Patient-Centric Trial Design & DEI

2024 ARCHIVES

Enrollment Planning and Patient Recruitment

Patient Engagement and Retention through Communities and Technology

Patient-centric protocol development and improving DEI are the latest hot-button issues impacting clinical trials today. Incorporating patient voice into clinical trial design and conduct leads to better recruitment, retention, satisfaction, and to increased likelihood of trial success. And at the same time, there is an imperative to improve diversity and inclusion of representative patient populations. CHI’s Patient-Centric Trial Design & Protocol Optimization evaluates new protocol design strategies, methods to incorporate participant voice, and collaborative approaches to reduce site and patient burden. The Developing & Executing DE&I Programs conference will provide the latest on the FDA’s diversity plan requirements and submission process, analyze barriers to clinical trial diversity and efforts to overcome them and offer actionable insights to improve diversity, equity, and inclusion in clinical trials.

Part 1: Patient-Centric Trial Design and Protocol Development

Part 2: Developing and Executing Effective Diversity Plans

Sunday, February 11

Part 1: Patient-Centric Trial Design and Protocol Development

SCOPE's 3rd Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)8:00 am

*Limited space available. Separate registration and fee required for Golf.

Registration Open9:00 am

– 1:45 pm [In-Person ONLY] Open Workshop: Introducing ClinEco, SCOPE's B2B Clinical Trial Community and Marketplace1:00 pm

Sit down with a small cross-industry group for a 45-minute hands-on session to learn about and register for the new B2B clinical trial community and marketplace featuring 65+ companies. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering, vendor research, innovation, and learning. This year we are also introducing ClinEco Commons, a collaborative space where you can access, visit, and share valuable content as well as contribute to the wealth of knowledge within the SCOPE and ClinEco Community. Join the ClinEco community now at: clineco.io/register. To register for the workshop, please opt into this workshop by selecting the checkbox under ‘Conference Selection.' Open to all SCOPE attendees.

– 2:30 pm [In-Person ONLY] The Path towards Sustainable Trials Workshop1:00 pm

Reducing the Environmental Impact of Global Clinical Trials
Developing frameworks to define and manage sustainability risks, and effective guidelines to reduce the carbon footprint of clinical trial operations is a collaborative effort. Beyond positive environmental impacts, sustainable approaches are expected from stakeholders and can be a deciding factor for customer selection and attracting talent. This workshop will discuss the current hotspots of carbon emissions in clinical research and suggest introductory reduction strategies in relation to each. To register, please opt into this workshop by selecting the checkbox under ‘Conference Selection.’ Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.

Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)

David Lumby, Executive Director, EHS, Thermo Fisher Scientific

3:00 pm

Organizer's Welcome Remarks & 3rd Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:10 pm PANEL DISCUSSION:Plenary Keynote Introduction

Fareed Melhem, Senior Vice President, Head of Medidata AI, Medidata

3:15 pm PANEL DISCUSSION:

The Next Horizon of Clinical Research: A Multi-Stakeholder Panel on Integrating Research into the Care Continuum

Uli Broedl, Senior Vice President, Head of Global Clinical Development & Operations, Boehringer Ingelheim

Janice Chang, CEO, TransCelerate Biopharma, Inc.

Christoph Koenen, Head of Clinical Development & Operations, Pharma Research & Development, Bayer

Katherine Taylor, Head, Risk Evaluation & Adaptive Integrated Monitoring, Merck & Co., Inc.

This presentation will foster discussion between a diverse set of biopharma leaders representing health authorities, sponsors, sites, and industry consortia on the current and future opportunities facing global R&D, clinical care, and patient satisfaction. Specific topics discussed will include opportunities and barriers to giving patients access to clinical research as part of the care continuum.

3:45 pm

SCOPE's 8th Annual Participant Engagement Awards Introduction

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:50 pm

SCOPE's 8th Annual Participant Engagement Awards

PANEL MODERATORS:

Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata; Co-Creator or the SCOPE Participant Engagement Award

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

Now in its 8th 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 2024 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE.

