Digital Measurements

Sensors, Wearables and Digital Biomarkers in Clinical Trials

Decentralized Trials and Clinical Innovation

CHIの第6回デジタル測定プログラムでは、センサーとウェアラブルを使用した治験のケーススタディが取り上げられます。このプログラムでは、治験におけるデジタルバイオマーカーとエンドポイントの実装に必要な今後のステップについても説明します。研究対象のトピックは、デジタルバイオマーカー(例と検証、NDE(結果と評価)、進化する規制、および分散型治験の主要イネーブラーとしてのデジタル測定などです。2部構成となっており、それぞれのトピックと登壇者が設けられています。第1部:センサー、ウェアラブル、デジタルバイオマーカー(2月7日〜8日)、第2部:分散型治験と臨床イノベーション(2月8日〜9日)

2月6日(月)

SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament* 8:00 am

Connect with your peers and colleagues at SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament.
*Limited space available. Separate registration and fee required for Golf.

Conference Registration Open9:00 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. 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: Sensors, Wearables, and Digital Biomarkers in Clinical Trials

ROOM LOCATION: Gatlin A1 & A2

ADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS

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 one 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

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

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

2月7日(火)

Registration Open (Gatlin Foyer)7:00 am

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

ROOM LOCATION: Gatlin A1 & A2

THE REALITY OF A TRIAL EXPERIENCE & NAVIGATING A GLOBAL CRISIS

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

For many years, our industry has been talking about becoming more patient-centric and innovative in our approach to clinical trials and all the great things we are doing to make clinical trials more convenient for participants. But have we really changed the experience for patients or are we just continuing to admire the problem? Would you really want YOUR mother to be part of one of your clinical trials? We need to get real. It should not take a pandemic to make changes to our protocols and processes and ways of working. But we still have so far to go and together we must continue to drive an uncomfortable level of change.

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

ROOM LOCATION: A4

DIGITAL BIOMARKERS IN CNS, SLEEP AND DERMATOLOGY TRIALS

10:35 am Chairperson's Remarks

David Anderson, Ph.D., Principal Scientist, Clinical ink

10:40 am

Precompetitive Development of Digital Measures in Parkinson’s Disease

Jie Shen, PhD, Director, Digital Science, AbbVie

Measurement of the signs and symptoms of Parkinson’s Disease using objective tools has a long history. This talk will cover the progress made by the precompetitive Digital Drug Development Tools (3DT) consortium led by the Critical Path for Parkinson’s and its members to advance the scientific, operational, and regulatory maturity of DHTs for use in PD research and therapeutic development.

11:00 am

Novel AI-Enabled Sensors for Quantifying Itch By Measuring Scratch

Shuai Steve Xu, Assistant Professor of Dermatology & Medical Director, Querrey Simpson Institute for Bioelectronics, Northwestern Memorial Hospital

As evidenced by a recent multi-pharma consortium with the Digital Medicine Society, there is strong interest in nocturnal scratch as a clinical endpoint. I am a board-certified dermatologist and biomedical engineer who has developed a novel wearable that quantifies scratch with an AI algorithm. We have validated this in children and adults with AD - with our papers being covered widely by the media.

11:20 am

Leveraging Clinical and Real-World Studies to Develop and Validate Nocturnal Scratch and Sleep Measurements

Sandra L. Goss, Director, Digital Health Strategy, AbbVie, Inc.

Measuring nocturnal scratch and sleep as digital endpoints in the clinic and real-world studies can generate insightful data, including feasibility, validation of digital tool and endpoint, and confirmation. Each study type and population bring its own set of benefits and challenges, and there are multiple ways to use studies throughout development to optimize the development of novel digital endpoints.

11:40 am

Validation and Application of the Novel Digital Endpoints of Nocturnal Scratch and Sleep

Carrie A. Northcott, PhD, Senior Director & Project Lead, Digital Medicine & Translational Imaging, Pfizer Inc.

Nocturnal scratching and sleep disruptions are key aspects of Atopic Dermatitis that until recently have been challenging to measure, especially in a quantitative manner. The use of digital health technology tools, via accelerometry, provides the opportunity to passively, quantitatively, and continuously measure these symptoms. A key aspect to provide value in these assessments is that they are validated and can detect clinically relevant changes. 

11:55 am

Scratching Detection Algorithm and Digital Endpoints Development for Atopic Dermatitis Patients

Ju Ji, PhD, Senior Advisor, Advanced Analytics and Data Science, Eli Lilly & Co.

We developed algorithms to detect scratch and restless motions based on wrist-worn actigraphy signal data. The algorithm is used to extract digital endpoints to quantify and evaluate itch and sleep disturbance in an objective way. The validity and clinical relevance of the novel digital endpoints is demonstrated through data collected from trials.

