3RD ANNUAL
Clinical Trials
Innovation Summit 2023
Innovation Summit 2023
27-28 JUNE 2023 | BASEL | ROCHE BUILDING 1
PRESENTED BY
The Clinical Trials Innovation Summit Returns to
Roche Headquarters in Basel on June 27-28!
Roche Headquarters in Basel on June 27-28!
PanAgora Pharma and Roche are collaborating to present the 3rd Annual Clinical Trials Innovation Summit. This year's conference agenda has expanded into a 2-day event focusing on how life sciences organizations are building more patient-centric clinical trials by improving patient diversity, engagement, retention, and recruitment.
Core themes for the 2023 conference agenda include:
• Delivering Human-Centered Clinical Trials (HC CTs)
• Enhancing Diversity, Equity & Inclusion in Clinical Trials
• Incorporating Lived Experiences and the Voice of the Patient into Clinical Trials
• The Latest Innovations in Virtual, Hybrid and Decentralized Trials
• Patient Collaboration: Involving Patients Early, Learning from Them, Scaling-Out
• Identifying Innovations & Technologies Accelerating Patient-Centric Trials
Join 30+ speakers and 200+ senior-level clinical operations, trial design, and research leaders this June 27-28 at Roche headquarters in Basel!
Location
Date & Time
27 June 2023
09:00-17:00 Local Time (GMT+2)
Apéro to Follow
28 June 2023
09:00-15:30 Local Time (GMT+2)
09:00-17:00 Local Time (GMT+2)
Apéro to Follow
28 June 2023
09:00-15:30 Local Time (GMT+2)
HOST SPONSOR
AGENDA THEMES FOR 2023
1. Delivering Human-Centered Clinical Trials (HC CTs)
2. Prioritizing Diversity, Equity & Inclusion in Clinical Trials
3. Incorporating Lived Experiences and the Voice of the Patient into Clinical Trials
4. The Latest Innovations in Virtual, Hybrid, and Decentralized Trials
5. Collaboration: Involving Patients & Stakeholders Early On, Learning, and Scaling
6. Identifying Innovations & Technologies Accelerating Patient-Centric Trials
Conference Schedule
DAY ONE
DAY ONE
27 June 2023
09:00 - 09:10
Opening Remarks from the Conference Chair
Léa Proulx, Patient Voice Partner, Roche
CONTENT BLOCK 1
HUMAN-CENTERED CLINICAL TRIAL DESIGN
09:15 - 09:40
The Struggle is Real: The day in the life of a patient managing their disease and responsibilities while participating in a clinical trial
Patient Speaker TBA
09:45 - 10:10
PANEL
Level Set on Human-Centered Trial Design: Stakeholder Perpsectives
Level Set on Human-Centered Trial Design: Stakeholder Perpsectives
• Trends we’re seeing to include DCT elements to bring trials to participants
• Keys to speaking the same language
• Understanding the different perspective when it comes to “human-centered design” and what it means for the different stakeholders
• Identify commonalities and differences so can we build on them / address them moving forward
Maria Kuthning, Global Medical Clinical Program Lead, Sobi (Swedish Orphan Biovitrum)
Janice Roeser, Global Patient Partnership Director, Roche
Patient Speaker TBA
Moderated by Steve Bourke, CEO, PersonalPulse
10:15 - 10:40
Morning Networking Break
10:40 - 11:00
Attitudes Towards Decentralized Clinical Trials (DCTs): The Patient Perspective
Patient Speaker TBA
11:05 - 11:30
PANEL
What is the Impact of DCT Elements in a Human-Centered Trial?
What is the Impact of DCT Elements in a Human-Centered Trial?
• Understanding the attitude of trial participants towards decentralized clinical trial elements
• Understanding from the site how they are having discussions around DCTs with potential trial participants
• Understanding how patient communities (both trial-naive and trial-experience) are considering DCT elements and how this information is taken into account when making a decision to participate or not in a clinical trial.
Isabela Niculae, Head, Global Clinical Sciences & Operations Innovation, UCB
James Donohue, Principal Clinical Innovation and Technology Leader, Genentech
Speaker TBA, Patient Representative
Speaker TBA, Site Representative
11:35 - 12:00
PANEL
Don’t Forget About Us… Designing Trials for Underserved Populations
Don’t Forget About Us… Designing Trials for Underserved Populations
• Define DE&I
• Clarify what is an “underserved / underrepresented population” and emphasize there’s not one definition that fits all.
