Cambridge Healthtech Institute's Inaugural
Digitalization of Clinical Trials
Digital Technology, AI, Real World Data and Advanced Analytics for Next-Gen Trials
17-18 September 2019
We are pleased to announce production of Cambridge Healthtech Institute’s Digitalization of Clinical Trials conference will be held 17-18 September 2019 at the Crowne Plaza Barcelona-Fira Center in Barcelona, Spain. This conference is designed to
bring together thought leaders in the field of clinical innovation, and to discuss the latest technological advances, as well as implementation approaches to improve clinical trials.
The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE) Europe, a two-day event made up of shared plenary keynotes from biopharma thought leaders, five conference tracks focused on specific issues and functions within
the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please see the overall program map below for 2019.
Tuesday, 17 September
7:30 - 17:00 Registration Open
7:30 Morning Coffee
8:35 Opening Plenary Keynotes
10:00 Grand Opening Coffee Break in the Exhibit Hall
10:50 Chairperson’s Opening Remarks
Mishal Patel, PhD, Head, Health Informatics, AstraZeneca
10:55 Digital Technologies and AI to Re-Shape Clinical Trials
Mishal Patel, PhD, Head, Health Informatics, AstraZeneca
Clinical development organizations are changing how they collect, manage and analyze clinical data and new measures of clinical outcomes are being adopted. Data will be the fuel that powers machine learning and AI. As a result we must re-imagine what
is required to create a data powered organization that unlocks value and insights. We will explore how information supply chains, elastic infrastructure, tools for data science, and automation enable a 21st century data backbone accelerating the delivery
of new medicines to patients.
11:20 CO-PRESENTATION: EHR2EDC – Pioneering Greenfields to Optimize Clinical Research Data Management
Agustín Gómez de la Cámara, MD, PhD, Senior Scientist & Head of the Central Unit of Clinical Research and Clinical Trials, Biomedical Research Institute, Hospital 12 de Octubre
Todorovic, Bridges Associate, Hospital Engagement Lead/Data Sciences, Janssen R&D, Clinical Innovation
EHR2EDC is a public-private eIT funded project which aims at developing processes, procedures and technology for automatic transfer of data elements from the electronic health records (EHRs) into the electronic data capture (EDC) environment. This novel
technology solution can improve the efficiency of clinical research in a GDPR compliant manner. A RWD/EHR platform, built according to the principles of federated data management, provides real world data and insights for protocol design, feasibility
and recruitment and allows for a streamlined communication path between a sponsor and the participating sites. In 2018-2019, the existing RWD/EHR platform services are being extended to demonstrate the possibility of EHR data extraction that will
be automatically uploaded in the EDC during trial execution. Several pilots will validate the technical capabilities paying attention to appropriate process optimization and regulatory requirements for future operational EHR2EDC solutions. Presenters
will share overall project experiences and lessons learned, advantages for all participants in the ecosystem, especially speaking from the hospital and sponsor perspective.
11:45 Trends, Insights, and Strategies to Improve Study Execution
Rik Van Mol, Vice President, Development Cloud Strategy, Europe, Veeva
During this presentation you will: 1) Hear new results from one of the industry's largest, global clinical operations surveys 2) Examine the drivers and barriers to unifying clinical systems and processes 3) Learn about trends in data sharing and collaboration
4) Discover innovative approaches for streamlining study execution 5) Hear about the steps the industry is taking to improve study quality and speed.
12:10 Exploring eConsent Options: Self-Authoring vs Vendor-Managed Models
Mika Lindroos, Director, Product Management, Signant Health
In this session, discover the difference between vendor-managed and self-authoring eConsent models and how to choose the right one for your study. Learn the ideal features that support self-authoring and ways to manage implementation within your teams.
12:35 Lunch in the Exhibit Hall (Community Networking)
13:55 Chairperson’s Remarks
Marija Todorovic, Bridges Associate, Hospital Engagement Lead/Data Sciences, Janssen R&D, Clinical Innovation
14:00 Digital Endpoints: Insights into Performance, Behaviour and Beyond
Ieuan Clay, PhD, Head, Digital Data Science, Translational Medicine, Novartis Institutes for Biomedical Research
As the field of digital endpoints matures, as well as more readouts progressing towards acceptance, we are also seeing new domains of readouts emerging. Focusing on our work on mobility, we will discuss how emerging capabilities in analytics and technology
have allowed us to move from gait performance measures into studying mobility behavior and bridging into subjective perceptions of independence.
14:30 Smartphone-Based Objective Assessments of Physical Function in Rheumatoid Arthritis Patients
PhD, Data Analytics Leader, Digital Biomarkers, GSK Associate Fellow, Biostatistics, R&D, GlaxoSmithKline
Analysis of iPhone sensor data collected by means of a mobile software application. Objective tasks were deployed during which gyroscope and accelerometer time-series data were captured. The tasks were performed remotely and without any medical supervision.
Machine learning-based processing schemes enabled the extraction of motion-specific features for comparison with subjective pain and mobility parameters collected from Rheumatoid Arthritis patients, which highlighted links between reduced mobility
and increased symptoms severity.
