Cambridge Healthtech Institute’s 5th Annual

Enrollment Planning, Participant Engagement and Recruitment

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

3 - 4 October 2022 ALL TIMES CEST

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 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

Andrés Escallón, Vice President, eClinical Innovation, Suvoda


E2E Trial Engagement through Use of Digital Health Capabilities and Home Health Services in Janssen's Phase 3 COVID-19 Vaccine Trials, ENSEMBLE 1 and 2

Ziyad Abushima, Head, Investigator & Patient Solutions, Pharma R&D, Janssen

Lieven Van Vijnckt, Head, Investigator & Patient Engagement, Infectious Disease and Vaccines (ID&V), Janssen Pharmaceuticals, Inc.

Janssen collaborated to engage several novel patient platforms for their Phase 3 COVID-19 vaccine trials, ENSEMBLE 1 and 2. New technology and services were leveraged end-to-end from participant referrals through enrollment, participant engagement, and remote data collection. We will share what we have learned so far with a focus on our EU experience.


Accelerating Recruitment and Significantly Reducing the Environmental Footprint of a Pregnancy and Post-Natal Clinical Trial through Decentralization

Motshewa Sesing, Head, Clinical Data Management, Nestle Research Center

A clinical trial aimed at evaluating the efficacy of a nutritional supplement in improving perinatal mood and stress was due to start in Singapore when the COVID-19 crisis hit. A fully decentralized operational model was then adopted to mitigate the impact of the strict lockdown measures. The fully decentralized model leveraged digital advertisement and recruitment modalities, electronic questionnaires, virtual visits, and the integration of a connected sensor for digital endpoint collection. Remarkably, there was a 33% acceleration in recruitment, and data capture achieved 100% completeness. Additionally, modeling the environmental impact of the decentralized operational model versus a site-centric model showed that decentralization decreased the impact on global warming by 61%. Furthermore, in all other environmental aspects, the decentralized model exhibited an impact that was between 23 to 80 times lower when compared to the site-centric one.

09:50 Making Patient Centricity for Sites & Sponsors: eConsent as a Case Study for Improving Trial Operational Efficiency

Andrés Escallón, Vice President, eClinical Innovation, Suvoda

Patient-centered technologies hold incredible promise and actually work toward improving patient enrollment and retention in clinical trials. And yet there is still an inertia that keeps many trials in-person and paper-based. The measured approach to change is valid, meant to ensure study integrity and protect patients. But, we can also be slow to adapt because of operational and logistical challenges associated with anything new. Using eConsent as an example, we will share how digital technologies can also improve operational efficiency for sites and sponsors to complete trials more smoothly and with more representative patient data.


Strategies for Patient-Centric Trial Planning and Digital Patient Engagement

Angela Bilkhu, Global Patient Partnership Director, R&D, Solid Tumor, Roche

Patient centricity is at the core of trial design. New technology and digital tools, better informed patients, hybrid/decentralized trials, and a more collaborative relationship between sponsors and trial volunteers are all driving this change in tandem. So, how do you improved your trials, your enrollment planning, and your patient engagement strategy in a digital world?

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


ROOM LOCATION: Vivaldi 1 and Vivaldi 2


Organizer's and Chairperson's Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute


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.


Building Clinical Trial Infrastructure for the Future


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?


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



Chairperson's Remarks

Thierry Escudier, Empowered Patient Strategy Lead, Pistoia Alliance


ACT4Patients: Integrated Innovation and Transformation Roadmap

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

To draw on the experience and learning today of best practices for Decentralised Clinical Trial (DCT) approaches in Europe and to think beyond just DCTs we are working on an integrated innovation and transformation roadmap for patients. This talk will provide insights into the opportunities and challenges, and give an update on our experience to date.

14:55 Expand Your Enrollment Reach and Accelerate Trial Timelines with Patient & Site-Centric Tech and Crowd-Sourced Recruitment

Diane Montross, Senior Director, Patient and Site Experience, Moderna

Ashley Schwalje, Head of Commercialization - Patient Recruitment & Engagement, Citeline

Clinical trial sponsors only have so much time in a day and can use that time to open only a finite number of channels to reach potential trial participants – until now. Citeline partnered with an industry-leading clinical trial sponsor to widen the recruitment funnel and streamline engagement and enrollment with precision. This was fueled by compliant, data-driven technology, trusted partners, and influential networks of HCPs and organizations with direct access to patients.

15:20 Building a Framework for Connected Research: Linking to a Fragmented Site Ecosystem

Blake Adams, Senior Vice President, Marketing, Florence Healthcare

A single unified platform in research is not coming - fragmented technology is here to stay. What is the answer for sponsors who want to connect to every site in their study and integrate with their workflows? Join us in this discussion to hear how innovative sponsors and CROs are increasing patient access and accelerating clinical trials by linking to three types of study sites: sites using the same platform as the sponsor, sites using a different platform, and sites without a platform at all.


