Bryan McDowell
Executive Director - Global Program Lead for Data & Digital , Novartis
09.00 ‘IMPACCT’ Panel Discussion: Driving Digital Transformation & Clinical Innovation in Clinical Research – Bridging the Gap to True Patient- Centricity
Donna Finch
Associate Director, Clinical Scientist, Respiratory, MedImmune
Tyler Guthrie
Director of Scientific Affairs & Data Management, ActiGraph
Bryan McDowell
Executive Director - Global Program Lead for Data & Digital , Novartis
Synopsis
Addressing the rapidly evolving mobile and digital health landscape and its potential to support, improve and drive clinical studies
Old vs. New – balancing optimisation of processes and approaches with digital tools vs. complete disruption of the clinical research paradigm (e.g. remote trials)
Ensuring the value and ROI of digital innovation in clinical trials – would we continue in our journey for patient-centricity, technology enabled trials without reductions in cost or time?
Advancing digital endpoint development – what are the current limitations?
Operationalising digital clinical innovation – recurrent pain points and moving forward, what’s next?
Discussing long term extensions in clinical trials
Rethinking Clinical Research Methodologies
09.45 Digital technology: Revolutionizing Care from Drug Development to the Clinic
Anne-Marie Li-Kwai-Cheung
Project Team Lead for the Multiple Sclerosis (Neuroscience) PHC Showcase , Roche
Synopsis
Understanding why neuroscience is one of the most difficult areas of drug research because diseases are poorly understood and disease processes are difficult to measure objectively
Using meaningful data at scale (MDAS), digital endpoints and outcomes to provide new, clinically meaningful insights into the disease, completely change our ability to measure disease processes, and reliably determine whether new therapies are impacting these processes
Changing how we manage disease by changing outcomes for patients, and in turn driving better research for the development of next generation therapies
10.15Speed Networking Session
10.45Morning Refreshments
11.15 Patient-Centric Trials – What’s next?
Sam Hariry
Head of Clinical Strategy & Operations , Novartis Institutes for Biomedical Research (NIBR)
Synopsis
Discussing how remote trials are transforming clinical studies and supporting patientcentricity
Moving from purely home-based remote trials – how we incorporate the patients’ own GP on these efforts?
11.45 Sampling Approaches in Patient-Centric Trials
Lisa Shipley
VP, Digital & Analytics Technologies , Merck & Co.
Synopsis
Discussing the need for patient-focused tools in clinical research
Exploring approaches for smart, home or outpatient sampling
Medable E2E: first and only end-to-end cloud platform for clinical trials
12.45Lunch & Networking
13.45 Building Patient Centricity into Clinical Trials with Digital Medicine & Digital Technologies
Corey Fowler
Associate Director - Global Clinical Development , Otsuka Pharmaceutical Co.
Synopsis
Utilising Digital Medicine as an objective measure of adherence in clinical studies and clinical practice
Exploring digital applications for conduct of virtual clinical trials in SMI patients
Applying technology to reduce placebo response while enrolling more diverse patient groups
Presenting the emerging challenges to measure traditional psychometric assessments in a remote environment, including technology and new innovations to combat these challenges
Digitisation in Clinical Studies – Behind the Spotlight
14.15 Bridging the Gap Between Innovation & Implementation
Data management (privacy, security & data management)
Enhancing data collection with wearables & mobile applications
15.25Afternoon Refreshments & Networking
15.55 Accelerating Patient Recruitment & Managing Clinical Data with Digital Tools
Theodoros Arvanitis
Professor of e-Health Innovation & Head of Research - Institute of Digital Healthcare (IDH) , University of Warwick
Synopsis
Overviewing EU FP7 Project Transform – utilising digital tools for patient recruitment
Enhancing clinical data management – the C.U.R.e Framework
Presenting implementation case-studies
16.25 Enabling World-Class Clinical Trials Using National NHS Data
Tom Denwood
Executive Director of Data, Insights & Statistics , NHS Digital
Synopsis
Exploring how the NHS Digital is working with HDR UK’s Oxford University site, and the National Institute for Health Research, to develop innovative clinical trial services
Using national NHS data, to support rapid, efficient trials that meet the needs of regulators (such as the MHRA and FDA) and NHS patients, while protecting individuals’ data rights
Seeing the benefits from the pilots of these services, that specifically support clinical trial cohort feasibility, selection and identification, and how they can be utilised by life sciences industry, to deliver more efficient trials
16.55Chair’s Closing Remarks
Bryan McDowell
Executive Director - Global Program Lead for Data & Digital , Novartis
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