Conference Day 2

ALL TIMES BELOW SHOWN IN EDT*

8:30 am | Log in to Morning Coffee Room

9:00 am Chair’s Opening Remarks

  • Kelly Zou Head of Global Medical Analytics & Real World Evidence, Viatris

Utilizing the Tools Available to Analyze Data

9:15 am Panel Discussion: Reviewing Best Practice When Analyzing Real World Data

  • Kelly Zou Head of Global Medical Analytics & Real World Evidence, Viatris
  • Lee Severson Global Regulatory Lead, Global Product Strategy, CSL Behring
  • Eric Sarpong Director Real World Data Analytics & Innovation, Center for Observational & Real World Evidence, Merck

Synopsis

  • Understanding the analyses possible and how they can be leveraged to generate meaningful evidence
  • Developing frameworks for the appropriate application of RWE to complement trial data
  • Addressing the limitations of RWE
  • Debating when you should start having an in-house RWE & RWD team – and why it’s not a big pharma privilege

10:00 am “Re-Usable” RWD Networks for Registries, Prospective Research, and Post Marketing Commitments

Synopsis

  • Automated, clinical ‘data networks’ are transforming the research paradigm and can be used from early clinical development through regulatory approval. This session will explore:
  • How do multi-purpose, ‘reusable’ data networks differ from traditional research models for real-world evidence and patient registries?
  • How are data networks built and what are some of the leading data networks in specialty areas such as dermatology, neurosciences, GI, respiratory and behavioral health?
  • How are data networks providing data for regulatory purposes?

10:30 am Statistical, Econometrics Methods & Techniques for the Analysis of RWE & RWD

  • Eric Sarpong Director Real World Data Analytics & Innovation, Center for Observational & Real World Evidence, Merck

Synopsis

  • Identifying methodology gaps in the application of advanced analytic methods of RWE generation
  • Overcoming these gaps by considering appropriate models and methods for analysis
  • Understanding the implications of analytical methodology selection for RWE research and publication

11:00 am | Speed Networking & Morning Break

From Clinical to Post-Approval – The Role of RWD & RWE

11:30 am Incorporating Real World Evidence to Drive Patient Outcomes Research

  • Kelly Zou Head of Global Medical Analytics & Real World Evidence, Viatris

Synopsis

  • Reviewing the use of RWE for regulatory purposes globally
  • Examining the role of AI for precision medicine and outcomes research
  • Evaluating the advantages and challenges of RWD/RWE for outcomes assessments

12:00 pm Using New Models for RWE in Post-Approval Activities

Synopsis

• How can Natural Language Processing support the healthcare industry
• The uses of Natural Language Processing
• Overview of Federated data networks

12:30 pm Roundtable: Turning Your RWE into Actionable Insights & Value Propositions For Patients & Payors

  • L. Allen Kindman MD. FACC Vice President, Protocol, Patient and Site Feasibility, Applied Data Science Center, IQVIA
  • Kraig Kinchen Senior Director, Center of Expertise, Global Patient Outcomes & Real World Evidence, Eli Lilly
  • Stuart Turner Executive Director RWE & Data Science , Novartis

Synopsis

This interactive session will give you the opportunity to dive into the conversation with your fellow colleagues to discuss, debate and get inspirations on how to approach RWE and RWD into actionable insights. Get your camera ready to be part of this conversation!

  • Investigating data gathered during clinical trials to provide evidence of value
  • Using RWE generated preapproval to bring payors in earlier
  • Analyzing RWD to identify and mitigate risks in outcomes research

1:15 pm | Networking Lunch

2:15 pm Utilizing RWE in Breast Cancer Treatment Research

Synopsis

  • Exploring the appropriateness of RWD for external control cohort development
  • Applying RWE to complement and support regulatory approval through an external control arm
  • Leveraging RWE for reimbursement post-approval

2:45 pm Designing Synthetic Arm Trials Using Real World Evidence

Synopsis

  • Understanding the methodologies for clinical trials using synthetic arms
  • Addressing the challenges of designing synthetic arm clinical trials in different disease modalities
  • How to design trials with RWD in mind to answer questions with scientific rigor

3:15 pm Chair’s Closing Remarks

  • Kelly Zou Head of Global Medical Analytics & Real World Evidence, Viatris