2023 Keynotes
TUESDAY, 17 OCTOBER
11:50 Organizer's Opening Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
11:55 KEYNOTE PRESENTATION: Clinical Ops as a Growth Driver
Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL Behring GmbH
Clinical Operations is the hardest job you'll ever love. It drives the growth of a clinical development portfolio that results in new therapeutic options for the patients who need them. This awesome responsibility may look "easy" from the outside, but starting and managing a clinical trial is like launching a new business into a saturated market each and every time. Let's talk about how inspiring you are!
12:20 KEYNOTE PRESENTATION: Returning Results to Patients—Not Just a Regulatory Requirement with a Grace Period
Kimbra Edwards, PhD, Senior Director, Health Communication Services, Center for Information and Study on Clinical Research Participation (CISCRP)
EU Regulation/2014/536 requires results from trials initiated after January 2022 to be shared publicly within a year of completion and yet some sponsors are not sharing results. Several EU countries have successfully turned up the heat on sponsors who haven't shared the findings of their clinical trials actively pushing negligent sponsors and investigators to publicly share the results of past trials, an enforcement practice that's picked up momentum. After attending this presentation, the audience will: recognize the importance of returning trial results, in plain language, to all trial participants; describe the ramifications of not submitting plain language results; and plan for a large-scale implementation plan for returning results.
12:35 INTERACTIVE PANEL: Navigating Global DCT Adoption—Driving Change through Collaboration
PANEL MODERATOR:
Angela Radcliffe, DTRA Member & Founder, How Mighty We Ventures
PANELISTS:
Dylan Bechtle, Associate Director, Regulatory Policy and Intelligence, The Janssen Pharmaceutical Companies
Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi
WEDNESDAY, 18 OCTOBER
11:00 Organizer's Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
11:05 INTERACTIVE PANEL: eCOA- and ePRO-Centricity in a Digital Health World
PANEL MODERATOR:
Andrew Studna, Editor, Applied Clinical Trials, MJH Life Sciences
PANELISTS:
Estrella Garcia Alvarez, PhD, Director, Global Clinical Operations, R&D, Almirall SA
Scottie Kern, Executive Director, eCOA Consortium, Critical Path Institut
Bryan McDowell, Vice President, eCOA Clinical Science & Consulting, eCOA Science, Clario
Bart Roofthooft, Head of Digital Health Solutions, EBIS/DHCoE, Janssen R&D
11:30 INTERACTIVE PANEL: From Concept to Reality—The eSource-to-EDC Revolution Gathers Pace
PANEL MODERATOR:
Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)
The eSource data captured daily in hospitals’ EHRs is increasingly gaining traction within the clinical research community as the basis of a powerful opportunity to transform the way clinical trials are run. This session discusses the potential and the challenges of direct transfer of clinically-validated data from EHR-to-EDC: Is there now a common impetus for investment in data quality by sites and sponsors? Can advances in technology deliver flexible and scalable solutions for EHR-to-EDC data transfer?
PANELISTS:
Peter Casteleyn, Director, Clinical Data Collection Solutions-EHR, The Janssen Pharmaceutical Companies of Johnson and Johnson
Paul Jacobs, Associate Director, Development Innovation, Regeneron Pharmaceuticals
Joe Lengfellner, Senior Director, Clinical Research Informatics, Memorial Sloan Kettering Cancer Center
15:20 Clinical Research News' Best of Show Award: Recognizing Exceptional Innovation in Technologies Used by Clinical Research Professionals (Sponsored by Clinical Research News & ClinEco)
Allison Proffitt, Editorial Director, Bio-IT World
The 2023 Best of Show Awards offer exhibitors of the SCOPE Summit Europe an exclusive opportunity to distinguish and highlight their products, ranging from an innovative application, technology, tool, or solution. The SCOPE community is invited to identify exceptional innovation in technologies used by life science professionals, voting on most impactful new products of the year. Exhibitors are invited to enter your products via the online submission form below. Attendees are encouraged to explore the novel technologies and solutions firsthand in the exhibit hall and vote for the People's Choice Award once the conference has begun. Submit your entry!
15:25 CASE STUDY: Patient-Centric Sampling Solutions in Action
Lewis Millen, Global Clinical Sciences & Operations Innovation Lead, UCB
Chiara Rospo, Bioanalytical Scientific Manager Development Science, Translational Biomarkers & Bioanalysis, UCB Pharma SA
Real case studies of implementation of a patient-centric sampling solution at UCB will be discussed, highlighting the complexity and the skills required to be successful. Tips on overcoming challenges will be shared.
15:35 INTERACTIVE PANEL: Patient-Centric Blood Sampling as an Enabler for Decentralised Clinical Trials
PANEL MODERATOR:
Neil Spooner, PhD, Co-Founder and Chair, Patient Centric Sampling Interest Group (PCSIG)
In order to fully realise the potential for enhancing patient recruitment and retention for DCTs, the impact of blood sample collection for the determination of pharmacokinetics, measurement of biomarkers, and clinical chemistry also needs to be considered. This interactive panel will introduce you to technologies and workflows that enable the collection of these samples in the patient's home, either by self-sampling or by a caregiver, thus increasing patient choice and engagement. By attending this session, you will learn: What PCS is; What the potential benefits are when incorporating patient-friendly blood sampling into DCTs; Practical considerations on how to implement into your DCTs.
PANELISTS:
Chiara Rospo, Bioanalytical Scientific Manager Development Science, Translational Biomarkers & Bioanalysis, UCB Pharma SA
John Corcoran, Director, Decentralized Trial Solutions, Q² Solutions
Lewis Millen, Global Clinical Sciences & Operations Innovation Lead, UCB
Silvia Alonso Rodriguez, AstraZeneca
16:00 PANEL DISCUSSION: Unlocking the Crucial Ingredients for a Successful Outsourcing Partnership: Time to Challenge the Status Quo and Focus on Value-Based Contracts
PANEL MODERATOR:
Sylvia Marecki, PhD, Head, Operational Design Center (ODC), Global Development Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
PANELISTS:
Jason Gubb, Co-Founder, ClinOpsClarity
Piet Theisohn, Vice President, Resource Management, Clinical Development & Operations, R&D Clinical Operations, Bayer AG-Pharma
Julia Vassiliadou, PhD, Vice President, Clinical Operations, F2G
Jane Twitchen, Head Clinical Trial Accelerator & Senior Director, Global Clinical Operations, Biogen Ltd.