Day One

Thursday 13th December 2018

8:45 am Chair’s Opening Remarks

9:00 am ‘IMPACCT’ Panel Discussion: Advancing the Generation & Utilization of RWE to Drive Patient-Centricity & Better Outcomes

  • Javier Jimenez VP & Global Head of RWE & Clinical Outcomes, Sanofi
  • Melvin Olson Global Head, RWD Strategy & Innovation, Novartis


• Focusing on patient-centered drug development – what is the role of RWE?
• Defining and establishing clinically meaningful evidence to support R&D
• How to bring RWE-enhanced drug development one step forward?
• Where does the biggest opportunity for next steps in this space lie?
• Discussing the current regulatory climate in RWE
• Analyzing the rise of AI and Machine Learning capabilities and its impact in RWE-driven patient-centric clinical innovation and outcomes

Supporting Clinical R&D with Real-World Evidence

9:45 am Advancing the Use of Advanced Analytics in RWE


• More information coming soon

10:15 am Session Reserved for Deloitte


• More information coming soon

10:45 am Speed Networking Session

11:15 am Morning Refreshments

11:45 am Using RWD to Augment the Cardiovascular Drug Development Process

  • Keith Friend Global Medical Director, Cardiovascular, Bristol-Myers Squibb


• Exploring the use of RWD in early development
• Using RWD in full development
• Discussing how to support registration, launch and market access activities with real-world data

12:15 pm Patient Perspective of Disease Burden & Prevailing Unmet Need in Serious Mental Illness Treatment Landscape


• Overviewing of study types to collect patient perspective data
• Choosing appropriate instruments with study objectives in mind
• Exploring examples of qualitative and quantitative patient perspective research to highlight disease burden & unmet need

12:45 pm Lunch & Networking

1:45 pm Real World Evidence to Support Regulatory Submissions


• Exploring the FDA’s RWE framework
• When and how can RWE best augment RCTs?
• Discussing the FDA’s demonstration projects

Tackling Implementation & Data Challenges

2:15 pm Lesson Learned from The Development & Implementation of an Integrated Data & Evidence Strategy at AbbVie


• Developing and implementing an original data and evidence strategy from first principles – delving into the experience at AbbVie, a new large cap biopharmaceutical company
• Exploring the continuous implementation process over the last five years – identifying several key learnings that have led to modifications and additions to the ongoing roll out
• Focusing on some of those key learnings and their impact on implementation of the data and evidence strategy at AbbVie

2:45 pm Session Reserved for Syneos Health


• More information coming soon

3:15 pm Afternoon Refreshments & Networking

3:45 pm Advanced Analytics in Clinical & Observational Research

  • David Anstatt Executive Director, Observational Research & Data Sciences, Bristol-Myers Squibb


• The Data Story: evolving and expanding to meet research demands (social media, genomics as RWD, unstructured to structured, data provenance, sensors, privacy, PRO, study metadata)
• The Methods Story: exploring the advances in research, grounded in FDA/EMA guidelines (boost techniques, NLP, prediction, optimization)
• The Impact Story: working across the development and commercialization process (discovery and development predictive analytics, study optimization, patient journey/treatment analytics, regulatory use of RWD)
• Exploring Social Media Data in Pharmacovigilance

4:15 pm Evolving Real World Evidence Strategy Across Lifecycle – Improving Evidence for Patient Care


• Identifying gaps is easy, addressing them requires a deep understanding of data sources available, including strengths, limitations, and accessibility
• Generating relevant RWE requires understanding of key audience needs, their understanding of RWE, and credible methods and data sources
• Successful RWE programs reflect cross-functional expertise and collaboration across internal and external stakeholders with disciplined approach to evidence generation

4:45 pm Making Choices in Evidence Development: Using Local Insights to Drive a Truly Global Evidence Base

  • Michael Lees Head of Value, Evidence & Portfolio Strategy , Takeda


• Generating a comprehensive evidence base for new medicines by using RCT and RWE in an integrated way
• Establishing trade-offs needed between competing needs of different country decision makers, when developing a truly global evidence base
• Effectively managing these trade-offs where strong local input, internal and external to the developer of the medicine, is provided early and systematically into the evidence team

5:15 pm Chair’s Closing Remarks