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.

Keynotes | Program 1-Feasibility | Program 2-Engagement | Program 3-Monitoring | Program 4-Digitalization | Program 5-Budgeting

Final Agenda

 

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

SMART TECHNOLOGIES FOR NEXT-GENERATION TRIALS

10:50 Chairperson’s Opening Remarks

10:55 Digital Technologies and AI to Re-Shape Clinical Trials

Patel_MishalMishal 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

GómezdelaCámara_AgustínAgustín 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


Todorović_MarijaMarija 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.

Veeva 11:45  Trends, Insights, and Strategies to Improve Study Execution

Val_Mol_RikRik 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.

SignantHealth

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)

DIGITAL ENDPOINTS AND BIOMARKERS

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

Clay_IeuanIeuan 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

Hamy_ValentinValentin Hamy, 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, AstraZeneca

  • Let'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

    BREAKOUT DISCUSSION GROUPS

    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

    AI: HOPE OR HYPE

    8:30 Chairperson’s Remarks

    Ronald Dorenbos, PhD, Head, Innovation Management & Scouting, Innovation & Technology Science, Takeda

    8:40 AI in Pharma & Clinical Trials

    Dorenbos_RonaldRonald 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

    Sethuraman_VenkatVenkat Sethuraman, 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

    Duff_Jennifer

    Jennifer Duff, Global Life Sciences Operations Lead, Accenture


    9:50 Coffee Break in the Exhibit Hall

    IMPLEMENTATION CHALLENGES AND SOLUTIONS

    10:35 Janssen’s Suite of Smart Technologies to Transform Clinical Trials: From Concept to Implementation

    Hartog_BertBert 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

    Hines_TeresaTeresa 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 CO-PRESENTATION: Cross-Industry Collaboration: Evaluating How Blockchain Can Transform the Pharmaceutical and Healthcare Industry, Part of Emerging Trends & Technology PhUSE Workgroup

    Ibrahim_AdamaAdama Ibrahim, Associate Director, Clinical Operations, Biogen


    Barot_AjiAji 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.

    IOMED 11:50 Automatized Patient-Recruitment System Based on RWD and Natural Language Processing

    de_Oca_JavierJavier 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

    BREAKOUT DISCUSSION GROUPS

    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


    PLENARY KEYNOTE PRESENTATIONS ON TUESDAY AND WEDNESDAY
    & CLINICAL RESEARCH NEWS EUROPEAN INNOVATIONS AWARDS

    Clinical Research News European Innovations Awards

    Clinical Research News' European Innovation Awards recognizes outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations—that manifestly improve the clinical trial process. Submit your work: http://www.clinicalinformaticsnews.com/BestPracticeAwards/

    INTERACTIVE BREAKOUT DISCUSSION GROUPS

    Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

    This year due to positive feedback we will be running two breakout discussion sessions, one on Tuesday afternoon and a second on Wednesday afternoon. Attendees will thus have a chance to join two topic discussions.

    Please see details at: https://www.scopesummiteurope.com/breakout-discussions



    For questions or suggestions about the meeting, please contact:

    Marina Filshtinsky, MD
    Executive Director, Conferences
    Cambridge Healthtech Institute (CHI)
    Phone: (+1) 781.972.5496
    Email: mfilshtinsky@healthtech.com

     

    For partnering and sponsorship information, please contact:

    Companies A-K:
    Ilana Quigley
    Sr. Manager, Business Development
    Cambridge Healthtech Institute (CHI)
    Phone: (+1) 781.972.5457
    Email: iquigley@healthtech.com

    Companies L-Z:
    Patty Rose
    Sr. Manager, Business Development
    Cambridge Healthtech Institute (CHI)
    Phone: (+1) 781.972.1349
    Email: prose@healthtech.com

    For media and association partnerships, please contact:
    Rich Handy
    Senior Director, Marketing
    Cambridge Healthtech Institute (CHI)
    Phone: (+1) 781.972.5456
    Email: rhandy@healthtech.com

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