PANELISTS:

Tricia Buchheit, Associate Director, Patient Recruitment, Alnylam Pharmaceuticals

Greg Christie, Chief Product Officer, StudyKIK

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

Otis Johnson, PhD, MPA, Principal Consultant, Trial Equity

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

Jeffrey Zucker, Principal Clinical Research Consultant

SCOPE's Big Game Tailgate4:35 pm

Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, in honor of the Big Game, rep your favorite team while joining SCOPE sponsors, speakers and attendees for a pre “Big Game” celebration at the Rosen’s outdoor Event Lot. Football jerseys or T-shirts encouraged, even if your team didn’t make the grade this year (for our European friends, YOUR football team jerseys are welcome too!). Sample some tailgate food, quench your thirst at the bar, and play some classic outdoor games. This event is always a SCOPE favorite, so please join us directly after the Sunday afternoon plenary session!

Close of Day5:50 pm

Monday, February 12

SCOPE’s Monday Morning Fun Run!7:00 am

Join SCOPE’s Coordinators for our 5K Fun Run!
All of us at Cambridge Healthtech Institute recognize the importance of integrating well-being and fitness into our work travel routines. We're excited to offer our support to faculty, sponsors, and attendees in fostering a culture of wellness. This is an easygoing, informal running (or walking) event. No time chips, running bibs, or energy bars—just a laid-back opportunity for a small group to start the day on a positive note. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk—the goal is to get up and get moving! Meet us in the Rosen Hotel’s front lobby near the birdcage at 7 am sharp!

RUN COORDINATORS:

Eileen Murphy, Associate Conference Producer, Production, Cambridge Healthtech Institute
Nate DePinto, Assistant Meeting Planner, Cambridge Healthtech Institute
Steve Wimmer, Vice President, Partnerships, Business Development, 1nHealth

Registration Open7:30 am

Morning Coffee7:30 am

Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and delicious treats, courtesy of our sponsors.

8:30 am

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

8:35 am Plenary Keynote Introduction

Chris Crucitti, Chief Revenue Officer, Citeline

8:40 am PLENARY KEYNOTE PRESENTATION:

Time Is Life: Pfizer’s Approach to Accelerating Clinical Development

Robert Goodwin, Senior Vice President, Clinical Development and Operations, Pfizer Inc.

How do we transform the development paradigm to make trials more accessible, more convenient for the participants, less costly, and most importantly, get us the answers we need faster? Because when you’re a patient waiting for a new treatment, every minute matters. Pfizer recognizes that time is life and has set a bold ambition to reduce three additional years off their development timelines, after successfully cutting down more than two years already since 2016. Hear from Rob Goodwin, Senior Vice President and Head of Clinical Development & Operations, on what it takes to accelerate development without compromising quality, compliance, or patient safety.

9:05 am INTERACTIVE PANEL:

Use Cases of Generative AI in Clinical Trials: Beyond Can We...Where and When Should We?

PANEL MODERATOR:

Brian Martin, Head of AI, R&D Information Research; Research Fellow, AbbVie, Inc.

Where are we now as an industry with integrating and utilizing AI in clinical research? What is next is an open question and the possibilities are many and the hype is loud, but the more important question to ask is “why should we?” in each and every case. AI is a tool, but not always the right one or the most efficient one. Where are you in the journey of bringing Generative AI into CT? Should teams focus on technology and use cases like Diversity in CT inclusion and other specific applications? Why? How was value measured? What risks exist? Where do we choose not to use AI in clin ops and why? Dive in with our expert panel.

PANELISTS:

Neil Garrett, PhD, Head of Regulatory Medical Writing, Johnson & Johnson

Samar Noor, Vice President, Head of Statistical Programming, Global Biometric Sciences, Bristol Myers Squibb Co.

Hoifung Poon, PhD, General Manager, Health Futures, Microsoft Research

Prasanna Rao, Senior Director, Global Head of AI/ML, Global Biometrics and Data Management, Pfizer Research & Development

Grand Opening Coffee & Refreshment Break in the Exhibit Hall Best of Show Voting Opens9:35 am

SCOPE’s exhibit hall is a one-of-a-kind experience. With 240 leading clinical trial technology and services companies represented it’s easy to find new, innovative companies to partner with, and don’t forget to visit your existing partners to see their latest and greatest. Take a minute to vote for SCOPE’s Best of Show, grab some refreshments, charge your devices, or ham it up in a photo booth, but above all, wear comfy shoes; you’ve got some miles to cover!

