Clinical Trials Innovation Summit 2022

Clinical Trials
Innovation Summit 2022

28 JUNE 2022 | ROCHE BUILDING 1 | BASEL

PRESENTED BY

"TO THRIVE AS A FIELD, DIGITAL MEDICINE REQUIRES AN UNPRECEDENTED LEVEL OF INTERDISCIPLINARY COLLABORATION. FROM REGULATORS TO WHITE-HAT HACKERS, ETHICISTS TO ENGINEERS, AND CLINICIANS TO CITIZEN SCIENTISTS, NEW COOPERATIVE NETWORKS MUST EMERGE TO ENSURE THAT DIGITAL MEDICINE REALIZES ITS FULL POTENTIAL TO IMPROVE HUMAN HEALTH." (DIGITAL MEDICINE SOCIETY)

Building off of recent advancements in the field, PanAgora Pharma and Roche are collaborating to build the Clinical Trials Innovation Summit 2022. The conference agenda focuses on how life sciences organizations are improving clinical trial design, recruitment, and retention, while collecting better data, saving on trial costs, and ultimately delivering a better patient experience. Join 25+ speakers and 200+ senior-level clinical research & decentralized clinical trials leaders this June at Roche Headquarters in Basel!

Key Topics Include:
• Human Centric Health Innovation
• Driving Innovation in Decentralized Clinical Trials
• Regulatory Process & Governance in Decentralized Clinical Trials
• Technologies Improving the DCT Patient Experience
• Standards and Technologies Enabling Data Sharing and Integration
• Accelerating Research by Empowering Patients
• Lab of the Future: Longevity

Location

Roche Building 1
Basel, Switzerland

Date & Time

28 June 2022
09:00-19:00 Local Time (GMT+2)

HOST SPONSOR

CORE THEMES:

1. Human-Centered Health Innovation
2. Driving Innovation in Decentralized Clinical Trials
3. Technologies Improving the Clinical Trials Patient Experience
4. Data Sharing and Integration: Standards & Technology

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

14:35 - 14:55

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

Speakers