CHI's Clinical Quality & Monitoring Conferences at SCOPE 2023

2023 ARCHIVES

RBQM is now being embraced to address the dramatic increase in research complexity, duration, and cost of clinical research. The latest version of the Good Clinical Practice (GCP) quality standard extends the RBM approach to every aspect of study execution, applying the principles to all areas of quality management, and requiring robust centralized monitoring systems and processes. CHI’s Quality & Monitoring track delivers real world lessons from organizations on the leading edge of implementation and advancing RBQM. Part A: Risk Based Quality Management provides regulatory updates, oversight and governance best practices, implementation strategies, Quality tolerance limits (QTLs) and key risk indicators (KRIs), as well as lessons learned from COVID-19. Part B: Central and Remote Monitoring discusses risk-based monitoring approaches, issues detection, monitoring decentralized trials, and overcoming challenges of ensuring patient safety and data integrity.

Part 1: Risk-Based Quality Monitoring

Part 2: Central and Remote Monitoring

Monday, February 6

SCOPE’s 2nd Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)8:00 am

Connect with your peers and colleagues at SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.
*Limited space available. Separate registration and fee required for Golf.

Conference Registration Open (Gatlin Foyer)9:00 am

Open Workshop: Introducing ClinEco, the New B2B Clnical Trial Community and Marketplace1:00 pm

Sit down with a small cross-industry group for a 45-minute hands-on session to learn about, share feedback, and register for free for the new B2B clinical trial community and marketplace. ClinEco unites sponsors, CRO's, service providers, and sites to streamline partnering and vendor selection. We are currently onboarding leaders in clinical research to: Explore the Ecosystem. Engage Partners. Exchange Capabilities. Join the ClinEco community now for free at: https://clineco.io/register. Let us know if you are joining us at: bgallant@clineco.io. Walk-ins welcome. Open to all SCOPE attendees.

User Group Meetings2:00 pm

Co-locate your User Group, a Workshop or even your company's Annual Meeting with SCOPE Summit. CHI will help market the event and manage logistical operations. We will co-market prospective attendees and extend your users a discount to attend the entire SCOPE conference. We are here to work with you. Use SCOPE as your gathering point! Learn more on the SCOPE Summit website.

Part 1: Risk-Based Quality Monitoring

5:00 pm

Organizer's Welcome Remarks and 2nd Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

5:05 pm Plenary Keynote Introduction

Tarra Shingler, Chief Commercial Officer, StudyKIK

5:10 pm INTERACTIVE PANEL:

Lighting a “Beacon of Hope” to Address Racial Inequity in Clinical Trials, Health, and Education

PANEL MODERATOR:

Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi

Launched in July 2021 as a $33.7M commitment from Novartis and the Novartis US Foundation, Beacon of Hope began as a 10-year collaboration to increase diversity among clinical trial participants and investigators; improve access to high-quality education and promising jobs; address inherent bias in the data standards; and find actionable solutions to environmental and climate issues that disproportionately affect health among communities of color. This session brings together leaders from collaborating partner companies Novartis, Sanofi, Merck, and four of the participating HBCUs to discuss how Beacon of Hope aims to improve the quality and inclusivity of clinical trials.

PANELISTS:

Adrelia Allen, PharmD, PMP, Director, Clinical Trial Patient Diversity, Merck

Rajbir Singh, MD, Executive Director of Precision Medicine and Health Equity Trials Design, Meharry Medical College

Priscilla Pemu, Doctorate, MBBS MS FACP, Associate Dean Clinical Research at Morehouse School of Medicine

Kimberly Fookes, Global Head, Diversity & Inclusion in Clinical Trials, Novartis

Celia J. Maxwell, MD, Associate Dean for Research, Howard University College of Medicine, Medicine & Health Affairs, Howard University Hospital

Beacon of Hope and the Center of Excellence for Clinical Studies at Charles R. Drew University of Medicine and Science (CDU)

Jay Vadgama, PhD, Professor & Executive Vice President Research & Health Affairs & Chief, Cancer Research & Training & Internal Medicine, Charles R. Drew University of Medicine & Science

This presentation describes the importance of creating a Center of Excellence for Clinical for Clinical Studies in South Los Angeles which has one of the highest rates of health disparities in the nation. It provides important information on social determinants of health and how they impact health disparities. We provide a road-map on how CDU plans to address health disparities with partnership with Novartis and the Beacon of Hope.