15:00 INTERACTIVE PANEL DISCUSSION: Moving Towards Virtual Trials
Moderator: Ieuan Clay, PhD, Head, Digital Data Science, Translational Medicine, Novartis Institutes for Biomedical Research
Panelists: Marija Todorovic, Bridges Associate, Hospital Engagement Lead/Data Sciences, Janssen R&D, Clinical Innovation
Mishal Patel, PhD, Head, Health Informatics, AstraZenecaLet's discuss terminology: Site-less, de-centralized, virtual?Does it have to be one model, or can we mix (e.g. traditional and remote)?Where do retrospective/eTrials fit in? virtual control arms?Does digital technology inevitably lead to virtual trials?What are some specific challenges in retaining patients and investigators?What are the data science considerations in de-centralized/virtual trial?
15:30 Refreshment Break in the Exhibit Hall
16:10 Find Your Table and Meet Your Moderator
16:15 Interactive Breakout Discussion Groups (Session #1)
17:00 Networking Reception in the Exhibit Hall
18:00 End of Day
Wednesday, 18 September
8:00 Morning Coffee
8:30 Chairperson’s Remarks
Ronald Dorenbos, PhD, Head, Innovation Management & Scouting, Innovation & Technology Science, Takeda
8:40 AI in Pharma & Clinical Trials
Dorenbos, PhD, Head, Innovation Management & Scouting, Innovation & Technology Science, Takeda
The presentation will discuss how AI-related approaches are changing the way clinical trials are executed. The patient’s perspective on implementation of AI in clinical trials will briefly be reviewed and the presentation will highlight implementation
of AI in a variety of areas within the pharma value chain. The presentation will be concluded with a brief look into the future.
9:10 Tangible Applications of Advanced Analytics
Chris Crabtree, Associate Principal, ZS
Machine Learning & AI have a variety of clinical research applications such as protocol digitization, anomaly detection, disease identification and safety prediction. In this session, we will share how companies are building capabilities and processes
that harness ML & AI to solve complex problems and optimize operations.
9:25 Enabling Intelligent Operations: Embracing Emerging Technology in Drug Development
Jennifer Duff, Global Life Sciences Operations Lead, Accenture
9:50 Coffee Break in the Exhibit Hall
10:35 Janssen’s Suite of Smart Technologies to Transform Clinical Trials: From Concept to Implementation
Bert Hartog, PhD, Senior Director, Clinical Innovation, Janssen Pharmaceutica N.V.
This talk will cover transforming clinical trials by disruptive partnerships with technology, software, mobile and package vendors. More specifically the impact of personalized patient engagement and automated real-time data collection on patients,
sites and companies via smart phones, smart blisters and scanning devices; ensuring the “right” kit and “right” pill is given to the “right” patient at all times; improving a patient’s understanding
of drug information and all-in-one digital drug labels; value of engaging patients, sites, health authorities and ethics committees directly during the development of smart technologies; and the learnings of a first Phase II study with Alzheimer
patients and the first feedback of the ongoing studies.
11:00 New Clinical Research Technologies: The Perspective of the Clinical Research Site
Teresa Hines, Associate Director, Clinical Management, Otsuka Pharmaceutical Development & Commercialization
In today’s clinical research environment there is a steady progression toward the use of a fully paperless environment including technologies like electronic source and electronic consent. These technologies have significant operational
impacts on sponsors and CROs but also, importantly, clinical research sites. Having deployed several trials now with a suite of technologies that are virtually paperless, we have obtained comprehensive feedback from clinical research sites
as to what they see as the advantages and challenges of the new technological environment. We will summarize the key finding of this data and speak to the implications for industry as we continue to deploy new technologies in clinical research.
11:25 Cross-Industry Collaboration: Evaluating How Blockchain Can Transform the Pharmaceutical and Healthcare Industry, Part of Emerging Trends & Technology PhUSE Workgroup
Aji Barot, Vice
President, Pharma (EMEA), Medisafe® Medication Management Platform
Describing the landscape in the pharma and healthcare settings, exploring the areas where blockchain could be used and presenting two detailed use cases (a. Drug Supply Chain using Smart Contracts; b. Patient Data Access/Transparency) and demo
several functionalities around Patient ID, eConsent and Data Sharing.
11:50 Automatized Patient-Recruitment System Based on RWD and Natural Language Processing
Javier de Oca, CEO, IOMED
Patient Recruitment is a major issue in Clinical Trials (CT). Increasingly complex and time-consuming CT are a challenge for sponsors and CROs. IOMED offers a system to accelerate patient recruitment, using electronic health records (EHR), routinely
collected in hospitals, and processing them with Natural Language Processing. The outcome is a structured database, containing all patient's clinical variables. As a result, we are able to find 3 times more patients in a 10% of the time.
12:15 Lunch in the Exhibit Hall (Community Networking)
13:25 Transition to Breakouts & Keynotes
13:35 Find Your Table and Meet Your Moderator
13:40 Interactive Breakout Discussion Groups (Session #2)
14:10 Clinical Research News’ European Innovations Awards & Closing Plenary Keynotes
15:25 Close of Conference