2021 Archived Content

Cambridge Healthtech Institute’s 11th Annual

Improving Study Start-Up and Performance in Site-Centered and Hybrid Trials

Strategically Implementing Process, Tech and Systems for Rapid Study Start-Up in All Paradigms

March 3 - 4, 2021 ALL TIMES EST

We are pleased to announce CHI’s 11th Annual Improving Study Start-Up and Performance in Site-Centered and Hybrid Trials conference being held March 3-4, 2021 as part of the 12th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 2,200 leaders in clinical innovation, operations and research in 2020. SCOPE 2021 takes place March 2-4, 2021 as a fully virtual event and we hope to reach more people than ever. During these difficult times of a global pandemic, the work this clinical research community does is more important than ever and requires collaboration and innovation.

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 amKEYNOTE 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.

BREAKOUT: Decentralized and Hybrid Trials: COVID-19 as an Accelerator

Jane Jacob, PhD, Vice President, Research & Clinical Affairs, Synergy Disc Replacement, Inc.

Laurie Halloran, President & CEO, Halloran Consulting Group Inc.

Matthew Moyer, Director Clinical Supply Technology, Global Clinical Supply, Merck & Co. Inc.

Vani Nilakantan, PhD, Vice President, Research, Allina Health System

Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics LLC

Nikala Kwech, eCOA Operations Lead, Data Sciences, AbbVie Inc.

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

Angie Botto-Van Bemden, PhD, Patient Advocate, Musculoskeletal Research International

David Fauvart, Associate Director, Janssen Clinical Innovation, Johnson & Johnson Pharmaceutical R&D

Michele Teufel, Patient & Site Engagement Lead, Development Operations, AstraZeneca Pharmaceuticals Inc.

Michael Mclaughlin, Associate Director, Clinical Operations, Dermavant Sciences Inc.

Decentralized approaches to rescue existing trials: case studies and best practices
Newly initiated decentralized and hybrid studies during last 12 months: how did these approaches impact time to study start up and budget consideration?
Three major bottlenecks for adoption of decentralized and hybrid trials

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.

12:35 pmSolutions Theater: Meeting all Endpoint Needs with a Single Platform

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.

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.

1:15 pm

Reflections on COVID-19: How Virtualization of Clinical Trials Proved Critical during the Pandemic

Manny Lazaro, Vice President & Head, Global Development Operations, Jounce Therapeutics Inc.

The pandemic disrupted many areas of life, including clinical trials. Many trials stopped or were disrupted, patient participation dropped, and FDA regulations continue to evolve. But this disruption also allowed for adoption of new standards and methods for clinical development, such as virtualization. Throughout the pandemic, moving towards virtualization allowed for clinical trials to progress with fewer interruptions, ongoing participation and robust data. As virtualization becomes critical, this discussion will focus on how clinical trials can adapt to changing needs in order to progress.

1:35 pmFireside Chat with Janssen's Kimberly Carlson: Leveraging Virtual Training and Site Engagement Throughout a Study

Robert Geckeler, Product Director, SMi Trial, ScienceMedia

Kimberly Carlson, Global Development Clinical Operations Program Leader, Research & Development, Janssen

While training provided in the context of the Investigator Meeting and Site Initiation Visit are critical for study success, virtual training and site engagement tools also offer a unique mechanism for continued training and site engagement over the life of a clinical study. Join us for a focused conversation on how these evolving platforms and the programs they deliver can enable improved site performance and enhance study outcomes.

1:55 pm

The Best Pandemic-Provoked Practices Are Here to Stay

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

Covid-19 has played an extreme catalyst role in implementing existing digital and remote clinical trial solutions, and has been the engine behind rapid evolution of a few new capabilities. Some of these newly deployed capabilities are quick fixes for the emergency that COVID brought to our day to day trial operations, while many will benefit from the catalyst effect and will probably be the new standard even after COVID.

