Wednesday, 20 April
06:30 Breakfast at the Hotel Restaurant, Arrel
Complimentary for SCOPE Europe Intercontinental Hotel Guests Only
07:30 Registration and Morning Coffee (Foyer)
08:50 Welcome by Conference Organizer
Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)
09:00 Incorporating Site and Patient Input into Clinical Development Planning
Barbara Valastro, PhD, Senior Director Patient Insights and Solutions, AstraZeneca
At AstraZeneca, our values guide everything we do and we are committed to improving the whole patient experience by embedding patient-centric thinking in the medicines, products and services we develop. For clinical trials, this means that we engage and listen to our patients and sites throughout the clinical development planning, and during this presentation, you will hear more about how we are implementing this approach by setting up processes and by engaging early with key stakeholders.
09:30 A Machine Learning Approach Using Real-World Data For Clinical Trial Site Selection
Hans Verstraete, PhD, Director, R&D Data Science, Janssen Pharmaceutical Companies of Johnson & Johnson
Janssen has created a model using a number of different data sources to enhance site selection for clinical trials in the United States. The model uses a machine learning approach, and includes such attributes as past site recruitment performance, number of eligible patients at site, patient referral performance by site and volume of clinical trials. This presentation will walk through the modelling approach, outcomes and lessons learned. Attendees will learn how we use Real-World data and public data sources to inform site selection and understand how to combine the various data sources and use ML to support decision making for sites.
What does “a better clinical trial experience” mean to patients, sites, clinicians and developers? This talk will share how Labcorp’s Patient Recruitment Ecosystem brings together data, AI and analytics, patient and site informed design, site enablement, direct-to-patient recruitment, and diversity & inclusion initiatives. We will explore examples of how Labcorp is integrating data driven AI to perform community screening for challenging disease areas – NASH.
10:30 What Do Sites in Europe Need to Do to be Business Ready to Run Decentralized Trials?
Elke Van Mol, R&D Global Functional Lead Clinical Trial Managers, Clinical Operations, Janssen Pharmaceutica NV
Decentralised clinical trials are nothing more than a revolution to the clinical trial eco-system. Hence, all stakeholders have to understand, what this revolution will mean to them. What is needed at a site, to become business-ready for those new trials? How can patients be properly educated what new trial formats will mean to them. Although the opportunities are obvious, the journey to maturity is probably longer than one might think.
11:00 Coffee Break in the Exhibit Hall (Verdi)
11:45 KEYNOTE PRESENTATION: Chairperson's Remarks
Cristina De Juan, PhD, Innovation Lead, Global Clinical Sciences and Operations (GCSO), UCB
Sam Hariry, Global Head, Clinical Innovation, Novartis Institutes for Biomedical Research
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: 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.
12:30 KEYNOTE PANEL DISCUSSION: What Can Clinical Innovation Teams Learn from Digital Health Startups?
Panel Moderator:
Francesca Wuttke, PhD, CEO and Founder, nen
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 Join Your Peers for a Networking Luncheon in the Exhibit Hall (Verdi)
14:55 Leveraging Feasibility Data to Predict Site Outcomes
Jonathan Crowther, PhD, Site Intelligence Lead, Study Optimization, Global Product Development, Pfizer Inc.
Erbin Lim, Site Intelligence Director, Pfizer Inc.
The application of machine learning in site and investigator identification has generated overwhelming traction. Innovative sponsors are tempted by ML/AI approaches with the aim of extensive savings in time and cost in conducting site feasibility. As part of our evolution in designing a robust site and investigator identification ML/AI pipeline, we share external data by encapsulating internal data-deriving patterns in the identification of the “right site, first time” philosophy.
PPD has developed a unique data asset of patient participation decisions to allow early clinical trial design decisions to be informed by quantitative estimates of participate rates. This presentation will report on the data asset and demonstrate its application to study design, including its use to simulate how participation rates vary with alternative study designs, such as decentralization strategies, type of data collection, and tactics to improve the representativeness of study samples.
There is a hard truth that clinical trial professionals face in each study; that there is often a gap between the trial plan and necessary diversions from the plan. We’ll discuss the many considerations that go into trial planning and ways to adapt quickly to realign to the plan when deviations occur. In this presentation, you’ll learn what to consider when planning clinical trial supplies, site feasibility, and trial conduct, as well as what tools and data you need to react quickly to align planning with actuals, and how flexibility in your IRT plays a pivotal role in closing the gap.
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 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 Discussions Page for a complete listing of topics and descriptions.
IN-PERSON INTERACTIVE DISCUSSION: Personalizing the Clinical Trial Experience: Connecting with the Person behind the Patient, through Empathy and the Understanding of Diverse Patient Preferences and Experiences
Alex Charge, Clinical Solutions Practice Lead, International Real Chemistry
Jason Gubb, Clinical Operations Consultant and Co-Founder of Emergent Teams
Sebastian Stratmann, Associate Director, Clinical Trial Patient & Site Engagement Lead, R&D, Merck Healthcare KGaA Germany
Patient experience and behavioural profiling is more critical than ever to truly understand who the patients are, rather than treating them as one monolithic group. Listening to patients from all walks of life needs to be built into our collective experience, then translated into hard evidence. If we approached our trials like a product, we'd focus on patients (the end users) requirements, their wants and needs, and then design our trials and enrollment strategies from this perspective. This would be truly customer or consumer focused. Topics to be discussed:
- Why does our industry need to listen deeper to patients, with empathy, to understand their behaviours and preferences, and how can this create more representative trials ultimately leading to accelerated performance?
