Cambridge Healthtech Institute’s

Analytics-Driven Feasibility, Site Selection and Study Activation

Improving Protocol Development, Global Site Selection, Feasibility and Site Management

16-17 October 2018

We are pleased to announce production of Cambridge Healthtech Institute’s Analytics-Driven Feasibility, Site Selection and Study Activation: Improving Protocol Development, Global Site Selection, Feasibility and Site Management being held 16-17 October 2018 at the Crowne Plaza Barcelona-Fira Center in Barcelona, Spain. Analytics and data-driven global site selection, an optimized protocol development and 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 trial planning and execution. In order to overcome challenges in clinical trial planning, operations and site management leaders should learn from the best practices of their peers, utilize multiple data sources and technology to support decision making, and improve communication and relationships between Sites, CROs, and Sponsors. 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

Keynotes | Track 1-Feasibility | Track 2-Engagement | Track 3-Monitoring | Breakouts
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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_Terrie Terrie Livingston, PharmD, Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen; Trial Volunteer/Patient

Askin_Scott Scott Askin, Digital Solutions Director, Digital Development, Novartis

McDowell_Bryan Bryan McDowell, Global Program Lead, Executive Director Digital Development, Novartis

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

Abbott-Fleming_Victoria Victoria Abbott-Fleming, Patient, Founder, Burning Nights CRPS

Zlatanova_Maya Maya Zlatanova, FindMeCure Foundation

Griffing_Sue Susan Griffing, Vice President, Global Head Country Clinical Operations, Roche

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10:15 Coffee Break with Exhibit Viewing

EVIDENCE-BASED AND PATIENT-CENTRIC PROTOCOL DEVELOPMENT AND SITE SELECTION

10:50 Chairperson’s Remarks

Oriol Serra Ortiz, MS, MBA, Senior Director, Head Site Intelligence & Selection, Study Optimization, Clinical Development & Operations, Pfizer

10:55 CO-PRESENTATION: Evidence Based Site Selection Tactics & Tools Driving Right Site/First Time

Serra-Ortiz_Oriol Oriol Serra Ortiz, MS, MBA, Senior Director, Head Site Intelligence & Selection, Study Optimization, Clinical Development & Operations, Pfizer

Crowther Jonathan Jonathan Crowther, PhD, Associate Director, Site Intelligence & Feasibility Lead, Clinical Development & Operations, Pfizer N.V./S.A.

This presentation will share how to determine how to effectively utilize the large amount of data available to create an ideal site profile based on feasibility, study start-up data and site experience. Attendees will learn about innovative approaches that leverage up-front intelligence and change downstream activities through evidence-based site selection.

11:20 Who’s Listening to the Patient? Building Insights into Clinical Development Plans and Protocols

Chopra_Narinder Narinder Chopra, Director, Feasibility, Enrollment & Retention Optimisation, Global Clinical Operations, Biogen

Over the years clinical development programs have been developed with great input and insights from pharma companies, expert medical advisory boards and regulators. However, a key stakeholder is missing from this list: the patient. Over the last few years the tide has changed somewhat and patients are now being asked what is important to them; and the industry is listening. In this session Narinder will review opportunities to gain insights from patients (and their families/caregivers) and share how these have been built into clinical development plans or protocols.

11:45 Redefining the Site Investigator Experience

Esther-Garcia-Cadenas_Ana Ana Esther Garcia Cadenas, Consultant Investigator Platforms, Clinical Information Process Automation, Eli Lilly and Company

The TransCelerate Shared Investigator Platform (SIP) was to redefine the Site Investigator experience and was developed with sites, for sites, to enable greater collaboration with participating sponsors, and make room for higher value activities, like trial execution and spending time with patients. The Site Qualification and Training (SQT) Initiative collaborated with sponsors, investigator sites, CROs and regulatory agencies to achieve the goal of enhancing and simplifying clinical trial SQT processes and to reduce administrative burden on sites. This session will share a real case study to explore how the SIP system and SQT model tools and resources have been successfully implemented to enable time savings and process efficiencies.

12:10 CO-PRESENTATION: Protocol Complexity Simplification: The Mythical Wish or a Realistic Measure?

