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September 19 – 21, 2017
Boston, USA

Day One
Wednesday September 20, 2017

Day Two
Thursday September 21, 2017

08.30
Chair’s Opening Remarks

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

Synopsis

Key Takeaways & Lessons Learned from Day One

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

08.45
Using RWD to Complement & Advance Scientific Insights

Synopsis

  • Using RWD to supplement and complement RCT results
  • Using RWD to promote safety and efficacy in the real-world and discussing the associated challenges
  • Debating whether RWD will be able to replace at least some of our traditional data generation activities in the future

09.15
Platform Based Approaches in RWE – Approaches, Methodologies & Examples

  • Jyotsna Mehta Director, Economics Value Evidence & Outcomes, Alkermes

Synopsis

  • Understanding platform based approaches in real world evidence
  • Providing examples to show its usefulness and value in drug development throughout the life cycle of drug products
  • Providing a framework of how and when to consider these for your studies and explain pros and cons through the use of examples

09.45
5 Steps to Getting Maximum Value from Real World Data

  • Dee Amanze Director of Clinical Consulting, Saama Technologies

Synopsis

  • Proper identification of business needs
  • Choosing the right data assets
  • Technology-enabled solutions, analytics platform, infrastructure
  • Human resources with appropriate domain expertise

10.15
Morning Refreshments & Networking

11.00
Predictive Analytics & Use of Real-World Data Analytics for Trial Design

  • Rajneesh Patil Senior Director - Risk Based Monitoring & Analytics, QuintilesIMS

Synopsis

  • Leveraging RWE to predict optimized design and operational strategy that can drive better trial design strategies based on disease detection and drive asset value

Evidence & Value Generation – Leveraging RWE & Analytics in Stakeholder Relationships

11.30
Panel Discussion: The Uptake of Real-World Analytics

  • Sebastian Schneeweiss Vice Chief, Division of Pharmacoepidemiology & Pharmacoeconomics , Brigham & Women’s Hospital
  • Tom Hughes Senior Director, Health Economics & Outcomes Research, Avanir Pharmaceuticals
  • Larry Pickett Former VP & CIO, Purdue Pharma LP

Synopsis

  • Escaping old models of evidence-based medicine – physician and patient buy-in to RWE driven approaches to care delivery
  • The payer perspective on real-world analytics assessment of drugs
  • Regulators – conservatives or drivers of innovation?
  • The evolving regulatory environment – the 21st Century Cures Act and the commitment to expanding the use of RWE in regulatory decision-making
  • Understanding the increasingly important collection of RWE due to changed regulatory approval perception – accelerated approvals, adaptive licensing, etc.

12.15
Unlocking the Power of Real World Evidence Data

  • Paul S. Barth CEO, Podium Data
  • Amanda Hart Director, US Regional Liaison, Real World Informatics &Analytics, Astellas Pharma US

Synopsis

  • Learning how to better harness real world evidence data and analytics for real world impact
  • Addressing how to increase leverage and ROI from investments in real world evidence data by empowering business teams to build their own RWE data sets on a self-service on-demand basis
  • Case-Study: sharing how Astellas Pharma has achieved a 30 fold increase in their use of RWE data in analytic projects by implementing an enterprise scale RWE data lake – the new platform is enabling better assessment of potential patient populations for new clinical trials during the pre-trial planing process and driving faster and more fact based sales reporting, promotional response measurement, and pricing evaluations
  • Outlining how Astellas implemented their RWE data lake in less than 6 months and how the resulting data platform – now less than 2 years old – has reduced the time required to deliver new analytic insights to the business from 3 months to 2 days, all while reducing the cost of data management by more than 50%

12.45
Lunch & Networking

13.45
Adapting Evidence-Based Medicine Methods For Toxicity & Exposure Assessments

  • Katya Tsaioun Executive Director, Evidence-Based Toxicology Collaboration, Johns Hopkins Bloomberg School of Public Health

Synopsis

  • Analyzing how efficacy and safety assessments of drugs become the scientific foundation of real-world analytics (RWA) and subsequent regulatory decisions
  • Describing the theory and principles of Evidence-based Medicine
  • Outlining how evidence-based methods (EBM), and Systematic Reviews (SR) are well positioned to be used for RWA
  • Adopting EBM approaches across the spectrum of drug discovery and development brings an opportunity to bridge discovery and post-marketing  research, thus closing the circle of discovery and development
  • Showing how the adoption of EBM by all stakeholders can increase reproducibility, transparency and objectivity of safety assessment and subsequently increase the confidence in regulatory decisions

14.15
The Rise of Analytic Tools in Real World Data Analytics: A Case-Study

  • Sebastian Schneeweiss Vice Chief, Division of Pharmacoepidemiology & Pharmacoeconomics , Brigham & Women’s Hospital

Synopsis

  • Analyzing the current practice of line-programming – slow, error-prone and not validated
  • Understanding how decision making in healthcare is a collaborative effort, often across multiple players in the industry, and analytic platforms can instil the required reproducibility, validity and confidence in RWD analyses that is lacking today
  • Substituting randomized trials with modern RWE to influence regulatory approval decisions – exploring the select circumstances

14.45
Afternoon Refreshments & Networking

15.15
Understanding & Reacting to the Patient Journey Through Real- World Evidence

  • Sandy Balkin Senior Director, Global Insights & Analytics , Sanofi US

Synopsis

  • Exploring the commercial value and insights obtainable from following the patient through the continuity of their healthcare experiences
  • Understanding the importance of longitudinal patient care to obtain good quality RWE and identify unmet medical needs
  • Optimizing development and promotional programs based on real-world analytics in support of marketing efforts

The Technical Challenges in RWE-Based Decision-Making

15.45
Panel Discussion: Addressing the Challenges in Successfully Leveraging Real-World Analytics

  • Sandy Balkin Senior Director, Global Insights & Analytics , Sanofi US
  • Wanmei Ou Director, Precision Medicine & Data Science, Center for Observational & Real World Evidence (CORE) , Merck

Synopsis

  • Exploring the issues of access and quality of the real-world data available – establishing cross-industry standards for data collection, transparency in RWE reporting and analytic methodologies
  • Better training and understanding of analysts – discussing the subjectivity of results and insights
  • Golden question: What to ask the data? – the understanding that not one solution or analytic tool fits all types of real-world scenarios
  • Extracting value requires a deep understanding of strengths and limitations of the conclusions that can be drawn – new analytic approaches to RWD
  • Overviewing the benefits and limitations of hub vs. decentralized real-world analytic capabilities

16.30
Chair’s Closing Remarks

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