2:15 pmBeyond Lab Services: A Patient-Centered Collaboration to Swiftly Migrate to Decentralized Clinical Trials

David Freeman, General Manager, Healthcare Analytics Solutions, Quest Diagnostics

Sam Asgarian, MD, Chief Medical Officer, Thrive, An Exact Sciences Company

At the onset of the pandemic, Thrive, an Exact Sciences Company needed a decentralized pathway to pursue their ambitious goals to improve and extend the lives of patients through earlier cancer detection. Join us for a groundbreaking discussion on how a collaboration with Quest Clinical Trials Connect helped Thrive meet expectations 4X faster, highlighting the power of comprehensive clinical data and partnerships that together, are changing the face of patient recruitment.

2:35 pm

Decentralized Trials – Behind the Curtain of a Play in 3 Acts: The Setup, the Confrontation and the Resolution

John Finn, Senior Director and Inflammation & Immunology TA Lead, Data Monitoring & Management, Pfizer Inc.

William Shakespeare wrote "All the World's a Stage" - and it is upon that stage that all of global pharma is wanting to perform their version of a decentralized trial. This session will pull back the curtain and share the backstage reality of a real-life troupe of players working on their planning, execution, and risk management of a decentralized trial.

2:55 pmImproving Evidence Generation and Clinical Trial Execution through Digital Health Solutions

Fan Gao, Principal, ZS

Imran Khan, Director, Digital Health & Innovation, AbbVie

Lauren Vitale, Program Lead, Clinical Program Development, AbbVie

In a post COVID-19 world, wider adoption of hybrid trials with digital health solutions is expected to build momentum. AbbVie collaborated with ZS to understand the critical challenges for patients and sites, and what digital health capabilities may improve trial experiences, evidence generation, and study performance. We will discuss general operational challenges and opportunities from a sponsor’s perspective in improving clinical trials through the use of digital technologies.

3:15 pmDecentralized Trials Through In-Home Services: Welcome to the Future

Melissa Nezos, Vice President, Clinical Operations, Firma Clinical

This session will review the use of in-home trial services that bring the study to the patient. A case study/example of how this is executed with a real-life study will be shared, along with the importance of this service being the standard for many studies.

3:35 pm LIVE PANEL DISCUSSION:

COVID-19 Impact: What is Temporary and What is Here to Stay

Panel Moderator:

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

Panelists:

Manny Lazaro, Vice President & Head, Global Development Operations, Jounce Therapeutics Inc.

John Finn, Senior Director and Inflammation & Immunology TA Lead, Data Monitoring & Management, Pfizer Inc.

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

We will discuss the impact of COVID on the conduct of clinical research. What are the "dinosaurs" of clinical research processes that will become extinct? What are the innovations that have helped us continue to find new therapies? What are the obstacles to change?

Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics LLC

Robert DiCicco, PharmD, Deputy Chief Health Officer, IBM Watson Health

Melissa Nezos, Vice President, Clinical Operations, Firma Clinical

4:25 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

Operationalizing Hybrid Trials

Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics LLC

COVID-19 interrupted clinical trials globally and presented our industry with the challenge of continuing clinical research while ensuring patient safety and data integrity. Cerevel Therapeutics analyzed ongoing trials to identify risks and implemented innovative solutions to meet those challenges, collaborating with a wide range of service providers to create a hybrid approach which supports patient needs, data requirements and site operations.

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

Multi-Stakeholder Collaboration for Adoption of Decentralized Trials

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.

10:30 amJust-in-Time Site Activation to Increase Community Access to Clinical Trials

Matthew Cooney, MD, Vice President, Oncology Therapeutic Development, Tempus

Abhinav Chandra, MD, Medical Director, Yuma Regional Medical Center Cancer Center

Faster decision making aided by tools like standardized CTAs, JIT site activations and biomarker-driven patient identification can help increase community access to novel clinical trials. Tempus & Yuma Regional Medical Center will review their successes and lessons utilizing the TIME Trial program to proactively identify eligible patients for biomarker-driven oncology trials from NGS testing and EMRs and then activating the trial site within 14 business days for patient enrollment.