ROOM LOCATION: Vivaldi 1 and Vivaldi 2

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.


TABLE 1: Strategies for Patient-Centric Trial Design and Digital Patient Engagement to Improve Outcomes and Diversity

Angela Bilkhu, Global Patient Partnership Director, R&D, Solid Tumor, Roche

Paul Duffy, Head, Global Clinical Site Partnerships, MSD

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

Motshewa Sesing, Head, Clinical Data Management, Nestle Research Center

Howard Turner, Senior Clinical Operations Lead, Roche

  • How can industry learn from patients, caregivers, HCPs, sites and each other to better design less burdensome and more efficient trials?
  • How can we rethink the use of data, technology, social science, and novel approaches to design truly patient-centered trials and ensure greater trial diversity?
  • What are current digital patient projects gaining traction, engagement pilots, new technologies, the role of patient communities?
  • What is a complete digital patient experience? What is required to make this a reality for all trials? Where and why do solutions and technologies still fall short in making an impact for patients?

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



09:00 Chairperson's Remarks

Larry Birch, CEO and Board Member, Anju Software


Diversity and Representation among Clinical Research Site Staff: A Factor in Patient Engagement and Recruitment?

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

The clinical research enterprise is more patient-centric than it has ever been and requires greater understanding of the factors that allow for increased participation and retention of volunteer patient-participants. This presentation will provide session participants with important takeaways resulting from peer-reviewed research. The audience will gain an understanding of: Relationship between diversity in patient volunteer participation, and diversity among the clinical research workforce; Current state of racial, ethnic, and gender in representation in clinical research volunteer participation at clinical research sites in North America, Europe, and ROW; and Potential workforce-related strategies to increase patient engagement and retention.


Recruitment of Minority Patients and Special Populations to Ensure Diversity in Your Trial Populations

Leah L. Peters, Senior Operations Lead, Genentech

Roche/Genentech prioritizes inclusive research to increase the representation of historically under-studied and under-represented patients, with a focus on diseases that disproportionately or differentially affect patients across races/ethnicities. This discussion will share insights from ongoing efforts to advance inclusive research, with a focus on operational tactics that support the recruitment of minority and special populations, to ensure that the populations which these new treatments will serve are represented in our clinical trials.

09:55 Participant Engagement: The Power of Communication, Inclusion and Flexibility

Angela La Ronde, Relationship Director, Greenphire

In this session you will hear from Angela LaRonde, Director, Relationship Management at Greenphire and Sandrine Lavelle (Title) at EUPATI as they discuss topics such as key industry trends and the impact on the participant experience; how to know what participants want and need to be better supported in a trial; and initiatives being implemented to improve the participant experience

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


ROOM LOCATION: Vivaldi 1 and Vivaldi 2


Chairperson's Remarks 

Brenda Yanak, Founder, Clinical Transformation Partners


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.


Considerations for Next-Gen Informed Consent 


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?


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

Charlie Hunt, Director, Clinical Trial Experience, Langland


Patient Involvement and Patient Preferences to Inform Clinical Trial Protocol Design, Regulatory, and HTA Decision-Making

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

Stakeholders involved in drug development, evaluation, and clinical use are presently calling for evidence-based insights into ways for assessing and including patients’ preferences in a meaningful and systematic manner. Widespread implementation of robustly designed patient involvement methods in all steps of the process, from drug development to treatment and surveillance, will amplify patients’ unique voices in the medicinal product life cycle. This presentation will offer insights into patient preferences and participation, preference exploration, and elicitation methods for use in clinical trial protocol development and submissions to regulators and HTA bodies. Methodological learnings proposed ways, and present challenges for systematically integrating preference studies in medical research and practice, complementing existing methods, and fostering targeted multi-stakeholder discussions and internationally accepted recommendations and guidelines.

14:25 Why Would I Join a Ciinical Trial?

Harry Yeates, Strategy Director, Clinical Trial Experience, Langland

Over 60% of clinical trial participants are highly likely to recommend one to a friend, but people need to navigate a steep learning curve before the full range of potential benefits of taking part become clear. Community, structure, self-knowledge, learning, altruism, and yes, the possibility of a treatment effect. Any one could be the key motivator for a particular individual. What if we could get people to ask "Why wouldn't I?"

Sponsored Presentation (Opportunity Available)14:37

Session Break14:50


ROOM LOCATION: Vivaldi 1 and Vivaldi 2


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


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.


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

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

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

Angela La Ronde, Relationship Director, Greenphire

Closing Remarks by Conference Organizer15:25

Close of Conference15:30