Keynote Sessions on Tuesday and Wednesday
TUESDAY, DAY 1 | 16 October
07:30 - 17:00 Registration Open
07:30 Morning Coffee
08:20 Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
08:25 Chairperson’s Opening Remarks
Terrie Livingston, PharmD, Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen
08:30 CO-PRESENTATION: Disruptive Trial Models – Enabling Radical Transformation in Clinical Trial Execution
Scott Askin, Digital Solutions Director, Digital Development, Novartis
Bryan McDowell, Global Program Lead, Executive Director
Digital Development, Novartis
Evolving patient expectations can be addressed with advancing technologies to conduct more patient centric trials, but it requires transformation of operational approaches and trial design. Could disruptive trial models be the solution? A deep dive into
patient-centric trial models and the challenges these present and the need for targeted solutions will be discussed in this co-presentation.
08:55 Digital Trials and Endpoints: Operationalising Trials of the Future Now Based on Tech Available Today
Bert Hartog, PhD, Senior Director, Clinical Innovation, Janssen
Pharmaceutica N.V.
Clinical trials are antiquated and have failed to catch up with changes in society. Despite dramatic developments in technology and rapidly changing expectations from patients and caregivers, trials are largely run the same way they always have, since
GCP was first introduced in the last century. Janssen’s Clinical Innovation team was created to change this, and through carefully selected demonstration projects develop novel capabilities for clinical operations. This talk will highlight some
of Janssen’s recent advancements and opportunities in remote data generation, continuous data generation and digital endpoints, and benefits this will bring to patients, sites and sponsor.
09:20 CO-PRESENTATION: Patients’ Accessibility in Clinical Trials: How to Better Engage Patients and Plan Future Trials
Victoria Abbott-Fleming, Patient,
Founder, Burning Nights CRPS
Maya Zlatanova, FindMeCure Foundation
Eligibility criteria are getting harder, so it is almost impossible to have the “perfect” network of sites to enroll the patients you need on time. At the same time, we are all facing a significant increase in the number of patients proactively
searching for trials, but they are blocked by regulations and a traditional clinical research approach. This presentation will challenge some of the old-fashioned beliefs and will bring the patient perspective of how we can engage better with them
and speed up drug development. The awarded “Inspirational Woman of the Year 2016” Victoria Abbott-Fleming and founder of Burning Nights CRPS will speak about her and her members’ stories of how patients struggle to get information
about clinical trials on time and what their journey looks like. These stories will be backed up with data coming from a research with over 1000 patients worldwide interested in joining clinical trials. Patient empowerment should start with the patients
and their needs and if this happens, then we can speak about real patient-centricity.
09:45 INTERACTIVE PANEL: Digital Endpoints and Remote Trials – Opportunities and Barriers
Moderator:
Susan Griffing, Vice President,
Global Head Country Clinical Operations, Roche
Panelists:
Bert Hartog, PhD, Senior Director, Clinical Innovation, Janssen
Pharmaceutica N.V.
Scott Askin, Digital Solutions Director, Digital Development, Novartis
Terrie Livingston,
PharmD, Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen; Trial Volunteer/Patient
Bryan McDowell, MBA, Global Program Lead, Digital Development,
Novartis
Is the industry clear about the value proposition for the digital transformation of clinical research? What is the impact to the various stakeholders? What are the most suitable use cases? Join this panel discussion to get insights about these questions
from industry thought leaders. Topics to be discussed:
- How to quantify the value of digital research methods
- Are you using the right tech for the right trial?
- Is digital going to replace the “human touch” and the site-patient relationship?
- Considerations for regulatory compliance, scientific integrity and patient safety
10:15 Coffee Break with Exhibit Viewing
WEDNESDAY, DAY 2 | 17 October
13:35 Chairperson’s Remarks
Brendan O’Neill, Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer
13:40 CO-PRESENTATION: EHR2EDC – Joining Forces to Enter the Digital Age for Clinical Research Data Capture
Martine Lewi, PhD, MBA, Scientific Director, Global R&D,
Clinical Innovation, Janssen
Nadir Ammour, DMD, MBA, Innovation Domain Leader, Patients and
Sites, R&D/Clinical Science & Operations, Sanofi
Use of electronic health records as an eSource has tremendous benefits in optimizing the collection of clinical data in the study execution and opens new opportunities in real world data clinical trials. The former IMI EHR4CR initiative has developed
innovative capabilities to enable secondary use of electronic health records for clinical research. Two services have already been developed through the InSite Platform: Services 1 (study design and study placement) and Services 2 (recruitment support).
These services are in use over a network of 30+ HCOs in Europe. EHR2EDC is a newly launched EIT funded consortium project which aims at facilitating the data extraction for applications used during trial execution, e.g. prefilling of CRF reports.
Sanofi – as program lead – will introduce the project objectives, the approach taken and status of the different work packages. Janssen will present the initial set up of the studies, the process of identifying data elements eligible for
automatic upload and the collaboration with the hospitals.
14:05 CO-PRESENTATION: Share4Rare: Collective Awareness Platform for Research in Paediatric Rare Diseases
Begonya Nafra, Clinical Research Unit, Sant Joan de Deu Barcelona
Children’s Hospital, Research Foundation Barcelona Children’s Hospital Patient Organization Representative
This special co-presentation will discuss key concerns related to paediatric rare diseases research and trials and share a case study. The case study will cover: 1) a collective intelligence methodology used for empowering patients and families, 2) how
smart clinical data was used for the natural history of the diseases and clinical trials recruitment, and 3) a description of current pilot studies in paediatric rare tumors and neuromuscular disorders.
14:30 Using Electronic Health Records in Clinical Studies: The Real World in Europe
Dipak Kalra, PhD, President, The European Institute for Innovation
through Health Data
The promised role EHRs to improve the efficiency of clinical studies, and to reduce costs, is well known. Through sustainable IMI results and an emerging market of products this promise is now emerging as a reality. Optimising protocol design and better
targeted recruitment are here, sharing EHR data with EDC systems is around the corner, Pragmatic Clinical Trials and Precision Medicine will be next to scale up. Professor Kalra will explain how the use of EHRs in industry research has grown and is
becoming well-accepted in Europe, and the initiatives that are enriching the capability and value of Real World Data in research.
14:55 INTERACTIVE PANEL: Making Real World Research a Reality in Europe and Beyond
Moderator:
Stephen Lock, Head of Business
Intelligence, NIHR (National Institute for Health Research)
Panelists:
Martine Lewi, PhD, MBA, Scientific Director, Global R&D,
Clinical Innovation, Janssen
Dipak Kalra, PhD, President, The European Institute for Innovation
through Health Data; President, The European Institute for Health Records (EuroRec)
Nadir Ammour, DMD, MBA, Innovation Domain Leader, Patients and
Sites, R&D/Clinical Science & Operations, Sanofi
People often discuss the advantages of real world vs. clinical trials data. But why does it have to be one or the other? How can we optimize clinical trial planning, execution and outcomes by using real world data and real world evidence as well as the
usual data sources? How can we improve site-study activation and performance and achieve trial success through data, technology and analytics? Topics to be discussed with an expert panel:
- RWD to optimize clinical research, with special focus on EMEA and US and emerging initiatives in ASIAPAC
- Role of Health Systems with EHRs in clinical trial planning and design
- Re-use of health data to improve study planning and start-up
- Building alliances with hospitals and networks to improve trial performance
15:30 Closing Remarks
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)