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.

Final Agenda

Tuesday, 17 September

8:00 - 17:00 Registration Open

8:00 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

Munther Baara, MS, Head, New Clinical Paradigm, Pfizer

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.

11:45 Create a Single Data Collection Hub to Promote Interoperability and Seamless Integration of Direct-to-Patient Activity

Baara_MuntherMunther Baara, MS, Head, New Clinical Paradigm, Pfizer

Innovative digital technologies are starting to disrupt the highly regulated and conservative biopharmaceutical industry. Learn how a single data hub can be utilized to harmonize recruitment, eConsent, patient outcomes and other relevant systems that must be simplified for direct-to-patient trials. Capitalize on opportunities to remotely administer wearables and other trial activity.

Lee_JeffJeff Lee, President, eCOA and Patient Engagement, Signant Health

Remote studies will never fully live up to their promise as a “next generation” study model unless we can verify the patient identity remotely. A study, particularly an interventional study, simply must know the true identity of each of the study patients. This has been an unsolved challenge to date, however new options are emerging that allow for better management of this topic. This session will explore different options for identity verification in clinical trials.

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 Experience in Sensors and Digital Endpoints: Dispelling the Myths

Munro_JanetJanet Munro, General Manager Digital Endpoints, Data and Digital – GDD, Novartis

Digital technologies provide an opportunity to modernize the current site-centric clinical trial model by enriching the quality of data collected and enabling real-time decision making, thereby increasing probability of success.


14:25 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.

14:50 INTERACTIVE PANEL DISCUSSION: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Regulatory Considerations

  • Where we are with NDE currently compared to three years ago? Are we making progress?
  • What are the barriers?
  • How should industry advance NDE development, standardization, validation, approval?
  • Audience's thoughts

Moderator: Munther Baara, MS, Head, New Clinical Paradigm, Pfizer

ZS_Associates 15:15 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.

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

8:35 From Real World Data Hype to AI Hype

Bartels_DorotheeProfessor Dr. Dorothee Bartels, Professor, Chief Digital Science Officer, BI X GmbH, Boehringer Ingelheim

The real-world data (RWD) hype caused high expectations, including how RCTs might only play a minor role in future drug development. RWD help to define target populations, and are key for drug utilization, safety and effectiveness studies. They are complementary to RCTs but cannot replace them. The same is true for artificial intelligence: AI is a tool applicable in different stages of drug development, supporting RCTs as well as RWD studies to generate evidence.

9:00 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.

9:25 Enabling Intelligent Operations: Embracing Emerging Technology in Drug Development

Duff_JenniferJennifer 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

Noyens_NicoleNicole Noyens, Director, Janssen Clinical Innovation, Janssen at J&J

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.

IOMED11:50 Presentation to be Announced

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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