Conference Schedule
28 June 2022
09:00 - 09:05
Opening Remarks from the Conference Chair
Matthias Ganninger, Head of Business Technology, pRED, Roche
09:05 - 09:15
Welcome Address
Scott Oloff, SVP of Data and Analytics, Roche
09:15 - 09:40
Panel: Human-Centric Clinical Innovations
Health systems are under immense strain, leading to a service that is far from optimal for both the patient, practitioner and the entire ecosystem. In this discussion, we look to demonstrate the value in a future where a human-centred innovation culture creates opportunities to reimagine healthcare and clinical trials.
Léa Proulx, Patient Voice Partner, Roche
Adama Ibrahim, Director, Digital Innovation, Novartis
Ursula Costa, Manager, Patient Centered Initiatives, DayOne
Camila Matheny, Sr. Director, Solution Consulting, Medable
Moderator: Steven Bourke, Founder, PersonalPulse
09:40 - 10:00
Use Case: MyStudyWindow - Lessons in Patient-Centricity
Sonia Houston Pichardo, Business Lead, MyStudyWindow, Boehringer Ingelheim
10:00 - 10:30
Diversity and Inclusion Panel: Designing Inclusive Innovation
Discussion on how diversity, inclusion, and equity need to be taken into consideration when designing innovations, so that these innovations are adding value for all clinical trials participants and also opening up new opportunities for people to join clinical trials.
Ed Merivale, Sr. Clinical Operations Lead, Roche
Fay Scott, Founder & Co-Chair of the Race Equality Public Action Group, NIHR
Disa Lee Choun, Head of Integrated Clinical and Operational Analytics, Janssen
Ambily Banerjee, Head of Diversity, Equity, & Inclusion, Novartis
Moderator: Amri Johnson, Chief Executive Officer, Inclusion Wins
10:30 - 11:00
Networking Break
11:00 - 11:20
Where are we with Decentralized Clinical Trials (DCTs) - A Sponsor’s review of the current regulatory landscape and potential barriers to scale
• A review of where the industry stands today in regards to Decentralized Clinical Trial (DCT) guidances, and why these are so important
• A discussion of Regulatory Barriers that may be slowing wider scale adoption
Scott Askin, Global Program Regulatory Director for Innovation, Novartis
11:20 - 11:40
Patient-Centric Tools: Big Hype, But Are We on the Right Track?
Hilde Vanaken, Head Industry Leaders, Life Sciences & Healthcare, TCS
11:40 - 12:00
Use Case: Decentralized Trials – Beyond the Glossy Sales Slides
Nora Dyer, VP, DCT Initiative Leader, Bayer
12:00 - 12:30
Panel: Leading Innovation in Decentralized Clinical Trials
Sam Hariry, Global Head, Clinical Innovation, Novartis Institutes for BioMedical Research (NIBR)
Jeremy Wyatt, Chief Executive Officer, ActiGraph
Karine Smadja, Study Lead, pRED, Roche
Moderator: Dan Karlin, Chief Medical Officer, MindMed
12:30 - 13:30
Networking Lunch
13:30 - 13:55
Panel: Technologies Improving the Clinical Trials Patient Experience
The clinical trials patient experience can be augmented via technology in many different ways. This panel will explore some of the technology solutions that are having a positive impact on the clinical trial experience, and examine some of the underlying tenets that power them. Also learn where the industry is still lacking and what's next.
Gerard Randolph, Principal Scientist, pRED, Roche
Michael Rebhan, Associate Director, Precision Medicine, Novartis
Paul O'Donohoe, Scientific Lead, eCOA and Mobile Health, Medidata
Moderated by: Uta Sweere, Program Leader, pRED Clinical Operations, Roche
13:55 - 14:15
Use Case: PSS - Predictive Site Selection
Data-driven selection of sites to increase inclusiveness & diversity of our trials.
Eric Malek, pRED Clinical Operations Data Scientist, Roche
14:15 - 14:35
Implementing Digital Medicine Approaches to Transform Clinical Trials
Using novel digital biomarkers in clinical trials can serve as both drug development tools and personalization of medication administration
Orel Swenson, M.D., Medical Director for Digital Therapeutics, Biofourmis
Use Case: Empowering Patients by Leveraging Blockchain Technology in a Clinical Trial
A proof of concept pilot testing the use of blockchain technology in a live clinical trial setting to better engage and empower patients
Baldwin Mak, Digital Expert, Dept. of Clinical Operations, Boehringer Ingelheim
14:55 - 15:20
Panel: Pushing the Boundaries in a Regulated Environment
• The different innovations in clinical trials we have heard of today and more
• The regulatory principles that we need to take into account when innovating
• Innovation not as the goal, but as the enabler for faster patient access
• Co-creating with regulators and the ecosystem to enhance the uptake of innovations
Scott Askin, Global Program Regulatory Director for Innovation, Novartis
Kevin Obana, Special Projects Lead, HumanFirst
Kai Langel, Sr. Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen
Matteo Lai, Co-founder and CEO, Empatica
Moderator: Lada Leyens, Regulatory Program Director, Roche
15:20 - 15:45
Networking Break
15:45 - 16:10
Panel: Data Sharing and Integration: Standards and Technology
Astrid Kiermeier, VP, Global Head of EDIS (Enhanced Data and Insights Sharing), Roche
Peter Speyer, Head of Customer Success, data42, Novartis
Moderator: James Donohue, Trial Innovation Partner, Early Research & Development ClinOps, Roche
16:10 - 16:30
Use Case: Digital Protocol Design
Data-driven design of clinical trials with recruitability and reduction of patient (and site) burden in mind.
Arianna Secco, Data Scientist, Roche
Todd Georgieff, External Engagement and Content Standards Lead, Roche
16:30 - 16:50
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.
Jimita Parekh, VP of Growth, Medable
Camila Matheny, Sr. Director, Solution Consulting, Medable
16:50 - 17:15
Patient Panel: Role of the Patient Perspectives in Clinical Trials
Hear from people having experience either participating in or designing clinical trials, and learn how sponsors can embed the patient’s perspective in an meaningful way, ensuring that innovation is supporting designing trials in a patient-centric fashion and providing opportunities for more people to participate.
Steve Bourke, Founder, PersonalPulse
Amri Johnson, Chief Executive Officer, Inclusion Wins
Rosine Mucklow, Managing Director, Buxtorf Quality Services GmbH
David Faluyi, Co-Chair of the Race Equality Public Action Group, NIHR
Moderator: Léa Proulx, Patient Voice Partner, Roche
17:15 - 17:40
Closing Panel: The Future of Clinical Innovation - What's Next?
Rob Wilson, VP, Marketing Strategy, VivoSense
James Donohue, Trial Innovation Partner, Early Research & Development ClinOps, Roche
Andy Coravos, CEO and Co-Founder, HumanFirst
Moderator: Matthias Ganninger, Head of Business Technology, pRED, Roche
17:40 - 19:00
APÉRO NETWORKING EVENT