October 2022 • Archived Content

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Cambridge Healthtech Institute’s 5th Annual

Clinical Data Strategy, Digital Endpoints and RWD

Digital Technology, AI, Real-World Data and Advanced Analytics for Next-Gen Trials

3 - 4 October 2022 ALL TIMES CEST

Digital technologies have the power to fundamentally transform clinical development, significantly increasing effectiveness of developing new therapies as well as enabling patient centricity in clinical trials. Implementing digital solutions is harder than it looks for several reasons such as regulatory constraints, long timelines to execute trials, clinical site resistance and others. 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, 4 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 join us at this year's "Clinical Data Strategy, Digital Endpoints and RWD" conference at SCOPE Europe in Barcelona in October!

Monday, 3 October

Registration and Morning Coffee (Terraza Jardin)07:45

08:50Organizer's Welcome Remarks

08:55

Chairperson's Remarks

Kai Langel, Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence Global Regulatory Affairs, Janssen R&D

09:00

Digital Healthcare to Reshape Clinical Trials

Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech

Digital Healthcare is becoming ubiquitous in our daily lives and has the potential to completely transform clinical trials with novel digital health tools, methods and endpoints. Apart from impacting every part of the clinical trial process from setup to recruitment to conduct and closeout, emerging possibilities include synthetic trials, RWD comparator arms and virtual/simulated patients. Leveraging such digital technologies will be instrumental in accelerating clinical evidence generation on a global level.

09:25

New Thinking and Solutions to Advance Regulatory Acceptance of Digital Endpoints

Kai Langel, Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence Global Regulatory Affairs, Janssen R&D

Digital technologies hold tremendous scientific potential to help understand the impact of disease and interventions in real-world settings. Technologies exist to measure relevant health concepts, but their use in clinical trials to support regulatory decision-making is limited. These solutions present new challenges for regulators and there is a need for the community to think different. This session will introduce some of the latest thinking and solutions in this area.

09:50

Clinical Data Strategy: “Data-Driven” Approach

Hari Priya, Senior Clinical Data Science Lead, Data Monitoring, Management & Innovation, Merck Healthcare KGaA

The main objective of this talk is to provide a forward‐looking and pragmatic view on how Clinical Data Scientists are coping up with constant changing needs of clinical trial design. In recent times, Clinical Data Scientists not just manage data rather they can even proactively predict the trial outcomes. The data-driven approaches when combined with machine learning capabilities, it adds value, save resources, focus on patients for the analysis, enable faster regulatory approvals and thus provide early access to treatments.

10:15 PANEL DISCUSSION:

Scaling Innovation in Clinical Data and Technology

PANEL MODERATOR:

Hari Priya, Senior Clinical Data Science Lead, Data Monitoring, Management & Innovation, Merck Healthcare KGaA

PANELISTS:

Kai Langel, Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence Global Regulatory Affairs, Janssen R&D

Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech

Grand Opening Coffee Break in the Exhibit Hall (Verdi)10:40

11:35

Organizer's and Chairperson's Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

11:40

Developing and Executing a Digital Strategy for Engagement, Safety Monitoring, and Retention in Clinical Trials/Hybrid Trials

Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech

Clinical development, in particular, hybrid trials with digital health tools/wearables have a challenge of balancing the need for high-quality data collection and the patient burden associated with such devices/digital methods. A carefully crafted digital strategy needs to be developed to optimize clinical development needs with patient-centric strategies for engagement, ensuring the safety of patients, keeping patients motivated, and avoiding drop-offs prior to study closeout. Digital strategy could help accelerate trials, improve diversity in recruitment and lead to better outcomes for patients.

12:10 PANEL DISCUSSION:

Building Clinical Trial Infrastructure for the Future

PANEL MODERATOR:

Mohanad Fors, Head, Global Commercial Digital Innovation, Almirall LLC

The key digital tools have long been at our disposal, but it was a global pandemic that served as the impetus to fundamentally change our approach to and acceptance of them. However, we misinterpreted the future and pharma didn’t succeed in creating the right infrastructure for the future. Most clinical trials stopped because we didn’t have investment in virtual clinical trials. An overcoming of cultural obstacles is required for digital mindsets to be adopted within the industry. So, how do we in small biotech, big pharma, CROs, and academic research participate in and build the clinical trial infrastructure for the future?

PANELISTS:

Shwen Gwee, Vice President & Head, Global Digital Strategy

Terttu Haring, MD, Global Head, Clinical Innovation Office, Sanofi

Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)

Paul Duffy, Head, Global Clinical Site Partnerships, MSD

Join Your Peers for a Networking Luncheon in the Exhibit Hall (Verdi)12:50

14:25

Chairperson's Remarks

Ankit Lodha, Director, Data Science Portfolio Management, Johnson & Johnson

14:30

Unlocking the Power of RWE through Tokenization to Accelerate R&D and Drive Patient Impact

Ankit Lodha, Director, Data Science Portfolio Management, Johnson & Johnson

Implementation of tokenization in clinical trials to enhance data collection and insight generation without increasing operational burden. Executed first-in-industry innovation project to link clinical trial data with real-world data (RWD) via tokenization to enable real-world effectiveness studies and long-term follow-up (LTFU) resulting in groundbreaking real-world evidence generation prior to licensure.