Special Book Signing10:30 am

Barnett’s 2024/2025 Good Clinical Practice: A Question & Answer Reference Guide
Edited By: Donna Dorozinsky, RN, MSN, CCRC President and CEO, Just in Time GCP

10:45 am

Chairperson's Remarks

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

10:50 am

How Boehringer Ingelheim Has Made It Systematic to Incorporate the Patient Voice into Trial Design and Conduct

Kimberley Kallsen, Head of Patient & Site Engagement, Global Clinical Development & Operations, Boehringer Ingelheim

End of 2021, BI decided to transform our clinical development. One goal was to systematically incorporate patient feedback into our trial designs. Before 2021, we had incorporated patient feedback only into two trials. In 2022, we incorporated patient feedback into 64% of our trial designs, and in the first half of 2023, into 86%. In this session, we will share our approach, experiences, and learnings.

11:20 am

Are We There Yet? DCT and Patient Centricity—Bayer's Journey through DCT Adoption and Adaption in Interventional Trials

Karen Van Benschoten, Associate Director, DCT Operations Manager, DCT Strategy and Implementation, Bayer

We have successfully implemented hybrid and fully remote DCT approaches across four Phase III, interventional trials, each progressively broader in approach. Recently, we have launched our first large-scale, fully remote arm—in a pivotal trial—in parallel with a traditional model. Building on previously shared early operational and implementation experiences, this talk focuses on the participant experience, and whether we have yet achieved true patient centricity.

11:50 am PANEL DISCUSSION:

Better Trials through Design Collaboration

PANEL MODERATOR:

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

Drug development organizations understand the need to include patient and site perspective in protocol design and planning. It's not a standard process yet, and perhaps it's because it's hard to start. In this mini-simulation and discussion, the panel will demonstrate how to create and deliver a protocol design input session that includes patient and site voices. After a short simulation, a discussion will highlight best practices and lessons learned.

PANELISTS:

Shelly Barnes, Global Clinical Innovations Lead, UCB

Angela Bilkhu, Senior Global Patient Partnership Director, Sickle Cell Disease and aHUS, Roche

Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata

12:20 pm

Prioritizing the Site and Patient Technology Experience in Trial Planning

Elisa Cascade, MBA, Chief Product Officer, Advarra

Technology can drive process efficiency, improve study compliance, and enhance site and patient engagement – but at what burden to our sites? Attend this session to discuss pragmatic trial delivery options for consideration during trial planning and hear real site feedback on ways to deliver value while reducing friction in site, sponsor, and patient interactions.

Transition to Lunch12:50 pm

12:55 pm

LUNCHEON PRESENTATION:The Power and Potential of AI for Clinical Trials & Diversity Planning

Alexandra Moens, PharmD, Director, Product Marketing, H1

As leaders in the healthcare industry, pharma companies have the opportunity to shape how data is used for good in improving patient care, specifically for clinical trials. By aligning their data strategies with the values of equity, ethics, and collaboration, they can contribute to creating a more equitable and innovative healthcare system and reach more diverse patient populations. As we look towards the future of healthcare in 2024 and beyond, one thing is clear: data will play a crucial role in shaping the industry and future of trials. With the rise of artificial intelligence and advancements in technology, there is endless potential for utilizing data to improve patient care and drive innovation.

Coffee & Dessert Break in the Exhibit Hall1:25 pm

Special Book Signing1:30 pm

Digital Health and Patient Data: Empowering Patients in the Healthcare Ecosystem
Authors: Disa Lee Choun and Anca Petra

2:20 pm Chairperson's Remarks

Emily Jordan, Senior Director, Sponsor Transformation, Customer Success, OneStudyTeam

2:25 pm

Protocol Design Trends and Their Impact on Performance

Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

This session presents the results of a new study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) characterizing trends in protocol design practices. Despite growing awareness of the importance of simplifying and streamlining protocol designs, nearly every design variable has increased in complexity during the past decade, most notably in costlier later-stage clinical trials. The session will examine the impact of protocol design practices on clinical trial performance and efficiency and will provide new insights into improving and optimizing protocol design leveraging patient-centric design principles.

