volume, variety, and velocity, expertise, and market entrants all increasing, and how life sciences innovator’s future success will become increasingly dependent on its ability to utilize data as a critical asset to better inform decision-making across the value chain
  • Discussing how success in evidence life cycle management will require increased transparency, advanced analytics, and linkages between disparate data types across R&D to commercialization
  • Data are frequently in silos across programs or even hidden in individual machines, so researchers cannot gain insights derived across studies and programs and may not know what data assets are available across the organization
  • Presenting Deloitte’s innovative approaches to tacking this evolving space including investments ConvergeHEALTH MinerTM , a platform currently deployed at a number of Life science clients

10.45
Morning Refreshments & Speed Networking

11.45
The Right Answer to the Wrong Question is Not Commercially Relevant

  • Tom Hughes Senior Director, Health Economics & Outcomes Research, Avanir Pharmaceuticals

Synopsis

  • Understanding the environmental context outside of the company
  • Defining a strategy – the payer value proposition
  • Defining tactics – communication and research plans

The Role of RWE & Analytics in Defining Market Access & Pricing Strategies

12.15
How to Create a Comprehensive Evidence Generation Plan Throughout the Life Cycle to Optimize Pricing & Market Access Potentials

  • Frank Zhang VP Market Access - Global Strategy & US, Alnylam Pharmaceuticals

Synopsis

  • Defining what is a compelling value proposition
  • Understanding how RWE could play a pivotal role in establishing a product’s value proposition
  • Exploring what kind of RWE is needed at each stage of clinical development to optimize for the pricing and reimbursement potential

12.45
Lunch & Networking

13.45
Optimizing Access With Real-World Evidence

  • James Harnett Senior Director, Real World Data & Analytics, Pfizer

Synopsis

  • Demonstrating how RWE informed R&D better addresses multiple stakeholder needs for access
  • Using RWE to identify rare disease populations and rare safety outcomes – avoiding labour and resource intensive patient registries
  • Analyzing RWE potential for comparative effectiveness studies, precision medicine and future label enhancements

14.15
Using RWE to Support Outcome-Based Contracting & Pricing Models

  • Julie Locklear VP & Head, Health Economics & Outcomes Research, EMD Serono

Synopsis

  • Developing a suitable framework to determine relevant therapeutic areas
  • Evaluating the operational impact and challenges around defining or assessing if a drug is generating value
  • Demonstrating product value to improve care delivery

14.45
Mastermind Session: Bridging the Gap to Commercial Success with Real-World Evidence & Analytics

Synopsis

This session facilitates in-depth discussions between participants in an informal environment. After splitting into small groups, participants will discuss key issues and challenges regarding RWE and analytics, and post-market activities.

15.15
The Development Hyperloop: Accelerating Clinical and Commercial Processes with Real World Evidence

  • Josh Ransom Head of Clinical Products , SHYFT Analytics

Synopsis

  • Analyzing how the rise and proliferation of Real World Evidence (RWE) in the Life Sciences – particularly in the Clinical and Commercial arenas – have given rise to massive opportunities in therapeutic innovation
  • Looking at how the potential for a paradigm shift in the development cycle has been stymied by the logistical challenges of managing, modeling, and analyzing petabytes of complex data
  • Pionnering the therapeutic landscape by effective using RWE leading to massive gains in clinical trial efficiency through better site selection, targeted geolocation of patient cohorts, and efficient patient recruitment
  • Addressing five data and analytics challenges commonly encountered throughout the development and go-to-market journey & offering strategies to overcome these challenges through the tactical and actionable use of RWE, arming therapeutic innovators with a playbook to streamline processes, maximize investments, and impact patients’ lives

15.45
Afternoon Refreshments & Networking

16.15
Utility of US Real World Evidence in Successful Global HTA Submissions

  • Kitty Rajagopalan VP & Head Global Health Economics & Outcomes Research & Market Access, Sunovion Pharmaceuticals

Synopsis

  • Analyzing the convergence of evidence requirements worldwide including the evolving interest in RWE
  • Understanding the application of Real World Evidence from one geography as supporting information in global HTA submission of other geographies
  • Exploring global case studies spanning ex-US HTA bodies

16.45
Using Real World Data to Inform the Design of Outcomes-Based Risk Share Agreements

  • Julie van Bavel Director, Medical Policy – Access Research, Center for Observational & Real World Evidence (CORE), Merck
  • Wanmei Ou Director, Precision Medicine & Data Science, Center for Observational & Real World Evidence (CORE) , Merck

Synopsis

  • Understanding the challenges and solutions in using RWD in Outcome-Based RSAs
  • Exploring the required data analysis: Defining the analytic framework and the pros and cons of different analytical approaches

17.15
RWD/RWE in the Life Cycle of Drug Development – Opportunities & Challenges

  • Lixia Wang Senior VP - Biometrics Health Economics & Outcomes Research, CTI Biopharma Corp

Synopsis

  • Shifting the drug development paradigm with real-world data and evidence
  • Providing opportunities and progress using real-world data in clinical development, HTA process, and post marketing
  • Exploring the existing challenges and how collaboration among industry, health authority and academia is required

17.45
Chair’s Closing Remarks

  • Tehseen Salimi Head of Medical Affairs for Primary Care & Women’s Health, Merck

17.50
Networking Drinks Reception