8:55 am Chair’s Opening Remarks

Case Studies in Measuring ROI for Non-Monetary Factors to Quantify Impact of Previously Qualitative Data

9:00 am Measuring the Impact of Decentralized Trials on Engaging Underrepresented Groups to Broaden Participant Diversity & Showcase More Accurate Findings Through Trial Findings

  • Teri Wright Director of Clinical Laboratory Sciences, Devices Innovation, Eli Lilly & Co

Synopsis

  • Changes that have occurred over the course of this last year
  • Case study/on-going learnings from current work
  • The value of non-monetary ROI

9:30 am Roundtable: Quantifying Non-Monetary Factors Such as Improving Patient Retention & Broadening Participant Diversity In Hybrid Clinical Trials

Synopsis

  • Importance of non-monetary ROI and how it can translate to monetary ROI
  • Value of increasing patient diversity in driving towards more reliable clinical trial outcomes
  • Strategies within HCT settings that will increase patient retention and translate into ROI

10:00 am Increasing Patient Centricity & Enhancing Cost Efficiencies to Achieve ROI & Increase Patient Retention

  • Michael Podias Clinical Innovation & Strategic Partnerships Manager, Pfizer

Synopsis

  • Measuring the effectiveness of innovation adoption across numerous clinical trials
  • Enhancing cost efficiencies to support patient centricity and retention
  • Ways to achieve ROI through the implementation of trial innovations

10:30 am Morning Break & Networking

11:30 am Navigating Ways to Use Digital Health Technologies to Measure What Is Clinically Meaningful to Patients

  • Sarah Small Associate Director, Patient Centricity, Moderna

Synopsis

  • Principal insights from digital diet diary experience
  • Importance of patient centricity in achieving ROI
  • Learnings from AI based patient retention analysis 

Overcoming Operational Challenges When Implementing Novel Technology

12:00 pm Considerations for Adopting Digital Measures in the Hybrid Setting: From Patient Experience to ROI

  • Xuemei Cai Senior Medical Director, Digital Medicine, Pfizer

Synopsis

  • How can the experience be made more seamless for patients?
  • How can the experience be made more seamless for sites and sponsors?
  • Discuss previous examples where digital measures can reduce sample size and enable faster go/no go decisions 

12:30 pm Lunch Break & Networking

1:30 pm Roundtable: Selecting & Optimizing Technology & Software to Enhance Data Collection

Synopsis

  • What are some user-friendly additions that will make a particular technology stand out among others?
  • Importance of gaining participant feedback before implementing technology
  • Barriers faced when collating data across multiple participants with varying data points 

2:00 pm The LLS/BAML Master Trial: Exploring the Findings From Previous Work and the Implications for the Clinical Trials Sector

  • Len Rosenberg Head Clinical Operations, Beat AML, a division of The Leukemia & Lymphoma Society

Synopsis

  • Overview of the work/results from the past 7,8 years
  • Review the current clinical research operations landscape verticals- examine whether critical advancements have occurred
  • Decoding jargon: disrupt and innovate in the clinical trials sector

Overcoming Barriers Put in Place Through Laws and Regulations

2:30 pm Regulatory Aspects of Digital Health Technology Use in Clinical Trials

  • Sarah Bilali Director of Global Regulatory Affairs Devices, UCB

Synopsis

  • Comparatively analyse DHT FDA guidance- opportunities and challenges with implementation
  • Case studies: Practical application of evolving regulatory considerations
  • Risk mitigation of clinical, cybersecurity and privacy risks are required to ensure patient safety

3:00 pm Roundtable: Optimizing Strategies to Improve Patient Recruitment, Diversity, and Engagement in Hybrid Clinical Trial Settings

Synopsis

  • Understanding the ongoing work that is occurring in this space
  • Importance of increasing access for patients in hybrid trials
  • Navigating the barriers around improving patient recruitment

3:30 pm Chair’s Closing Remarks