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

Feasibility, Site Selection and Study Activation

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

20 - 21 April 2022 CET

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, a hybrid conference in 2021 serving both in-person and virtual attendees.

Tuesday, 5 October

07:30 Registration and Morning Coffee

INCORPORATING SITE AND PATIENT INPUT INTO CLINICAL DEVELOPMENT AND FEASIBILITY PLANNING

08:50 Welcome by Conference Organizer

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

08:55

Chairperson's Remarks

Jonathan Crowther, PhD, Site Intelligence Lead, Study Optimization, Global Product Development, Pfizer Inc.
09:00

Incorporating Site and Patient Input into Clinical Development Planning

Barbara Valastro, PhD, Innovation Partner & Director, Clinical Program, AstraZeneca R&D

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

Ipsen’s Approach to Site Feasibility Assessment: Understanding Medical and Operational Aspects

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

Data-driven global site selection, an optimized feasibility assessment process, and effective site management are critical to improving clinical trial timelines and outcomes. Too often companies fail to learn from past mistakes and take the same approach to protocol development, trial planning and program execution. This talk will discuss understanding medical and operational aspects of site feasibility assessment.

10:00 Sponsored Presentation (Opportunity Available)
10:30

What Do Sites in Europe Need to Do to be Business Ready to Run Decentralized Trials?

Karl-Ludwig Radek, Assistant Director, Global Clinical Operations & Janssen Internal Project Lead for IMI Trials@Home

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 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

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 PRESENTATION:

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

LEVERAGING FEASIBILITY DATA TO IMPROVE SITE SELECTION AND PREDICT OUTCOMES

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.

15:25

Leveraging Data and Analytics to Improve Global Site Selection

Kieran Whelton, Associate Director, Patient Recruitment & Retention, AbbVie

Ensuring the optimum site selection is critical for successful trials. This presentation will show how to leverage data and analytics to identify the most appropriate and highest performing sites for new studies. The processes, systems/databases, and best practises to analyse site data for the creation of the master site list will be discussed. Potential future analytics advances in global site selection will be reviewed.

15:55 Sponsored Presentation (Opportunity Available)
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. 

17:05 SCOPE Europe Connects Exhibit Hall Viewing
18:00 Close of Day

Wednesday, 6 October

08:30 Registration and Morning Coffee

IMPROVING STUDY FEASIBILITY AND ACTIVATION FOR SITE, HOSPITAL, NON-HOSPITAL, AND AT-HOME SETTINGS

09:05

Bringing Trials to the Patients’ Homes: Overcoming Challenges in Study Feasibility and Activation for Decentralised Clinical Trials

Cristina De Juan, PhD, Innovation Lead, Global Clinical Sciences and Operations (GCSO), UCB

Overcoming challenges in study feasibility and activation for decentralised clinical trials is a topic of discussion in all biopharma companies executing trials during this difficult times. Bringing trials to patients’ homes and giving them the choice can lead to better outcomes for all involved, but the operational aspects must be understood and managed.

09:35

Collaborating with the Community for Faster Commercial Clinical Research

Richard Evans, PhD, National Patient Recruitment Center Manager, NIHR Clinical Research Network

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.

Speaker to be Announced

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

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.

15:00 Sponsored Presentation (Opportunity Available)
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.

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