Original Agenda
We are actively working with our speakers to confirm their availability for our new dates. Initial response from our speakers has been very positive, and we are optimistic we will have the new programs ready to share here soon.


Cambridge Healthtech Institute’s 4th Annual

Clinical Data Strategy, Digital Endpoints and RWD

Data and Technology for Digital and Decentralized Trials

20 - 21 April 2022 CET

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, a hybrid conference in 2021serving both in-person and virtual attendees

Tuesday, 5 October

07:30 Registration and Morning Coffee

CLINICAL DATA STRATEGY IN NOVEL TRIALS

08:50 Welcome by Conference Organizer

Marina Filshtinsky, MD, Executive Director, Cambridge Healthtech Institute (CHI)

08:55

Chairperson's Remarks 

Giacomo Ricca, Lead, Data Processing Solutions, Janssen R&D
09:00

Clinical Data Strategy in Novel Trials 

Dermot Kenny, Global Head, Clinical Technology & Innovation, Novartis Ireland Ltd.

With the changing landscape of drug development which includes novel therapies and modalities, remote/decentralized trials, growing use of wearable technologies, e-source, and use of AI and ML algorithms, integrated data analytics plays more critical role than ever. This presentation explores a novel approaches to data management and analytics pertinent for the next generation clinical trial design.

09:30

Leveraging Clinical and Operational Data to Conduct Risk-Based Sponsor Oversight in Outsourced Clinical Trials.

Marcel Mackiewicz, Director and Head, Late Stage Program Data Management, Merck Group

In a traditional setup Operational Data and associated risks are evaluated by one part of the trial team (Clinical) whereas Clinical Data are reviewed by a different team (Data Management; Medical; Safety etc.). Combining the two strategies into one integrated approach will support an efficient execution of Sponsor Oversight on key criteria impacting trial endpoints.

10:00 Sponsored Presentation (Opportunity Available)
10:30

Novel Data Streams – The Next Challenge in Digital Health?

Giacomo Ricca, Lead, Data Processing Solutions, Janssen R&D

The usage of biosensors – as a subset of digital health capabilities - is becoming increasingly prevalent in Clinical Trials. These technologies allow for continuous data collection, offering a plethora of advantages over the traditional collection of discrete data points. That same continuous data collection also comes with several new questions and challenges: how do we ingest these large amounts of data and how do we best summarize, analyze, report, visualize and archive them?

11:00 Exhibit Hall Viewing

DIGITAL TRANSFORMATION AND EXPANDING ON INNOVATION LESSONS FROM COVID-19

11:45 KEYNOTE PRESENTATION:

Chairperson's Remarks

Nick Carroll, PhD, Transformation Lead, Digital Health, R&D, AstraZeneca
11:50 KEYNOTE PRESENTATION:

FIRESIDE CHAT: Combining Innovation and Collaboration to Advance Research across the Industry...We Can’t Do It Alone​

Sam Hariry, Global Head, Clinical Innovation, Novartis Institutes for Biomedical Research
Lewis Millen, Operations Innovation Lead, Global Clinical Sciences & Dev Solutions, UCB Pharma

The biopharma, medical device, digital medicine, healthcare and tech industries involved in clinical research are learning from one another, improving innovation, re-thinking business process, and expanding what used to be a much more siloed ecosystem. These are exciting times, but it is a very complex garden to navigate. How do we continue to innovate beyond pilots? How do we scale innovation and collaborate across departments, companies and industries to improve clinical trials and research?

12:20 KEYNOTE PRESENTATION:

What Could Digital Transformation of an Entire Biopharma Company Look Like?

Francesca Wuttke, PhD, Chief Digital Officer, Almirall SA

Biopharma companies are trying to change business processes, drug discovery, manufacturing, clinical trials…their entire cultures, to provide more digital solutions and services to their customers but it’s a long road. What are the main impediments to adoption? How can companies do different things (digitally enabled business models) rather than just do things differently (digitization)? Where can companies find the best chance of success and how do they start? How can large pharma, biotech, specialty pharma and traditional life sci organizations transition?

12:30 KEYNOTE PRESENTATION:

Digital Health in the Circular Economy, Novel Partnerships Required

Bert Hartog, PhD, Senior Director Clinical Innovation, Janssen Pharmaceutica NV

The talk will be about the environmental impact of digital health, and how circular economy principles can help minimize eWaste and maximize repurposing, reuse and recycling of digital health technologies.

12:40 KEYNOTE PANEL DISCUSSION:

What Can Clinical Innovation Teams Learn from Digital Health Startups?

Panel Moderator:
Francesca Wuttke, PhD, Chief Digital Officer, Almirall SA

Working with startups can provide the Pharma industry with the innovation capabilities required to accelerate the digital transformation of the company, while embedding a culture of experimentation where there is freedom to try and fail, through the exposure to and collaboration with young and risk-taking startups. Partnering with Startups offers Pharma access to solution-driven technology which allows them to accelerate their growth and drive strategy.

