Day One

Tuesday October 24, 2023

Day Two

Wednesday October 25, 2023

8:30 am Morning Registration & Networking

9:20 am Chair’s Opening Remarks

Overcoming Data Quality Challenges & Harnessing RWD to Innovate Early Clinical Development

9:30 am Overcoming Data Quality Challenges; Perspective on the European and US Data Quality Guidelines

  • Kelly Zou Head, Global Medical Analytics and Real World Evidence, Viatris Inc.

Synopsis

• Discover the key differences between the EU and US approaches

• Implement data quality solutions into your own frameworks

10:00 am Leveraging a Data Blending Approach to Overcome Data Quality Challenges & Address Unmet Patient Needs

  • Angela Dobes Senior Vice President, Inflammatory bowel disease Plexus, Crohn's & Colitis Foundation of America

Synopsis

• Integration of multi-source data to produce high-quality RWE for informing clinical development

• Thinking critically about the reasons behind data collection to increase trust in data leveraged for evidence generation

• Tackling compliance and privacy concerns regarding linkage of data from multiple, diverse sources

10:30 am Transforming Safety & Effectiveness Studies with Near-Real-Time EHR Data

Synopsis

  • Overcoming EHR data quality, fragmentation, and access barriers with a 30+ health system partnership
  • Using clinical expert-led AI to normalize daily healthcare data streams and extract concepts from free-text clinician notes
  • Generating near-real-time insights on prescribing trends, drug/device performance, rare diseases, and more

11:00 am Morning Break & Networking

Utilizing RWE to Pioneer & Inform Clinical Trial Design

11:30 am Pragmatic Data Capture to Support Drug Development; A Patient Centric Approach

  • Stephanie Watkins Senior Director - Real World Evidence Inflammation, Gilead Sciences

Synopsis

• Harnessing approaches to pragmatic data capture which drive patient centricity and overcome missingness of data challenges

• How can we work with partners to create a complete picture of a patient’s healthcare journey

• How can we leverage this information to innovate clinical development

12:00 pm Leveraging Real World Data to Mitigate Safety Risks & Deliver Answers to Internal Stakeholders Faster & More Cost-Effectively

  • William Blumentals Sr. Director, Head of Pharmacoepidemiology for Specialty Care, Sanofi

Synopsis

  • What types of RWD can be used to for rapid safety signal assessments?
  • How do we put safety issues in clinical trials into context utilizing RWD?
  • How can we bridge what we see in clinical trials with RWD to complement or explain findings?

12:30 pm Lunch & Networking

Leveraging RWD to Understand Patient Populations & Drive DE&I

1:30 pm Leveraging Real World Data to Understand the Targeted Patient Population & Inform Clinical Trial Development

  • Sunday Clark Director - Real-World Evidence Scientist, Takeda

Synopsis

• Case study utilizing the Medicare claims database to estimate the prevalence of anorexia of aging to inform early clinical development

• Utilization of an innovative EHR platform to inform clinical trial design and implementation

2:00 pm Harnessing RWE to Drive Diversity, Equity, & Inclusion in Clinical Trials to Meet Regulatory Guidance

  • Alexander Cole Executive Director, Head of Epidemiology & Real World Science, Alexion Pharmaceuticals

Synopsis

• Using RWD to understand your patient population and their geographies to demonstrate the reality

• Informing clinical trial exclusion and inclusion criteria to ensure representation of the patient population and prevent mismatch to disease population

• Applying these insights to meet the FDA’ diversity action plans

2:30 pm Round Table Discussions

Integrated Real World Evidence Planning to Streamline RWE Functions & Inform Early Decision Making

Developing Methodologies to Increase Regulatory Acceptability of External Control Arms

Effectively Using RWE to Identify & Enrol Patients for Clinical Trials

  • Lina Titievsky Head Health Economic Modeling and Decision Sciences, GlaxoSmithKline Plc

Implementing and Optimizing an RWE Strategy in Early Development

  • Suvi Hokkanen Head of Department, Real-World Science - Obesity, NASH & OSCD, Novo Nordisk

3:00 pm Chair’s Closing Remarks

3:10 pm End of Conference

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