• Discuss how to design inclusive trials from the start (e.g. site selection, protocol)
• Discuss the importance of designing inclusive R&R strategy
Moderated by: Amri Johnson, Chief Executive Officer, Inclusion Wins
12:05 - 12:15
Morning Reflection
Angela Bilkhu, Sr. Global Patient Partnership Director, Genentech
12:20 - 13:20
Networking Lunch
13:25 - 14:10
BREAKOUT SESSIONS
Problem We Are Solving:
How do we bring clinical trials to the patient rather than patients to the clinical trial?
How do we bring clinical trials to the patient rather than patients to the clinical trial?
14:15 - 14:35
Human-Centered and Innovative Clinical Trials: The Site Perspective
• For a site representative to share what is considered as “site burden”
• Discuss what could be the site representative role when it comes to measure the “lived experience” from trial participants
Speaker TBA, Site Representative
14:40 - 15:00
The Importance of Study Coordinators and Study Nurses
• Understand how we could better engage with sites when it comes to study design & Recruitment/retention strategy
• Understanding what sites needs from trial sponsors to be able to explain a clinical trial to potential participants and answered their questions
• Identify concrete actions that sponsors could do to build the partnership with sites during and after the trial
Speaker TBA, Site Representative
15:00 - 15:30
Afternoon Networking Break
15:35 - 16:20
BREAKOUT SESSIONS
Problem We Are Solving:
What will you do differently tomorrow to…
What will you do differently tomorrow to…
16:25 - 16:45
Switching the Narrative: Treating a Person Rather Than Treating a Disease
Tonya Winders, President & CEO, Allergy & Asthma Network
16:45 - 17:00
Closing Reflection and Setting the Stage for Day 2
Matthias Ganninger, Head of Business Technology, pRED, Roche
Clyde Campbell, Founder & CEO, Shake It Up Australia Foundation
17:00 - 18:00
APÉRO NETWORKING EVENT
Conference Schedule
Day TWO
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
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
09:45 - 10:00
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
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
'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
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
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)
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
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
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
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
15:30
End of Conference
SpeakING FACULTY
Natalia Sofia
TAKEDA
Lea Proulx
ROCHE
Matthias Ganninger
ROCHE
Roland Barge
REGENERON
Sam Hariry
NOVARTIS
Jannice Roeser
ROCHE
Esther Seeberger
Universitätsspital Basel (USB)
Marisa Cruz
EMPATICA
Regina Grossmann
Universitätsspital Zürich (USZ)
Luc-Alexis Leuthold
NOVARTIS
Jeremy Wyatt
ACTIGRAPH
Clyde Campbell
SHAKE IT UP AUSTRALIA FOUNDATION
Scott Askin
NOVARTIS
James Donohue
GENENTECH
Steve Bourke
Personalpulse
Isabela Niculae
UCB
Dudley Tabakin
VIVOSENSE
Maria Kuthning
Sobi
Dan Karlin
MINDMED
Sarah T'Kindt
FAGG / FAMHP
William Johnston
NOVARTIS
Angela Bilkhu
GENENTECH
Amri Johnson
INCLUSION WINS
Lorcan Walsh
NOVARTIS
Annette Magnin
CANTONAL ETHICS COMMITTEE, ZURICH
Camila Matheny
MEDABLE
Stefan Dürr
IQVIA
Tonya Winders
ALLERGY & ASTHMA NETWORK
Interested in Sponsorship or
Exhibition Opportunities?
Exhibition Opportunities?
Roche Tower (Building 1)
The Clinical Trials Innovation Summit (27-28 June) and the Digital Biomarkers Summit (29 June) will both be held in the Auditorium of Building 1 on the Roche campus in Basel.
Address:
Roche Tower (Building 1)
Grenzacherstrasse 124
4070 Basel, Switzerland
Address:
Roche Tower (Building 1)
Grenzacherstrasse 124
4070 Basel, Switzerland
Roche Building 1: The building, standing 178 meters tall, counts a total of 41 floors and presents a profile shaped like a terraced wedge. This new office building houses approximately 2,100 workplaces related to various departments heretofore scattered throughout the city. The concentration of all these in one place allows for a smoother flow of communication, the integration of staff and the promotion of synergy between different fields.
