Cambridge Healthtech Institute’s
Patient-Centric Enrollment Planning and Engagement
Utilizing New Technology, Analytics and Outreach to Improve Patient Recruitment
16-17 October 2018
We are pleased to announce production of Cambridge Healthtech Institute’s
Patient-Centric Enrollment Planning and Engagement: Utilizing New Technology, Analytics and Outreach to Improve Patient Recruitment conference being held 16-17 October 2018 at the Crowne Plaza Barcelona-Fira Center in Barcelona, Spain. Patient recruitment and up-front enrollment planning are critical
to drug development programs and if not adequately planned for or properly executed can extend your development timeline by a number of years. Clinical researchers and study teams are working hard to better identify, understand and engage patients.
Developing both a patient-centric culture and systems are 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, 3 conference tracks focused
on specific issues and functions within the clin ops and research enterprise, informal and interactive breakout discussion groups, and networking.
Final Agenda
TUESDAY, DAY 1 | 16 October
07:30 - 17:00 Registration Open
07:30 Morning Coffee
08:20 Organizer’s Welcome & Chairperson’s Opening Remarks
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
Tuesday Plenary Keynote Session Featuring:
Terrie Livingston,
PharmD, Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen; Trial Volunteer/Patient
Scott Askin, Digital Solutions Director, Digital Development,
Novartis
Bryan McDowell, Global Program Lead, Executive Director
Digital Development, Novartis
Bert Hartog, PhD, Senior Director, Clinical Innovation, Janssen
Pharmaceutica N.V.
Victoria Abbott-Fleming, Patient, Founder, Burning Nights CRPS
Maya Zlatanova, FindMeCure Foundation
Susan Griffing, Vice President,
Global Head Country Clinical Operations, Roche
10:15 Coffee Break with Exhibit Viewing
10:50 Chairperson’s Remarks
Divya Chadha Manek, PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network
10:55 Leveraging Data and Analytics for Enrollment Planning and Trial Execution
Susan Griffing, Vice President,
Global Head Country Clinical Operations, Roche
Clinical trials are still taking longer than planned and costing companies more than predicted. Of the challenges faced in trial execution, enrollment is still a major bottleneck for research. This presentation will talk to industry trends in this area
and specifically how we are leveraging data to make decisions around operations.
11:20 CO-PRESENTATION: European Insights from a Patient Technology Landscape Assessment
Ashley Polhemus, Innovation Specialist, Global Innovation
Center, Merck and Company
Anne Tinggaard, E-Trials System Specialist, Novo Nordisk
Despite the noted benefits of patient technology in numerous healthcare settings, its use in clinical trials remains limited. The TransCelerate Patient Technology Initiative has conducted a landscape assessment to understand factors affecting implementation.
This session will describe the current experiences and perceptions of European stakeholders (e.g., sponsors, sites, and patients) with patient technology, and also explore potential approaches to enable its accelerated implementation. General consensus
was reached around the potential global value of patient-facing technologies, as well as the recognition that barriers to adoption are numerous.
11:45 PARADIGM INTERACTIVE PANEL: Understanding Patients’ Needs, a Patient-Industry-Academia Joint Effort to Develop a Global Patient Engagement Strategy
Moderator:
Robert Kroes, Project Manager, Clinical Dermatology and Pain Global Medical
Affairs, Eli Lilly and Company
Panelists:
Begonya Nafra, Clinical Research Unit, Sant Joan de Deu Barcelona
Children’s Hospital, Research Foundation Barcelona Children’s Hospital
Ana Diaz, PhD, Project Officer, Alzheimer Europe
The objective of PARADIGM is to develop much needed processes and tools for three key decision-making points: research priority setting, design of clinical trials and early dialogue. Building on advances at international level, PARADIGM will integrate
the needs, perspectives and expectations of all actors (including vulnerable populations) involved and will also produce a set of metrics to measure the impact of patient engagement. This panel will discuss:
- Why do we need PARADIGM?
- What will PARADIGM deliver?
- Will the patient voice really be heard?