Naikia Byrd-Atkinson, Director, US Clinical Trials Diversity and Inclusion, Sanofi

SCOPE's 7th Annual Participant Engagement Awards Introduction5:40 pm

5:45 pm

SCOPE's 7th Annual Participant Engagement Awards

PANEL MODERATOR:

Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 7th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2023 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award

PANELISTS:

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Anne Marie Mercurio, Clinical Trial Volunteer and Patient Advocate

Marisa Rackley, Vice President, Clinical Site Start Up, Site Engagement, Trial Optimization, Takeda

Irena Webster, Vice President, Head of Development Operations, Forma Therapeutics

Kelly White, Senior Director, Head, Global Trial Optimization, Oncology, Merck & Co.

Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Co.

SCOPE's Kick-Off Happy Hour6:30 pm

Close of Day7:45 pm

Tuesday, February 7

Registration Open (Gatlin Foyer)7:00 am

Morning Brew & Pastries to Jumpstart Your Day (Sponsorship Opportunities Available) or Morning Coffee7:30 am

8:30 am

Chairperson's Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

8:35 am Chairperson'sPlenary Keynote Introduction

Jim Reilly, Vice President, Development Cloud Strategy, Veeva Systems

8:40 am

Would I Want My Mother to Be Part of a Clinical Trial?

Virginia Nido, Global Head, Product Development Industry Collaborations, Genentech, a member of the Roche Group

Have the quality and efficiency of trials improved in the past 20 years? Have biopharma industry collaborations changed the landscape of clinical trials? Would you want YOUR mother to be part of one of your clinical trials? Learn about the breadth and scope of solutions that have come out of industry collaborations and how YOU, as a biopharma executive, have the power to adopt changes that impact the entire industry.

9:05 am INTERACTIVE PANEL:

Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It

PANEL MODERATOR:

Balazs Flink, Senior Director, Clinical Development Operations, Daiichi Sankyo, Inc.

Running a complex clinical trial involves a lot of moving pieces, forward planning, modeling, allocation of resources, and a neverending ability to adjust while maintaining the highest standards. It has never been easy, but many of us in the clinical research profession know how to do our part. The advent of DCTs, novel tech and data sources, and then the pandemic put us all to the test. However, we are now facing supply chain disruptions and other human/material resource challenges that make everything even more complicated. What is a clinical ops leader to do?

PANELISTS:

Gaurav Sawhney, Vice President, Head, Clinical Partner Management, Takeda Pharmaceuticals, Inc.

Bryan O'Neill, Global Head, Clinical Supply Operations, Daiichi Sankyo, Inc.

Deborah Profit, PhD, Vice President, Clinical Management & Applied Innovation, Otsuka America Pharmaceutical, Inc.

Ken Getz, Executive Director, Tufts Center for the Study of Drug Development

Help Us Set a Guinness World Record: Join Everyone for a Group Photo at 9:25 Sharp in the Keynote to Make History!9:30 am

Grand Opening Coffee & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available)9:35 am

10:35 am Chairperson's Remarks

David Lacagnina, Chief Business Officer, Company Management, Cyntegrity Germany GmbH

10:40 am

The Renovation of ICH Good Clinical Practice – TransCelerate Framework for ICH E8

Melissa Suprin, Head, Quality Risk Management, Clinical Development, Pfizer Inc.

Madeleine Whitehead, Process Excellence Leader, Product Development Quality Solutions, Roche Products Ltd.

ICH’s renovation of Good Clinical Practice (GCP) achieved the first milestone with the release of revision 1 of ICH E8 General Considerations of Clinical Studies. The updated ICH E8 represents a philosophical shift in the conduct of clinical research, promoting a proactive, risk-based approach, and definitively moving away from a one-size-fits-all, linear application. TransCelerate has developed a framework focusing on the elements of ICH E8 (R1) identified by member companies as essential for successful implementation and to prepare the path for the release of ICH E6 (R3) which sets the operational parameters required.

11:10 am

Quality by Design: Why Monitoring Quality is so Critical in RBQM

Esther Huffman O’Keefe, Director Adaptive Monitoring Excellence, Takeda

Quality by Design (QbD) is now a foundational element in our industry, and it’s the premise of Risk-Based Quality Management methodologies. This presentation will cover the main aspects of QbD, and then explore the possibilities of 1) monitoring for study quality, and 2) assessing the quality of a study’s monitoring activities. Current industry standards will be examined and recommendations for leveraging QbD in monitoring strategies will be provided.

