October 2022 • Archived Content
OVERVIEW | DOWNLOAD BROCHURE | INTERACTIVE DISCUSSIONS | ATTENDEES | ATTENDEES PROFILE

Cambridge Healthtech Institute’s 5th Annual

Feasibility, Site Selection and Study Activation

Analytics-Driven Trial Design and Execution for Site-Centered and Hybrid Trials

3 - 4 October 2022 ALL TIMES CEST

Early development planning, feasibility assessment, protocol development, and site selection are arguably the most critical components of the clinical trial process. Performing these first steps effectively will significantly impact the likelihood of completing the trial on time and within budget. Innovative data and analytics capabilities, new protocol development and feasibility assessment processes, and novel approaches to stakeholder communication and collaboration are improving clinical trial timelines and outcomes and driving trial success. 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 “Feasibility, Site Selection and Study Activation” conference at SCOPE Europe in Barcelona in October!

Monday, 3 October

Registration and Morning Coffee (Terraza Jardin)07:45

INCORPORATING SITE AND PATIENT INPUT INTO EARLY STRATEGY AND PROTOCOL DEVELOPMENT

ROOM LOCATION: Vivaldi 1

08:50Organizer's Welcome Remarks
08:55 Chairperson's Remarks

Darcy Forman, Chief Delivery Officer, Science 37

09:00

Patient-Centric Solutions to Enhance Patient Experience in Clinical Trials

Howard Turner, Senior Clinical Operations Lead, Roche

True empathy for the patient's experience comes from deep listening to what really makes a difference in the patient's life. In order to make meaningful changes to a patient's experience whilst participating in a clinical trial, we need to listen and (more critically) act on patient feedback. Improving technologies and an evolving global mindset of patient centricity provide the perfect opportunities to develop such support services for patients. Join me to hear more on the ways we are leveraging new and existing technologies to enhance patient experience and value in our trials.

09:25

Utilizing Insights from Patients, Parents, and Professionals to Improve Logistics and Operational Point of View In Clinical Studies

Joana Claverol, Clinical Research Unit Manager, Sant Joan de Deu Barcelona Children's Hospital

Begonya Nafria Escalera, Patient Engagement & Research Coordinator, eYPAGnet, Sant Joan de Deu Barcelona Hospital

Pediatric clinical trials entail complexity from the point of view of the study design, the vulnerability of minors participating, and the impact that this experience has on the family. Sant Joan de Déu Clinical Research Unit is a patient-centered site that has analyzed the patient's and staff's preferences in terms of decentralized clinical trials. In this talk, the outcomes of this research will be presented with the aim to inform all the stakeholders involved in pediatric research about the benefits of consulting patients, families, and professionals prior to the definition of the clinical trial design.

09:50 Feasibility and DCT – What to Expect from a Virtual Site Regarding Metrics and Start-Up Time

Darcy Forman, Chief Delivery Officer, Science 37

Sponsors globally are beginning to leverage virtual sites to expand patient access, deliver greater patient diversity, reduce study timelines, and as a solution for vulnerable studies. They are also a seamless first step to decentralization. Discover how a virtual site can be implemented with regulatory adherence. 

10:15

Targeted Management of High-Performing Clinical Research Sites, One Company's Perspective

Paul Duffy, Head, Global Clinical Site Partnerships, MSD

This presentation will cover MSD’s approach to support long-term strategic partnerships with some of our key sites across the globe. How should we approach this project and with whom? What do we mean by strategic partnership and why? What are we hoping to deliver for our sites, studies, and patients? Where to next?

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

MORNING SHARED PLENARY KEYNOTE: BUILDING CLINICAL TRIAL INFRASTRUCTURE FOR THE FUTURE

ROOM LOCATION: Vivaldi 1 and Vivaldi 2

11:35

Organizer's and Chairperson's Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

11:40

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.

12:10 PANEL DISCUSSION:

Building Clinical Trial Infrastructure for the Future

PANEL MODERATOR:

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?