Panelists:
Andrea Coravos, CEO & Co-Founder, HumanFirst
Bert Hartog, PhD, Senior Director Clinical Innovation, Janssen Pharmaceutica NV
Nader Alaghband, Co-Founder & CEO, Ampersand Health
13:20 Enjoy Lunch on Your Own
14:20 Exhibit Hall Viewing

AI IN CLINICAL RESEARCH

14:50

Chairperson's Remarks 

Fabrizio Messina, Senior Statistician, Bayer Pharmaceuticals
14:55

Optimized Learning in Clinical Data Management: How DM Is Adopting AI

Ashley Howard, Associate Director, Asset Lead, Data Monitoring & Management, Oncology Global Biometrics & Data Management, Global Product Development (GPD) , Pfizer Ltd.

Clinical Research is evolving to be more technology driven. The Volume, Velocity and Variety of data are increasing rapidly. How can we leverage machines to not just perform repetitive data cleaning tasks but take on higher complexity activities in tandem with humans? In this session we will discuss how AI is transforming Clinical Data Management. We will review a practical DM use case which is adopting state-of-the art AI techniques.

15:25

Deriving Further Insight through the Application of Machine Learning to the Analysis of Clinical Trials

Fabrizio Messina, Senior Statistician, Bayer Pharmaceuticals

The talk will give an overview of artificial intelligence/machine learning methodologies that can be used for clinical data. The focus of the presentation will be on specific machine learning algorithms used to analyze clinical data, with particular interests in survival analysis. Different case studies involving random survival forest and clustering methodologies will be shown. An overview of the advantages will be presented.

15:55 Sponsored Presentation (Opportunity Available)
16:25 Interactive Discussions

Interactive 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 a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. For virtual attendees, the format will be in a Zoom room. 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 Discussions Page on the conference website for a complete listing of topics and descriptions. 

17:05 SCOPE Europe Connects Exhibit Hall Viewing
18:00 Close of Day

Wednesday, 6 October

08:30 Registration and Morning Coffee

RWD TO TRANSFORM CLINICAL TRIALS

09:00

Chairperson's Remarks 

Mats Sundgren, PhD, Director, Health Data Science, AstraZeneca R&D
09:05

Seeing Value in What’s “Real”: How Real-World Data Can Support Drug Development

Xia Wang, PhD, Director, Healthcare and Imaging Analytics, Data Science & AI, R&D, AstraZeneca Pharmaceuticals LP

The widely known challenges associated with the planning and execution of trials have been partly exacerbated by the global pandemic, placing additional demands on researchers to identify innovative ways to accelerate and reduce the cost of trials. In this presentation, I'll be reviewing some of the latest thinking behind the use of real-world data in response to this challenge, including the role of electronic healthcare data in “decentralised trials.”

09:35

Digital Epidemiology – Maximizing Real-World Evidence Generation

Dorothee B. Bartels, PhD, Global Head of RWE and Digital Sciences, UCB

As Real World Evidence (RWE) studies will not fully replace clinical trials, machine learning (ML) will not fully replace established (pharmaco)epidemiological methods. It is the complementary use which will advance the field of big data for public health. Important learnings from the development of transparent, reproducable RWE generation and synergistic applications can inform and foster AI/ML in the healthcare sector.

Speaker to be Announced

SPECIAL CATALAN ECOSYSTEM PANEL: DIGITAL TRANSFORMATION AND CLINICAL TRIALS

10:35 PANEL DISCUSSION:

Special Catalan Ecosystem Panel: Digital Transformation and Clinical trials: The Next Challenge in Health

Panel Moderator:
Montse Daban, Director, Scientific and International Relations, Biocat

The healthcare community agrees on the need to foster digital transformation throughout the entire healthcare value chain, including the framework for the clinical validation of innovative technologies, i.e., the evidence for real-world positive and significant health outcomes for patients and society. The final objective is to accelerate technology adoption, provide support for the validated ideas, and improve their market access. The session will share perspectives of actors connecting clinical research and industry in a comprehensive way and it will highlight the successful coordination in clinical trials key stakeholders in Catalonia.

