October 2022 • Archived Content

OVERVIEW | DOWNLOAD BROCHURE | INTERACTIVE DISCUSSIONS | ATTENDEES | ATTENDEES PROFILE

Cambridge Healthtech Institute’s 5th Annual

Risk-Based Quality Management and Monitoring

Beyond COVID-19: Tools and Processes to Accelerate RBQM and Improve Monitoring

3 - 4 October 2022 ALL TIMES CEST

Where RBQM implementation had proceeded in a conservative, iterative manner pre-pandemic, the challenges presented during this unexpected crisis resulted in acceleration with respect to onsite and remote monitoring practices in clinical trials. With the backdrop of lessons from COVID-19, CHI’s 5th Annual Risk-Based Quality Management and Monitoring conference provides processes and tools for acceleration of RBQM implementation, regulatory requirements, QTL & KRI setup and monitoring, early risk and issue detection, and monitoring approaches. 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, 4 conference tracks focused on specific issues and functions within the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please join us at this year's "Risk-Based Quality Management and Monitoring" conference at SCOPE Europe in Barcelona in October!

Monday, 3 October

Registration and Morning Coffee (Terraza Jardin)07:45

08:50Organizer's Welcome Remarks

08:55

Chairperson's Remarks

Łukasz Bojarski, Head of Centralized Monitoring, AstraZeneca Pharmaceuticals, Inc.

09:00

What Are We Monitoring – Studies or Sites?

Katarzyna Zukiewicz, Central Monitoring Process Manager, GlaxoSmithKline

Having a great variety of strategies available and flexibility in the extent and nature of monitoring ensured in ICH GCP E6, the question that we should ask ourselves is, “Are we monitoring studies or sites?” This session explores how different approaches to monitoring allow us to protect data integrity and prevent study failure.

09:25

KPIs Are Used for Oversight – But Can They Monitor Risks Too?

Steve Crow, PhD, Associate Director, Clinical Performance, Operational Quality & Excellence, Global Clinical Development Operations, Jazz Pharmaceuticals

Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.

Key Performance Indicators are an important part of oversight in clinical trials. They are typically considered completely separately from the metrics used as part of RBQM (KRIs and QTLs) – but why? This presentation will show how KPIs are used to help manage risk and discuss lessons learned from selection, implementation, and use of KPIs between a sponsor and CRO.

09:50

Meeting Disruption – Can an RBQM Implementation Journey Address Lack of Diversity in Clinical Trials?

Grzegorz Cinciala, Director, Risk Evaluation & Adaptive Integrated Monitoring, Clinical Trials, MSD

Lydia Matombo, Director, Risk Evaluation & Adaptive Integrated Monitoring, System & Data Integration Lead, MSD

Implementing RBQM principles into existing clinical trial processes has proven to be challenging in supporting complex study designs. In addition, there is an impetus for the industry to explore whether RBQM can be leveraged in addressing the lack of clinical trial diversity. Can this be accomplished via industry-wide Key Risk Indicators?

10:15 PANEL DISCUSSION:

The Place of Quality Tolerance Limits in a Changing Regulatory Environment

PANEL MODERATOR:

Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.

The ICH E6(R3) and ICH E8(R1) revisions are part of the (GCP) Renovation initiative. The two guidelines interplay to support clinical trial design, conduct, and data quality. The ICH E9 (R1) addendum presents a structured framework to strengthen the dialogue between disciplines involved in the formulation of clinical trial objectives, design, conduct, analysis, and interpretation, as well as between sponsor and regulator regarding the treatment effect(s) of interest that a clinical trial should address. While Quality Tolerance Limits are specifically called out in ICH E6 (R2), they are no longer in the revisions. Do QTLs still have a place in the Quality Management System? And if so, what are the recommendations on how to best implement QTLs to ensure regulatory compliance and ensure our clinical trials produce quality data that will answer the scientific questions of the trial, as well as trial participant safety?