12:10 Right-Sizing Technology for Early Clinical Proof-of-Concept Studies
Lorraine Rusch, PhD, President, High Point Clinical Trials
Center
This presentation reviews the current landscape of early clinical trial digital and software technologies used in translational studies including safety, visual analog scales, and electronic source.
12:35 NEW: LUNCHEON PRESENTATION: Bringing the Trial to the Patient: Virtual Trials and the Promise of Patient Engagement
Bola Oyegunwa, Director, Strategic Planning, Research & Development
Solutions Business, IQVIA
The shift to virtual trials is upon us. With it comes a myriad of benefits to both the patient and sponsor. This presentation will share how early adopter studies are delivering more rapid patient enrollment, higher retention, better data quality and
overall faster cycle times.
13:55 Chairperson’s Remarks
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC
14:00 PILOT CASE STUDY: Integrating Patient-Centricity into the Reality of Clinical Research
Divya Chadha Manek,
PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network
Meaningful patient engagement by life sciences organisations was virtually unheard of until a few years ago. Now it has become a topical buzzword. Despite this, there has been a lack of strong examples of true adoption of ‘patient centricity’
in commercial clinical research. This session will share an example of how the National Institute for Health Research in the UK has supported a company to engage patients in protocol development. The session will examine lessons learned and will provide
an opportunity to discuss challenges and successes.
14:25 How Patient Centricity Fits in an Innovative Hospital?
Joana Claverol, Clinical Research Unit Manager, Sant Joan
de Deu Barcelona Children’s Hospital, Research Foundation Barcelona Children’s Hospital
In the conservation healthcare and clinical research industry what does an “innovative organization” look like today? Is it possible to be or to create such an organization? How have we at our hospital pursued the goal of being a patient-centric
organization by co-working with patients at all levels: co-design; co-development; co-decision making? This talk will discuss our hospital’s approach to research and healthcare and how those in industry can work with hospital centers and a patient-centric
organization to improve research.
14:50 INTERACTIVE PANEL: Understanding the Barriers to Embedding Patient Centricity into Study Design and Clinical Research Operations
Moderator:
Divya Chadha Manek,
PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network
Panelists:
Sophie Evett, PhD, Director, Feasibility Lead, Clinical Development
& Operations, Global Product Development, Pfizer
Sammy Ainsworth, Parent
and Patient Research Ambassador
Brendan O’Neill,
Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer
Michael Keens, COO, Firma Clinical
Everybody is talking about the benefits of patient centricity, but implementation of meaningful patient centricity comes with a unique set of challenges. This panel will examine both. Panel members will discuss the challenges and advantages of embedding
patient centric approaches in clinical research from their own perspective.
- What are the current challenges in engaging patients within the clinical development?
- Can you share any successes from your perspective where the challenges have been overcome?
- What do you see in the crystal ball about where patient centricity is heading?
15:15 Taking Study Visits to the Patients the Ultimate in Patient Centric Clinical Trials
Gail Adinamis, CEO & Founder, GlobalCare Clinical Trials
Patient recruitment and retention are key factors in establishing the objectives and ultimate success of clinical trials. A patient-centric service model has evolved allowing study visits to be conducted at the patient's home where it is more convenient
and comfortable than at the investigator site.
15:30 Refreshment Break with Exhibit Viewing
16:10 Find Your Table and Meet Your Moderators
16:15 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become
an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from
your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
17:00 - 18:00 Networking Reception with Exhibit Viewing
WEDNESDAY, DAY 2 | 17 October
08:00 Morning Coffee
08:30 Chairperson’s Remarks
Gail Adinamis, CEO & Founder, GlobalCare Clinical Trials
08:35 Optimizing Site Selection and Patient Recruitment Planning
Brendan O’Neill,
Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer
In order to drive down the number of non-performing sites, we are working with our site management experts to validate a site’s access to patients at the time of site selection. We continue this process to establish a site-specific recruitment
plan to ensure that sites hit their contracted target. In this session, you will see how planning and technology can come together to ensure that sites and studies are set up for success. You will see the successful impact of this approach starting
at initial study planning and rescue situations.
09:00 CO-PRESENTATION: Dos and Don’ts in Development & Implementation of Global Patient Recruitment Strategies: A Roadmap for Success!
