Chair’s Opening Remarks

Driving Patient-Centricity with Digital-Enabled Approaches


Incorporating the Patient Voice to Inform & Support Trial Design

• More details coming soon

Leyla Rich
Associate Director, Clinical Trial Engagement & Enrollment, Global Clinical Operations
Bristol-Myers Squibb


Fox Insight: Driving Discovery with the Patient Voice

• Addressing how patient reported outcomes (PRO) data complement traditional clinical research with scale & accessibility, as well as patient-centricity
• Advancing patient-centered drug development and amplifying the potential impact the research stands to have on the field at-large – the MJFF sponsored study objectives
• Discussing Fox Insight Study data (including PROs and genetic SNPs of interest), which will be made available to qualified researchers in April 2019

Lindsey Riley
Associate Director - Research Partnerships 
The Michael J. Fox Foundation for Parkinson’s Research



Implementing a Patient Facing App in a Phase III Clinical Trial

• Overviewing the implementation of a patient engagement app in a Phase III clinical trial
• Addressing the operational challenges faced and how these could inform future considerations

Emily Malseed
Director, Global Clinical Program Management


Morning Refreshments & Networking


Re-Imagining Clinical Trials Using Digital Technologies - The Healthcare Setting Perspective

• Driving innovations in the conduct of trials using digital technologies at
Partners Healthcare Pivot Labs – analyzing the advent and adoption of digital technologies and the huge opportunities generated to connect more meaningfully with research participants during clinical trials
• Case-studies: highlighting opportunities to use sensors, wearables and other remote monitoring technologies to enrich data collection from participants, as well as use AI to improve the quality of the data collected
• Using digital technologies to ease the burden on participant recruitment and retention in trials

Kamal Jethwani
Senior Director, Pivot Labs
Partners Healthcare


Siteless Studies & Video-based Visits in Clinical Research

• Discussing the rationale for video-based research visits in clinical trials and natural history studies
• Reviewing the evidence for virtual visits with a focus on research in Parkinson disease and other neurological conditions
• Discussing barriers to and next steps toward broader implementation

Christopher Tarolli
Assistant Professor of Neurology & Movement Disorders Specialist
University of Rochester Medical Center





Mastermind Session: Driving Digital Innovation Towards Truly Patient- Centric Clinical Studies

This session facilitates in-depth discussions among participants in an informal environment. After splitting into groups, participants will discuss key challenges and opportunities regarding the current landscape in mobile and digitally-enabled clinical research.


Lunch & Networking

Driving Innovation By Collaborating with Stakeholders


The Digital Medicine (DiMe) Society

• Learning about the recently launched DiMe Society, established to serve professionals at the intersection of the global healthcare and technology communities, advancing the practice of digital medicine through interdisciplinary collaboration, research, teaching, and the promotion of best practices
• Discovering opportunities for engagement
• Discussing opportunities to advance digital medicine as part of this new professional society

Elena Izmailova
Co-founder, Strategic Advisory Board Member & Co-Chair of DiME Research Committee
Digital Medicine (DiMe) Society



Driving a Cross Functional Consortium to Deliver Patient Value

• Addressing unmet patient need
• Epilepsy today: from R&D to RCT to daily practice and its outcome
• Discussing public private partnership pros and cons
• Overviewing key learnings from the project and defining next steps based on our current results (medical certification in EU/US)
• Defining a long term vision and its potential impact on patients

Gergely Vertes
Solution Accelerator, Wearable for Epilepsy




Afternoon Refreshments & Networking


Engaging Patients & Sites to Drive Adoption of Mobile Technology in Clinical Trials

• Understanding the perspectives of patients and investigative site personnel and incorporating those perspectives into trial design and execution – maximizing opportunities and minimizing challenges in the use of mobile technology in clinical trials
• Sharing recommendations and resources developed by the Clinical Trials Transformation Initiative (CTTI) to:
- Engage patients and investigative site personnel early and often in planning, including protocol design, technology selection, and pilot testing
- Set participant expectations, protect privacy, return individual patient data, enhance participant-site interactions, and provide technical support
- Address needs of sites, through contracting and budgeting to evaluating site readiness for mobile clinical trials and implementing effective and streamlined training

Cindy Geoghegan
Principal, Patient & Partners, & Project Lead, Mobile Clinical Trials: Engaging Patients & Sites Project
Clinical Trials Transformation Initiative (CTTI)



‘IMPACCT’ Panel Discussion: All Aboard the Clinical Innovation Boat! – A Multi-Stakeholder Collaboration to Drive Patient Engagement

• Establishing a collaborative community discussion on how advance digital innovation in clinical trials to the next level and work towards the same goal of patient-centricity and clinical innovation
• Defining best practice and key considerations for enhancing the incorporation of patients’ perspectives in clinical trial access, design, conduct and post-trial follow-up
• The patient as a partner – exploring the unique opportunity digital tools present for how clinical trials monitor, communicate and work alongside patients
• Working with the regulators on understanding and defining the standards for acceptance and implementation of digital approaches for data collection in clinical research
• Collaborating with physicians and sites – how to close the loop at the site level
• Looking inwards and demonstrating the value to internal stakeholders – working with procurement teams to advance digital approaches

Cindy Geoghegan
Clinical Trials Transformation Initiative (CTTI)

Elena Izmailova
Digital Medicine (DiMe) Society

Gergely Vertes

Hassan Kadhim
Bristol-Myers Squibb



Chair’s Closing Remarks