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 Accounting for the Patient Experience in Decentralized Trials
Sebastian Stratmann, Associate Director, Clinical Trial Patient & Site Engagement Lead, R&D, Merck Healthcare KGaA Germany
The COVID-19 crisis has forced many organizations to move to virtual patient engagement interactions. This proved to be a challenge in the short-run while providing additional operational flexibility for the future. TransCelerate recently released updates to their existing patient-centered toolkits to address the unique burdens virtual interactions can create for patients and caregivers. Learn how the TransCelerate Patient Experience and Patient Technology Initiatives have modernized their toolkits to account for this opportunity.
09:30 Operationalizing a Digital Recruitment Strategy
April Monge, Global Head, Digital Recruiting Capability Center, Novartis Pharma AG
To optimize your digital patient recruitment strategy for today’s hybrid or decentralized trials you must have your digital recruitment strategy in place but you also must be able to implement it effectively. This involves patient-centric messaging and channel mix, understanding barriers to enrollment, and identifying proper digital solutions to support patient retention throughout a trial.
DCTs involve an ecosystem of tools, people, and processes – allowing patients, sites, and sponsors to participate, contribute, and monitor any clinical trial. Successfully executing DCTs often requires multiple disparate solutions integrated across the clinical continuum in order to talk to each other. But what if patients, sites, and sponsors could participate and monitor clinical trials without the integration hassles? Join our experts to discuss how to deliver DCTs so everyone wins.
10:30 Trials@Home: Working with Patients to Assess and Evaluate the Concept of DCTs In a Pan-European Setting
Tanja Keiper, PhD, Director, Patient Centricity Recruitment & Retention, Merck KGaA
Bart Lagerwaard, PhD, Assistant Professor, University Medical Centre Utrecht
Maartje Roskams, Youth & Project Coordinator, Patient Expert Panel Coordination, Person Living with Diabetes, IDF Europe (International Diabetes Federation European Region)
IMI Trials@Home project (www.trialsathome.com) aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations, and tools for the definition and operationalization of decentralized clinical trials in Europe. In its pilot study, RADIAL, we work with patients to assess and evaluate preferences and satisfaction around the concept of DCTs. In our presentation we will introduce you to the RADIAL trial and show you how we will approach questions on patient satisfaction on conventional compared to hybrid and DCT trial models, including specific patient-facing technologies.
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)
14:50 Chairperson’s Remarks: Are Trials Less Complex, More Accessible and Inclusive after the Pandemic, or Are we Slipping Back to Pre-Pandemic Ways Already?
Jason Gubb, Clinical Operations Consultant and Co-Founder of Emergent Teams
14:55 Assessment of Patient Burden and Impact on Recruitment Strategy
Matthew Bonam, Head BioPharmaceuticals R&D, Digital Patient Health & Innovation, AstraZeneca R&D
Nick Carroll, PhD, Transformation Lead, Digital Health, R&D, AstraZeneca
Patient insight work conducted by AZ has determined that trial burden is a key factor in a patient deciding to join a trial, but it is difficult for scientists designing studies to model the impact of design choices on burden. We will present an approach developed through patient insight collection and data-driven analysis which allows us to quantify burden and identify procedures which have the greatest impact on patient experience, which allows trial designers to assess the impact of design choices on trial execution.
Rare disease drug development is the fastest growing sector of therapeutics development and accounts for one-third of the drugs in development. However, these studies are amongst the most complex to plan and execute, given the scarcity of relevant data, inexperience of investigators, and limited participant populations. In this panel session, we will gather sponsor and CRO perspectives on effectively planning, tracking, and monitoring rare disease studies.
The COVID-19 pandemic transformed nearly every aspect of everyday life. To combat the largest pandemic in recent history, the World Health Organization (WHO) needed to mount a massive clinical trial, while addressing varying challenges and complexity of bringing together thousands of investigators and sites in over 30 countries. In this presentation learn how to leverage emerging technology and incorporate these same practices in your clinical development and DCT strategy.
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 Patient Involvement: We Don’t Yet Have a Golden Standard
Joana Claverol, Clinical Research Unit Manager, Sant Joan de Deu Barcelona Children's Hospital
Anna Bergos, Medical Advisor, Clinical Studies Unit, Sanofi Espana
This case study shares how we used a focus group with parents and a simulation of the screening visit with the consent process. We will present the pros and cons of both methodologies, when one is better than the other, and the benefits of a combination of methods and activities.
09:35 Utilizing Patient Insights and Data to Speed the Transition to Decentralized Trials
Marta Garcia, PharmD, R&D, Chief Patient Officer, Servier
Decentralized Clinical trials is shifting the classical paradigm of site-centric to direct-to patient trials. This model is increasingly being incorporated along the whole development process in all areas and the recent COVID-19 Pandemia has undoubtedly speeded up this transformation. Decentralized trials are supposed to bring numerous advantages to patients: flexibility, reduction of study burden, etc, but they may not be adapted to everyone. Co-designing this new scenario of clinical research with patients will ensure that we move towards a truly patient-centric model, flexible and adaptable to the diversity of the patient population.
This presentation will discuss how to leverage behavioral science to better engage and understand patient preference. It will go deeper into the voice of the patient and how it must be more than a mere “tick-box” exercise. Topics include: Voice of the patient: more than a mere “tick-box” exercise? Voice of patient and why it’s important – creating “A better clinical trial experience”; Experience from a troubled patient group; What behavioral science can teach us in our approach; and Shifting the paradigm to encompassing treatment ecosystems.
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 Illuminating Diverse Enrollment in HIV Clinical Trials
Jennifer Niesz, Program Director, Global Trial Optimization, Merck & Co.
This case study showcases a methodology for effectively enrolling and retaining diverse participants in clinical trials. Specifically, it will describe strategies and tactics implemented throughout 2 years, via the collaboration of many stakeholders, to achieve our goals in enrolling and retaining women, as well as diverse races and ethnicities, into our “Illuminate” once daily HIV treatment studies in adults. Our methods implemented within this program may serve as a model for other companies with similar goals.
15:15 Collaborating with the Community for Faster Commercial Clinical Research
Gail Melvin, Research Business Manager, NIHR Patient Recruitment Centre: Leicester, University Hospitals of Leicester NHS Trust
The UK Government has recently set out its vision for the future of clinical research delivery in the UK. The aim is to create more diverse and accessible research, embedded within an increasingly efficient research delivery system. The NIHR Patient Recruitment Centres (PRCs) specialise in recruiting non-hospitalised patients by harnessing the recruitment potential of healthcare communities, extending their reach beyond secondary care to access a wider cohort of patients. Our PRCs were purpose-designed to deliver these ambitions and are relevant, live examples of implementation. This presentation will use a collaborative case study to explore how our PRCs are already helping to achieve the UK’s vision.
Improving access, choice and equity is key to achieving fairer, more effective clinical trials. Lightship will address flexible new approaches for driving access in clinical trials, including the important role that ‘the third place’ has to play. By prioritising patient choice in our industry, we are meeting people where they are, breaking down the barriers preventing the inclusion of underrepresented groups, to deliver better clinical studies.
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