Zembrodt_Sara Sara Zembrodt, Associate Business Systems Director, Design Offerings, IQVIA Technologies

Makowski_Marcin Marcin Makowski, Principal Data Scientist, Head, Risk Based Monitoring & Standards, UCB

Industry is slowly coming to terms with the growing evidence that the studies they have designed and planned have become overly complex. As a result, they have also become lengthier and costlier. The challenge for stakeholders in this process has been how to prove it – and then what to do about it. Is there a way to assess each contributing parameter against relevant reference protocols for a true measure of necessity and complexity? Is there an objective way to balance a streamlined yet effective design and while still including items that will satisfy internal stakeholders and regulators?

12:35 LUNCHEON PRESENTATION: Improving Feasibility Through Data-Driven Models

Komelasky_Christopher Christopher Komelasky, Senior Director, Strategic Feasibility, Site and Patient Access, PPD

Drug developers must address two challenges: recruit greater numbers of patients in a crowded research space and reduce unsustainable costs. By accessing and applying data through expanded, data-rich models, PPD identifies patients who meet inclusion/exclusion criteria and sites to access these patients, delivering qualified patients for enrollment. Learn how data-driven feasibility is central to today’s challenges. Connecting relevant patient, site and investigator data with tools/processes to ensure efficient, cost-effective study design, start-up and patient recruitment.

REMOTE RESEARCH, PROTOCOL HARMONIZATION AND MODERNIZING THE FEASIBILITY PROCESS

13:55 Chairperson’s Remarks

David Cocker, CSO, Ta-scan Business Intelligence Systems, MDC Partners

14:00 CASE STUDY: How to Use Remote Research Methods to Modernize Clinical Research

Langel_Kai Kai Langel, Director, Clinical Innovation, Janssen

Remote and virtual trials represent perhaps the most significant transformation of clinical trials since the introduction of the randomized trial model. Yet despite the immense promise these methods have for better science, patient centricity and overall efficiencies, the industry is very early in its adoption. This talk covers the most significant solutions and utilization strategies that help companies benefit from these methods in order to improve the process for delivering their research pipeline.

14:25 Accelerating Drug Development through Protocol Harmonization

Polavieja Pepa Pepa Polavieja, Senior Research Scientist, Consultant Quality & Operations, Statistical Sciences, Lilly S.A.

Since 2010, 20,000 new studies have been registered in Clinical Trials.gov each year. However, increasing complexity in trial protocols makes implementation and reporting difficult for sites, regulators and patients. The lack of consistency across protocols compounds the issue. Data suggests that a significant opportunity exists for an improvement in quality and simplification through protocol harmonization, as all protocols rely on the same health care and regulatory infrastructure for design, review and implementation. This session will explore: the collaboration between TransCelerate and global regulators to achieve alignment on a common protocol structure, how the CPT enables use of data standards, and next steps towards automation and data traceability from protocol through to downstream processes.

14:50 Targeting Research by Disease Burden in the NIHR

Lock_Stephen Stephen Lock, Head, Business Intelligence, NIHR (National Institute for Health Research)

The Business Intelligence Team at the UK’s National Institute of Health Research Clinical Research Network (NIHR CRN) is developing online tools to help researchers target research in a smarter way. For example, by analyzing disease prevalence alongside research activity, we can show under- and over-researched populations to help site-selection as part of the feasibility process. Coupled with self-serve mapping tools, this gives a powerful insight into where to place and activate studies. In this talk, Stephen Lock, Head of BI, will describe how this is done and how it can be applied nationwide in key disease areas.

15:15 Metrics, Standards & Technology: How to Harness Digital to Transform Protocol Creation

Brindle_Bob Bob Brindle, Venture Leader, Cognizant Protocol Creator, Cognizant

How much effort do you waste during clinical trial protocol creation? How do you know? How do you fix it? In this increasingly digital world, it's frustrating to be constrained by traditional word processing tools, but making the shift to a digital process can be daunting. Join this session to discover the practical steps that will set you up to transform your process - and get a peek at what a digital protocol will enable.

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

Keynotes | Track 1-Feasibility | Track 2-Engagement | Track 3-Monitoring | Breakouts
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WEDNESDAY, DAY 2 | 17 October

08:00 Morning Coffee

ANALYTICS- AND DATA-DRIVEN STUDY PLANNING AND SITE SELECTION

08:30 Chairperson’s Remarks

Shawn Tedman, Head, Trial Optimization Offerings, CTOS, IQVIA

08:35 Protocol Complexity: What Can We Do to Ensure That We Create Scientifically Relevant Protocols That Are Also Patient-Centric in Design?