11:40 am PANEL DISCUSSION:

The Place of Quality Tolerance Limits in a Changing Regulatory Environment

PANEL MODERATOR:

Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

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:

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

Chris Wells, Principle Clinical Data Specialist/Statistical Scientist, Roche Pharmaceuticals

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

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 answers the scientific questions of the trial as well as trial participant safety.

12:10 pm

Evolution of Risk-Based Monitoring — Shaped by Digital Transformation

Jonathan Hill, Associate Director, Digital Strategy, Innovation & Analytics, IQVIA

Rajneesh Patil, Vice President, Clinical Operations Digital Strategy, Innovation, Analytics, IQVIA

Risk Based Monitoring has evolved significantly in the past decade, with increasing adoption of centralization, remotization and analytics-based processes in clinical monitoring. This session shall further explore the impact on RBM model, of digital transformation, novel clinical technologies like mobility platforms and edge technologies, increase in patient generated data and the convergence with delivery models like decentralized clinical trials. Let’s co-discover the future of clinical and risk based monitoring.

Transition to Lunch12:40 pm

12:45 pm

LUNCHEON PRESENTATION:Principles of RBQM Success: Why It's Important and What Happens without an RBQM Program

Kristen Bennett, Director, Client Delivery, WCG Avoca

This presentation will walk through real-life scenarios and examples on the importance of RBQM and what happens when a robust RBQM program is not in place. The lifecycle of RBQM will also be reviewed, as well as how to incorporate these principles into the clinical execution process to prevent issues.

Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)1:15 pm

2:10 pm

Chairperson's Remarks

Anthea Dransfield, BSc, MSc, CChem, MRSC, Managing Director, Quality Center of Excellence, Advarra

2:15 pm

"DCT in Quality Track? Am I in the Right Session?" – Considerations for Imbedding Quality into DCT Approaches

Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck

Yes, you are in the right session! We will discuss considerations to maintain quality and oversight of clinical trials while balancing new challenges and options associated with the wide variety of decentralized clinical trial approaches now available.

2:45 pm

Improve Trial Experiences with Remote Monitoring and Technology

Kyle Hogan, President, Datacubed Health

In this presentation, we will discuss why improving the patient experience is critical to clinical trial success and the role remote patient monitoring and digital technologies play. We'll discuss how real-time data and transparency enable quicker decisions, patient safety, and an overall better experience for Sponsors, CROs, Sites, and patients.

3:15 pm

Avoiding Duplication of Efforts in RbQM Implementation

Shawntel Swannack, Director, Central Monitoring & Data Analytics, GSK

As the industry adapts to new ways of working, RbQM processes are driving quality in our clinical trials. In evaluating your business’ direction forward, reviewing the infrastructure and defining new responsibilities and accountabilities is key to ensuring efficient ways of working and reducing potential duplication of efforts in cross functional teams. In this session we will explore the different functions that have key accountabilities and offer insight into division of tasks, proper change management and effective implementation plans.

3:45 pm

Harnessing Risk-Based Quality Management and Deep Learning to Improve Trial Knowledge and Drive Better Outcomes

Francois Torche, Co-Founder & CEO, CluePoints

In this session, Francois will share his depth of knowledge and experience as it relates to the challenges that our industry has been facing in adopting an RBM approach and are now facing in transitioning to RBQM following ICH E6 R2 (R3) recommendations. He will also present the opportunities offered by recent technologies and analytical techniques to help study teams get the most out of their data.

4:15 pmFind Your Table and Meet Your Moderator

4:20 pmInteractive 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. Please visit the Interactive Breakout Discussion Groups Page for more information.

Welcome Reception in the Exhibit Hall (Gatlin BCD)5:00 pm

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle* (Sponsorship Opportunities Available)6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from The Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Wednesday, February 8

8:00 amRegistration Open

8:30 am

Breakfast Presentation Option #1:Achieving the Impossible: Maximizing Patient Experience and Data Quality in a Complex Rare Disease Program

Caroline Jackson, Executive Vice President, Patient Services, mdgroup

Mobile health has a significant impact on patient retention and experience in clinical trials. However,it’s still under-utilized as there is a perception that more complex assessments and procedures cannot be conducted effectively in the home. This case study highlights how mdgroup worked with a client to implement complex sample collections in the homes of patients suffering from a rare disease, resulting in reduced travel burden and low dropout rates.