2:55 pm

A Multi-Stakeholder Approach to Bringing the Patient Voice to Protocol Development

Tricia Buchheit, Associate Director, Patient Recruitment, Alnylam Pharmaceuticals

Sasha Sakay, Manager, Strategy, Publicis Health

Tracy White, Associate Director, Clinical Operations, Alnylam Pharmaceuticals Inc

Patient-centered clinical trials have a significantly increased likelihood of success. However, traditional methodologies to include the patient voice often occur too late in the development process to make a meaningful difference. This session will explore the benefits of introducing the voice of the patient even earlier into protocol development, and how by taking a global approach to co-creation in partnership with patients, care partners, and study sites we can further our learnings and ensure ALL key stakeholders are heard and listened to.

3:25 pm

Fostering Patient-Centricity & DEI: Leveraging Patient Insurance? You’re Missing Out

Samit Bhatt, Vice President, Clinical Trial Patient Solutions, Myonex

Explore the impact of DEI and enrollment barriers in clinical trials during Fostering Patient-Centricity & DEI: Leveraging patient insurance? You’re missing out. Learn how Patient Insurance issues contribute to delayed enrollment and dropouts and discover how the CTRx model removes financial obstacles, reduces costs, enhances patient flexibility, and improves DEI–creating an equitable and inclusive environment for diverse patients.

3:55 pm

Patient Voice in Clinical Trials

Tuba Bas, PhD, Senior Director, Clinical Center of Excellence, Bristol Myers Squibb Co.

In this session, BMS shares its innovative process of incorporating patient perspectives throughout the drug development process across markets and therapeutic areas within the organization, through its Patient Expert Engagement Resource (PEER) and Patient Voice capability. Explore how they achieve patient-centric protocol design, including partnering with advocacy organizations, obtaining timely expert and lay patient feedback, and integrating patient feedback into trial designs and recruitment efforts.

4:25 pm

CO-PRESENTATION:Using Patient Feedback to Fuel Technology Innovation and Improve the Clinical Trial Patient Journey

Dave Hine, Senior Director, Solutions Consulting, Greenphire

Jen Horonjeff, Founder/CEO, Savvy Cooperative

Don’t assume you know what patients need – ask them! Join Savvy and Greenphire as they provide actionable best practices on how to gather feedback, analyze it and use it to improve the patient experience. Plus, you’ll hear how Greenphire is leveraging patient insights to further remove burden, streamline communication and improve the patient journey, enabling sponsors to bolster recruitment and retention for studies around the globe.

Welcome Reception in the Exhibit Hall4:55 pm

Close of Day6:15 pm

Evening Shuttles to Pointe Orlando6:30 pm

Shuttles will be available Monday and Tuesday 6:30-10:30 pm (last pick up), bringing you to and from Pointe Orlando.
Pointe Orlando is an open-air entertainment destination featuring local and brand-name restaurants, bars, nightclubs, 20-screen movie theater, comedy club, and family attractions.
Look for SCOPE shuttle signage at each of the SCOPE hotels: Rosen Shingle Creek, DoubleTree by Hilton Hotel Orlando at SeaWorld, Element Orlando International Drive, Residence Inn Orlando at SeaWorld, and Hotel Kinetic (soon being named Hotel Landy).

Tuesday, February 13

Registration Open8:00 am

8:30 am

BREAKFAST PRESENTATION OPTION #1:The New Frontier: How Intelligent Automation is Transforming Clinical Deployment

Colin Weller, General Manager, Evidence Generation Platform, Product, Medable

Join us as Colin Weller, GM, Evidence Generation Platform at Medable, unveils how intelligent automation technology reduces clinical trial deployment timelines and accelerates evidence generation at scale as shown in their latest results to reduce trial deployment timelines by 50%. Weller will discuss how Top-10 global pharmaceutical companies are benefiting from Medable’s novel technology, and how the expanded use of digital measures and biomarkers will continue to accelerate clinical development timelines.

