Identifying Key Factors for Planning a Decentralized Clinical Trial

8:50 am Opening Remarks

9:00 am Panel Discussion: Achieving Buy-in & Adoption from Stakeholders for DCTs

  • Wendi Lau Senior Director Clinical Development Operations, TA Lead Specialty Medicine, AbbVie
  • Jeremy Price Senior Director, Clinical Innovation & Strategic Partnerships, Pfizer
  • Sandeep Bhat Senior Leader, Digital Engagement, Implementation & Global Clinical Operations, GSK
  • Maimah Karmo Patient Advocate & CEO, Tigerlily Foundation

Synopsis

  • Discussing strategies to convey the value proposition and benefits of DCTs to stakeholders
  • Improving internal and external collaboration to maximize DCT success
  • Debating the potential methods to measure the success of DCTs

9:30 am Case Study: Meeting Patients and Health Systems Where They Are

  • Anna Yang Senior Medical Science Director, Genentech

Synopsis

  • Incorporating the patient voice to optimize DCT design
  •  Considerations for a strategic and adaptive protocol design
  • Metrics and key performance indicators of success

9:45 am Understanding the Multiple Factors & Trends Influencing DCT Designs & Deployment

Synopsis

  • Understanding key factors to consider when designing and deploying DCTs
  • Linking factors with quality by evidence in DCTs
  • Appraising trends in DCTs and the changing landscape in clinical research

10:15 am Proactively Preparing for Successful Deployment of a DCT

  • Heidi Johnson Director, DCT Operations, DCT Strategy & Implementation, Bayer

Synopsis

  • Factoring operational challenges into the planning stage
  • Aligning internal teams for operational success
  • Establishing collaborative relationships with external partners

10:45 am

Structured Networking

11:00 am

Morning Break

Creating the Playbook for Navigating Global Regulations

11:15 am Panel Discussion: Identifying Where Different DCT Opportunities are Globally

  • Imran Shakur Associate Director, Clinical Supply Capabilities, Biogen
  • Hassan Kadhim Senior Director, Head of Clinical Trial Business Capabilities, Bristol Myers Squibb
  • Heidi Johnson Director, DCT Operations, DCT Strategy & Implementation, Bayer
  • Alan Go Regional Medical Director, Kaiser Permanente
  • Sandeep Bhat Senior Leader, Digital Engagement, Implementation & Global Clinical Operations, GSK
  • Lewis Millen Global Clinical Sciences & Operations Lead, UCB

Synopsis

  • Highlighting different technologies that best support DCTs
  • Discussing different approaches to identifying effective technologies
  • Comparing different country’s attitudes and approaches towards DCTs

12:00 pm Reserved for Syneos Health

Synopsis

12:30 pm Planning & Adapting to New DCT Regulations

Synopsis

This interactive session will give you the opportunity to dive into the conversation
with your fellow colleagues to discuss, debate and get inspiration on how
to approach:

  • Evolving DCT regulations
  • Exploring synergies between RWE and DCTs – approaches and use cases
  • Managing the collection of data from the RWE and DCTs using digital health
    technologies

1:00 pm

Lunch Break

Designing Equitable & Patient-First Decentralized Clinical Trials

2:00 pm TECH SPOTLIGHT! LIGHTNING ROUNDS – New for 2022

Synopsis

You can’t run a DCT without technology – and with the technology that enables these trials innovating at lightning speed, its vital that you know what best-in class
looks like! In this rapid-fire tech spotlight, three of the most innovative new DCT enabling tech providers will give you a lightning-speed overview of how they can revolutionize your DCT.

2:30 pm Designing a Clinical Trail Around the Patient

  • Tracey Robertson Global Clinical Development & Operations Patient & Site Engagement Process Lead, Boehringer Ingelheim

Synopsis

  • Reducing the burden on the patient and caregivers
  • Reflecting on the lessons learned to factor into future planning
  • Dedicating continuous technical support to optimize technology

3:00 pm

Afternoon Break

3:30 pm Considering Optionality and Agility while Planning a DCT

  • Taras Carpiac Executive Director, Global Development Operations, Amgen

Synopsis

  • Addressing the need to select appropriate DCT techniques for specific studies and populations, while maintaining optionality for patients
  • Applying various DCT techniques in clinical trials
  • Leveraging agility in remote study monitoring and outlining novel techniques
    that add the most value

4:00 pm Trail Card Presentation: Providing Technology Solutions for an Enhanced Patient and Provider Experience

Synopsis

4:30 pm Panel Discussion: Examining DCT Patient Engagement Issues

Synopsis

  • Discussing ideas to increase patient awareness
  • Improving the education of patients
  • Analyzing global regulations regarding patient involvement

5:15 pm Closing Remarks