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

Enrollment Planning, Participant Engagement and Recruitment

Patient Insights, Patient-Facing Tech, and Analytics to Predict and Improve Patient Recruitment

20 - 21 April 2022 CET

Clinical researchers, clinical innovation leaders and study teams are working hard to better identify, understand and engage a diverse patient population. At the same time, the biopharma industry is embracing the new reality of hybrid, decentralized, remote trials and direct-to-patient models being both friendlier to the customer, our trial participants, and often more efficient. However, there are key challenges to developing both a patient-centric culture and systems in this new set of modalities, both of which key to enrolling and retaining patients throughout the life of a clinical trial. There are strategies, new technologies and techniques to empower patients, improve outreach and better match trials to the patients who need them. 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 “Enrollment Planning, Participant Engagement and Recruitment” conference at SCOPE Europe, a hybrid conference in 2021 serving both in-person and virtual attendees.

Tuesday, 5 October

07:30 Registration and Morning Coffee

UTILIZING PATIENT EXPERIENCE AND TECH TO IMPROVE VIRTUAL ENGAGEMENT

08:50 Welcome by Conference Organizer

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)

08:55

Chairperson's Remarks

Matthew Bonam, Head BioPharmaceuticals R&D, Digital Patient Health & Innovation, AstraZeneca R&D
09:00

Accounting for the Patient Experience in Decentralized Trials

Sebastian Stratmann, Clinical Trial Recruitment & Retention Lead, R&D, Merck KGaA

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.

Speaker to be Announced
10:30

The Diabetes Carousel: The Innovative Cloud-Based Home for IMI’s Trials@Home Decentralized Clinical Trial

Tanja Keiper, PhD, Director, Patient Centricity Recruitment & Retention, Merck KGaA

The Diabetes Carousel is an innovative online platform designed to connect with patients and the interested public by sharing relevant information about clinical trials in a patient friendly format, and by enabling patients to connect with each other in a safe and private peer-to-peer network. The Carousel provides information about ongoing clinical trials, it invites patients to learn more about IMI’s T@Home DCT PILOT, and it attracts interested patients to check their eligibility for PILOT on PILOT’s online pre-screener.

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

IMPACT OF PATIENT BURDEN ON ENROLLMENT STRATEGY AND RECRUITMENT OPERATIONS

14:50

Chairperson's Remarks

Jason Gubb, Head Delivery Optimization & Informatics, Global Clinical Operations, GlaxoSmithKline
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.

15:25

New Patient Insights around Hospital Appointments and Infrastructure during COVID Pandemic (and What We Did to Address These Challenges)

Oleksandr Gorbenko, MD, PhD, Global Patient Centricity Director, IPSEN Pharma

Due to the pandemic industry had to adapt quickly to ensure both existing research and new emergency vaccine research were able to move forward with all of the limitations that come with a global pandemic. This is a tall order. Technology, process and infrastructure all had to be re-evaluated and deployed across all programs. This presentation will share what we did to address operational challenges faced by sites and patients.

Derk Arts, MD PhD, Founder & CEO, Castor

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 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. 

Leveraging Behavioural Science in Understanding and Engaging Patient Preference to Ensure Greater Trial Diversity and Participation Convenience

Jason Gubb, Head Delivery Optimization & Informatics, Global Clinical Operations, GlaxoSmithKline
  • Why does our industry need to better utilize behavioural science to better understand and engage patients?
  • How can behavioral economics deliver the right set of tools to drive trial literacy & education, raise empowerment in care decisions, and deliver a sense of health equity?
  • Where do solutions and tools (telehealth, digital health tools, patient portals) fall short of driving behavior change and why?​​
17:05 SCOPE Europe Connects Exhibit Hall Viewing
18:00 Close of Day

Wednesday, 6 October

08:30 Registration and Morning Coffee

BUILDING A PATIENT-FRIENDLY AND TRANSPARENT EXPERIENCE TO ENSURE A DIVERSE AND EMPOWERED PATIENT POPULATION

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
Bibiana Figueres i Ribés, MD, Clinical Study Unit – Iberic Cluster Head (Spain and Portugal), Clinical Sciences and Operations, Sanofi

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

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.

10:05 Sponsored Presentation (Opportunity Available)

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

HYBRID TRIALS, DIVERSITY & INCLUSION, TRANSPARENCY AND PATIENT PARTNERS TO ACHIEVE TRULY PATIENT-CENTRIC DESIGN

14:30

Utilizing Patient Insights and Data to Speed the Transition to Decentralized Trials

Marta Garcia, PharmD, MPH, Director, Patient Involvement in R&D, Clinical Development, 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.

Samantha Eells, Co-Founder, Chief Design Officer, Lightship, Inc.

The virtual-first clinical trial model, with a care team that comes to the patient, is making it safer, more comfortable, and more convenient for patients to participate in and benefit from clinical research. Lightship will address how operational excellence with both patients and investigators makes the best use of virtual tools and an in-house care team have enabled them to build and provide greater access to clinical trials for all patients.   

15:15 PANEL DISCUSSION:

Building Blocks for Patient-Centric Design: How Hybrid Trials, D&I and Trial Transparency Make for the Best Trial-Design

Panel Moderator:
Sebastian Stratmann, Clinical Trial Recruitment & Retention Lead, R&D, Merck KGaA

What are the key building blocks for patient-centric design? How do you operationalize these key strategies and components into your processes and culture? Come engage with panelists discussing how hybrid trials, patient engagement, diversity and inclusion (D&I), and trial transparency make for the best trial-design.

Panelists:
Marta Garcia, PharmD, MPH, Director, Patient Involvement in R&D, Clinical Development, Servier
Oleksandr Gorbenko, MD, PhD, Global Patient Centricity Director, IPSEN Pharma
15:45 Sponsored Presentation (Opportunity Available)
16:00 PANEL DISCUSSION:

The Role of Patients 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.

Panelist:
Alexandre Kharazov, MD, PhD, Associate Professor & Senior Researcher, A V Vishnevsky Institute of Surgery
16:30 Closing Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)

16:35 Close of Conference