Conference Schedule
Day TWO
28 June 2023
09:00 - 09:10
Opening Remarks and Day One Recap from the Conference Chair
Matthias Ganninger, Head of Business Technology, pRED, Roche
CONTENT BLOCK 2
INNOVATIONS IN DECENTRALIZED CLINICAL TRIALS (DCTs)
09:15 - 09:30
EU Recommendations on Decentralized Elements in Clinical Trials
Overview of newly published recommendation paper on DCT elements by European Medicines Regulatory Network: a consolidated view from regulatory bodies, ethics committees and GCP inspectors including perspectives from patient organisations, investigators and health care professionals on clinical trial oversight, eConsent, direct to patient IMP shipment and trial procedures at home with a participant-centred and risk-based implementation ensuring safety, rights, dignity and well-being of trial participants and reliability and management of the collected data.
Sarah T'Kindt, GCP inspector, FAGG, FAHMP (Federal Agency for Health and Medical Products, Belgium)
09:30 - 09:45
PANEL
Recommendations on DCT Elements in Clinical Trials: The Role of Ethics
Sarah T'Kindt, GCP inspector, FAGG, FAHMP (Federal Agency for Health and Medical Products, Belgium)
Annette Magnin, Managing Director of the Cantonal Ethics Committee, Zurich
Moderated by: Elizabeth Theogaraj. Global Regulatory Lead, Roche
09:45 - 10:00
Transforming the Industry with "Patients First" Mindset
Three perspectives (Sponsor, Decentralized Clinical Trials Solutions and Platform, and Enablers) into one harmonized view that underpins the importance of the transformations required to innovate the Clinical Trial Ecosystem in service of patients and the need for these perspectives to work in harmony to avoid disruptions and additional cost to society.
Camila Matheny, Executive Director, DCT, Medable
Three perspectives (Sponsor, Decentralized Clinical Trials Solutions and Platform, and Enablers) into one harmonized view that underpins the importance of the transformations required to innovate the Clinical Trial Ecosystem in service of patients and the need for these perspectives to work in harmony to avoid disruptions and additional cost to society.
Camila Matheny, Executive Director, DCT, Medable
10:30 - 10:55
PANEL
DCT Innovations: Deep Dive Into the Hybrid and Virtual Trial Ecosystem
Discussion on the latest innovations driving how fully virtual and hybrid trials are being used to enable remote clinical trial participation that expands access to diverse patient populations and improves trial efficiencies.
James Donohue, Principal Clinical Innovation and Technology Leader, Genentech
Scott Askin, Director, Portfolio Innovation Partner, Novartis
Stefan Dürr, Sr. Director, Client Delivery, Cenduit IRT, IQVIA
Moderated by: Matthias Ganninger, Head of Business Technology, pRED, Roche
11:00 - 11:25
Morning Networking Break
11:30 - 11:50
USE CASE
'Smart Sampling': Innovations in Patient-Centric Sampling
• Patient-Centric Sampling enables the collection of some blood samples anywhere, anytime, by anyone
• Sampling e.g., lower blood volumes, in a painless way, at-home, brings more patient-centricity in addition to being one enabler of DCTs
• Latest innovations into this field will be presented, as well as some implementations
Luc-Alexis Leuthold, Clinical Innovation, Sr. Principal Scientist, Novartis
11:55 - 12:15
USE CASE
Actigraphy in Clinical Trials to Support Drug Development
Jeremy Wyatt, Chief Executive Officer, Actigraph
12:20 - 12:45
PANEL
Technologies Enabling Patient-Centric Drug Development
• Evaluating digital technologies that can reduce patient burden and build trust
• Digital and sensor technologies revolutionizing data collection
• Determining which technologies are right for your study, recruitment, or protocol design
• Keys to implementation and lessons learned
Sam Hariry, Global Head, Clinical Innovation, NIBR TM, Novartis
Natalia Sofia, Digital Patient Access Manager, Health Equity & Patient Affairs, Takeda
Dudley Tabakin, Chief Executive Officer, VivoSense
Moderated by: Dan Karlin, Chief Medical Officer, MindMed
12:45 - 13:45
Networking Lunch
CONTENT BLOCK 3
DIGITAL HEALTH TECHNOLOGIES (DHTs) IN CLINICAL TRIALS
13:45 - 14:05
USE CASE
USER EXPERIENCE RESEARCH @ REGENERON
Measuring Digital Biomarker Acceptability & Usability: Where are we with Decentralized Clinical Trials (DCTs)
Regeneron is focused on enhancing user experiences by incorporating user feedback into our work. This presentation will cover our User Experience Research (UXR) vision and mission, as well as their approach to conducting UXR. Including their digital biomarker acceptance and usability assessment strategy. The presentation will also include case studies highlighting their outputs and our plans for the future.
Roland Barge, Associate Director, User Experience Research, Regeneron
14:10 - 14:30
Scale your Decentralized Trials with Clinically Validated Wearables
Marisa Cruz, Chief Medical Officer, Empatica
14:35 - 14:55
USE CASE
Digital Endpoints: Putting Innovation into Practice – Defining Digital Endpoint Strategies & Processes for Operational Excellence within Drug Development
William Johnston, Digital Endpoint Lead, Clinical Development Excellence, Global Drug Development, Novartis
15:00 - 15:30
PANEL
Looking to the Future of DCTs and DHTs in Clinical Trials
Lorcan Walsh, Digital Endpoint Capability Centre Lead, Novartis
Joachim Luithle, Former SVP, Head of Clinical Operations, Bayer
Speaker TBA, Science37
Moderated by: Matthias Ganninger, Head of Business Technology, pRED, Roche