8:30 am

BREAKFAST PRESENTATION OPTION #2:Medpace with Trialbee | How a Patient Recruitment Platform (PRP) Overcomes Global Challenges

Matt Walz, CEO, Business Operations, Trialbee

Miaesha Campbell, Senior Director, Patient Recruitment, Medpace

Join Miaesha Campbell (Medpace) and Matt Walz (Trialbee) for a practical discussion of global challenges a Patient Recruitment Platform (PRP) helps to overcome. Topics include….Data standardization across all recruitment sources; Consistent medical pre-qualification of all referrals; Human interaction with patients; Reducing burden on sites; and Actionable ROI analysis by channel. Attendees will learn how a PRP centralizes activity from all partners to improve recruitment globally.

Transition to Sessions9:00 am

9:10 am Chairperson's Remarks

Kuno van der Post, Chief Revenue Officer, Scout

9:15 am PANEL DISCUSSION:

Brainstorming to Break Down Barriers: Real Talk about What We Can Do Collaboratively to Move the Needle on DEI

PANEL MODERATOR:

Kim Doggett, Senior Director, Clinical Trial Diversity, Clinical Operations, BeiGene

Join this group of industry innovators who are leading efforts to overcome barriers to recruiting racially, ethnically, and socioeconomically diverse populations. Engage with them and your colleagues in candid dialogue, share innovative ideas, and collectively strategize actionable steps towards advancing Diversity, Equity, and Inclusion in clinical trials.

PANELISTS:

Monique Adams, PhD, MS, Executive Director, Global Head Diversity & Inclusion in Clinical Trials, Sanofi

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

Crystal Parker, Clinical Operations Lead, Diversity Equity and Inclusion in Clinical Trials, Oncology, Janssen

Michel Reid, Senior Director & Head, Global Demographics & Diversity, GSK

Kate Wilson, Head of Clinical Trial Diversity, Global Clinical Operations, Biogen

10:15 am

The Root Cause of All Problems in Life Science

Brian Ongioni, Vice President, ClinOne

Okay, maybe not all.

You’re a busy person engaged in clinical research. If I gave you a magic wand and told you that you could fix one problem in the industry, it’s possible—or should I say probable?—that API standardization may not be on the top of your list, but it is on the top of ours, and here is why.

Coffee Break in the Exhibit Hall10:45 am

Special Book Signing10:50 am

The Patient Recruitment Conundrum
Author: Ross Jackson

11:40 am Chairperson's Remarks

Alexandra Moens, PharmD, Director Product Marketing, Marketing, H1

11:45 am

Diversity by Design: Accessing Solutions from the Start

Sandra Amaro, Head, Clinical Trial Diversity, Pfizer Inc.

The audience can expect to learn more about solutions available to support the diversity of participants in clinical trials, which include: An aggregated collection of insights and considerations gathered from the sponsor interviews that can help to inform operational strategies and identify how practical implementation of FDA Diversity Plans may progress as industry thinking matures in this area. A regulatory landscape resource designed to help identify key U.S. legislation and U.S. FDA policy, regulation, and guidance, as well as regulatory precedent to consider when working to understand and improve diversity & inclusion (D&I) of adult patients in clinical trials, focusing on the inclusion of racial and ethnic minorities. An effort to share and aggregate patient enrollment information (e.g., race, ethnicity, gender, and sex) to help sponsors understand their current industry-wide performance by disease state and opportunities for improvement.

12:15 pm

Why Disability Inclusion & Digital Accessibility are Critical to a Successful DEI Strategy

Stephen Framil, PhD, Corporate Global Head Accessibility, Office of Corporate Accessibility, Merck & Co., Inc.

At Merck, we have a global digital accessibility policy that has embarked on a companywide initiative to provide equal access to our digital landscape for our workforce, patients, and consumers. This session will explore the Why, What, and How disability inclusion and digital accessibility are critical to a successful DEI strategy in global pharma: The WHY: diversity equity & inclusion, environmental social governance. The WHAT: the scope of information & communication technologies (ICTs). The HOW: accessibility by design and shifting left with universal design.

