CHI's Decentralized (DCT) & Hybrid Clinical Trials Conferences at SCOPE 2023

2023 ARCHIVES

Decentralized Trials and Clinical Innovation

SCOPE’s Decentralized and Hybrid stream is designed to bring together leaders in the field of clinical innovation to discuss best practices and winning strategies for decentralized and hybrid trials. Industry leaders will share their insights on the current state and future of decentralized and hybrid trials as well as on the pandemic-triggered innovation in general. Conversations will focus on the global regulatory update on DCTs, role of retail pharmacies in the DCT space, use cases and metrics for DCTs, technology breakthroughs and lessons learned. The stream includes two unique parts, each of which features its own set of topics and speakers. Part 1: Decentralized and Hybrid Trials (February 7-8) Part 2: Decentralized Trials and Clinical Innovation (February 8-9)

Part 1: Decentralized and Hybrid Trials

Part 2: Decentralized Trials and Clinical Innovation

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: Decentralized and Hybrid Trials

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 and Refreshment Break in the Exhibit Hall9:35 am

10:35 am Chairperson's Remarks

Mark Maietta, President, YPrime

10:40 am

Transforming Clinical Trials of the Future: A Look into Clinical Trials 2031 and beyond

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

This session will focus on TransCelerate’s work to transform clinical trials of the future to be more patient-centric, including introduction of a scenario-planning methodology to explore the potential drivers influencing the future of clinical trials and considerations for enabling participant data return.

11:00 am

Implementing Disruptive DCT Approaches

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc

Multiple deficiencies have impacted traditional trials with recruitment and enrollment challenges, difficulties to retain trial participants, lack of inclusion and diversity, and difficulties with data quality. Traditional trials are now disrupted with novel DCT designs which represent multi-dimensional and multi-functional delivery approaches that combine scientific, medical, clinical research, operational, regulatory, legal, and Qa/Qc expertise working in synchronicity. This presentation discusses views on disrupting traditional trials with novel DCT strategies and elements, noting current trends and influencing factors such as the regulations that will yield the next cadence of DCT solutions for the field.

11:20 am

Decentralized Trials Are Here to Stay – Do the Industry, Investigators, and Patients All Have the Same Understanding of the Concept?

Roland Barge, Associate Director, User Experience Research, Regeneron Pharmaceuticals, Inc.

Patrick A. Floody, Executive Director, Global Clinicl Trial Services, Regeneron Pharmaceuticals, Inc.

Advances in technology and changes in expectations due to COVID-19 have reportedly increased adoption of decentralized trials. Regeneron conducted two U.S.-focused surveys to determine the current perception and awareness of decentralized clinical trials from two non-industry perspectives. The first focused on clinical trial site perceptions of decentralized trials, and the second focused on clinical trial patients and healthy subjects. We also compared our results to recent industry data.

11:45 am

Clinical Trial Conduct across More USA Zip Codes – A Decentralized Approach

Conor Kane, Senior Director, Janssen Clinical Innovation

Rachel Soon, Director, Janssen Clinical Innovation

The pandemic disrupted the traditional clinical trial model, accelerating the adoption of new patient-centered options. In line with this shift, multiple service providers in clinical research are answering the call from patients to bring research opportunities directly to their neighborhood, and supporting sponsors by offering access to novel datasets. Armed with the knowledge that 50% of FDA trials are conducted in 1-2% of zip codes in the US today, Janssen are exploring multiple, innovative options to expand into the remaining zip codes and enhance participant representation in our trials. We will aim to share lessons learned to date from our experience in providing more localized options to clinical trial participants.

12:10 pm

Defining a Digital and Connected Future for Clinical Trials

Lorena Gomez, R., Global Head Study Start Up, COA, and Digital Implementation, Abbvie

Rakesh Maniar, Head of eClinical Technologies, Global Data Management and Standards, Clinical Trial Operations, Merck

Jim Reilly, Vice President, Development Cloud Strategy, Veeva

Matt Southwick, Executive Director of Business Operations and Strategic Initiatives, Gilead

Richard Young, Vice President, Vault CDMS Strategy, Veeva

The industry is accelerating technology adoption under a decentralized umbrella. However, stakeholder collaboration remains a challenge. How can we deliver efficient practices that connect sites, patients, and researchers in a sustainable manner? We must continue the momentum toward patient- and site-centric trials with a digital model that is paperless, connected, and harmonizes data for a complete and concurrent view of studies. Join Veeva to discuss best practices driving digital trial transformation.

