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
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
Andy Lawton, Director and Consultant, Risk Based Approach Ltd.
10:55 Why Is Vendor Oversight So Difficult?
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
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
Andy Lawton, Director and Consultant, Risk Based Approach
Ltd.
Charlotte French, Principal, CAF Consulting
LLC; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas
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
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
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
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
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
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
8:00 Morning Coffee
08:30 Chairperson’s Remarks
Johann Proeve, CSO, Cyntegrity, Cyntegrity
08:35 Implementing Risk-Based Monitoring: Lessons Learned from Planning to Execution
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
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
10:25 RBM, Technology, and a New Era for Clinical Trials
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
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?
Andy Lawton, Director and Consultant, Risk Based
Approach Ltd.
Gergely Kokas, PharmD, Director, Regional
Head (EU North & South), Global Study Operations, Site Management, Amgen
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
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, MBA, Head, Clinical Digital Innovation,
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)