10:50 amHow to Use Machine Learning to Avoid Rescue Studies, Reduce Costs and Accelerate Timelines

Elvin Thalund, Director, Industry Strategy, Product Development, Oracle Health Sciences

Keith Dorricott, Ambassador, Metrics Champion Consortium, Metrics Champion Consortium

Standardized metrics are central to efforts to rein in clinical trials that are either poorly initiated or have incurred unforeseen events, which place the original timelines and/or budgets at risk of overages. There’s no silver bullet when it comes to improving operational efficiencies, but innovative machine learning techniques show great promise in helping life science companies identify and rectify systemic inefficiencies, allowing them to learn and adapt.

11:00 am LIVE PANEL DISCUSSION:

Engaging and Understanding Patient Behavior to Improve Accessibility, Retention and Outcomes: Outreach, Apps, Shared Insights and Behavioral Economics

Panel Moderator:

Alex Charge, Senior Vice President, Strategy, Hū

Panelists:

Karen Horgan, CEO & Co-Founder, VAL Health LLC

Brendan O'Neill, Senior Director Patient Recruitment Programs, Clinical Development & Operations & Global Product Development, Pfizer

Juliette Chen, Director, Global Evidence and Outcomes, Takeda Pharmaceuticals

Emily Freeman, PhD, Senior Director, Patient Insights, Global R&D, Lundbeck

Michele Teufel, Patient & Site Engagement Lead, Development Operations, AstraZeneca Pharmaceuticals Inc.

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

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

CO-PRESENTATION: Moving the Needle in a Large Clinical Trial Portfolio through Innovation and Communication: Sanofi's Patient and Investigator Site-Focused Programs

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

Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi

Thanks to a global effort focusing on reducing site burden, Sanofi rose to the #1 position in the CenterWatch Survey in 2019. This was the biggest jump any sponsor had achieved in consecutive surveys. In parallel, Sanofi has continued their patient-informed R&D model, bringing the patient voice into each of their programs. This has been the catalyst for various award-winning recognitions and further supported accelerated medicines development.

12:30 pm Sponsored Presentation (Opportunity Available)

12:50 pm

Propelling into a New Era of Trial Optimization for Operational Success with Data Science-Infused Analytics and Technology

Miruna Sasu, PhD, Executive Director Global Development Feasibility & Advanced Analytics, Johnson & Johnson

The Janssen Global Development Feasibility team has built a sustainable global model to support every trial with data science and technology at an industrial scale. This presentation will focus on briefly showcasing several tools and algorithms that were built internally to bring unfathomable value and data-driven solutions to trial teams that aids them in making solid decisions on how to operationalize each trial for ultimate success and decreased patient and site burden.

1:10 pmTop 5 Things I Wish I Knew About Virtual Investigator Training Before COVID

Amanda Steenbergen, Senior Director, Global Clinical Training, WCG Trifecta

1:30 pm LIVE PANEL DISCUSSION:

Pandemic-Proof Trials of 2030: Applying Lessons Learned from COVID-19

Panel Moderators:

Pamela Tenaerts, MD, MBA, Executive Director, Clinical Trials Transformation Initiative (CTTI)

Lindsay Kehoe, Project Manager, Clinical Trials Transformation Initiative

For many clinical trials, survival during the pandemic has centered on transitioning to remote practices midstream. What have we learned from these remote experiences that should carry forth into future trials? How do we approach trial design and conduct in new ways to ensure the next generation of research is resilient? This panel will discuss lessons learned from the COVID-19 pandemic, provide recommendations for improved future trials, and outline a system-wide vision for clinical trials in 2030.

Panelists:

Janice Chang, Chief Operating Officer, TransCelerate Biopharma Inc.

Patricia Hurley, Director, Center for Research & Analytics, American Society of Clinical Oncology

Angie Botto-Van Bemden, PhD, Patient Advocate, Musculoskeletal Research International

1:50 pm SCOPE Summit 2021 Adjourns