8:30 am

Breakfast Presentation Option #2:Strategies for Biopharma Companies to Boost Clinical Trial Enrollment

Dennis Akkaya, Chief Commercial Officer, myTomorrows

We would like to invite you to join us for an informative event about overcoming obstacles in recruiting patients for BioPharma clinical trials. During this event, we will delve into barriers such as lack of awareness and financial considerations that can impede clinical trial recruitment success. Additionally, impactful strategies to increase clinical trial participation and recruitment success will be shared.

9:00 amSession Break

9:10 am

Chairperson's Remarks

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

9:15 am

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

Naveen KK, Executive Director & Global Head Central Monitoring and Clinical Trial Safety. Labcorp

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?

9:45 am

Great Expectations: Harnessing Historical Insights to Accelerate RBQM Strategies

Olgica Klindworth, Senior Director, R&D, RBQM, Medidata, a Dassault Systèmes company

Heidi McIntyre, Director, Clinical Data-Central Monitoring and Oversight, Moderna

As data collected in trials increases in volume and variety, it opens up new opportunities to harness insights across the trial lifecycle - from reducing protocol complexity (QbD), to improving site site selection with analytics, to executing better risk monitoring strategies with KRIs and QTLs. Learn how to take advantage of historical trial data and analytics to unlock powerful insights that improve risk-based oversight across the study.

10:15 am

Three Key Strategies to Successfully Implement Central Monitoring as Part of RBQM

Nicole Stansbury, Principal Consultant, BioTex Consulting LLC

Crystal Stone, Director, Customer Engagement, Remarque Systems

Central monitoring is a key component of a well-designed RBQM strategy yet it’s still relatively new to the industry. This session will focus on the foundational components of central monitoring and will provide a roadmap for success including people, processes, and technology.

Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)10:45 am

11:40 am

Chairperson's Remarks

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

11:45 am

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.

12:15 pm

The Growing Importance of Independent DSMB and EAC/CECs as Part of Your RBQM Program

James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarra

In this session we will delve into the role and function of Data Monitoring Committees (DMC/DSMB) and Endpoint Adjudication Committees (EAC/CEC) as part of a risk based quality monitoring program. These committees are increasingly seen as best practice to provide an independent and objective evaluation of individual clinical trial events and broader clinical trial safety thresholds. Sponsors should consider their approach to DMCs and EACs in the context of risk, and how these committees support an overall RBQM program.

12:30 pm

Navigating the Past to Chart the Future: Harnessing the Power of Retrospective Analysis for Quality-by-Design in Clinical Trials

Artem Andrianov, CEO, Cyntegrity

In this presentation, Artem will delve into the topic of retrospective analysis of clinical trials and its potential as an enabler of Quality by Design. By looking back at past data and identifying patterns and trends, we can gain valuable insights that can inform and improve the design and implementation of future clinical trials. This approach can lead to more efficient and effective trials, resulting in better patient outcomes. Join us as we explore the benefits and practical applications of retrospective analysis and discover how it can help shape the future of clinical trial design.

Transition to Lunch12:45 pm

Part 2: Central and Remote Monitoring

12:50 pm

LUNCHEON PRESENTATION:Simulation-Based eLearning: Practical Application for Complex Trials

David Hadden, Founder & President, Innovation, Pro-ficiency

Joseph Stavas, MD, MPH, Senior Vice President, Head of Global Clinical Development and Interventional Procedures, Clinical Operations, ProKidney

Come join Pro-ficiency’s Founder & President, Dave Hadden, and ProKidney’s SVP, Head of Global Clinical Development and Interventional Procedures, Dr. Joseph Stavas, as they review a past Phase 3 case study, focusing on how they addressed their unique challenges by adopting a simulation-based training approach. And both leaders and learners stand to benefit from a simulation training methodology, which pinpoints relevant site-based trends to guide targeted monitoring strategies.

Coffee & Dessert Break in the Exhibit Hall with "Best of Show Award" Winner Announcement (Gatlin BCD)1:20 pm

2:20 pm Plenary Keynote Introduction

Ivor Clarke, CEO, SubjectWell

2:25 pm

Faster, Better, Cheaper: The Increasing Role and Opportunities for Real-World Evidence in Informing Regulatory Pathways

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

An open dialogue on the facilitators, barriers, and open opportunities to effectively utilize RWE for informing regulatory pathways from a biopharma company perspective. Additionally, we will highlight some of the novel use cases and key lessons learned by biopharma companies in utilizing RWE for discovery and development purposes.

