All agenda timings below are displayed in EDT. For PDT, please download the full program here.

Day Two

WEDNESDAY, SEPTEMBER 30

9:30 am Virtual Coffee Networking

9:55 am Chair’s Opening Remarks

Challenges With Data & Implementation

10:00 am Panel: Integration Within the Pharmaceutical Community

  • David Anstatt Executive Director, Center for Observational Research & Data Sciences, Bristol-Myers Squibb
  • Michael Lees Head of Value, Evidence and Portfolio Strategy, Takeda
  • Ipek Stillman Head, Globak Health Economics, Takeda

Synopsis

  • Big players in the field discuss their issues in company structure to compare bottlenecks and advantages

10:45 am Strategic Vision for RWE Generation Across the Product Lifecycle

Synopsis

  • Examining evidence generation as a key deliverable and an important strategic capability to enable efficient drug development and commercialization across the product lifecycle
  • Discussing the importance of understanding RWE approaches to address key questions, and an aligned leadership structure that embraces cross-functional trust, collaboration and communication
  • Defining the challenges impeding the full realization of benefit from RWE and opportunities to better ensure that needed evidence is generated

11:15 am Pushing the envelope on RWE and RWD Analytics

  • Manish Menon Associate Principal RWD&I India Head, ZS
  • Sudhir Ghuge Associate Principal, RWD&I Technology Head India, ZS

Synopsis

• Actionable RWE – ZS’s point of view to create actionable RWE strategies
• ML and AI disruptions impacting RWD analytics

11:45 am Morning Break & Networking

12:15 pm Synthea: Augmenting RWD & Synthetic Data into a Limitless Platform

Synopsis

  • Presenting an introduction to Synthea – a synthetic universe
  • Augmenting clinical data for insight discovery
  • Reimagining AI and ML testing with synthetic data

12:45 pm Considerations for integrating digital and sensor data into the RWD ecosystem

Synopsis

  • Opportunities and challenges in data generated by remote monitoring systems
  • Augmenting real-world patient data with open-source public data
  • Personalizing RWE with AI

1:15 pm Leveraging RWD across Clinical Development for Autoimmune and Chronic Diseases

Synopsis

Across clinical development, real-world data can transform clinical trials, regulatory submissions, market access programs and more. This session explores the basics of what makes RWD high-quality and its applications for accelerating research and for evaluating treatment outcomes in immunology and other chronic conditions, including RA, SLE, MS, and HF.

  • RWD utility across research and development
  • Data quality and getting to regulatory-grade results
  • How new technologies can collect and process data for RWE applications
  • Case examples

1:45 pm Lunch & Networking

Optimizing Post-Clinical Commercial Success

2:45 pm Strategizing Market Access – Ensuring Implementation for the Whole of the Drug Development Continuum

Synopsis

  • Comparing the differences between Medical Affairs and Market Access departments
  • Describing the transition from European to global outreach

3:15 pm Global Medical Affairs (GMA): Lessons Learnt from Creating a Department

  • Amy Place Senior Director, Field Medical Affairs, Scholar Rock

Synopsis

  • Revealing the plans and impact of building out a GMA branch
  • Recollecting on current observations and future challenges
  • Detailing personal accounts of introducing and incorporating GMA into trial design

3:45 pm Understanding Market Access Methodology

  • Omar Ali Pharmacist Consultant, QIPP Adviser Payer Network

Synopsis

  • Ensuring real world data effectiveness at other ends of the value chain
  • How to realize the full potential and seize the opportunity RWE presents
  • RWE usage perspectives of pharma and payers and how this will change in the next few years

4:15 pm Chair’s Closing Remarks & End of Conference