Chair’s Opening Remarks


‘IMPACCT’ Panel Discussion: Implementing Patient-Centric Clinical Transformation – A Guide on What We Know & What We Still Look to Achieve

• Analyzing the changing clinical research paradigm and the role of digitallyenabled approaches in clinical innovation – enhancing research outcomes and patient-facing medicine
• Old vs. New – balancing optimization of processes and approaches with digital tools vs.
complete disruption of the clinical R&D model (e.g. virtual trials)
• Are we transforming the traditional model of clinical research, or just disrupting it with technology?
• Discussing technology implementation in clinical research – is it happening because it’s
available or are we solving any specific problems?
• Ensuring the value and ROI of digital innovation in clinical trials – would we continue in our
journey for patient-centric, technology-enabled trials without reductions in cost or time?
• How can digital and clinical innovation teams be effectively organized and structured? And how can we integrate them in to the process?
• Defining a holistic view on how to implement technology into clinical research: key challenges and what’s next

Craig Lipset

Georgia Mitsi
Sunovion Pharmaceuticals

Jeremy Wyatt

Kyle Holen

Rethinking Clinical Trial Methodology


From the Current State to the Future – What Digital Gaps Remain?

• Reviewing the current state of digital in medicine development against a desired future
• Identifying the gaps that remain to create the future of digital in clinical development
• Exploring what it will take to create the future

Craig Lipset
Head of Clinical Innovation



Speed Networking Session


Morning Refreshments


The End of Manual Data Entry in Clinical Research

• Why is our current system of data capture failing us?
• How is AbbVie tackling this problem? – reviewing case-studies
• Discussing the future of data capture in clinical research

Kyle Holen
Head of Development, Design Center


Reimagining the Current Standard Clinical Trial Approach – The Patient
Centric Remote Trial Model

• Analyzing the patient centric remote trial model and the huge potential it offers to reimagine the current standard clinical trial approach
• Discussing the possibilities and pathways to approach this promising new paradigm
• Sharing Novartis experience on bringing trials to patients, the challenges and learnings in implementation, and considerations for scalability

Ching Tian
General Manager, Digital Accelerator



Digitization of Dermatology – Is It Happening?

• Overviewing the use of digital patient tools in dermatology
• Digitization of clinical trials in dermatology – addressing real-world data generated in clinical trials from digital tools
• Providing insight into LEO Innovation Lab’s first virtual clinical trial

Rasmus Hogreffe
Head of Virtual Clinical Trials
LEO Innovation Lab



Deriving Clinical Biomarkers from Wearable Sensor Data in Regulated Clinical Trials?

• Acquiring and integrating physiologic sensor data from patients
• Visualization, cleaning an contextualization of data
• Delivering clinically meaningful biomarkers

Patrick Hankey
Strategic Business Development



Lunch & Networking


Verily’s Study Watch Program

• Overview of Verily’s Study Watch program
• Enabling continuous real-world wearable data collection in clinical trials across the globe
• Enabling a clinical studies platform for evidence generation

Tushar Parlikar
Product Lead
Verily Life Sciences LLC


Using Passive Monitoring & AI to Characterize the Home Lives of those with Parkinson Disease

• Describing a novel remote sensing technology, Emerald, and how artificial intelligence can enhance its capabilities
• Demonstrating real world feasibility of Emerald to analyze and interpreting the clinical meaning of its output
• Presenting initial results of a Parkinson Disease Study with a particular focus on gait, home activity, and time in bed

Zachary Kabelac
Senior Researcher


Digitization in Clinical Studies – Behind the Scenes


Lessons Learned from Implementing Technologies in Large Scale Trials

• Deciding on the right technology and the right trial
• Ensuring seamless coordination among external stakeholders
• Defining success

Georgia Mitsi
Senior Director – Search Evaluation, Digital Healthcare
Sunovion Pharmaceuticals



Conducting a Successful Digital Clinical Trial – Key Considerations from The Field

• Discussing what are the key stakeholders to involve when setting up your digital trial
• Addressing data security & privacy from a patient and hospital perspective
• Setting yourself up for success by matching your digital solution to the right trial setting and participant group

Amanda Centi
Research Program Manager
Partners Healthcare



Afternoon Refreshments & Networking


Mobile Measures in Parkinson's Disease & Huntington's Disease

• Discussing the rationale for incorporating mobile measures into clinical trials
• Reviewing Parkinson’s disease and Huntington’s disease wearable sensor and smartphone application studies conducted at the University of Rochester
• Considering future directions

Jamie Adams
Assistant Professor, Department of Neurology & Center for Health + Technology
University of Rochester Medical Center


Understanding Behavior in App-Based Fully Remote Trials

• Exploring the benefits of N-of-1 trials for understanding individual-level effectiveness
• Analyzing the challenges of operationalizing fully remote N-of-1s using app stores
• Discussing researcher and user perspectives in using in-device smartphone sensors for collecting physical activity data

Claire McCallum
Postdoctoral Researcher, Institute of Health & Wellbeing
University of Glasgow


AI, Blockchain & Wearables in Clinical Trials: A Dose of Reality

• Analyzing the massive uptick in pharma industry’s interest in technology, especially in artificial intelligence (AI), blockchain and wearables and how these can be leveraged to lower the time to market for specific drugs
• Addressing some use cases – real-world viability and blockers preventing them from becoming a reality
• Discussing new developments in the space that have the potential to significantly impact incumbent practices in clinical research
• Focusing on the right questions to ask

Ameya Phadke
Senior Manager, Technology & Digital Partnerships
Chiesi USA



Chair’s Closing Remarks