Conference Day One

9:00 am Conference Registration

9:30 am Chair’s Opening Remarks

  • Emily Mitchell Executive Director, Decentralized Clinical Trial Solutions, ICON

Decentralized Clinical Research – The Current State of Play

9:40 am Discover: The Current State of Decentralized Clinical Research: A Global Perspective

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

Synopsis

  • Moving from DCT 1.0 to 2.0; what is the latest from industry collaborations on advancing decentralized clinical research?
  • How do we sustain momentum against regulatory delays, reform, and funding challenges to drive the widespread adoption of DCTs?
  • An update from the DTRA on their tubestop interface for navigating decentralized clinical research

10:00 am Discover: The Evolving Landscape of Retail Clinical Trials as The Next Evolution of DCTs

  • Josh Rose Vice President & Head of Clinical Trial Delivery, Site Solutions & Strategy, CVS Health

Synopsis

  • What do clinical trials look like in the retail setting?
  • Understand how retail clinical trials can drive diversity in the patient population to meet regulatory requirements for DCTs
  • Detailing how retail clinical retails are allowing DCTs to operate at a larger scale and achieving greater adoption of DCTs

10:20 am Develop and Action: What More Can We Learn About the Current Landscape of Decentralized Clinical Research & What are the Next Steps for the Industry?

  • Craig Lipset Co-Chair, Decentralized Trials & Research Alliance (DTRA)
  • Josh Rose Vice President & Head of Clinical Trial Delivery, Site Solutions & Strategy, CVS Health

Synopsis

Q&A and Interactive Discussion Facilitated by the Chair

10:40 am Morning Break & Speed Networking

Synopsis

This session is a great opportunity to introduce yourself to clinical trial experts across the different stakeholders involved in operationalizing DCTs. This session presents the chance to get face-to-face time with many of the brightest minds capturing the main challenges and changes in the DCT space to establish meaningful business relationships.

Reinventing Approaches to Start Up DCTs

11:40 am Discover: Turning Clinical Research to Virtual Capacity

Synopsis

  • Clinical trial design for seamless integration into patient daily life
  • Defining different means for virtual capacity
  • Exploring the benefits to patients, sites and sponsors
  • Case studies/scenarios to see this in action

12:00 pm Discover: DCT Trials & Tribulations in Oncology: a 7-year Ongoing Experiment

  • Len Rosenberg Head of Clinical Operations, The Leukemia & Lymphoma Society

Synopsis

  • Designing DCTs to achieve approvals and get therapeutics to market for oncology
  • Utilizing fit-for-purpose solutions that make sense for a DCT in oncology
  • Learnings from the experience of conducting DCTs in complex disease indications

12:20 pm Develop and Action: What Can We Learn About the Gold Standard for DCT Planning & How Can We Mirror This?

Synopsis

Q&A and Interactive Discussion Facilitated by the Chair

12:40 pm Lunch & Networking

Defining Success Across Stakeholders

Afternoon Chair:

  • Len Rosenberg Head of Clinical Operations, The Leukemia & Lymphoma Society

1:40 pm Discover: Listening & Learning: What Does a Successful DCT Look Like From the Patient Perspective?

  • Jen Horonjeff Chief Executive Officer & Founder, Savvy Cooperative

Synopsis

Asking patients about disease burden, protocols and digital experiences to inform DCTs

Minimizing patient burden by ensuring a clean informed consent process, visit optionality and options for remote monitoring

What does meaningful support look like, taking into consideration people around the patient?

2:00 pm Discover: Characteristics of a Successful Decentralized Clinical Trial from the Trial Site Perspective

  • David Vulcano Vice President, Clinical Research Compliance & Integrity, HCA Healthcare

Synopsis

  • How can sponsors better support clinical trial sites to facilitate DCTs?
  • How can training clinical trial site employees for DCTs be improved?
  • How can we work together to ensure trial sites are on board with utilizing DCT platform technologies?

2:20 pm Discover: What a Successful DCT Looks Like From the Sponsor Perspective – Assessing Business Metrics

  • Anna Yang Clinical Innovation & Technology Leader, Genentech

Synopsis

  • Sharing sample business metrics relevant to DCT stakeholders: Sponsor, Site, Patients
  • Walking through a use case and how to collect data for each metric
  • Summarizing findings and next steps for the industry

2:40 pm Develop and Action: How Can We Develop a Successful Decentralized Clinical Trial to Satisfy Requirements Across Stakeholders?

  • Jen Horonjeff Chief Executive Officer & Founder, Savvy Cooperative
  • Anna Yang Clinical Innovation & Technology Leader, Genentech
  • David Vulcano Vice President, Clinical Research Compliance & Integrity, HCA Healthcare

Synopsis

Q&A and Interactive Discussion Facilitated by the Chair  

3:00 pm Afternoon Break & Networking

4:00 pm Speed Learning

  • Steven Cummings Executive Director, San Francisco Coordinating Center at California Pacific Medical Center Research Institute
  • Aubryn Samaroo Clinical Trial Manager, Praxis Precision Medicines, Inc.
  • Cynthia Schmittlein Senior Director, Sourcing & Partnering Strategy, Merck & Co
  • Sandeep Bhat Manager, Digital Engagement & Implementation, Global Clinical Operations, GSK
  • Sharmin Nasrullah Senior Director - Digital Health, AstraZeneca

Synopsis

In this quick-fire session, each table will be hosted by a DCT stakeholder who will share their insights and knowledge. You then get the opportunity to question the host before moving on to your next table.

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4:45 pm Chair’s Closing Remarks

  • Len Rosenberg Head of Clinical Operations, The Leukemia & Lymphoma Society

5:00 pm End of Conference Day 1