Holen_Kyle Kyle Holen, MD, Head, Development Design Center, AbbVie

Over the years, protocol complexity has steadily increased from both an operational and scientific perspective. This increasing complexity has caused operational delays as well as an increase in the number of protocol amendments. It has also increased the burden on sites and patients, which has led to increased challenges in patient recruitment. All of these factors lead to increase in the cost of drug development. In this session, we will be presenting new data that correlates the patient burden to cost savings and enrollment metrics. The consideration of complexity in protocol design is clearly important, but what is the best way to assess protocol complexity and how can we change the way we develop protocols to reduce complexity?

09:00 CO-PRESENTATION: Good, Better, Best: A Realistic Approach to Study Planning Using Variable Data Across Multiple Sources

Hu_Daoying Daoying Hu, MBA, PhD, Associate Director, Strategic Feasibility, UCB BioSciences

Shawn Tedman, Head, Trial Optimization Offerings, CTOS, IQVIA

Everywhere we turn there’s talk of machine learning, artificial intelligence, electronic health records, and the promise of applications in clinical research that will save time and increase insights. Progress in these areas is exciting but has also been uneven and resulted in some therapeutic areas or indications where advanced data are available and others where teams need to fall back on more traditional data and approaches. What happens when you don’t have access to the most robust EHR, patient identification, biomarker, or lab data? Maybe you’re working in a new indication and don’t have perfect data to define a recruitment rate? We’ll outline a pragmatic framework from a sponsor, CRO, and clinical technology perspective for assessing and incorporating data from different datasets. This flexible framework will work with the various levels of data availability that today’s teams are encountering and inform the best decisions with available data.

09:25 Multi-Sponsor Collaboration Platform Enables Data Driven Feasibility & Site Selection: Shared Investigator Platform

Kapoor_Beenu Beenu Kapoor, Shared Investigator Platform (SIP) - Market Leader, Cognizant Technology Solutions

Cognizant’s Shared Investigator Platform (SIP), a multi-sponsor collaboration platform, revolutionizes the interaction between Sponsors and Site users during Clinical Trial Planning, Startup, Execution and Closeout phases. SIP enables efficiency and harmonized experience for Sponsor Companies by providing savings through shared system investment and maintenance costs; and to Clinical Sites by reducing the number of systems needed to interact with multiple sponsors using an intuitive user interface, harmonized content and processes.

09:50 Coffee Break with Exhibit Viewing

USING RWD AND EHR RESEARCH PLATFORMS FOR OPTIMIZING CLINICAL RESEARCH

10:25 Federated EHR Research Platforms in Europe: The Case of InSite Platform and EHR-Enabled Recruitment in Oncology Studies

Sundgren_Mats Mats Sundgren, PhD, Director Health Informatics, AstraZeneca

This case study presentation will help attendees understand how the InSite EHR platform is enhancing protocol design and patient recruitment across Europe. Learn how both industry and health care can benefit from EHR-enabled services. See how understanding of the full stakeholder environment involved enables optimum use of EHR.

10:50 Using RWD through the Integration of Information to Optimize Clinical Research

Mayer_Miguel Miguel Angel Mayer, MD, PhD, Research Programme on Biomedical Informatics (GRIB), Hospital del Mar Medical Research Institute (IMIM), Universitat Pompeu Fabra (UPF)

It is very common that clinical data in Electronic Medical Records (EMR) is registered in different formats and in several databases in the same information system, such as coded diagnosis for billing purposes, free text in clinical notes, drug registry or discharge summaries. The integration of these sources of information in a unique system and in dedicated platforms as well, is critical and it can be very valuable for optimizing the reuse of clinical information for research purposes. We present the experience of our healthcare organization in such activities.

11:15 Sponsored Presentation (Opportunity Available)

11:40 Utilizing EHR Data: Overcoming Industry’s Biggest Challenges to Enable More Efficient Digital Data Gathering Practices to Benefit Patients, Sites and Sponsors

Ammour_Nadir 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

SCOPE EUROPE OPENING 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_Martine Martine Lewi, PhD, MBA, Scientific Director, Global R&D, Clinical Innovation, Janssen

Ammour_Nadir Nadir Ammour, DMD, MBA, Innovation Domain Leader, Patients and Sites, R&D/Clinical Science & Operations, Sanofi

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

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

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