08:50 - 15:45 EST | 14:50 - 21:45 CEST

* Please note that the following agenda timings are Eastern Standard Time.  

For Central Euroean Summer Times, please download the full event guide here

Diving into Data, Technology & Unpacking Hybridization

8:50 am Chair’s Opening Remarks

  • Amir Lahav Digital Healthcare Innovation, Head of Digital R&D, Mitsubishi Tanabe Pharma Holding America

Building in Technological & Data Considerations to Ensure Optimal Trial Design

9:00 am Keynote: New Trends in Remote Digital Monitoring Technology for Decentralized Trials in Patients with Neurodegenerative Diseases

  • Amir Lahav Digital Healthcare Innovation, Head of Digital R&D, Mitsubishi Tanabe Pharma Holding America

Synopsis

• Considering processes for selecting remote monitoring technology and mobile health apps for your DCT
• Exploring pros and cons for active vs passive monitoring.
• Exploring the validation of digital endpoints using real-time AI-driven analytics

9:25 am Exploring the IMI Trials@Home Initiative

  • Rebecca Jackson Clinical R&D SME - Clinical Data IT, Clinical Trials, Clinical Supply Chain, Johnson & Johnson

Synopsis

• Covid-19 – a catalyst for change
• Innovation – the land of unicorns and rainbows
• Designing a DCT to compare traditional, hybrid and remote scenarios
• Sharktopus vs whalewolf – Redefining operational and technology approaches to DCTs

9:50 am Science 37 Presentation

10:20 am Morning Q&A & Panel Forum

  • Amir Lahav Digital Healthcare Innovation, Head of Digital R&D, Mitsubishi Tanabe Pharma Holding America
  • Rebecca Jackson Clinical R&D SME - Clinical Data IT, Clinical Trials, Clinical Supply Chain, Johnson & Johnson
  • Science 37 Speaker TBC,

10:35 am Panel: Common Mistakes & Operationalize Recommendations When Deploying Technology Solutions in DCTs

  • Amir Lahav Digital Healthcare Innovation, Head of Digital R&D, Mitsubishi Tanabe Pharma Holding America
  • Erica Lawson Director, Applied Innovation, Otsuka
  • Shoibal Datta Head, R&D Digital Strategy Group, Data Sciences Institute, Takeda
  • Tracey Robertson Global Clinical Development & Operations – Head of Patient & Site Engagement Process , Boehringer Ingelheim
  • Maria Harrison Senior Vice President, Decentralized Clinical Trials and Real World Solutions , ICON

Synopsis

• Detailing methods to decentralize clinical trials with flexibility: enabling eConsent, remote screening, and TeleVisit anywhere
• Finding the right balance between clinical validation, data quality, protocol adherence, and patient burden
• Operationalize mistakes in implementing home-based monitoring technology in DCTs
• Providing patients with intelligent real-time alerts using home-based connected devices and AI-driven analytics
• Describing pharma strategy and readiness for scaling up and powering the future of DCTs

11:20 am Coffee Break

11:35 am Speed Networking

Synopsis

Network with other attendees in our quick-fire networking session. Grab a hot drink and let the computer match you randomly with a range of attendees in 1-1 formats. Make sure to click “connect” to swap virtual business cards

12:05 pm Using Vendors: What to Ask Them and What to Look For?

  • Jim Ternyila Senior Business Relationship Manager - Digital Therapeutics, AstraZeneca

Synopsis

• Considering how to determine a studies primary, secondary and exploratory endpoints
• Providing methodologies for the selection, communication, and delivery with service providers
• Leveraging DiMe’s playbook for replicating strategies and operationalizing them

12:30 pm Datacubed Health Presentation

12:45 pm Lunchtime Q&A & Panel Forum

12:55 pm Lunch

Halfway There: Detailing the Importance and Value in Hybridization & Decentralizing Aspects of a Trial

1:55 pm DCTs as Agile Clinical Experiments to Develop Novel Methods

Synopsis

• Understanding how to reduce the risk and optimize trial design using a DCTs
• Considering technological tools to enhance data quality and quantity
• Providing examples of previous outcomes data, iterations and amendments

2:20 pm Collaboration to Accelerate the Global Adoption of Decentralized Trials

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

Synopsis

• Highlighting the challenges in DCT scale that may best be addressed through collaboration
• Reviewing the goals and progress of the Decentralized Trials & Research Alliance to support global adoption
• Describing a future-state enabled through collaboration

2:45 pm Lessons from Observational, Remote Research Studies in Neurodegenerative Diseases

Synopsis

• Recounting practical DCT experience with two current remote research studies
• Unpacking the lessons learnt from video-based visits and technology incorporation
• Analysing strategies for recruitment and retention of 500 participants through a decentralized format

3:10 pm Afternoon Q&A & Panel Forum

3:25 pm Panel: Too Hybrid, or Not to Hybridize?

  • Daniel R Karlin, MD, MA Chief Medical Officer, MindMed
  • Amy Bohn Director, DCT Operations DCT Strategy & Implementation, Bayer
  • Arthur Combs, MD President, FutureTech Strategies, Inc.
  • Amir Lahav Digital Healthcare Innovation, Head of Digital R&D, Mitsubishi Tanabe Pharma Holding America

Synopsis

• Discussing the various aspects of trials which can be decentralized
• Sharing past experience and thoughts for varying sized trial sponsors

4:10 pm Chair’s Closing Remarks

  • Tracey Robertson Global Clinical Development & Operations – Head of Patient & Site Engagement Process , Boehringer Ingelheim