Day One

Wednesday 18th September 2019

8:15 am Chair’s Opening Remarks

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

8:30 am ‘IMPACCT’ Panel Discussion: Advancing the Generation & Utilization of Real World Evidence to Drive Patient-Centricity & Better Outcomes

  • Javier Jimenez VP & Global Head of RWE & Clinical Outcomes, Sanofi
  • Kara Dennis SVP & General Manager, Life Sciences, Clarify Health Solutions
  • Melvin Olson Global Head, RWD Strategy & Innovation, Novartis
  • Michael Lees Head of Value, Evidence & Portfolio Strategy , Takeda


• 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

9:15 am Advancing the Use of Advanced Analytics in Real World Evidence


• More information coming soon

9:45 am Building an Enterprise-Wide Analytics Platform for Real World & Observational Data Across the Drug Development Lifecycle

  • Raveen Sharma Specialist Leader, Life Sciences Analytics, Engagement Lead, ConvergeHEALTH by Deloitte
  • Weilin Meng Associate Director, Data Science, Center for Observational & RWE (CORE), Merck & Co.


  • Evolving RWE landscape and opportunities
  • Merck RWDEx Platform – mission and approach to build capabilities
  • Impact and future state

10:15 am Speed Networking Session

10:45 am Morning Refreshments

11:15 am Using Real World Data 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

11:45 am Using NLP to Improve Identification of Patients of Interest & Safety Events

  • Dongmu Zhang Director & Head of Epidemiology Data Analytics, AbbVie


  • Discussing EHR data vs. claims data
  • Exploring the use of NLP to identify and segment patients of interest
  • Developing NLP-based algorithm in safety events identification

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 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

3:15 pm Going Virtual in Real-World Research: Opportunities & Challenges


  • Analyzing how the proliferation of real-world data (RWD) sources is driving innovation in how traditional randomized controlled trials (RCTs) are planned, designed and executed
  • Discussing the role of Real-World research in pilot testing new technologies and process innovations for subsequent use in RCTs (e.g. “virtual” studies)
  • Highlighting the opportunities and challenges for going virtual in real-world research, using an ongoing fully-virtual prospective cohort study as a case example

3:45 pm Afternoon Refreshments & Networking

4:15 pm Emerging Areas of Real-World Data, Analytics & Application: Learnings from the Trenches

  • Ying Bao Director - Center for Observational Research & Data Science, Bristol-Myers Squibb


  • Case Study 1 (Non-traditional Data): Harnessing social media for real-world data
  • Case Study 2 (Advanced Analytics): Applying causal machine learning to understand disease
  • Case Studies 3 & 4 (New Applications): Using RWE to support regulatory submission and value-based contracting

4:45 pm Rigor vs Speed: RWE in Oncology Drug Development Throughout the Lifecycle

  • Hui Huang Executive Director & Head of Global Outcomes Research Oncology, Takeda


  • Do we have the right questions, right approaches at the right time?
  • How does RWE change our way of framing questions throughout the Oncology development cycle?
  • Robust yet pragmatic approach to incorporate patient voice into oncology trial design

5:15 pm What’s Driving Real World Data Utilization from Early to Late Phase Development

  • CJ Hameed Senior Director, Real World Data & Analytics, Chief Digital Office, Pfizer


  • Reviewing the current landscape, identify gaps and opportunities for RWD utilizing in drug development
  • Discussing RWE Methodologies, Data management for RWD Assets and advance analytics
  • How to effectively engage the stakeholders in RWD use and evidence generation and where to go next?

5:45 pm Chair’s Closing Remarks

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