Panelists:
Montserrat Barcelo Riera, MD, Vice President, Europe, Veristat
Xavier Cañas, Director, Promotion and Development of Clinical Research, Vall d’Hebron Hospital
Dani Prieto-Alhambra, MD, PhD, Professor, Pharmaco- and Device Epidemiology, University of Oxford
Lidia Cánovas, General Manager, Regulatory Affairs, Asphalion
11:05 Exhibit Hall Viewing

ROLE OF HEALTH DATA EXCHANGE & IMPLEMENTING HYBRID/DECENTRALIZED TRIALS

11:50 KEYNOTE PRESENTATION:

Chairperson's Remarks

Karl-Ludwig Radek, Assistant Director, Global Clinical Operations & Janssen Internal Project Lead for IMI Trials@Home
11:55 KEYNOTE PRESENTATION:

Harnessing the Power of Real-World Data for Clinical Research: European Initiatives

Dipak Kalra, PhD, President, European Institute for Health Records & President, European Institute for Innovation through Health Data

Real World Data has historically been regarded as siloed within healthcare provider systems (and therefore fragmented, difficult to access at scale), with patchy coverage and often of poor quality - so not very reliable for research. A further barrier is data protection legislation, in Europe with the GDPR. Large-scale research infrastructure initiatives are now being established across Europe to tackle these issues and to make RWD more available for observational data studies and the reuse of EHRs for clinical trials. This talk will present this exciting landscape, including the Commission proposals for a European Health Data Space, and explain how some of the perceived issues with RWD are being tackled, including winning public support for the use of RWD by industry.

12:15 KEYNOTE PRESENTATION:

Hybrid and Decentralized Trials: The Future Is Here

Panel Moderator:
Karl-Ludwig Radek, Assistant Director, Global Clinical Operations & Janssen Internal Project Lead for IMI Trials@Home

Covid-19 has played an extreme catalyst role in implementing existing digital and remote clinical trial solutions and has been the engine behind rapid evolution of a few new capabilities. Some of these newly deployed capabilities are quick fixes for the emergency that COVID brought to our day-to-day trial operations, while many will benefit from the catalyst effect and will probably be the new standard even after COVID. Today, we have the chance to continue driving adoption of decentralized clinical trials – and innovating to advance the benefits DCTs offer to patients, sites and sponsors.

Panelists:
Dipak Kalra, PhD, President, European Institute for Health Records & President, European Institute for Innovation through Health Data
Cristina De Juan, PhD, Innovation Lead, Global Clinical Sciences and Operations (GCSO), UCB
Xia Wang, PhD, Director, Healthcare and Imaging Analytics, Data Science & AI, R&D, AstraZeneca Pharmaceuticals LP
Marta Arias-Salgado Ruiz-Gimenez, Head of Quality & Continuous Improvement, Global Clinical Trials Organization, MSD
Kavita Rattan, PhD, Lead, AI-Data Sciences & RBM, Data Monitoring & Management, Pfizer Inc.
12:55 Enjoy Lunch on Your Own
13:55 Exhibit Hall Viewing

RWD TO TRANSFORM CLINICAL TRIALS (CONTINUED)

14:30

Transforming the Way We Do Clinical Trials: Pragmatic Trials Combined with EHR Enabled Services

Mats Sundgren, PhD, Director, Health Data Science, AstraZeneca R&D
Dipak Kalra, PhD, President, European Institute for Health Records & President, European Institute for Innovation through Health Data

Clinical research needs to make much better use of real-world data, for a diversity of use cases including better optimization and efficiencies in clinical trials design and conduct. Healthcare also needs to make much better use of its own (real world) data. Various health initiatives that are scaling up data reuse and they are facing challenges that need to be overcome for success. This co-presentation will feature some of the initiatives and projects that have pioneered unlocking the real world data opportunity over the past several years as well as a future outlook for real world data in clinical trials.

15:00 Sponsored Presentation (Opportunity Available)
15:15

How Can Blockchain Transform Health Data Exchange and Lead to Better Experiences and Outcomes? A Real-Life Digital Transformation Case Study 

Robert Kroes, International TA Analytics Consultant, Medical Affairs, Lilly Nederland BV

In the presentation I will demonstrate a real case example on how Lilly co-created a blockchain solution with a start-up company. I will walk through the steps taken and summarize the outcomes on getting real time data and share key learnings.

15:45 Sponsored Presentation (Opportunity Available)
16:00 PANEL DISCUSSION:

Panel Discussion: Unlocking Potential and Developing Processes for RWD Use in Clinical Trials

Panel Moderator:
Mats Sundgren, PhD, Director, Health Data Science, AstraZeneca R&D
Panelists:
Dorothee B. Bartels, PhD, Global Head of RWE and Digital Sciences, UCB
Xia Wang, PhD, Director, Healthcare and Imaging Analytics, Data Science & AI, R&D, AstraZeneca Pharmaceuticals LP
Dipak Kalra, PhD, President, European Institute for Health Records & President, European Institute for Innovation through Health Data
Robert Kroes, International TA Analytics Consultant, Medical Affairs, Lilly Nederland BV
16:30 Closing Remarks

Marina Filshtinsky, MD, Executive Director, Cambridge Healthtech Institute (CHI)

16:35 Close of Conference