The Clinical Trials Innovation Summit returns to 
Roche Headquarters in Basel on June 27-28, 2023!

PanAgora Pharma and Roche are collaborating to present the 3rd Annual Clinical Trials Innovation Summit. This year's conference agenda will focus 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


Stay tuned for updates on the 2023 Summit! Join 40+ speakers and 200+ senior-level clinical research, operations, and trial design leaders on June 27-28th at Roche headquarters in Basel!
 
Location
Roche Building 1
Grenzacherstrasse 124
4070 Basel, Switzerland
Date & Time
27 June 2023
09:00-17:30 Local Time (GMT+2)
Apéro to Follow

28 June 2023
09:00-13:00 Local Time (GMT+2)
Lunch to Follow

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

SpeakING FACULTY (2023)
Sam Hariry

NOVARTIS
Léa Proulx

ROCHE
Matthias Ganninger

ROCHE
Roland Barge

REGENERON
Karl McEvoy

YPRIME
Catherine Ofori-Atta  

ROCHE
Joachim Lövin

NOVO NORDISK
Marisa Cruz

EMPATICA
Kimberly Barnholt 

ROCHE
Luc-Alexis Leuthold

NOVARTIS
Jeremy Wyatt

ACTIGRAPH
Andy Coravos

HUMANFIRST
Scott Askin

NOVARTIS
James Donohue

GENENTECH
Steve Bourke

Personalpulse
Isabela Niculae

UCB
Dudley Tabakin

VIVOSENSE
Maria Kuthning

(FORMER) Sobi
Dan Karlin

MINDMED
Sarah T'Kindt

FAGG / FAMHP
William Johnston

NOVARTIS
Angela Bilkhu

GENENTECH
Amri Johnson

INCLUSION WINS
Lorcan Walsh

NOVARTIS
Elizabeth Theogaraj

ROCHE
Alison Holland

MEDABLE
Stefan Dürr

IQVIA
Darcy Forman

SCIENCE37
Robin Rehmann

PATIENT ADVOCATE
Hanna Boëthius 

PATIENT ADVOCATE
Huwaida Bulhan

ROCHE
 Dr. Maren Schinz

DIABETES CENTER BERNE
Clyde Campbell

Shake It Up Australia
Annette Magnin

Cantonal Ethics Committee ZuricH
Alfred Samuels

PATIENT ADVOCATE
Jennifer Eyerman

ROCHE
Susanne Brandl
ROCHE
Matodzi Nelwamondo

ROCHE
Grace Sanders

PATIENT ADVOCATE
Tonya Winders
GAAPP
Suki Balendra
IMPERIAL COLLEGE HEALTHCARE NHS TRUST
Hanae Ibn El Haj

ROCHE
Aaron Mitchell

Zs
Gladys Mills
ROCHE
Conference Schedule (2023)
DAY ONE



27 June 2023
09:00
Opening Remarks from the Day 1 Conference Chair

Léa Proulx, Patient Voice Partner, Roche



CONTENT BLOCK 1 
HUMAN-CENTERED CLINICAL TRIAL DESIGN

09:15
FIRESIDE CHAT
The Struggle is Real: A day in the life of a patient managing their disease and responsibilities while participating in a clinical trial

Clyde Campbell, Chief Executive Officer, Shake It Up Australia Foundation for Parkinson's Research

Moderated by: Steve Bourke, Chief Executive Officer, PersonalPulse


09:45
PANEL
Defining Human-Centered Design: What Does It Mean and Where Can It Take Us?

• Trends we’re seeing to include DCT elements in clinical trials
• 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

Léa Proulx, Patient Voice Partner, Roche
Maria Kuthning, (Former) Global Medical Clinical Program Lead, Sobi (Swedish Orphan Biovitrum)
Clyde Campbell, Chief Executive Officer, Shake It Up Australia Foundation for Parkinson's Research

Moderated by: Steve Bourke, Chief Executive Officer, PersonalPulse


10:15
PATIENT PERSPECTIVES
Lived Experience Participating in a Clinical Trial as a Representative from an Underserved/Underrepresented Community
 
Alfred Samuels, Patient Advocate


10:45
Morning Networking Break



11:15
PANEL
Don’t Forget About Us… Designing Trials for Underserved Populations

• Defining DE&I
• Clarifying what is an “underserved / underrepresented population” - knowing not one definition fits all
• Discussion on how to design inclusive trials from the start (e.g. site selection, protocol)
• Discussion on the importance of designing inclusive R&R strategy

Cristina Crisan Tran, VP, Medical Education, Zimmer Biomet
Alfred Samuels, Patient Advocate
Melissa Lewis, Vice President, AXON
Suki Balendra , Director of Strategic Partnerships (Paddington Life Sciences), Imperial College Healthcare NHS Trust

Moderated by: Amri Johnson, Chief Executive Officer, Inclusion Wins

11:45
PANEL
Considering New Geographies for Clinical Trials

This panel will bring together a group of Roche clinical operations leaders from around the globe to share what they are doing in their region to address diversity, equity, and inclusion in clinical trials.

Hanae Ibn El Haj, Country Study Manager, Roche Morocco
Huwaida Bulhan, Senior Clinical Operations Team Lead, Area Africa, Roche Kenya (East & West Africa)
Gladys Mills, Clinical Operations Lead, Roche Ghana
Matodzi Nelwamondo, Senior Clinical Operations Lead, Roche South Africa

Moderated by: Catherine Ofori-Atta, Senior Clinical Operations Leader, Roche

12:15
Morning Reflection

Angela Bilkhu, Global Patient Partnership Leader, Genentech
Steve Bourke, Chief Executive Officer, PersonalPulse

12:30
Networking Lunch


13:30
BREAKOUT SESSIONS

Problem We Are Solving:
How do we bring clinical trials to the patient rather than patients to the clinical trial?