Transition to Lunch12:40 pm

12:45 pm

LUNCHEON PRESENTATION:Push & Pull: The Duality of Modern Clinical Trials

Derk Arts, MD, PhD, Founder & CEO, Castor

During this panel, Castor’s Derk Arts will moderate a discussion on how to solve design and interoperability challenges that should be imperative in modern trials, and how we can break the shackles that still hold us back.

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

Chairperson's Remarks (Opportunity Available)2:10 pm

2:15 pm

The Transforming Landscape of Clinical Trial Locations: Community-Based, Home, Traditional, Retail, and Virtual

Sidharth (Sid) Jain, Head, Global Dev Data Science Strategy & Portfolio, Janssen Pharmaceuticals Inc

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

Josh Rose, Clinical Trial Innovation and Drug Development Executive, CVS Health

The traditional dedicated clinical trial site approach model has served its purpose well for years as the gold standard for clinical research. However, the industry is still plagued with low patient enrollment, imbalance in participant diversity, elongated timelines, and increasing study costs. It's time for the industry to embrace more current and evolved approach to clinical trial locations.

2:45 pm

Designing for Decentralization: An Evidence Driven Approach to Optimize Protocols to Realize the Promises of DCTs

Amit Mudgal, Associate Principal, ZS

Arnab Roy, Decision Analytics Manager, ZS

Which assessments & visits can we feasibly decentralize? What are the risks and benefits to patients and sites if we were to decentralize specific assessments? Creating an analytical ecosystem to enable data & evidence based decision is critical for fit-for-purpose DCT study design and for upfront operational planning & risk mitigation.

3:15 pm

Trust Is a Two-Way Street: How Industry Can Lead and Maintain Patient Engagement in DCTs

John Campbell, Head of Decentralized Trials, Walgreen Co.

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

The unprecedented increase in the volume of data from digital technologies is an opportunity to address long-standing challenges in clinical research. To ensure equitable outcomes from clinical trial innovation requires an initial acknowledgment and sustainable plan. During this session, we will highlight recent activities to showcase the impact on patients, providers, and other key stakeholders.

3:45 pm

Integration of Patient-Mediated Medical Records Into Clinical Trials

Jeff Lowry, Director of Enterprise Data Services, UBC

4:00 pm

Beyond DCT—What’s Next in Clinical Research?

Darcy Forman, Chief Delivery Officer, Science 37

In this session, Science 37’s Chief Delivery Officer, Darcy Forman will share where clinical research is headed next, and how the Metasite is at the forefront of a long-term industry shift, where virtual sites work alongside traditional sites to bring research to the patient—delivering clinical trials without boundaries.

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 Hall5:00 pm

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.

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

David Hadden, President and Founder, Pro-ficiency

9:15 am

DCT by Design – Using a Design Studio to Optimize SoA and DCT

Jade Dennis, Senior Director, Design Hub, Eli Lilly & Company

Sara Doshi, PhD, Senior Director, Decentralized Design & Delivery Integration, Eli Lilly & Co.

The Schedule of Activities (SoA) requires strong cross-functional collaboration to achieve an optimal design. A web-based design studio, backed by an SoA taxonomy, enables exploration of SoA designs that streamline trial delivery and support decentralization opportunities. As the digital design library grows and more studies deploy DCT capabilities, frequency of DCT utilization and impact to downstream operational metrics will be critical to future study success.

9:45 am

DCT Fireside Chat with Industry Leaders

James Chennells, Head Clinical Trial Technology Strategy, Bayer

Gretchen Goller, Senior Director, Head of Patient Recruitment/Retention Solutions, Clinical Development Operations, Seagen

Angela May, Head DCT Strategy & Implementation, Clinical Operations, Bayer

Kelly McKee, VP, Decentralized Clinical Trials (DCTs) and Patient Registries, Medidata, a Dassault Systèmes company

Peter O'Neill, MBA, Senior Director, Clinical Operations, Incyte

Designing and executing successful DCTs requires leadership, vision, and operational excellence. Join this session to hear from senior leaders in the industry on how to successfully implement DCT programs and why optimizing patient, site, and sponsor experiences is essential to running global clinical trials.

10:15 am

Improving the Patient Experience Through User-Focused Design

Karl McEvoy, Product Director, Decentralized Trial Technology, eCOA Product Innovation, YPrime

Expanding global reach and the move towards decentralized trial models means that we must evolve our technology to improve study experience for patients and sponsors. Software will be more heavily relied upon to keep patients connected, informed, and engaged. Let’s explore the importance of utilizing user-focused research on software design and implementation in clinical trials.