PANELISTS:

Grzegorz Cinciala, Director, Risk Evaluation & Adaptive Integrated Monitoring, Clinical Trials, MSD

Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

Grand Opening Coffee Break in the Exhibit Hall (Verdi)10:40

11:35

Organizer's and Chairperson's Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

11:40

Developing and Executing a Digital Strategy for Engagement, Safety Monitoring, and Retention in Clinical Trials/Hybrid Trials

Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech

Clinical development, in particular, hybrid trials with digital health tools/wearables have a challenge of balancing the need for high-quality data collection and the patient burden associated with such devices/digital methods. A carefully crafted digital strategy needs to be developed to optimize clinical development needs with patient-centric strategies for engagement, ensuring the safety of patients, keeping patients motivated, and avoiding drop-offs prior to study closeout. Digital strategy could help accelerate trials, improve diversity in recruitment and lead to better outcomes for patients.

12:10 PANEL DISCUSSION:

Building Clinical Trial Infrastructure for the Future

PANEL MODERATOR:

Mohanad Fors, Head, Global Commercial Digital Innovation, Almirall LLC

The key digital tools have long been at our disposal, but it was a global pandemic that served as the impetus to fundamentally change our approach to and acceptance of them. However, we misinterpreted the future and pharma didn’t succeed in creating the right infrastructure for the future. Most clinical trials stopped because we didn’t have investment in virtual clinical trials. An overcoming of cultural obstacles is required for digital mindsets to be adopted within the industry. So, how do we in small biotech, big pharma, CROs, and academic research participate in and build the clinical trial infrastructure for the future?

PANELISTS:

Shwen Gwee, Vice President & Head, Global Digital Strategy

Terttu Haring, MD, Global Head, Clinical Innovation Office, Sanofi

Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)

Paul Duffy, Head, Global Clinical Site Partnerships, MSD

Join Your Peers for a Networking Luncheon in the Exhibit Hall (Verdi)12:50

14:25

Chairperson's Remarks

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

14:30

Beyond Trial Risk Analyses: Leveraging RBQM to Support Process Improvement and Educational Efforts

Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

While RBM originally was focused on identifying site- and study-level risks, expanding our risk analyses beyond trial level gave us the opportunity to identify broader systemic issues that may be caused by external and internal processes. Conducting a proper root cause analysis and ensuring feedback loops have led to process improvement and educational efforts. During the session, I will share examples of how we at Janssen – JnJ are using beyond trial level risk analyses to support process improvement and educational efforts.

14:55

A Journey towards Mature RBQM and CM – Notes from the Logbook

Łukasz Bojarski, Head of Centralized Monitoring, AstraZeneca Pharmaceuticals, Inc.

I will take a glance into the rear-view mirror to highlight key implementation milestones, successes, and challenges we encountered on the way towards the 8th year of Risk-Based Quality Management and Centralized Monitoring history at AstraZeneca. I will discuss these elements of RBQM which bring the biggest value now and will make an attempt to foresee how they are going to change in the not-so-far future.

15:20

The Road to Successful Risk Monitoring in Clinical Studies

Joseph Goodgame, Co-Founder and CTO, Remarque Systems

Andrea Ochoa, MS, Senior Vice President, Clinical Development EMEA & APAC, Premier Research

Risk monitoring traditionally has been treated as an add-on to clinical trial management, leading to uncertainty among monitoring and clinical groups. This presentation will demonstrate that a consistent, unified approach to risk assessment that encompasses multiple monitoring platforms — on-site, remote, centralized, and risk-based — can create a process and organization structure that positions you for success in any circumstance.

15:45Find Your Table and Meet Your Moderator

15:50Interactive Breakout Discussions

Interactive Breakout Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by facilitators who keep the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Breakout Discussions Page for a complete listing of topics and descriptions.

