Conference Day 1

ALL TIMES BELOW SHOWN IN EDT*

8:30 am | Log in to Join Coffee Chatroom to Meet Your Fellow Colleagues

9:00 am Chair’s Opening Remarks

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

9:15 am The 10-Year Journey of Real-World Evidence (RWE) in Pharma & Beyond, & Building for the Next 10 Years

Synopsis

  • How the industry has embraced RWE in the past decade and emerging opportunities
  • Evaluating the uses of RWE throughout product lifecyles
  • Building upon learnings over the last decade and preparing for the evolution and growth of RWE

Maximizing The Value of Real World Data

9:45 am Reimagining Your Clinical Trial by Embracing Real-World Data

  • Paul Petraro Executive Director, Real World Evidence Analytic Centre of Excellence, Boehringer Ingelheim

Synopsis

  • Shifting the paradigm of how RWE can be utilized to complement existing clinical data collection
  • Integrating RWE into data generation pipeline early to reduce costs and optimize trial design
  • Identifying where RWD can be applied to generate evidence cost-effectively

10:15 am Generating Real World Evidence for COVID-19 Treatments During a Global Pandemic

Synopsis

  • Harnessing compassionate use and secondary data to communicate with regulatory authorities
  • Generating fit for purpose external comparators for single arm trial populations
  • Post-authorization assessment of real-world effectiveness in secondary datasets

10:45 am | Speed Networking & Morning Break

Synopsis

Join this interactive ice-breaking session to reconnect and meet with fellow colleagues to share your challenges, and top tips on RWE in this speed networking break!

11:15 am Panel Discussion: Understanding the Data Quality Required

  • Paul Petraro Executive Director, Real World Evidence Analytic Centre of Excellence, Boehringer Ingelheim
  • Jolyon Fairburn-Beech Director, Real World Evidence Strategic Partnerships, GSK

Synopsis

  • Ensuring data generated are fit for purpose
  • What are the new sources of RWD – from EHR to claims to wearable technology?
  • Breaking away from regulatory grade data to uncover new opportunities to utilize RWD
  • Reviewing the data available outside the US and how it can be accessed

The Emerging Trends – Integrating RWE in Preclinical & Clinical Activities

12:00 pm Using RWD External Control to Emulate a Target Trial When a Randomized Trial is Not Available: Methodology & Regulatory Engagement in Cell & Gene Therapy

  • Yanni Hao Executive Director, RWE & Data Science, Novartis

Synopsis

  • Optimizing data sources, study design and analytical approaches for RWD control arms in cell and gene therapy
  • Maximizing health authority engagement for your RWE strategy
  • Assessing target trial framework applications for RWD external controls

12:30 pm | Networking Lunch

1:30 pm Utilizing Real-World Evidence to Gain a Greater Understanding of Patient Populations

Synopsis

  • How RWE can be used with genomic data for drug discovery?
  • Understanding the inter-relationships between diseases in patients using RWE
  • Using multi-state analyses to predict patient outcomes and mitigate risks

2:00 pm Using Real World Data to Promote Diversity and Inclusivity in Clinical Trials

Synopsis

• Participants of clinical trials should be representative of the populations likely to be treated with the marketed product
• Metadata from prior clinical trials can identify investigators who have enrolled more diverse populations and are more likely to do so in the future
• Consumer data combined with more traditional real world data sets can characterize the racial and ethnic composition of the patient population of institutions and of individual physicians, allowing more targeted investigator selection

2:30 pm Demonstrating the Value of Real-World Evidence to Clinical Colleagues

  • Kraig Kinchen Senior Director, Center of Expertise, Global Patient Outcomes & Real World Evidence, Eli Lilly

Synopsis

  • Leveraging RWE for insights to inform clinical trials
  • Overcoming the challenge of endpoints for RWE
  • Incorporating patient reported outcomes and wearables to inform assessments of effectiveness

3:00 pm | Afternoon Break & Networking

3:30 pm Assessing the Value of Natural Language Processing

Synopsis

  • Leveraging natural language processing to generate patient outcomes data
  • Extracting data from clinical notes to complement research programs
  • Assessing the impact of natural language processing adoption on RWD generation

4:00 pm Partnering to Democratize Data & Accelerate Research

  • Angela Dobes Vice President, IBD Plexus, Crohn’s & Colitis Foundation

Synopsis

  • Working with patient organizations to enhance trust
  • Bringing patient centricity to data collection
  • Clearly demonstrating value and purpose to stakeholders and patients

4:30 pm Chair’s Closing Remarks

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