14:55

‘Faster and Better’: Automating Data between Electronic Health Records and Electronic Data Capture Systems at Hospitals

Dan Hydes, CEO & Co-Founder, IgniteData

Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)

Nearly 50% of clinical trial data is duplicated between Electronic Health Records (EHRs) and Electronic Data Capture systems (EDCs), wasting time and valuable resources. The emergence of eSource-ready hospitals and new providers with applications addressing this historic interoperability challenge heralds a pivotal change in clinical trials. IgniteData’s cloud-based Archer technology transports regulatory grade, clinically validated patient data from EHRs to sponsors’ EDCs using HL7® FHIR and SMART on FHIR. Archer has the potential to fundamentally improve the delivery of clinical trials in hospital settings, that ultimately could lead to industry wide transformational change.

Presentation to be Announced15:20

15:45Find Your Table and Meet Your Moderator

15:50Interactive Breakout Discussions

Interactive Breakout Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by facilitators who keep the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Breakout Discussions Page for a complete listing of topics and descriptions.

BREAKOUT DISCUSSION:

TABLE 2: Data Management Strategies to Ensure Quality and Improve Analytics

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

Risk Based Clinical Data Management approaches
RWD to accelerate design and execution of clinical trials
Innovative technologies and processes to ensure quality data
Elevating data insights to action

Welcome Reception and Booth Crawl in the Exhibit Hall with Beer, Wine, and Tapas (Sponsorship Opportunities Available)16:25

Close of Day17:30

Tuesday, 4 October

Morning Coffee (Terraza Jardin)08:30

09:25

Chairperson's Remarks

Dan Hydes, CEO & Co-Founder, IgniteData

09:30

Enriched Data Insights Enhances Decision-Making in the Design and Delivery of Clinical Trials

Ubong Peters, PhD, Operations Insights Analyst, Product Development Global Clinical Operations, Genentech

To successfully deliver on clinical trial commitments, clin-ops executives must proficiently navigate many operational issues including a highly competitive clinical trial landscape, challenges in identifying and recruiting eligible patients, underrepresentation of racial/ethnic minorities, and onerous regulatory requirements. This presentation describes how data analytics and insights can be used to effectively characterize these issues so clin-ops executives can make better and faster trade-off decisions that enhance clinical trial planning and execution.

09:55

Operationalizing Precision Medicine through Industrializing Human BioAsset and Digital Asset Management

Brenda Yanak, Founder, Clinical Transformation Partners

This presentation will discuss the use of Design Thinking to accelerate the digitization of specimen and consent management, and how this approach enables the transformation of clinical trial operations via digitization and automation.

Coffee Break in the Exhibit Hall (Verdi)10:20

11:05

Chairperson's Remarks

Brenda Yanak, Founder, Clinical Transformation Partners

11:10

Innovation Adoption Cycle for Technologies That Support Decentralized Clinical Trials

Maria Florez, Research Consultant, Tufts Center for the Study of Drug Development

This presentation will provide insights from original global research looking at the length and stages of the innovation adoption cycle for innovations supporting virtual and decentralized clinical trials – for example, eCOAs, ePROs, eCONSENT, RBM, RWE, etc. The audience will gain an understanding of the length of the innovation adoption cycle, factors that shape innovation adoption of technologies and capabilities supporting clinical trial execution, challenges associated with the completion of each of the stages of the innovation adoption cycle for technologies, and capabilities supporting clinical trial execution – initiation, evaluation, adoption decision, and full implementation – and what to do to reduce the barriers to full adoption.

11:40 PANEL DISCUSSION:

Considerations for Next-Gen Informed Consent

PANEL MODERATOR:

Brenda Yanak, Founder, Clinical Transformation Partners

Come join a panel of industry leaders as we discuss ethical considerations and practical impacts of advances in science and technology on informed consent - ex, AI, gene editing, big data. What do scientists and technologists want to do? How can we work together to explain such complex topics to trial participants, as well as risks and benefits? What are the process and technology considerations?

PANELISTS:

Catherine Mela, PhD, Head Biosamples, AstraZeneca

Sofiane Nacia, Associate Director, Strategic Trial Participant Liaison, Novartis

Katrina Bramstedt, PhD, Global Head of Bioethics, Roche

Join Your Peers for a Networking Luncheon in the Exhibit Hall (Verdi)12:20

13:55

Chairperson's Remarks

Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

14:00

INTERACTIVE DEMO: Data Analysis as Part of RBQM

Łukasz Bojarski, Head of Centralized Monitoring, AstraZeneca Pharmaceuticals, Inc.

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

Join this interactive data analysis demo to gain hands-on experience analyzing clinical data to identify sites at risk, systemic issues, translate signals into action, and educational efforts.

Session Break14:50

14:55 PANEL DISCUSSION:

Intersection of Clinical Trials and Healthcare: Current Trends and Innovation in Changing Regulatory Landscape

PANEL MODERATOR:

Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine

This presentation will explore challenges clinical teams and sponsors face in developing and implementing protocols to ensure the right patients are enrolled and accurate data collected to demonstrate a drug/device/biologic is safe and efficacious, while at the same time managing study costs/complexity, especially in trials that involve multiple healthcare services, digital technology, and special populations. Key factors to consider, when developing protocols and techniques to minimize complexity will be discussed.

PANELISTS:

Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech

Rosanne Janssens, PhD, Postdoctoral Researcher, Pharmaceutical Sciences, KU Leuven