2021 Archived Content

Cambridge Healthtech Institute’s 7th Annual

Central and Remote Monitoring

Leveraging Central and Remote Monitoring in Risk-Based Quality Management

March 3 - 4, 2021 ALL TIMES EST

The principals of RBQM require effective monitoring, and effective trial monitoring is critical for the protection of subjects, the integrity of the data produced, and the success of the trial. With clinical study monitors and patients restricted from travel, sites, sponsors, and contract research organizations (CROs) are reassessing ways to keep existing trials on track, as well as initiating and expediting trials in a post-pandemic world. The Central and Remote Monitoring conference provides recent lessons learned from the COVID-19 pandemic and interactive discussion on the path forward, including new remote monitoring and centralized monitoring tools and strategies can support continuity of clinical trials. Topics discussed include optimizing the use of central and remote monitoring post COVID-19, understanding FDA guidance on remote and centralized monitoring, data quality and analytics, lessons learned and best practices around remote site and remote patient visits. Program Advisors: Laurie Halloran, CEO, Halloran Consulting Group, Inc. Andy Lawton, Director & Consultant, Risk Based Approach Ltd. Michael Walega, Head, Centralized Monitoring, Bristol-Myers Squib

Day 1
Day 2

Wednesday, March 3

10:55 am KEYNOTE PRESENTATION:

COVID-19: How an External Event Redoubled Janssen’s Culture of Innovation

Darren Weston, Vice President, Integrated Data Analytics & Reporting (IDAR), Janssen

The external threat posed by the pandemic forced Janssen to reckon with longstanding cultural barriers to innovation. Faced with an urgent need to ensure patient safety and continuity of care, Janssen found a way to overcome these barriers and evolve the way they conduct clinical trials. Not only did Janssen minimize overall trial impact, but Janssen’s clinical operations have become more efficient and resilient in the face of future challenges. We will discuss the cultural and operational adaptations Janssen undertook to adapt to the pandemic environment and how we see these actions positioning us for the future.

11:20 am KEYNOTE PRESENTATION: KEYNOTE PRESENTATION: Virtual Investigator Meetings During COVID-19 & Beyond

Steven Sulkin, Founder & CEO, SimuLyve International, Inc.®

Steven Sulkin, CEO, SimuLyve International

Marina Ziehn, PhD, Global Med. Affairs Dir. Neuroscience, Novartis

Markus Krüer, PhD, Head Clinical Project Mgt, Merz

Nico Wegener, PhD, Senior Clinical Project Mgr, Merz

Dave Matthews, Clinical Project Dir., Merz

Training worldwide staff on complicated protocols virtually with the added issue of language barriers can seem daunting. Our panel of virtual experts will show you how to perfect virtual skills and enhance virtual meetings.

11:20 am KEYNOTE PRESENTATION:

Option 2: New Players and Innovators in Clinical Trials, the Impact of Non-Pharma Entrants...Meet Salesforce and CVS Health

Shwen Gwee, Vice President & Head, Global Digital Strategy, Bristol-Myers Squibb Co.

Gary Gabriel, PhD, Healthcare and Life Sciences Lead, Salesforce

Lou Sanquini, Vice President, Life Sciences Group, CVS Health

11:45 am Tech Break, Transition to Interactive Breakout Discussions

12:00 pm Interactive Breakout Discussions - Visit Our Virtual Exhibit Hall

Join your colleagues and fellow delegates for a focused, informal discussion moderated by a member of our speaking faculty. A small group format allows participants to meet potential collaborators, share examples from their own work and discuss ideas with peers. View all topics here.

12:30 pm Session Break - Visit Our Virtual Exhibit Hall

12:35 pmSolutions Theater: Highthinkmed, One of the Top-5 Clinical CROs in China, Provides One-Stop Full Clinical Services with Ultimate Quality

Leon Sun, Chief Science Officer, RA，PV，MD, Beijing Highthink Technology Co., Ltd

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

4:10 pmSolutions Theater: Trends in Trial Design and Technology for Pediatric Research

Bernadette Tosti, Vice President, Patient Experience, Science 37

Lindsay Singler, Director, Research Communications & Engagement, Operations Management Team, Duke Clinical Research Institute

Current events have driven pediatric clinical research to be more flexible and efficient—to increase patient access and enhance the patient experience both during the COVID-19 pandemic and beyond. With increased regulatory support for direct-to-family (decentralized) trials, learn how to leverage technology to safely and efficiently conduct research using a current, real-life example of trial design.

Geoff Gill, President, Shimmer Americas, Shimmer Research

Different endpoints derived from wearables can require very different wearable sensors. Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain. Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

1:15 pm

RBQM to the Rescue: Strategic Monitoring during a Pandemic (and Beyond!)

Esther Huffman O’Keefe, Associate Director, Monitoring, Regeneron Pharmaceuticals

The COVID-19 pandemic made clinical trial continuity a priority for our industry, and COVID-19 treatment trials required a new focus on strategic approaches. Fortunately, the principles of RBQM enabled both! This session will focus on lessons learned from monitoring COVID-19 studies that changed the way Regeneron thinks about remote SDV, remote SDR, central monitoring and issues management.

