2023 ARCHIVES

2023 Keynotes

Now more than ever, the important work of this clinical research community requires collaboration and innovation. In its 14th year of fostering these goals, SCOPE Summit 2023 will take place February 6-9, 2023 in Orlando, FL at the Rosen Shingle Creek, over four stimulating days of in-depth discussions in 28 different conferences, 3 plenary keynote sessions, the 7th annual Participant Engagement Awards, special cross-department panels, the 2nd annual golf tournament, and the ever-popular interactive breakout discussions. The programming focuses on advances and innovative solutions in all aspects of clinical trial innovation, planning, management and operations. SCOPE 2022 attracted more than 2,300 leaders in clinical operations and research and we look forward to you and your team joining us!

View All 2023 Conference Programs | Breakouts | Participant Engagement Award

Monday, February 6

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

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.

9:00 amConference Registration Open

1:00 pmOpen Workshop: Introducing ClinEco, the New B2B Clnical Trial Community and Marketplace

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.

2:00 pmUser Group Meetings

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.

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 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

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

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

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

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

Rajbir Singh, M.D Rajbir Singh, M.D., Director of Clinical and Translational Research

5:40 pm

SCOPE's 7th Annual Participant Engagement Awards Introduction

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: /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 Boots Alliance

6:30 pmSCOPE's Kick-Off Happy Hour

7:45 pmClose of Day

Tuesday, February 7

8:30 am

Chairperson's Remarks

Marina Filshtinsky, Conference Producer, 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 Dev 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:

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

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

Ken Getz Ken Getz, MBA, Founder, CISCRP; Deputy Director, Center for the Study of Drug Development, Tufts University School of Medicine

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

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

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

Wednesday, February 8

1:20 pmCoffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)

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

Jane Hiatt 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.

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

PROGRAMS | SPONSORSHIP & EXHIBIT | REGISTER

Key Contacts

PARTNERING AND SPONSORSHIP
(COMPANIES A-K):

Ilana Quigley
Sr. Manager, Business Development
(+1) 781-972-5457
iquigley@healthtech.com

PARTNERING AND SPONSORSHIP
(COMPANIES L-Z):

Patty Rose
Sr. Manager, Business Development
(+1) 781-972-1349
prose@healthtech.com

GROUP DISCOUNTS ARE AVAILABLE! FOR INFORMATION, CONTACT:

Melissa Dolen
Account Manager
(+1) 781-972-5418
mdolen@healthtech.com

2025 Conference Programs

◆ Sunday Golf, Kick-Off Keynote & Participant Engagement Award

◆SCOPE’s Kickoff Reception

◆Pre-Con User Group & Workshops

◆ Patient Voice in Trial Design and Protocol Development

◆ Developing and Executing Effective Diversity Plans

◆ Data-Informed Feasibility and Investigator Selection

◆ Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

◆ Enrollment Planning and Patient Recruitment

◆ Patient Engagement and Retention through Communities and Technology

◆ (NEW) Collaborative Strategies to Improve Trial Execution

◆ Tech and Collaboration to Streamline Start-Up and Reduce Operational Burden

◆ Clinical Trial Forecasting, Budgeting and Contracting

◆ Resource Management and Capacity Planning for Clinical Trials

◆ Mastering an Outsourcing Strategy

◆ Relationship and Alliance Management in Outsourced Clinical Trials

◆ Partner Selection and Trial Design

◆ Vendor Oversight & Resource Management

◆ Clinical Data Strategy and Analytics

◆ Data Science, ML, and AI

◆ Decentralized and Hybrid Trials

◆ DCTs and Clinical Innovation

◆ Digital Biomarkers and Endpoints in Clinical Trials

◆ Digital Measurements Implementation at Scale

◆ Accessing and Generating RWD

◆ Leveraging RWD for Clinical Research

◆ (NEW) Generative AI in Clinical Research

◆ (NEW) AI for Trial Optimization

◆ Risk-Based Quality Management

◆ Central and Remote Monitoring

◆ Modernizing Lab, Biomarker & Data Management Operations

◆ Biomarker & Biospecimen Technology & Innovation

◆ Data Technology for End-to-End Clinical Supply Management

◆ Clinical Supply Chain Strategies to Align Process, Products and Patients

◆ Clinical Trial Venture, Innovation & Partnering *
*Separate Registration Required

2023 Keynotes

MONDAY EVENING KICK-OFF PLENARY KEYNOTE
ADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS

TUESDAY MORNING PLENARY SESSION
THE REALITY OF A TRIAL EXPERIENCE & NAVIGATING A GLOBAL CRISIS

WEDNESDAY AFTERNOON PLENARY SESSION
NEXT-GENERATION DATA SOURCES & BUILDING A ROADMAP FOR A R&D ORGANIZATION

2023 Keynotes

MONDAY EVENING KICK-OFF PLENARY KEYNOTEADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS

TUESDAY MORNING PLENARY SESSIONTHE REALITY OF A TRIAL EXPERIENCE & NAVIGATING A GLOBAL CRISIS

WEDNESDAY AFTERNOON PLENARY SESSIONNEXT-GENERATION DATA SOURCES & BUILDING A ROADMAP FOR A R&D ORGANIZATION

MONDAY EVENING KICK-OFF PLENARY KEYNOTE
ADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS

TUESDAY MORNING PLENARY SESSION
THE REALITY OF A TRIAL EXPERIENCE & NAVIGATING A GLOBAL CRISIS

WEDNESDAY AFTERNOON PLENARY SESSION
NEXT-GENERATION DATA SOURCES & BUILDING A ROADMAP FOR A R&D ORGANIZATION