14:10
PANEL
What DCT Tools Are Available to Drive Human-Centered Trials?

• Understanding the attitude of trial participants towards decentralized clinical trial elements
• Understanding the perspective of sites and how they are having discussions around DCTs with potential trial participants
• Understanding how patient communities (both trial-naive and trial-experienced) 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
Scott Askin, Director, Global Clinical Operations Innovation, Novartis
Dr. Maren Schinz, Innovation Manager & Patient Advocate, Diabetes Centre Bern
Aaron Mitchell, Principal, R&D Global Practice, ZS

Moderated by: James Donohue, Principal Clinical Innovation and Technology Leader, Genentech

 
14:40
USE CASE
Leveraging TransCelerate’s Patient Centric Tools to Improve the Clinical Trials Patient Experience

Joachim Lövin, DCT Specialist, Novo Nordisk

15:05
PANEL
Looking to the Future of DCTs and DHTs in Clinical Trials

Lorcan Walsh, Digital Endpoint Capability Centre Lead, Novartis
Dan Karlin, Chief Medical Officer, MindMed
Darcy Forman, Chief Delivery Officer, Science37

Moderated by: Matthias Ganninger, Head of Business Technology, pRED, Roche

15:35
Afternoon Networking Break



16:00
SITE PERSPECTIVES
Human-Centered and Innovative Trials - What Does This Mean From the Site Perspective?

• 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

Speakers TBA, Site Representatives
Grace Sanders, Patient Advocate

Moderated by: Jennifer Eyerman, Clinical Trial Partner, Roche


16:30
FIRESIDE CHAT
Human-Centered and Innovative Trials: What Does This Mean From a Patient Perspective?

Robin Rehmann, Patient Advocate
Hanna Boëthius, Patient Advocate

Moderated by: Angela Bilkhu, Global Patient Partnership Leader, Genentech


16:55
FIRESIDE CHAT
Switching the Narrative: Treating a Person Rather Than Treating a Disease

Tonya Winders, President, GAAPP (Global Allergy & Airways Patient Platform)

Moderated by: Susanne Brandl, Global Patient Partnership Leader, Roche


17:20
Closing Reflection and Setting the Stage for Day 2

Matthias Ganninger, Head of Business Technology, pRED, Roche
Clyde Campbell, Chief Executive Officer, Shake It Up Australia Foundation for Parkinson's Research



APÉRO / NETWORKING RECEPTION TO FOLLOW
Conference Schedule (2023)
Day TWO


28 June 2023
08:45
Opening Remarks from the Day 2 Conference Chair

Matthias Ganninger, Head of Business Technology, pRED, Roche



CONTENT BLOCK 2
INNOVATIONS IN DECENTRALIZED CLINICAL TRIALS (DCTs)

08:50
PANEL
Stakeholder Collaboration to Facilitate DCTs: Regulatory and Ethics Perspectives

Sarah T'Kindt, GCP inspector, FAGG, FAHMP (Belgium)
Annette Magnin, Managing Director, Cantonal Ethics Committee Zurich

Moderated by: Elizabeth Theogaraj, Global Regulatory Lead, Roche

09:15
Transforming the Industry with "Patients First" Mindset

Alison Holland, Executive General Manager, Digital and Decentralized Solutions, Medable

09:35
USE CASE
IMI's TRIALS @ HOME

Learn how the IMI is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need.

Scott Askin, Director, Global Clinical Operations Innovation, Novartis


09:50
Improving the Patient Experience Through User-Focused Design

Karl McEvoy, Product Director, DCT Technology, YPrime


10:10
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.

Sam Hariry, Global Head, Clinical Innovation, NIBR TM, Novartis
James Donohue, Principal Clinical Innovation and Technology Leader, Genentech
Stefan Dürr, Sr. Director of Product Management, Head of Drug Supply Center of Excellence, IQVIA

Moderated by: Dan Karlin, Chief Medical Officer, MindMed

10:35
Morning Networking Break
10:55
An Evidence Based Approach to Human-Centric Design

Learn how we can leverage digital/DCT approaches to gather information more in line with how patients live their lives, exploring novel data techniques (like tokenization/RWD) to gain a more 360° lens of a patient's life, and the data they share with us through PROs, patient voice, etc.

Kimberly Barnholt, USMA Evidence Generation Leader, Roche


11:10
Top 5 Regulatory and Operational Considerations for Deploying a Digital Health Technology (DHT) as a Primary Endpoint

Jeremy Wyatt, Chief Executive Officer, Actigraph


11:30
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


11:50
Scaling Decentralized Trials with Clinically Validated Wearables

Marisa Cruz, Chief Medical Officer, Empatica


12:10
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


12:30
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

Joachim Luithle, Former SVP, Head of Clinical Operations, Bayer
Dudley Tabakin, Chief Executive Officer, VivoSense
William Johnston, Director, Digital Endpoint Lead, Novartis
Andy Coravos, CEO and Co-Founder, HumanFirst

Moderated by: Matthias Ganninger, Head of Business Technology, pRED, Roche


12:55
Closing Reflection
 
Matthias Ganninger, Head of Business Technology, pRED, Roche

13:00
Networking Lunch

14:00
End of Conference

Interested in Sponsorship or 
Exhibition Opportunities?
Roche Tower (Building 1)
The Clinical Trials Innovation Summit (25 June) and the Digital Biomarkers Summit (26 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
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.

Processing Registration...