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

11:40 am

Chairperson's Remarks

Mary Jo Lamberti, PhD, Director and Research Assistant Professor, Tufts Center for the Study of Drug Development (CSDD)

11:45 am

The Impact of Decentralized and Hybrid Trials on Sponsor-CRO Collaborations

Mary Jo Lamberti, PhD, Director and Research Assistant Professor, Tufts Center for the Study of Drug Development (CSDD)

The presentation will assess the impact of decentralized and hybrid clinical trials on sponsor-CRO relationships based on the results of a global survey conducted by Tufts CSDD among biopharmaceutical companies and CROs. Current and planned usage of specific DCT solutions and technologies by organizations will be discussed. The role of CROs in DCT adoption and implementation will also be examined as well as those technologies and outsourcing approaches that are viewed as most effective by organizations to implement and the challenges organizations face in their collaborations.

12:05 pm

Lessons Learned that Transform the Sponsor-CRO Relationship for Hybrid Decentralized Trials

Trinette Mitchell, Head, Emerging Priorities & Innovation, Takeda Pharmaceuticals, Inc.

The presentation will report on a pilot DCT program launched in 2021. eTools including eConsent, telehealth, eCOA, and wearables that support remote data capture and remote visits were the primary solutions offered in the trials. A collaborative operating model between the sponsor and CRO was amended to facilitate working with new technologies and vendors. At the conclusion of the study start-up, a retrospective review of the process was conducted by the sponsor. Considering the lessons learned during the pilot program, the sponsor-CRO relationship has been modified further to support site success with DCT.

12:25 pm

DCTs: Driving a New Paradigm of Partnering

Tina Caruana, Subject Matter Expert, eClinical Solutions, Digital & Decentralized Trials, Medrio

While there have been many rapid advances in clinical trial conduct fueled by the COVID-19 pandemic, the move to decentralization has been challenging. DCTs offer a plethora of decentralized options, however, novel and often unproven approaches can be costly and complex for Sponsors and CROs to operationalize. At times, these new models have also created unwanted burdens on clinical trial sites, a key stakeholder in the research continuum, and one that DCTs are meant to serve and empower. In this session, attendees will learn the strategies that Medrio has used to effectively guide sites through the uncharted waters of DCTs.

Transition to Lunch12:45 pm

Part 2: Decentralized Trials and Clinical Innovation

12:50 pm

LUNCHEON PRESENTATION:Clinical Outcome Assessments (COAs): Applying Scientific Rigor and Good Instrument Design

Lindsay Hughes, PhD, Director, eCOA Science & Consulting, eCOA Science, Clario

Jowita Marszewska, PhD, Scientific Advisor, eCOA Science & Consulting, Clario

The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges.

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

Lindsay Hughes, PhD, Director, eCOA Science & Consulting, eCOA Science, Clario

4:30 pm PANEL DISCUSSION:

How Digital Measurements Can Modernize Clinical Trials

PANEL MODERATOR:

Rinol Alaj, Director, Head of COA and Patient Innovation, Regeneron

PANELISTS:

Jeremy Wyatt, CEO, ActiGraph

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

Lada Leyens, PhD, PD Regulatory, Personalized Healthcare, Digital Health Regulatory Shaping Lead, Clinical Trial Innovation, F. Hoffmann-La Roche Ltd.

Guangchen Ruan, Associate Director, Research & Development, Eli Lilly & Company

Hui Zhang, PhD, Senior Director, Digital Office, Eli Lilly & Co.

5:00 pm

Future Direction of Decentralized Clinical Trial Capabilities within a Quality Framework

Teri Breedlove, Senior Director, Clinical Services and Capabilities, Eli Lilly & Company

Peter Thompson

Since the COVID pandemic, the implementation of clinical trials utilizing Decentralized Trial (DCT) capabilities has become a priority for pharmaceutical companies. Trials that incorporate DCT capabilities include new complexities, often around remote patient visits. Here at Lilly, we have discovered new approaches for remote trial activities, while concurrently remaining focused on patient safety and data integrity. This proposal shares a path forward to address these complexities, including shared best practices.