1:35 pmA Case Study: How Centralized Remote Monitoring is Powering the Global Race to COVID Vaccines

Blake Adams, Vice President, Marketing, Florence

Learn how companies like Pfizer are deploying remote site access solutions to power their global COVID vaccine studies and how you can harness the same technology to accelerate your research operations.

1:55 pm

Case Study: Strategies and Recommendations for the Use of Centralized Monitoring Techniques to Evaluate Cohorts in Clinical Trials

Michael Walega, Head, Centralized Monitoring, Bristol-Myers Squibb Co.

Oncology trials, by their nature, are very complicated to execute, with the potential the evaluation of many treatment regimens and disease targets in a single trial. This introduces many opportunities for risks to appear / disappear / re-appear during ongoing trial conduct. This presentation will provide an overview of some of the approaches that BMS has undertaken / is building to address how we can effectively identify realized risks in these complex clinical trial ecosystems.

2:15 pm Welcome to the Content Cloud: One Secure Platform for Remote Site Monitoring

Manu Vohra, Managing Director, Life Sciences, Box

Accelerate clinical R&D processes across the value chain, maintain GxP compliance and reduce your overall IT footprint. Designed with content at the center, Box is the content cloud: one secure platform for managing your regulated and non regulated content in the cloud.

2:35 pm

CO-PRESENTATION: A Decentralized Hybrid Model for Remote Monitoring: The eSource Opportunity

Rakesh Maniar, Head of eClinical Technologies, Global Data Management & Standards, Merck & Co., Co-Lead, TransCelerate eSource Initiative, Immediate Past Co-Chair/Co-Founder SCDM eSource Implementation Consortium

Joe Dustin, Head of Clinical Innovation, Bristol-Myers Squibb

TransCelerate’s eSource initiative supports decentralized trials and remote monitoring with a variety of tools and tactics, including direct data capture from electronic health records and consumer or patient-driven tools like apps and wearable devices. eSource allows sites and sponsors to collaborate effectively in both traditional and remote trials, the development of which has accelerated significantly. This presentation will discuss the role of eSource technologies and best practices from various TransCelerate’s initiatives including regulatory landscape assessment conducted to enable data collection, remote monitoring, source data review, source data verification, and plans for the future, including how sites and sponsors can work together using technology to monitor patients remotely in real-time.

2:55 pm Tech Break, Transition to Live Panel Discussion

3:05 pm LIVE PANEL DISCUSSION:

Monitoring Approaches to Support RBQM

Panel Moderator:

Michael Walega, Head, Centralized Monitoring, Bristol-Myers Squibb Co.

Panelists:

Esther Huffman O’Keefe, Associate Director, Monitoring, Regeneron Pharmaceuticals

Joe Dustin, Head of Clinical Innovation, Bristol-Myers Squibb

3:30 pm Close of Day

Day 1
Day 2

Thursday, March 4

9:00 am

Moving toward Platform Thinking: Creating a More Seamless Front-End and Back-End to Future-Proof and Advance Digital Transformation in Pharma

Panel Moderator:

Adama Ibrahim, Director, Digital Solutions & Technology & Platforms, Data & Digital Global Drug Development, Novartis Pharma AG

COVID has been a reality check for the biopharma industry and it is evident we should be focused on future proofing. We operate through webs of legacy systems, complex org charts and entrenched 'resistance to change' cultures. Platform thinking is the opposite. Imagine a patient or physician able to find, learn about and participate in clinical research similar to the way we all interact with our own financial services companies through apps and sophisticated yet simple technology solutions! This can be possible through common enterprise thinking and approaches that are adopted across the industry.

Panelists:

Mohammed Ali, VP Digital Analytics & Performance, GlaxoSmithKline

Hassan Kadhim, Director & Head, Clinical Trial Business Capabilities, Bristol-Myers Squibb Co.

Craig Lipset, Founder & Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)

Disa Lee Choun, Head, GCSO Innovation, UCB Pharma

9:30 am

Remote Monitoring: Data Quality Risk Assessment during and after a Pandemic

Amy Jimmerson, RN, BSN, MSHCA, CCRA, Clinical Monitoring Director, Medtronic

This topic will focus on how one company developed and implemented a Remote Monitoring Quality Assessment tool and process post COVID-19. The discussion will focus on the process development aspect, why the process was necessary and the determinants/components used for developing the tool. The discussion will include factors to consider when determining if there is a difference in data quality between remote monitoring and on-site monitoring.

9:50 am

Implementation of RBQM for Site Management at Bayer and Impact to Resource Management

Piet Theisohn, Vice President, Resource Management, Clinical Operations, R&D Clinical Operations, Bayer AG - Pharma

Subrata Bose, PhD, Global Head Clinical Trials Analytics & Insights, Bayer

Bayer has applied elements of “Risk-Based Monitoring” in clinical trials for years. In 2019, we set up a project to compile the experience made and design and establish a revised framework and corresponding dashboard for the next phase of “Risk-Based Quality Management." This includes using data and advanced statistical analytics for identifying early risk signals, monitoring visit planning, and mitigation. Results are driving a revision of our resourcing approach.

