Cambridge Healthtech Institute’s

Risk-Based Monitoring Europe

Integrating Quality into Clinical Trials to Ensure Effective Monitoring

16-17 October 2018

We are pleased to announce production of Cambridge Healthtech Institute’s Risk-Based Monitoring Europe: Integrating Quality into Clinical Trials to Ensure Effective Monitoring being held 16-17 October 2018 at the Crowne Plaza Barcelona-Fira Center in Barcelona, Spain. With the passing of ICH E6 R2, the biopharma industry now places greater emphasis on clinical trial quality and oversight than ever before. Ensuring clinical trial quality from the onset of clinical trial planning lays the foundation for successful trials and risk-based monitoring (RBM) implementation. As industry adoption of risk-based monitoring increases, it is clear that although RBM takes many forms – remote, centralized, and risk-based monitoring – successful risk-based monitoring implementation from pilot studies to full-scale rollout requires proper change management, analytics and processes. Once established RBM and its resulting data can be leveraged to drive future clinical trial decision making. 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:

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

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10:15 Coffee Break with Exhibit Viewing

Clinical Trial Quality and Oversight in the Age of ICH E6 R2

10:50 Chairperson’s Remarks

Andy Lawton, Director and Consultant, Risk Based Approach Ltd.

10:55 Why Is Vendor Oversight So Difficult?

Lawton_Andy Andy Lawton, Director and Consultant, Risk Based Approach Ltd.

With the passage of ICH E6 (R2) addendum, the pharma industry is taking a closer look at how they approach clinical trial quality and oversight with their partners. From a quality perspective, this talk will address the challenges to vendor oversight, how to define it and how to manage it.

11:20Refining the RBM Approach: Lessons Learned in Risk Based Monitoring

Belgrave_Graham Graham Belgrave, Senior Vice President, Head, European Operations, Advanced Clinical

As usage of Risk Based Monitoring (RBM) grows across the clinical development industry, its impact is clear. RBM improves the efﬁciency and effectiveness of the clinical oversight process as measured in improvements to quality, time, and cost. While benefits are apparent, the industry is cluttered with methodologies and strategies for implementation. Advanced Clinical offers lessons learned from recent experience in RBM, and best practices for a refined approach to RBM implementation.

11:45 PANEL DISCUSSION: CRO Oversight, RBM and ICH E6 R2

Lawton_Andy Andy Lawton, Director and Consultant, Risk Based Approach Ltd.

French_Charlotte1 Charlotte French, Principal, CAF Consulting LLC; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

Scaife_Richard Richard Scaife, Chair, Pharmaceutical Contract Management Group (PCMG)

With the passage of ICH E6 (R2) addendum, the pharma industry is taking a closer look at how they approach clinical trial quality and oversight with their partners. This panel will cover:

What does ICH E6 R2 mean for risk-based monitoring?
How is the industry approaching the ICH E6 R2 addendum changes: the struggles and challenges they faced or continue to face?
What does a sponsor expect the CRO to handle on its behalf?
How are sponsors and CROs collaborating to ensure clinical quality risk management?
How are sponsors and CROs handling oversight, especially when CROs subcontract to third party vendors?

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

Lessons Learned from Planning to Execution of RBM

13:55 Chairperson’s Remarks

Suzanne Lukac, Senior Account Director, CluePoints; Director, Risk-Based Monitoring Implementation, MSD

14:00 The Impact of Final ICH GCP E6 R2 Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites

Marina Malikova, PhD, MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

The ICH revised E6 guidelines was issued to reflect on the current research landscape: increases in globalization, study complexity, and technological capabilities. The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This session will explore the changes to provide a better understanding of how they impact conduct of clinical trials. Practical information and a systematic approach in assessing organizational SOPs, processes and practices as well as designing modifications to assist with implementation will also be provided.

14:25 Quality Tolerance Limits Implementation from the Perspective of Mid-Size Pharma

Makowski_Marcin Marcin Makowski, Head, Risk Based Monitoring & Standards, UCB

ICH E6 R2 Good Clinical Practice introduced the requirement for Quality Tolerance Limits implementation based on medical and statistical characteristics of the trial. TransCelerate proposed a framework for QTLs implementation in its position paper. The speaker will present a model of QTLs implementation based on the paper in a mid-size pharma company including selection of parameters, analysis of historical data and process framework. The potential synergy with implementation of new statistical concept of estimands stemming from draft ICH E9 revision will be discussed.

