8:25 am Chairperson’s Opening Remarks

  • Shrividya Iyer Executive Director, Oncology Worldwide Real World Evidence (RWE) & US HEOR, Eisai

Improving Clinical Trial Design by Leveraging RWE

8:30 am Application of Digital Therapeutics (DTx) in Real World Data Studies

Synopsis

  • Exploring what value can be brought from digital therapeutics to RWD & RWE studies
  • What steps need to be taken to use data from DTx devices for RWE insight

9:00 am “Re-Usable” Data Networks for Prospective Research & Evidence Generation

Synopsis

Real-world data (RWD) networks are changing how data is collected and leveraged for evidence generation. This RWD network model leverages software platforms to significantly automate and reduce the burden of clinical study programs and registries, improve site and patient engagement and dramatically lower costs. The presentation will explore this new paradigm for research and evidence, its benefits and special considerations, including:

  • Creating automated networks with examples
  • Enriching real world data dynamically, including for regulatory
  • Generating provider and patient engagement
  • The value of automation and reusability
  • Accelerating product differentiation or meeting FDA requirements with RWE

9:30 am Exploring How Analytics Techniques Have Been Applied to Improve Quality of Data- Case Study

  • Yijie Zhou Executive Director, Head of RealWorld Statistics and Analysis, Vertex Pharmaceuticals

Synopsis

  • Illustrating how issues with data collection and data entry points in large EMR and claims databases
  • Highlighting how interactive analytics platforms can help enhance understanding of data quality

10:00 am Morning Coffee Break

Exploring How to Optimize Patient Selection by Implementing RWE

11:00 am Using RWE to Best Understand Your Patient Population: Diversity & Inclusion Strategies

  • Marjorie Zettler Executive Director of Clinical Science, Regor Pharmaceuticals

Synopsis

  • Understanding the recent FDA guidance recommending the prospective development of a diversity plan to ensure adequate representation of racial and ethnic subgroups in clinical trials
  • Leveraging RWE to define diversity enrolment goals, determine protocol feasibility, and identify clinical sites with a diverse patient population
  • Utilizing RWE in the post-marketing setting to complement clinical trial findings and support post-marketing requirements or commitments for safety and efficacy data in a diverse patient population

11:30 am Applying Public Health Learnings to Life Science: Linking primary and real world data to drive integrated evidence generation

  • Sandy Leonard Senior Vice President, Partnerships and RWD Solutions, Health Verity

Synopsis

  • COVID has accelerated the reliance on RWD both for research and public health
  • Learn about identity resolution and privacy preserving record linkage technology and how the government has leveraged it along with RWD to meet the challenges of COVID
  • Explore how life science sponsors are leveraging similar approaches to meet research and regulatory needs for COVID and beyond.

12:00 pm Looking Beyond Regulatory Approval: RWE & Patient Access

Synopsis

  • Exploring the role of RWE in the post-regulatory approval environment to inform appropriate use of therapy in the clinical practice.
  • Case studies will illuminate how RWE can help fill the gap in data when it comes to patient population and competitor therapies studied.

12:30 pm Lunch Break & Networking

Working with Partners and Stakeholders to Establish Novel Expectations in Clinical Research

1:30 pm Leveraging Electronic Health Record (EHR) Data to Power Real-world Safety and Outcomes Studies

Synopsis

  • Understand the value of electronic health record (EHR) data, specifically unstructured
    clinician notes and key abstracted variables, to inform research across the drug and
    device lifecycle
  • Review a real-world safety and efficacy case study featuring Dina Akasheh, PhD, Medical Director at Ocular Therapeutix
  • Recognize opportunities where EHR data may be most applicable to satisfy regulatory requirements, better understand patient journey, track treatments and outcomes, and more

2:00 pm Round Tables – Your chance to deep dive into discussions about your topic of choice. Find your table and get stuck in

Synopsis

  • Dealing with low quality data sets: missing data & small patient cohorts
  • Establishing and submitting prespecified protocols
  • Leveraging the use of analytics tools
  • Improving clinical trial design through the better use of RWD & RWE• Enhancing patient experience

2:45 pm Afternoon Break

Discussing Key RWE Challenges to Navigate the Future Roadmap

3:00 pm Fireside Discussion: How Can Internal and External Trust be Built & the Value of RWE be Appreciated?

  • John Cai Executive Director, Real World Evidence and Analytics Innovation, Merck
  • Lina Titievsky RWE Industry Expert and Pharmaco- epidemiologist, Vertex Pharmaceuticals

Synopsis

  • Internal trust within sponsor organisation
  • External trust from regulators
  • External trust from physicians and clinical teams
  • External trust from Payers/HTAs/ Health Policy Decision Maker

3:30 pm Defining Core Competencies & Capabilities for Future Success in RWE Studies

  • Alexander Cole Executive Director, Global Head Epidemiology, Alexion

Synopsis

  • Exploring what skills need to be developed within organization
  • Approaching data sources and platforms effectively
  • Looking at a future framework for succes

4:00 pm Chairperson’s Closing Remarks

  • Shrividya Iyer Executive Director, Oncology Worldwide Real World Evidence (RWE) & US HEOR, Eisai