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)

SCOPE EUROPE opening KEYNOTES:
OPERATIONALISING DIGITAL TRIALS

Tuesday Plenary Keynote Session Featuring:

Livingston_TerrieTerrie Livingston, PharmD, Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen; Trial Volunteer/Patient


Askin_ScottScott Askin, Digital Solutions Director, Digital Development, Novartis


McDowell_BryanBryan McDowell, Global Program Lead, Executive Director Digital Development, Novartis


Hartog_BertBert Hartog, PhD, Senior Director, Clinical Innovation, Janssen Pharmaceutica N.V.


Abbott-Fleming_VictoriaVictoria Abbott-Fleming, Patient, Founder, Burning Nights CRPS


Zlatanova_MayaMaya Zlatanova, FindMeCure Foundation


Griffing_SueSusan Griffing, Vice President, Global Head Country Clinical Operations, Roche


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10:15 Coffee Break with Exhibit Viewing

ANALYTICS-DRIVEN ENROLLMENT PLANNING & THE CURRENT PATIENT CENTRICITY LANDSCAPE

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

Griffing_SueSusan 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

Polhemus_AshleyAshley 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:

Kroes_RobRobert Kroes, Project Manager, Clinical Dermatology and Pain Global Medical Affairs, Eli Lilly and Company


Panelists:

Claverol_JoanaJoana Claverol, Clinical Research Unit Manager, Sant Joan de Deu Barcelona Children’s Hospital, Research Foundation Barcelona Children’s Hospital


Diaz_AnaAna 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

Rusch_LorraineLorraine 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 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

IMPROVING PATIENT ENGAGEMENT AND EMBEDDING PATIENT CENTRICITY INTO STUDY OPERATIONS

13:55 Chairperson’s Remarks

14:00 PILOT CASE STUDY: Integrating Patient-Centricity into the Reality of Clinical Research

ChadhaManek_DivyaDivya 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 El Tema de Patient Centricity in an Innovative Hospital?

Claverol_JoanaJoana 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:

ChadhaManek_DivyaDivya Chadha Manek, PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network


Panelists:

Evett_SophieSophie Evett, PhD, Feasibility Lead, Feasibility Center of Excellence, Study Optimization, Pfizer


Ainsworth_SammySammy Ainsworth, Parent and Patient Research Ambassador


O’Neill_BrendanBrendan O’Neill, Senior Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer


Keens_MichaelMichael 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 Sponsored Presentation (Opportunity Available)

15:30 Refreshment Break with Exhibit Viewing

INTERACTIVE BREAKOUT DISCUSSION GROUPS

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.
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17:00 - 18:00 Networking Reception with Exhibit Viewing

WEDNESDAY, DAY 2 | 17 October

08:00 Morning Coffee

DEVELOPMENT AND IMPLEMENTATION OF GLOBAL PATIENT RECRUITMENT STRATEGIES

08:30 Chairperson’s Remarks

08:35 Optimizing Site Selection and Patient Recruitment Planning

O’Neill_BrendanBrendan 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!

Strommenger_SilkeSilke 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

Davarpanah_KouroshKourosh Davarpanah, CEO, Inato

Patient recruitment is notoriously hard to predict, costly and increasingly complex with the emergence of precision medicine. The problem is mainly that a site’s recruitment track record says very little about future recruitment performance: it is the context in which a site enrolls patients at the time of the trial that matters (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 AI-powered data analytics and behavioural science. Equipped with the right insights, study teams can select sites with the highest potential and optimize recruitment strategy by modelling different scenarios.

09:50 Coffee Break with Exhibit Viewing

INTEGRATING CAREGIVERS, PROS, SOCIAL NETWORKS AND EHR DATA TO ENHANCE ENGAGEMENT

10:25 CASE STUDY: An Approach to Patient Engagement and Recruitment: LillyTrialGuide and Building on Caregiver Relationships

Kroes_RobRobert 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

Livingston_TerrieTerrie 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.

FIRMA-Clinical-Research 11:15 Direct-to-Participant Trials and Patient Advocacy Groups: Putting Patient Centricity into Practice

Keens_MichaelMichael 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

Sposaro_JeanJean Sposaro, Program Director, TransCelerate Biopharma, Inc.

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

SCOPE EUROPE Closing KEYNOTES: USING DATA AND REAL-WORLD EVIDENCE (RWE) TO IMPROVE TRIAL DESIGN AND EXECUTION

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:

Lewi_MartineMartine Lewi, PhD, MBA, Scientific Director, Global R&D, Clinical Innovation, Janssen


Ammour_NadirNadir Ammour, MBA, Head, Clinical Digital Innovation, Sanofi


Nafra_BegonyaBegonya Nafra, Clinical Research Unit, Sant Joan de Deu Barcelona Children’s Hospital, Research Foundation Barcelona Children’s Hospital


Lock_StephenStephen Lock, Head of Business Intelligence, NIHR (National Institute for Health Research)


Kalra_DipakDipak Kalra, PhD, President, The European Institute for Innovation through Health Data; President, The European Institute for Health Records (EuroRec)


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15:30 Closing Remarks

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