14:50 Change Management and Overcoming Resistance to Implementing RBM

Kokas_Gergely Gergely Kokas, PharmD, Director, Regional Head (EU North & South), Global Study Operations, Site Management, Amgen

This presentation will cover 1. Amgen RBM roadmap and touchpoints with change management requirements, 2. Internal and external aspects of change management for RBM, and 3. Example of Amgen change management strategy.

15:15 Predictive Analytics in RBM

Andrianov_Artem Artem Andrianov, CEO, Cyntegrity

Predictive Analytics(PA) is extracting data from existing data sets with the goal of identifying trends and patterns. PA can proactively identify risks for most important KRIs. Time series forecast is not enough for a risk identification. That model can be created by aggregating all available information related to the KRI.

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

8:00 Morning Coffee

Insights on Successfully Executing RBM

08:30 Chairperson’s Remarks

Johann Proeve, CSO, Cyntegrity, Cyntegrity

08:35 Implementing Risk-Based Monitoring: Lessons Learned from Planning to Execution

Lukac_Suzanne Suzanne Lukac, Senior Account Director, CluePoints; Director, Risk-Based Monitoring Implementation, MSD

When implementing risk-based monitoring, there are a number of things to consider. How do you define your approach and align team members? How do you communicate your vision and implementation strategy? Are pilot studies necessary? These are just some of the questions that will be explored in the effort to share some lessons learned from implementing RBM at a large pharma company.

09:00 The Risk Assessment Is Done – Now What? Setting up Centralized Monitoring and Addressing the Gap in Critical Thinking

Dorricott_Keith Keith Dorricott, Ambassador, Metrics Champion Consortium; Director, DMPI Ltd.

A group of industry sponsors, CROs and RBM/data analytic system vendors had worked together to consider best practices in data/metrics use in centralized monitoring. This includes development of a map showing data sources and flow for centralized monitoring, clearly defined roles and responsibilities, detailing the specific assessments that are carried out, and the pathway for tackling emerging risks and issues. The flow of data between vendors, CROs and the sponsor has been a particular focus of the group. This has led to development of a Guidance Document to assist organizations as they implement centralized monitoring on their studies.

09:50 Coffee Break with Exhibit Viewing

Insights on Successfully Executing RBM (CONT.)

10:25 RBM, Technology, and a New Era for Clinical Trials

Coskun_Nurcan Nurcan Coskun, PhD, Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic

This presentation will cover the evolution of RBM at Medtronic starting from implementing quality into clinical trials to the use of technology to globally roll out RBM. The ensuing discussion will cover the challenges and changes that RBM brought to the organization and steps to move forward including sharing the implementation of centralized monitoring with a case study from a pilot.

10:50 Sanofi’s Approach to Risked-Based Monitoring from Project to Industrialization

Mbrati_Asmaa Asmaa Mrabti, Study Risks and RBM Expert, Trial Operations, Sanofi

Starting with description of the centralized monitoring and risked based approach at Sanofi, the presentation will highlight the different strategies taken in the implementation phase of the RBM process. This will include a discussion on the challenges met and the consideration taken for a successful transition to the industrialization phase.

11:15 PANEL DISCUSSION: How Is Data Collected from RBM Driving Site Selection Decisions?

Lawton_Andy Andy Lawton, Director and Consultant, Risk Based Approach Ltd.

Kokas_Gergely Gergely Kokas, PharmD, Director, Regional Head (EU North & South), Global Study Operations, Site Management, Amgen

Makowski_Marcin Marcin Makowski, Head, Risk Based Monitoring & Standards, UCB

Topics to be discussed:

Current state of the industry in using RBM data for predictive analytics and clinical ops decision-making
Based on RBM data and statistical monitoring, are data trends emerging across sites and studies?
How is pharma/biotech and CRO leveraging the wealth of data that they are collecting from RBM for clinical ops decisions, especially around site selection and site capabilities?
What are future uses of RBM data?

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

Ammour_Nadir Nadir Ammour, MBA, Head, Clinical Digital Innovation, 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)