BREAKOUT DISCUSSION:

TABLE 2: Data Management Strategies to Ensure Quality and Improve Analytics

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

Risk Based Clinical Data Management approaches
RWD to accelerate design and execution of clinical trials
Innovative technologies and processes to ensure quality data
Elevating data insights to action

Welcome Reception and Booth Crawl in the Exhibit Hall with Beer, Wine and Tapas (Sponsorship Opportunities Available)16:25

Close of Day17:30

Tuesday, 4 October

Morning Coffee (Terraza Jardin)08:30

09:25 Chairperson's Remarks

Joseph Goodgame, Co-Founder and CTO, Remarque Systems

09:30

Risk Acceptance – Undervalued Aspect of RBQM

Anna Grudnicka, Director Centralized Monitoring, AstraZeneca

Why conscious risk acceptance is important, and how risk acceptance, as a risk mitigation strategy, is currently leveraged by AstraZeneca.

09:55

Risk-Based Quality Management – Tools and Processes at Roche

Herman Gavin R Boodoo, PhD, MBA, DLSHTM, Joint Product Owner, CRL Community Leader, Roche

Explore key elements of risk-based quality management and implementation at Roche. Hear experiences and best practices performing risk assessments, KRI selection and programming, issue detection/action/escalation, and QTL selection and tracking.

Coffee Break in the Exhibit Hall (Verdi)10:20

11:05

Chairperson's Remarks

Brenda Yanak, Founder, Clinical Transformation Partners

11:10

Innovation Adoption Cycle for Technologies That Support Decentralized Clinical Trials

Maria Florez, Research Consultant, Tufts Center for the Study of Drug Development

This presentation will provide insights from original global research looking at the length and stages of the innovation adoption cycle for innovations supporting virtual and decentralized clinical trials – for example, eCOAs, ePROs, eCONSENT, RBM, RWE, etc. The audience will gain an understanding of the length of the innovation adoption cycle, factors that shape innovation adoption of technologies and capabilities supporting clinical trial execution, challenges associated with the completion of each of the stages of the innovation adoption cycle for technologies, and capabilities supporting clinical trial execution – initiation, evaluation, adoption decision, and full implementation – and what to do to reduce the barriers to full adoption.

11:40 PANEL DISCUSSION:

Considerations for Next-Gen Informed Consent

PANEL MODERATOR:

Brenda Yanak, Founder, Clinical Transformation Partners

Come join a panel of industry leaders as we discuss ethical considerations and practical impacts of advances in science and technology on informed consent - ex, AI, gene editing, big data. What do scientists and technologists want to do? How can we work together to explain such complex topics to trial participants, as well as risks and benefits? What are the process and technology considerations?

PANELISTS:

Catherine Mela, PhD, Head Biosamples, AstraZeneca

Sofiane Nacia, Associate Director, Strategic Trial Participant Liaison, Novartis

Katrina Bramstedt, PhD, Global Head of Bioethics, Roche

Join Your Peers for a Networking Luncheon in the Exhibit Hall (Verdi)12:20

13:55

Chairperson's Remarks

Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

14:00

INTERACTIVE DEMO: Data Analysis as Part of RBQM

Łukasz Bojarski, Head of Centralized Monitoring, AstraZeneca Pharmaceuticals, Inc.

Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline

Marion Wolfs, Head, Senior Director, Risk Management & Central Monitoring, Janssen Pharmaceutical Companies of Johnson & Johnson

Join this interactive data analysis demo to gain hands-on experience analyzing clinical data to identify sites at risk, systemic issues, translate signals into action, and educational efforts.

Session Break14:50

14:55 PANEL DISCUSSION:

Intersection of Clinical Trials and Healthcare: Current Trends and Innovation in Changing Regulatory Landscape

PANEL MODERATOR:

Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine

This presentation will explore challenges clinical teams and sponsors face in developing and implementing protocols to ensure the right patients are enrolled and accurate data collected to demonstrate a drug/device/biologic is safe and efficacious, while at the same time managing study costs/complexity, especially in trials that involve multiple healthcare services, digital technology, and special populations. Key factors to consider, when developing protocols and techniques to minimize complexity will be discussed.

PANELISTS:

Rajesh Ghosh, Head, Digital Safety and Decision Support, Genentech

Rosanne Janssens, PhD, Postdoctoral Researcher, Pharmaceutical Sciences, KU Leuven