12:10 pm The Value of Passive Data Collection: Tying Active Assessments to Passive Measurements in Clinical Research

Joan Severson, Chief Innovation Officer, Clinical ink

Learn how patient-centric, clinically relevant measurements and advanced analytics provide better context for data interpretation. Severson, a human-computer interaction expert for leading pharmaceutical, government, and research institutions, details how to unlock the value of passive data collection by tying the rich, voluminous patient data from mobile sensors and wearables to active mobile measurements.  Learn how to develop digital biomarkers from voice data collection and processing, multimodal signal processing, and feature engineering. 

Transition to Lunch12:40 pm

12:45 pm LUNCHEON PRESENTATION:Reinventing the Six Minute Walk Test: A Novel Approach to Digital Measures

Melissa Ceruolo, Senior Directior, Biomarker Analytics, Medidata, a Dassault Systemes company

Traditional functional measures like the six minute walk test are status quo despite the widely held perception that they are imperfect and subjective. Sensors offer the promise of frequent and objective quantitation in real world environments with low patient burden. Attend this talk to learn about our cutting edge approach to reinvent the most commonly used functional test in life science research. Validation and regulatory pathways will be discussed.

Coffee and Dessert Break in the Exhibit Hall1:15 pm

DHT EVOLVING REGULATIONS; DIGITAL ENDPOINTS

2:10 pm

Chairperson's Remarks 

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

2:15 pm

 A Learning Regulatory Ecosystem: Advances in Regulatory Thinking in the Use of DHTs in Clinical Trials (EMA, FDA and ICH guidance)

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

There are different regulatory pathways available for digital endpoint development teams to get health authority advice on the validation of novel digital measures and their acceptability as label enabling endpoint in pivotal clinical trials. This presentation will cover examples of digital endpoint developments that used different regulatory pathways, their challenges and opportunities and considerations for regulatory strategies

2:40 pm How to improve clinical trial data with Continuous Glucose Monitoring (CGM)

Robert Sala, Director of External Research and CRO Integration, Research, Dexcom

Join Robert Sala, Director of External Research and CRO Integration at Dexcom, and Michael Brown, Executive VP of Global Commercial Operations at Woodley Trial Solutions. We discuss the significance of real-time data collection from a world-leading wearable CGM device innovation, and how this is utilized in hybrid clinical trials. We'll also make time for a Q&A session, so please don't miss your chance to ask your burning questions to the experts.

3:10 pm Considerations for Digital Endpoints: Digital biomarkers, sensors and PRO empowering clinical trials

David Kiger, Global Vice President, Biofourmis

This session will address how new ML-enabled digital health technologies and remote monitoring advancements can complement ePRO and decentralized clinical trials to transform development.

 

 

3:25 pm

Regulatory Update on Digital Endpoints 

Michael Benecky, Senior Director, Regulatory Affairs, UCB

This presentation will discuss the evolving regulatory guidelines for use of Digital Health Technology (DHT) within pharmaceutical clinical development programs. Good regulatory practice is based on the mitigation of potential patient risks mitigation prior to implementation that may arise from DHT use within a pharmaceutical clinical trial. DHT risks that require mitigation include errors in patient management due to DHT malfunction, patient data privacy/cybersecurity, electrical safety, and material biocompatibility. Use of the DHT will be subject to FDA Investigational Device Exemption requirements if the output of the DHT is shared with the patient or clinical investigator during the investigation.

3:45 pm The Need for Novel Endpoints: Using Multimedia, Audio and Video to Capture Novel Digital Endpoints

Scott Bergeron, Partner, Clinical, Red Nucleus

We’ll discuss how digital audio and video evidence generated in clinical trials is being used to provide quantitative and qualitative data to evaluate the efficacy of novel treatments for patients.

ROOM LOCATION: Gatlin Foyer

INTERACTIVE BREAKOUT DISCUSSION GROUPS

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* (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.

2月8日(水)

ROOM LOCATION: Gatlin A3 & A4

BREAKFAST PRESENTATIONS

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

ROOM LOCATION: Gatlin A4

REGULATORY UPDATE

9:10 am

Chairperson's Remarks

Sandra L. Goss, Director, Digital Health Strategy, AbbVie, Inc.

9:15 am PANEL DISCUSSION:

Novel Evidence for Regulatory Decisions: The Key Factors for Success

PANEL MODERATOR:

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

We define the scope of novel evidence, including RWE, Digital Biomarkers, and Novel Digital Endpoints. There has been a proliferation and adoption of RWE and DHT in the life cycle of drug development to improve outcome measurements and accelerate medicine development. The Panelists will discuss lessons learned and dissect successful cases to identify key “must haves” on how to use novel evidence to support regulatory decisions.