Silke Strommenger, MD, Head, Feasibility Analytics
& Planning, Bayer
Nils Drews, MD, CMO, Clariness
This presentation will share a case study for recruitment support in a huge multi-center, multi-national Phase III study in diabetes and kidney disease patients/CV outcome. Key learnings about the project set up and focus areas for successful cooperation
between sponsor/vendor will also be shared. Lastly, insights on timelines, challenges and success factors for setting up a recruitment and retention support project in multiple countries will be discussed.
09:25 Recruitment and Retention in Clinical Trials: AI-Powered Site Selection
Jean-David Zeitoun, CMO, Inato
Patient recruitment is notoriously hard to predict and depend on the context (e.g. competing trials, operational capacity, available staff, investigator motivation & experience etc.). Inato’s feasibility platform helps sponsors understand
each site's recruitment context in real time, leveraging data analytics and behavioural science. It has been developed alongside clinical operations professionals from top10 pharma companies. Study teams can select sites with the highest potential
and optimize recruitment strategy by modelling different scenarios.
09:50 Coffee Break with Exhibit Viewing
10:25 CASE STUDY: An Approach to Patient Engagement and Recruitment: LillyTrialGuide and Building on Caregiver Relationships
Robert Kroes, Project Manager, Clinical Dermatology and Pain Global
Medical Affairs, Eli Lilly and Company
There is currently a lot of focus on patient experience in clinical trials. This new focus is crucial to start improving clinical trials. With the focus on oncology, neurodegeneration, pediatric clinical trials, we should also start listening to other
stake holders like their caregivers. This presentation will cover: the role of caregivers in clinical trials, a video of caregivers and patients talking about their experience, and reference to patient and caregiver resource: LillyTrialguide.com.
10:50 Inclusion of Patient Reported Outcomes (PROs) in Rare Disease Trial Design: How Social Networks Can Enhance Patient Engagement and Patient Experience
Terrie Livingston,
PharmD, Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen
This presentation is given from the perspective of someone who understands clinical research both as a member of industry, but also as a patient. It will cover: developing meaningful patient reported outcomes by gathering information about their disease
journey through an independent social network, whether PROs will be used to run 3b trials to produce further evidence to support approval, strategies and tools to enhance patient engagement and patient experience.
11:15 Direct-to-Participant Trials and Patient Advocacy Groups: Putting Patient Centricity into Practice
Michael Keens, COO, Firma Clinical
The clinical trial industry has been undertaking a renewed effort on patient focus within protocols, known as “Patient Centricity.” This approach can involve direct patient input on protocols, fewer office visits using home health care,
and data collection efforts using wearable technology. This discussion will review how to align these direct-to-participant efforts while integrating patient advocacy groups to improve patient participation, experience, and retention in clinical
trials.
11:40 Utilizing EHR Data: Overcoming Industry’s Biggest Challenges to Enable More Efficient Digital Data Gathering Practices to Benefit Patients, Sites and Sponsors
Nadir Ammour, DMD, MBA, Innovation Domain Leader, Patients and Sites, R&D/Clinical Science & Operations,
Sanofi
Although regulators have urged increased use of eSource for several years, application of the use of electronic sources of data for clinical trials has been slow to be adopted across the industry, particularly for registration trials, due in part
to difficulties in operationalization. Research indicates there are numerous obstacles and challenges behind this delay; some real and some perceived. In Europe, specific regulatory and other landscape challenges exist which complicate data interoperability.
This session will explore how TransCelerate’s eSource initiative is addressing these real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors. Specifically, it will discuss
European-specific findings and share a framework to enable adoption of eSource.
12:05 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
13:35 Chairperson’s Remarks
Brendan O’Neill, Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer
WEDNESDAY Plenary Keynote Session Featuring:
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
Begonya Nafra, Clinical Research Unit, Sant Joan de Deu
Barcelona Children’s Hospital, Research Foundation Barcelona Children’s Hospital
Stephen Lock, Head of Business Intelligence, NIHR (National
Institute for Health Research)
Dipak Kalra, PhD, President, The European Institute for Innovation
through Health Data; President, The European Institute for Health Records (EuroRec)
15:30 Closing Remarks
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)