5:30 pm

A Digital Device Case Study: Deploy, Connect, and Send Digital Data in Clinical Trials

Erika Moree, Head of Learning and Development, ProofPilot

For decades, clinical research has been mostly centered on an "entered data" orientation. As clinical research becomes more remote and more digital, the challenges to collect this sort of data faithfully and responsibly has far exceeded our conventional capabilities. ProofPilot is proud to present a case study along with best practices on what it takes to efficiently deploy devices, connect them, send digital data, and return them.

6:00 pm

Benchmarking Clinical Trials Digital Maturity

Denisa McKnight, Senior Consultant Customer Experience, DT Consulting (an Indegene Company)

By gathering insights from a group of senior leaders and innovation experts, we developed a groundbreaking methodology to assess and measure digital maturity of clinical trials (CT-DEMA). The 2022 survey included responses from 12 large-cap pharma companies and showed a wide variation in digital maturity, capability prioritization, and best practice adoption.

6:10 pm

Data-Driven Approaches to Redesign Clinical Trials to Enable Decentralization

Shivani Mehta, Associate Director Data Science, Janssen R&D

This presentation will focus on the strategy and approach for decentralized clinical trials using a data-driven AI/ML approach. Key highlights of the presentation will include developing our vision and strategy, and more specifically our suite of tools that focus on protocol optimization by reimagining Schedule of Activities.

Close of Day6:30 pm

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

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

Melissa Nezos, Executive VP, Clinical Operations, Firma Clinical Research

8:30 am

Developing Industry Guidelines and Standards for DCTs Enabled by Digital Health Technologies

Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc

Mathew Rose, MD, Co-Chair, IEEE, Founder and CEO, SAAVHA, Inc.

Historical limitations of traditional trials have led the industry to find better solutions – DCTs enabled by technology whose value proposition includes optimized efficiencies in all steps of trials while enhancing diversity, inclusivity, and participant-centric approaches. Despite fast DCT adoption, there is confusion. The IEEE-SA-DCT program is set up to develop the industry DCT guidelines and standards to harmonize best practices. This program will be discussed in this presentation.

9:00 am

The Role of the Community Pharmacist in Decentralized and Hybrid Trials

Jake, Galdo, PharmD, MBA, BCPS, BCGP ESPhA Pharmacy Quality Advisory and Consultant

Tina Schlecht, PharmD, MBA, Chief Pharmacy Officer at RxE2

Norris G. Turner, PharmD, PhD, resident & CEO, Turner Healthcare Quality Consulting, Inc.

Community pharmacists play a key role in the future of clinical trials. Learn how community pharmacists are currently recruiting for clinical trials in their communities and the future opportunities for active roles as more trials move to hybrid and decentralized conduct. Hear from pharmacists engaged in the process about the success of patient recruitment via local pharmacies and the next steps for addressing patient diversity and patient retention.

Topics covered:

Independent community pharmacy overview
The pharmacist-patient trust factor
Activities community pharmacists can support in clinical trials
Community pharmacies serving diverse populations

9:30 am

Increasing Patient Engagement and Retention through Patient-First Digital Trial Solutions

Mohammed "Mo" Ali, Chief Domain Expert, Medable

Access to clinical trials is a human right and participation should be easy yet lack of diverse patient populations and high drop-out rates remain persistent challenges for sponsors alike. In this discussion, Mohammed Ali will share how Medable is dramatically broadening the reach of research to increase trial diversity while easing patient and site burden through the use of Patient-first digital trial tools designed to improve engagement, retention and data quality.

9:45 am

Innovation Enabling New Approaches to Clinical Development

Mark Brown, Vice President, Global Patient & Site Solutions, IQVIA

Melissa Easy, Vice President & General Manager, Clinical Technologies, IQVIA

New technologies are enabling Decentralized Clinical Trials (DCTs) to become the standard for clinical development, but much more is required to deploy and implement them successfully. Changes to roles and responsibilities and new processes are required. Attend this insightful presentation to understand the people, processes and technology including eConsent, eCOA, IRT, monitoring, and more that help streamline and automate development and hear of recent ROI results coming from successfully deployed DCTs.

10:15 am

Clinical Trial Tokenization – understanding the fundamentals for success

Adam Halbridge, MBA, Head of Clinical Trial Tokenization, ICON plc

The ability to tokenize patients in clinical trials and leverage data from multiple data sources, gives sponsors and payers an expanded view of patients treated with an investigational product. It will also deliver valuable insights into long-term safety and effectiveness that can support regulatory and reimbursement discussions as a drug moves towards commercialization. So, what do you need to know when considering a Clinical Trial Tokenization solution?

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