Conference Day One

8:45 am Check In & Coffee

8:55 am Chair’s Opening Remarks

Case Studies to Explore Routes Into Maximising Monetary ROI When Carrying Out Hybrid Clinical Trials

9:00 am Curating a Strong Financial Case to Gain Approval to Run a Hybrid Clinical Trial From Internal Executives Within The Company

Synopsis

  • Showcasing strategies to demonstrate financial gain and provide a thorough risk-management assessment
  • Scalability and evidence generation with DCTs
  • Strategies used to decide which elements should be decentralized in a hybrid setting

9:30 am State of the Global Clinical Trials Landscape & the Evolving Role of Technology & Data Analytics

  • Kenneth Getz Executive Director, Research Professor (PHCM), Tufts Center for the Study of Drug Development

Synopsis

  • Overview of operating environment for global clinical trials
  • Underlying trends and factors driving these operating conditions
  • Evidence on the evolving use and impact of technology solutions and data analytics on clinical trial performances

10:00 am Strategies to Leverage Vendor Relationship Management in Hybrid Clinical Trials

  • Stephanie Jones Senior Manager, Vendor Relationship Management, Gilead Sciences

Synopsis

  • Showcasing examples of vendor relationship management under the context of ROI
  • Ensuring operational efficiency and effectiveness of business relationships
  • Insights from oversight between the vendors and clinical operations

10:30 am Speed Networking

Synopsis

This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the hybrid clinical trial/DCT world and establish meaningful business relationships.

11:00 am Morning Break & Networking

11:30 am Making the Case to Decentralize: Getting Beyond ROI

  • Craig Lipset Co-Chair, Decentralized Trials & Research Alliance (DTRA)

Synopsis

  • Opportunities for direct and indirect cost benefit
  • Engaging leaders in the value proposition beyond cost savings
  • Urgency to collaborate to gather meaningful evidence of impact and value

12:00 pm Roundtable: Developing an Internal Tracking System to Assess Costs of Decentralized Trials & Standardizing Industry Metrics to Better Demonstrate ROI

Synopsis

  • Elucidating industry setbacks in budgeting
  • Forecasting cross-industry insight without crossing the barriers of company privacy
  • Ways to standardize industry metrics to showcase ROI in a more holistic level

12:30 pm Lunch Break & Networking

1:30 pm Panel Discussion: Creating Cost Efficiencies & Elevating ROI Through Strategic Procurement & Vendor Management

  • Kenneth Getz Executive Director, Research Professor (PHCM), Tufts Center for the Study of Drug Development
  • Teri Wright Director of Clinical Laboratory Sciences, Devices Innovation, Eli Lilly & Co
  • Stephanie Jones Senior Manager, Vendor Relationship Management, Gilead Sciences
  • Dennis Salotti Executive Director & Head, Clinical Outsourcing & Innovation, Jazz Pharma

Synopsis

  • The role of strategic procurement in elevating ROI
  • Within the DCT industry, what are the major procurement issues being faced?
  • Potential solutions to navigate these issues

2:00 pm Streamlining Site-coordinator Costs & Negotiating Cost Savings For a Hybrid Clinical Trial

  • Samantha Gray Clinical Trials Center Manager, Veterans Health Foundation

Synopsis

  • Integrating site workflow and establishing frameworks to streamline the process
  • Case study-based learnings and implementations for the future
  • Navigating patient burden while ensuring ROI

2:30 pm Afternoon Break & Networking

Bullet-Proofing Remote Data Collection to Confidently Tie Data to Primary Endpoints

3:00 pm Panel Discussion: Addressing the Concerns & Barriers Faced by Clinical Trial Sites in Adopting Digital Endpoints to Improve ROI

  • Craig Lipset Co-Chair, Decentralized Trials & Research Alliance (DTRA)
  • Michelle Crouthamel Head of Digital Science, AbbVie
  • Janet Moga DCT Operations Lead, Astellas Pharmaceuticals
  • Len Rosenberg Head Clinical Operations, Beat AML, a division of The Leukemia & Lymphoma Society

Synopsis

  • What are the some of the regulatory obstacles?
  • What are the issues with implementing digital health technology to develop novel digital endpoints?
  • Case studies to showcase the learning curve that has occurred in this space

3:30 pm Utilizing Pilot-to-Scale Strategy for Implementing & Measuring New Technology in Clinical Trials

  • Janet Moga DCT Operations Lead, Astellas Pharmaceuticals

Synopsis

  • Outlining ways to gain alignment with study teams on pilot testing to scaling new technology in clinical trials
  • Potential metrics that can be used to assess pilot success/failure
  • Important cross functional team collaborations to enable success

4:00 pm Chair’s Closing Remarks