10:10 am

Risk-Based Quality Management, Verb or Noun? Uncovering & Addressing the Gaps

Sandra 'Sam' Sather, Vice President, Clinical Operations & Quality Initiatives, Clinical Pathways LLC

Have you ever heard or stated, “We are not doing RBM for this study”? This is using the term RBM to refer to a service vs. an integrated process. Per ICH E6, RBQM should be part of a sponsors QMS. Even more complicated is when a CRO is involved, “we rely on their RBQM." This session discusses this challenge, and recommendations to support the relationship and quality of the trial.

10:30 amAdvancing Clinical Trial Monitoring

Zabir Macci, Associate Director Central Monitoring, Clinical Operations Process Design & Analytics, IQVIA

Beenu Kapoor, Vice President, IT, Trial Management, IQVIA

Site availability during COVID-19 drove more studies to remote monitoring and increased the adoption rate of RBM processes. Risk-based monitoring (RBM) continues to evolve, using AI/ML with advanced and predictive analytics, enhancing patient safety while increasing study quality. This presentation is a discussion, complete with use cases and examples of monitoring approaches, RBM - remote and centralized monitoring, cloud-based or resource-based approaches- which are changing monitoring is today's clinical development market.

10:50 am Tech Break, Transition to Live Q&A

11:00 am LIVE PANEL DISCUSSION:

Monitoring Approaches to Support RBQM

Panel Moderator:

Amy Jimmerson, RN, BSN, MSHCA, CCRA, Clinical Monitoring Director, Medtronic

Panelists:

Jeffrey Siracuse, MD, MBA, Associate Professor, Surgery, Boston University

Sandra 'Sam' Sather, Vice President, Clinical Operations & Quality Initiatives, Clinical Pathways LLC

Bree Burks, Vice President, Strategy & Site Solutions, Veeva Systems

Zabir Macci, Associate Director Central Monitoring, Clinical Operations Process Design & Analytics, IQVIA

Beenu Kapoor, Vice President, IT, Trial Management, IQVIA

11:25 am KEYNOTE PRESENTATION:

Option 1: Tokenization of Our Clinical Trial Participants

Kyle Holen, Head, Development Design Center, AbbVie Inc.

Unique, encrypted patient identifiers allow you to match the world's data with the people that participate in your clinical research studies. The opportunities to learn more from the study participants are endless; however, there are significant legal and privacy concerns that need to be addressed. This presentation will walk you through how to address these concerns, the implications to the consent and protocol, and how to implement at sites.

11:25 am KEYNOTE PRESENTATION:

Option 2: Social Determinants of Health (SDoH) and Its Relevance to Clinical Trials

Laurie Myers, Director, Global Health Literacy, Merck & Co Inc

It is well documented that clinical trials have struggled to achieve equitable participation of racial-ethnic minorities and women. However, the role of social determinants of health (SDOH) on participation and retention rates of research participants in clinical trials has not been well studied. Additionally, there are a few studies that suggest SDOH may have an impact on clinical trial results, highlighting the importance for more studies to consider the SDOH as another dimension when developing clinical programs.

11:50 am Session Break - Visit Our Virtual Exhibit Hall

12:10 pm

Getting Closer to the Data in a Socially Distanced World

Sarah Bednarski, MS, Director, Strategic Monitoring Analytics, Clinical Operations, Sunovion Pharmaceuticals

Get valuable takeaways that can be implemented right away, such as: 1. How to leverage your risk assessment to understand the gaps due to COVID-19; 2. How a subject-level focus within select time frames can yield insight about what's really happening on site; 3. How to leverage pre and post-COVID performance in an ongoing trial.

12:30 pm LIVE PANEL DISCUSSION:

Balancing Patient Safety, Quality and Data Integrity: Lessons Learned from Remote and Centralized Monitoring Implementations

Panel Moderator:

Todd Johnson, MPH, MBA, Principal Consultant, Organizational Solutions, Halloran Consulting Group

It is no secret that the pandemic has ushered in a new interest in remote and centralized monitoring solutions and processes. Companies have been forced to pivot to more innovative methods to collecting and overseeing trial data – and this change has needed to happen rapidly. In this interactive panel, attendees will learn about the challenges in implementing remote and centralized monitoring processes in a global organization.

Panelists:

Amy Jimmerson, RN, BSN, MSHCA, CCRA, Clinical Monitoring Director, Medtronic

Launa Aspeslet, PhD, CEO, TRIO

1:10 pm Tech Break, Transition to Live Panel Discussion

1:20 pm LIVE PANEL DISCUSSION:

Overcoming Challenges to Technology Adoption in Clinical Trials

Panel Moderator:

Todd Johnson, MPH, MBA, Principal Consultant, Organizational Solutions, Halloran Consulting Group

Panelists:

Michelle Bulliard, Vice President, Global Head Real World Evidence, IQVIA MedTech

Amy Jimmerson, RN, BSN, MSHCA, CCRA, Clinical Monitoring Director, Medtronic

Launa Aspeslet, PhD, CEO, TRIO