Léa Proulx, Patient Voice Partner, Roche

• 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

 
Alfred Samuels, Patient Advocate

• 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

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

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

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

• 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

 

Joachim Lövin, DCT Specialist, Novo Nordisk

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

• 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

Robin Rehmann, Patient Advocate
Hanna Boëthius, Patient Advocate

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

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

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

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

Matthias Ganninger, Head of Business Technology, pRED, Roche

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

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

Karl McEvoy, Product Director, DCT Technology, YPrime

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

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

Jeremy Wyatt, Chief Executive Officer, Actigraph

• 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

Marisa Cruz, Chief Medical Officer, Empatica

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

• 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

 
Matthias Ganninger, Head of Business Technology, pRED, Roche