2:35 pm

Advancing Evidence Generation of the Future

Amy Abernethy, MD, PhD, President of Product Development and Chief Medical Officer at Verily; Former Principal Deputy Commissioner, FDA

Clinical research is undergoing a major shift, as we move towards continuous evidence generation to support accelerated drug development and approvals. In this talk, Dr. Abernethy will share her firsthand experience with the evolving use of real-world data and evidence at FDA during COVID. She'll speak to the need for quality longitudinal data sets, the role of technology, and how new approaches are transforming the clinical research field.

2:45 pm

Fireside Chat: Next-Generation Data Sources

Amy Abernethy, MD, PhD, President of Product Development and Chief Medical Officer at Verily; Former Principal Deputy Commissioner, FDA

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

2:55 pm

Fireside Chat: Future-Ready Operations: Building a Multi-Year Roadmap

Lynne M. Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

Jane Hiatt, Executive Director, Site Management and Monitoring, Early-Stage Development, Merck

Ward Lemaire, Head of Data Management, Integrated Data Analytics & Reporting, Janssen, J&J

With increases in complexity and new trial modalities, organizations need to constantly assess what the future needs. This chat will focus on the strategic choices and approaches to be considered, and how to plan out such a multi-year roadmap.

Booth Crawl & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available). Last Chance for Viewing. (Gatlin BCD)3:25 pm

4:25 pm

Chairperson's Remarks

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

4:30 pm

Effective QMS Oversight and Governance – Focusing on the Risks That Matter

Jason Urban, PhD, Executive Director, R&D Quality Risk Management, Governance, & Analytics, Gilead Sciences

The Quality Management System provides a framework for defining and delivering quality outcomes across R&D. Hallmarks of an effective QMS are enhanced patient safety, assurance of data integrity, and minimized delays in trials and filings. Though the overall framework for an effective QMS may vary, it must contain these three elements: 1) achieving a state of control 2) active risk management, and 3) a culture where quality is everyone’s responsibility.

5:00 pm

Monitoring Clinical Trials – Identifying Trends, Patterns, and Unusual Data: Is Simple Better?

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

As clinical trials become more complex, so has the technology that could identify realized risks. There is much value to be extracted and exploited from clinical and operational data repositories, utilizing analytics with incredibly nuanced capabilities. This presentation will touch on certain elements of monitoring where technology can be a help or a hindrance, to identifying realized risks and communicating their impact to protocol teams. Is simple better?

5:30 pm

Site Enablement: How to Accelerate Study Operations while Becoming a Sponsor of Choice

Blake Adams, Senior Vice President of Marketing, Marketing, Florence Healthcare

Discover how sponsors are utilizing site-centric connected technology to enable continuous collaboration with their sites.You’ll hear specifically how sponsors are:

Helping sites overcome staffing shortages, duplicative work and broken processes through integrated technology
Expanding patient access by enabling Frontier Sites, those new to research, with best-in-class technology that is easy to use
Maximizing CRA productivity with always-on remote monitoring of study sites
Selecting technology that does not disrupt site operations

5:45 pm

Revolutionizing Clinical Trials: The Use of Artificial Intelligence in Remote Monitoring

Veeps Piravi, CSO, InnovoCommerce

Optimal remote monitoring strategies can depend on the specific trial, but there are key elements that significantly boost their effectiveness:

An AI-driven eISF that includes source, site, and regulatory documents
A single spot for Training Records, Delegation Log, IRB approval gaps, ICF logs, etc., with the ability to monitor and address discrepancies in real time
Applying artificial intelligence to automate quality control processes for improved data accuracy and integrity

6:00 pm

Centralized and Medical Monitoring – A Marriage of Convenience or for Love?

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

ICH E6 and E8 require sponsors to focus their oversight activities on the aspects of studies which are critical for ensuring study integrity and protecting patient safety. This requirement results in prioritisation of data and processes ensuring clinical and scientific integrity of the study and makes them the primary area of focus for multiple parties involved in study oversight and delivery, including centralized monitoring and medical monitoring. In this talk I’ll discuss the challenges and opportunities resulting from looking at the same set of data and study activities from different perspectives but with risk-based quality management in mind.