PANELISTS:

Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)

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

Amy Abernethy, MD, PhD, President, Clinical Studies Platforms at Verily; Former Principal Deputy Commissioner, FDA

9:45 am Disruptive and Patient-Focused: Innovation to Meet Digital Endpoints

Konstantinos Kostikas, Professor of Respiratory Medicine & Head Respiratory Medicine Department, University Hospital of Ioannina

Furat Shawki, Head, Product and Operations, Clinical Trials, NuvoAir

This session explores the value of integrating clinical trials as part of patients’ daily lives. Topics include: performing complex data collection outside the traditional model; innovative, patient-centric solutions integrating medical devices, wearables, and activity trackers; and the role of AI and machine learning in disrupting clinical trials. Hear the benefits of capturing digital endpoints in both home and clinic-from the points of view of patients, study personnel, and sponsors alike.

10:15 am Remote Symptom Monitoring: Combining Active and Passive Digital Measures

Nathan Cashdollar, PhD, Director of Digital Neuroscience, Operations, Cambridge Cognition

Many innovative approaches for remote symptom monitoring of patients have recently emerged to optimize the metrics captured in decentralized clinical trials. One of these techniques is deploying high frequency active assessments to enhance the contextual insight of measures captured via passive physiological sensors. Combining active and passive data capture allows for a more comprehensive characterization of patients’ fluctuating symptoms and thereby provides a higher fidelity to detect therapeutic interventions. 

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

DATA SOLUTIONS FOR DIGITAL TRIALS

11:40 am

Chairperson's Remarks

Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.

11:45 am

MagnolAI - A Sensor Cloud for Connected Clinical Trials

Regan Giesting, Data Engineer, Digital Health Office, Eli Lilly & Company

Leah Miller, Data Engineer, Digital Health Office, Eli Lilly & Company

Neel K. Patel, Data Engineer, Eli Lilly

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

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

While digital health technology promotes the ability to collect wearable sensor data, what matters more than that is how some of these most complex digital data can be efficiently visualized, extracted and analyzed for digital measures development. We would like to present Lilly's example of what a digital data platform should (and can) do to ensure dBM research is done efficiently and rigorously.

12:15 pm

The Anatomy of Connected Digital Health Platform

Gian Prakash, Associate Director, Data Engineering, Information Research, AbbVie Inc.

Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.

In recent years, clinical trials have been collecting different sources of digital data, such as data from wearables, sensors, apps, images, audio, and video files. These digital data sources have created immense opportunities for sponsors to develop drugs for unmet needs and acquire better, meaningful, quality patient data. However, to manage these data sources, sponsors are developing modern platforms. This session will provide an overview of the capabilities required to develop a Digital Health Platform and prepare data for review and submission.

Transition to Lunch12:45 pm

Part 2: Decentralized Trials and Clinical Innovation

12:50 pm LUNCHEON PRESENTATION:Utilizing AI-Powered Technology for Patient Matching & Site Selection to Expedite Research to Patient's Doorsteps

Joshua Ransom, PhD, Head of Customer Experience and Product, BEKHealth & Associate Director GBEMTI at the NAMCP, Customer Experience and Product, BEKHealth

With technological advancement & innovation being at the forefront of clinical research and the decentralized clinical trials (DCT) landscape, manual processes still lurk throughout workflows. In this talk, Joshua Ransom, Head of CX & Product at BEKHealth, presents a case study illustrating how BEKHealth utilizes AI technology solutions to expand clinical trial access and accelerate timelines through patient identification and matching.

 
 

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

ROOM LOCATION: Gatlin A1 & A2

NEXT-GENERATION DATA SOURCES & BUILDING A ROADMAP FOR AN R&D ORGANIZATION

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, Clinical Studies Platforms 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, Clinical Studies Platforms 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

ROOM LOCATION: Gatlin A4

DCT LEGO BLOCKS: WEARABLES, DATA, QUALITY

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, Advisor Clinical Services and Capabilities, Eli Lilly and Company

Joanne Dourado, Senior Director, Medicines Quality Organization

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.

5:45 pm

Benchmarking Clinical Trials Digital Maturity

Francesca Properzi, PhD, Director Research, Thought Leadership, DT Consulting

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.

6:00 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* (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.

2月9日(木)

Registration Open (Gatlin Foyer)7:15 am

ROOM LOCATION: Gatlin A1 & A2

BREAKFAST PRESENTATIONS

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

Session Break8:15 am

ROOM LOCATION: Gatlin A4

SCALING DECENTRALIZATION WITH NEW STANDARDS AND APPROACHES

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, Vice Chair, IEEE-SA-DCT Program

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

ROOM LOCATION: Gatlin A4

SCALING DCT EFFORTS BEYOND ZIP CODE AND COMPANY LIMITS

11:05 am

Chairperson's Remarks 

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

11:10 am Putting Patients First: How to Scale DCTs within Large Pharma

Kim Boericke, COO, THREAD

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

11:40 am

Real-World Results from Ongoing DCT Collaboration 

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

Jeff Kingsley, Founder & CEO, IACT Health

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

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