Day One
Wednesday, July 11th, 2018
Day Two
Thursday, 12th July, 2018
08.15 Chair’s Opening Remarks
08.30 Opening Keynote Panel Discussion: Innovating the Conduct of Clinical Studies & Accelerating the Delivery of New Therapies to Patients with Mobile-Enabled Clinical Trials
Synopsis
- Addressing the rapidly evolving mHealth landscape in pharma, the growing interest and the latest and exciting advances on the use of these technologies to support and drive clinical programs
- Overcoming the operational and regulatory challenges to running mHealth supported clinical trials
- Maximizing patient-centricity and clinical innovation with mHealth technology
- Discussing the role of external stakeholders and collaborations (vendors, big tech companies, payers, academia, etc.) for digital innovation in clinical trials
- Outlining where we are and where we are going – key learnings to date and perspectives on future directions
09.15 Keynote: Accelerating & Transforming Clinical Development with mHealth Technology
Synopsis
- Addressing the unavoidable tidal wave of digital innovation across multiple dimensions in pharma, and the potential to streamline drug development by embracing opportunities brought by technology advances
- Discussing how AbbVie is embracing digital in clinical – from the use of RWD and predictive analytics to optimize clinical trial design, to automation of low value work, creation of immersive clinical trial environments, or harvesting of EMR data to reduce data entry at site and passive data collection through wearables and IoT enabled devices
09.45 Speed Networking & Morning Refreshments
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Operational & Technical Track:
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Strategic & Regulatory Track:
Transforming Clinical Research Methodologies – Decentralized Clinical Trials
11.15 Virtual Trials in the Context of Big Pharma R&D: New Opportunities & Challenges
- Discussing how this novel clinical operational model, virtual clinical trials, creates significant opportunity for clinical development
- Analyzing how it works in Big Pharma, and presenting Janssen’s experience (case study): promises and challenges
- Developing novel operational capabilities
- Path forward: key questions that should be addressed in the nearest future
Dmitri Talantov (Janssen Pharmaceuticals)
11.45 Tackling Practical & Technical Challenges to ‘Bring Your Own Device’ (BYOD) Approaches in Clinical Trials: The Pfizer Experience
- Reviewing the value and impact of BYOD at both the clinical and organization level
- Discussing the mitigation strategies to overcome the obstacles associated with BYOD
- Exploring strategies for enterprise-wide adoption of BYOD platforms
Stephen Amato (Pfizer)
Enhancing Patient-Centricity In Clinical Research
11.15 Fox Insight Trial: Facilitating Patient & Care Partner Information Sharing About the Lived Experience of Parkinson’s Disease
- Detailing on Fox Insight: an online, longitudinal, patient-centric study
- Understanding how the Fox Insight’s structure (with over 16,000 participants enrolled) facilitates research participation and rapid data collection – both patient-reported and objective measures
- Overviewing the Fox Insight platform, novel recruitment strategies, and unique collaborations with 23andMe and the Medical Device Innovation Consortium
Lauren Bataille (The Michael J. Fox Foundation for Parkinson’s Research)
11.45 Mobilizing mHealth Innovations for Research
- mHealth gives researchers the opportunity to collect previously-unavailable data, including novel and/or more frequent/triggered measurements, that may be more meaningful to patients
- Need for greater understanding of how patients interact with mHealth tech to improve sustained engagement
- Using mHealth to communicate and engage with participants in clinical trials
Christina Silcox (Duke-Margolis Center for Health Policy)
12.15 Lunch & Networking
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Operational & Technical Track:
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Strategic & Regulatory Track:
Wearables & Sensors In Clinical Developement
13.15 Three Case Studies Highlighting the Implementation of Wearable Devices in Clinical Trials
- Discussing the pros and cons of commercial grade devices vs. medical grade devices
- Delving into practical techniques for boosting compliance
- Presenting learnings from regulatory interactions
- Relevant wearable endpoints in oncology, immunology and neuroscience indications
Kyle Holen (AbbVie)
13.45 Wearables & Their Promise for Patients – Epilepsy Care Today
- Understanding the promise of wearables and their reality – gadgets or clinical devices?
- Analyzing the application of wearables in clinical trials – fit for purpose/consequence
- Discussing epilepsy trials and standard of care in 2030
Gergely Vertes (UCB)
14.15 The Technology & Supporting Ecosystem Behind Novel Digital Endpoints
- Overcoming inherent technology challenges behind continuous-time measurements
- Analyzing the value of historical academic research in digital biomarkers
- Do we need medical devices?
- Discussing the role and importance of a digital ecosystem in big-data-management (EDC integration, wearable configuration, data integrity, and compliance)
- Exploring trends in cloud technology that are enabling better insights into novel endpoints and helping data teams identify meaningful endpoints in big data
Jeremy Wyatt (ActiGraph)
ENHANCING PATIENT-CENTRICITY IN CLINICAL RESEARCH
13.15 Innovative Use of Real World Data Through Smartphone Apps & More: Revolutionizing The Way We Look at Trial Design in Children
- Traditional RCT to evaluate medical devices and pharmaceutical agents in children is exceedingly challenging due to the small volume and highly heterogeneous population
- Need alternative sources of data to inform clinical practice and expand labeling of devices and drugs to children- Real World Data and Patient Reported Outcomes
- Use of specifically tailored smartphone apps can be a valuable source of this type of data
Christina VanderPluym, Medical Director, Ventricular Assist Device Program & Medical Director, Cardiac Antithrombosis Management & Monitoring Program (CAMP), Boston Children’s Hospital
NOVEL DIGITAL CLINICAL ENDPOINTS
13.45 Strategic Roadmap for Moving Digital Endpoints Beyond the Exploratory Phase
- Defining clinically meaningful novel endpoints to justify the scientific rationale for the journey from exploratory to primary
- Choosing the right data streams and digital analytics to maximize validation and accelerate clinical development process
- Discussing the regulatory framework to validation of novel primary digital endpoints from wearable devices
Amir Lahav (Pfizer)
14.15 Accelerating Clinical Development – Incorporating mHealth into Biomarker Discovery Research on Depression
- Understanding the current landscape and emerging opportunities for digital health/m-health in mental health research
- Sharing early findings of m-health embedded into ¡¥traditional¡¦ biomarker discovery research in depression
- Appreciating opportunities for partnerships between academic research consortia and m-health developers
Claudio Soares (Queen’s University School of Medicine)
14.45 Afternoon Refreshments & Networking
DRIVING CLINICAL INNOVATION WITH DIGITAL & MOBILE APPROACHES
15.15 Novartis Journey on Decentralized Clinical Trials
Synopsis
- Exploring implementation approaches to decentralized clinical programs
- Delving into Novartis results to date
- Where do we go from here? – discussing future steps to enhance patient centricity with decentralized clinical studies and remote monitoring
15.45 Panel Discussion: Debating Developments in New Clinical Digital Endpoints
Synopsis
- Bridging the gaps to identifying, developing and incorporating technology-derived endpoints into clinical trials
- Addressing the evolving regulatory landscape and approval pathway in tool and biomarker validation
- Discussing novel digital endpoint and their application in different therapeutic areas