- As clinical trials are in the business of people, how can we rethink the use of data, technology, social science, and novel approaches to design truly patient-centered trials?
- How can linguistics, behavioural science, and technology be applied to drive trial literacy, education, patient empowerment, and deliver health equity?
- Where and why do solutions and technologies still fall short in making an impact for patients?
17:05 Welcome Reception in the Exhibit Hall with Beer, Wine and Tapas (Verdi)
18:00 Close of Day
Thursday, 21 April
06:30 Breakfast at the Hotel Restaurant, Arrel
Complimentary for SCOPE Europe Intercontinental Hotel Guests Only
08:30 Registration and Morning Coffee (Foyer)
09:05 The Pathway to Innovation in Clinical Trials
Cristina De Juan, PhD, Innovation Lead, Global Clinical Sciences and Operations (GCSO), UCB
As innovative solutions are on the increase, where are we and what we can do to bring innovation to clinical trials to serve our patients better?
COVID-19 accelerated decentralized trial adoption, however, a decentralized model is only the beginning. We must continue the momentum toward patient- and site-centric trials with a digital trial model that is paperless and connected. Join Veeva as we explore the industrywide move toward end-to-end digital trials for seamless process execution and data flow across patients, sites, and sponsors to create a connected trial ecosystem.
The need for diversity and inclusion in clinical trials. How thinking about diversity differently can improve patient outcomes. Methods of identifying and engaging these groups and the HCPs treating them. There are many important factors to consider in the changing healthcare landscape and we have a robust platform to help accelerate your goals in 2022.
10:35 PANEL DISCUSSION: Reimagining Clinical Trials: The Digital Transformation in Catalonia
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
Alessandro Monterosso, Director, Digital Health Solutions, Alira Health
Oriol Penon, PhD, Business Account Director, ASPHALION
11:05 Coffee Break in the Exhibit Hall (Verdi)
11:50 KEYNOTE PRESENTATION: Chairperson's Remarks
Elke Van Mol, R&D Global Functional Lead Clinical Trial Managers, Clinical Operations, Janssen Pharmaceutica NV
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:
Elke Van Mol, R&D Global Functional Lead Clinical Trial Managers, Clinical Operations, Janssen Pharmaceutica NV
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
Kavita Rattan, PhD, Lead, AI-Data Sciences & RBM, Data Monitoring & Management, Pfizer Inc.
Sidharth (Sid) Jain, Head, Global Dev Data Science Strategy & Portfolio, Janssen Pharmaceuticals Inc
12:55 Join Your Peers for a Networking Luncheon in the Exhibit Hall (Verdi)
14:30 Protocol Optimization at CDP Stage to Streamline Process
Silke Strommenger, Head Feasibility, CDO, Bayer Pharma AG
Sven Oechsner, Senior Strategist, Feasibility, Bayer Pharma AG
This presentation will share a protocol optimization strategy, which we currently implement at Bayer. The process involves an early deep-dive at the CDP stage and streamlines available process elements, e.g. investigator and data insights, to optimize the clinical and operational strategy of the clinical development plans including DCT, patient engagement, recruitment and retention strategy.
The initial phase of a clinical trial relies on a constant flow of communication and documentations. Yet, the tools used today haven’t changed in decades. From a flurry of emails with different instructions to documents passing back and forth either as PDFs or paper, it’s a challenge to keep things straight. We’ll look at a simplified, centralized approach to managing content and communication that means everyone stays on the same page.
15:15 Delivering Patient-Centered Projects in an Academic Institution: From Basic Research to Clinical Research and Innovation
Begonya Nafria Escalera, Patient Engagement & Research Coordinator, eYPAGnet, Sant Joan de Deu Barcelona Hospital
Our institution is working on a holistic and system-wide plan to organize, support and assess the patients’ involvement activities in the whole spectrum of activities that we deliver in the field of research. This will help researchers and management staff to better deliver patient centered projects. This presentation will share our model that will also facilitate patients’ involvement services in the field of paediatrics for pharma companies and other organizations.
Brexit, COVID-19, Ukraine, supply chain, site closures, failing audits needing study rescue… just some examples of the type of challenges we are all facing. What lies beyond the horizon? These obstacles are becoming more frequent, more demanding, more urgent. How should we tackle them?
16:00 PANEL DISCUSSION: The Role of Patients, Data, and Patient-Facing Technologies in Clinical Trial Design: Lessons from COVID-19 Pandemic
Panel Moderator:
Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine
Patient centricity has been discussed in industry circles for quite some time now, with sponsors connecting it to either reduced protocol assessments or increased use of technology in trials. The industry still has a lot to learn about patient-centric trials, but having patients’ input will help to gain their perspective and better understand their concerns during and after COVID-19. This session will provide a large inventory of countermeasures to offset challenges brought on by COVID-19 pandemic, including: clinical trial design from a site perspective, patient-centric digital solutions, creating an inclusive/equitable environment, collaborating within regulatory affairs.
Mats Sundgren, PhD, Director, Health Data Science, AstraZeneca R&D
Robert Kroes, International Associate Director TA Analytics , Marketing Analytics, Lilly Nederland BV
Florin Sirzen, MD, PhD, Senior Director, Medical Affairs, F. Hoffmann-La Roche
16:30 Closing Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)
16:35 Close of Conference