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle*6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Thursday, February 9

Registration Open (Gatlin Foyer)7:15 am

7:45 am

Breakfast Presentation: Impacting Timelines vs Impacting Resources — It's Not Either / Or Anymore

Lisa Moneymaker, Chief Technology & Product Officer, Saama

Our industry is challenged to find the right resources to drive operational best practice. There is also an expectation to move at the “speed of Covid” for every trial. It feels like an either/or. However, you can have both. You can accelerate timelines with fewer resources. Join this exciting session to learn about: The biggest time and resource drains on clinical trials; Applying AI/ML to improve efficiency; Challenging your own internal processes to get to market faster.

Transition to Sessions8:15 am

8:25 am

Chairperson's Remarks

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

8:30 am

Artificial Intelligence for Oversight of Monitoring Trip Reports

Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics LLC

Sponsors review monitoring trip reports as part of effective oversight, but the process can be very manual. Cerevel worked with two vendors to design and develop an Artificial Intelligence tool to scan reports for key data points, flag reports for review based on business criteria, and built a user interface that allows for quick insight into important report content.

9:00 am

INTERACTIVE EXERCISE: Breaking the Simplest Trial Ever

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

It is well recognized that errors in trial execution lead to audit, inspection findings. However, can a trial be done so badly that it produces a totally false answer to the scientific question?In the exercise we will try to model such situation. The participants will be conducting a simple trial checking if glasses improve vision of near-sighted people (true answer: they do). We will introduce errors to the trial execution and evaluate the impact on the answer to the scientific question.

9:45 am

(Real) Remote Monitoring of the Future: Predictive Analytics to Operationalize Monitoring

Sherrine Eid, Principal Industry Consultant, Health Care & Life Sciences, SAS

Has remote patient monitoring become a buzzword, or an actionable – and impactful – part of the clinical development and clinical trial journey? By combining predictive analytics and a clinical enrollment solution, remote patient monitoring can move beyond the R2 guidance into a real-world, explainable, and data-driven tool. Hear from industry expert, Sherrine Eid, as she uncovers how organizations can use predictive analytics and enrollment forecasts to operationalize remote monitoring.

10:15 am

How to Build a Culture of Openness and Critical Thinking (per ICH E8) to Enable Better Error Detection

Nechama Katan, Director of Data Science, Data Monitoring and Management, Pfizer

We will review current practice in error detection and risked based practices. Then talk about how critical thinking is needed to move from a check box, expensive and not effective way to detect errors, to a lower cost, lower risk way to solve problems. We will address people, process and the necessary technology.

Networking Coffee Break (Gatlin Foyer)10:45 am

11:05 am

Chairperson's Remarks

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

11:10 am

Power in Partnership: Scaling DCTs with Large Pharma

Kim Boericke, COO, THREAD

Kim Hawkins, Global Head of Clinical Project Operations & Dossier Delivery, Sanofi

Today, the discussion will begin with Sanofi's journey to move from piloting DCTS to full global expansion partnering with THREAD as the technology enabler to support their ACT4Patients initiative. The discussion will continue outlining the five (5) steps needed to adopt and fully scale DCTS within a large pharma organization. The discussion will close with the ROI for scaling DCTs globally.

11:40 am

Real-World Results from Ongoing DCT Collaboration

Ricardo De Lemos, Executive Director, Project Management, Clinical Trial Services, CVS Health

Jeff Kingsley, CEO, Centricity Research

DCT design requires more complexity than brick-and-mortar research. Despite your best intentions, items can get overlooked. Our real-world experience can help guide you to success by demonstrating what we overlooked or dismissed and what we learned.

12:00 pm PANEL DISCUSSION:

Cross Industry Initiatives to Ease DCT Adoption: Updates from DTRA

PANEL MODERATOR:

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

The Decentralized Trials & Research Alliance enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research.

PANELISTS:

Jane E. Myles, Co-Lead, Priority Iniative 3B, DCT Playbook, Decentralized Trials & Research Alliance (DTRA)

Jonathan Andrus, MS, CQA, CCDM, President and COO, CRIO and Treasurer and Past Chair, Society for Clinical Data Management

Caroline Redeker, Senior Vice President, Corporate Development, Advanced Clinical

Transition to Lunch12:40 pm

12:45 pm

LUNCHEON PRESENTATION:EmPowering Communities and Underserved Populations with Localized Access to Clinical Trials

Thad Wolfram, President, EmVenio Research

Join Thad Wolfram, President of EmVenio Research, as he discusses bringing clinical trial access to a community setting using a localization approach. Learn how to provide access to hard-to-reach and underserved populations while removing barriers and unlocking doors to innovation.

Closing Remarks1:15 pm

Scope Summit 2023 Adjourns1:20 pm