PANELISTS:

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

DECENTRALISED CLINICAL TRIALS, CASE STUDIES, AND KEY LEARNINGS

14:25

Chairperson's Remarks

Thierry Escudier, Empowered Patient Strategy Lead, Pistoia Alliance

14:30

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.

INTERACTIVE BREAKOUT DISCUSSIONS

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.

BREAKOUT DISCUSSION:

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

DELIVERING HYBRID TRIALS WITH PATIENT-CENTRIC PROTOCOLS AND RELIABLE FEASIBILITY

ROOM LOCATION: Vivaldi 1

09:00 Chairperson's Remarks

Faisal Shahzad, Head of Business Development, EMEA, Patient Centered Technologies, IQVIA

09:05 INTERACTIVE PANEL:

Planning and Deploying Hybrid Trials by Developing Truly Patient-Centric Protocols that Enable Patient Choice

PANEL MODERATOR:

Jose Manuel Ordonez, CCO Therapeutic Area Leader, Onco Haematology, Roche Farma SA

This cross-functional team was responsible for the first fully decentralized oncology study at Roche, which very much provided the learnings and momentum for decentralized / hybrid trials across our organization. They play key roles in an internal initiative aimed at ensuring Roche leads the way in patient-centric clinical trials by accommodating patient circumstances and offering choice. They share their expertise across the organization and many are also involved in related industry collaboration workstreams such as TransCelerate and Society for Clinical Research Sites. They're currently involved in the design of a protocol that provides patients with "a la carte" choice.

PANELISTS:

Maja Michaelsen, Clinical Operational Lead, Roche (Denmark)

Adam Szulkin, PhD, Scientific Ecosystem Partner, Roche, Sweden

Rania Xeniou, Global Studies Leader, Roche

09:30 CASE STUDY CO-PRESENTATION:

The Importance of Fast and Reliable Feasibility in Delivering Commercial Research in Primary Care

Jonathan Abraham, CEO and Co-Founder, Healum

Karen Matthews, PhD, Business Development Manager, NIHR Clinical Research Network (CRN)

This case study will share the story of a difficult though ultimately successful journey taken by the NIHR in the UK and a digital therapeutics company new to trials. Attendees will learn of the collaborative model used and how in this partnership both sides had to adapt to the challenges of researching digital therapeutics. Additionally, we had to pivot during the pandemic and switch to remote care in a primary care setting, which further complicated things. Fast and reliable feasibility is fundamental to success – right study, right time, right location, right skills, and expertise. Whether for drug, device, or digital therapy clinical studies must be set up efficiently and achieve their recruitment targets…and teams must remain flexible.

Sponsored Presentation (Opportunity Available)09:55

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

MORNING SHARED PLENARY KEYNOTE: CHOOSING AND IMPLEMENTING INNOVATIONS TO SUPPORT HYBRID CLINICAL TRIAL OPERATIONS

ROOM LOCATION: Vivaldi 1 and Vivaldi 2

11:05

Chairperson's Remarks 

Brenda Yanak, Founder, Clinical Transformation Partners

11:10

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.

11:40 PANEL DISCUSSION:

Considerations for Next-Gen Informed Consent 

PANEL MODERATOR:

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?


PANELISTS:

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

PATIENT ENGAGEMENT AND HEALTH TECHNOLOGY ASSESSMENTS (HTA) TO IMPROVE TRIAL PLANNING AND RECRUITMENT

13:55 Chairperson's Remarks

Charlie Hunt, Director, Clinical Trial Experience, Langland

14:00

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

CLOSING SHARED PLENARY KEYNOTE: CURRENT TRENDS AND INNOVATION AT THE INTERSECTION OF CLINICAL TRIALS AND HEALTHCARE

ROOM LOCATION: Vivaldi 1 and Vivaldi 2

14:55 PANEL DISCUSSION:

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

PANEL MODERATOR:

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.

PANELISTS:

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