Transition to Lunch12:45 pm

12:50 pm

LUNCHEON PRESENTATION:Achieving Study Objectives and Maximizing Participant and Site Experience through Effective Stakeholder Collaborations

Caroline Jackson, Executive Vice President, Patient Services, Patient Primary, mdgroup

Katie Vogel, BSN RN, Clinical Trial Manager, Clinical Trials, New Day Diagnostics

In this presentation, Caroline Jackson from mdgroup and Katie Vogel from New Day Diagnostics explore some of the typical challenges impacting site and participant experience with clinical trials and discuss examples of successful collaboration between clients, vendors and sites that have led to positive study outcomes.

Coffee & Dessert Break in the Exhibit Hall Best of Show Winner to be Announced1:20 pm

SCOPE’s hall this year is bigger than ever; there’s no way to cover it all in just one break. So, after lunch, grab some dessert and a cup of coffee and visit all those booths that you just couldn’t make it to this morning. Stay to hear our Best of Show Winner announcement and congratulate the winner!

Special Book SIgning1:25 pm

Quantum Kids Guardians of AI: Story Quest and Activity Book
Author: Angela Radcliffe

Part 2: Developing and Executing Effective Diversity Plans

2:20 pm

Organizer's Welcome Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute; Co-Founder, ClinEco

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

2:25 pm Chairperson's Remarks

Jie Wu, PhD, Co-Founder & CDO, Segmed, Inc.

2:30 pm PANEL DISCUSSION:

Fireside Chat with FDA on Modernizing Clinical Trials

PANEL MODERATOR:

Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Prospectively randomized, placebo-controlled clinical trials are often the most powerful tool that we have for answering fundamental questions about the safety and efficacy of new medical products. But greater efficiency is needed, as clinical trials are becoming more costly and complex to administer. Moreover, many of the new products that we’re being asked to evaluate aren’t easily evaluated using these traditional approaches. At the same time, new technologies and sources of data and analysis make better approaches possible. FDA has been engaged in a comprehensive effort to advance new innovations and to enable the modernization of clinical trials, so what does this mean to you and to our industry?

PANELISTS:

Kevin Bugin, PhD, Deputy Director, Operations, Office of New Drugs (OND), FDA Center for Drug Evaluation and Research (CDER)

Marsha Samson, PhD, Analyst, Office of Medical Policy, FDA

3:00 pm CROSS-INDUSTRY PANEL:

Intersection of Innovative Development Models and Investment Approaches That Move the Needle at the Portfolio Level

PANEL MODERATOR:

Jacob LaPorte, PhD, Co-Founder, Prisma Therapeutics

New to SCOPE 2024—we bring together for the first time, a business-focused panel of strategics from the pharma, investor, healthcare, CRO, and technology start-up communities, to discuss partnership models that drive much needed innovation in clinical trials and impact development at the portfolio level. How can Pharma manage risks and investments while continuing to remain at the forefront of drug development, clinical research, and trial technology? Which alternative business models and risk-sharing partnerships can support innovation in a resource-constrained environment? Where are the opportunities and the ROI from such partnerships? Which emerging technologies are showing growth and investment and are moving the needle in clinical research?

PANELISTS:

Angela DeLuca, Vice President, Head of Oncology & Cell Therapies Clinical Operations, Global Development Office, R&D, Takeda

Michael Greeley, Co-Founder & General Partner, Healthcare Technology, Flare Capital Partners

Michelle Longmire, Co-Founder & CEO, Medable, Inc.

Sam Srivastava, CEO, WCG

Booth Crawl & Refreshment Break in the Exhibit Hall (Opportunities Available) Last Chance for Viewing3:30 pm

Join your colleagues in the Exhibit Hall for one last visit. Enjoy SCOPE’s “Booth Crawl,” where sponsoring booths have a silent competition to see who can serve the most fun or fancy food and drink. Visit their booths to see for yourself! Take a final lap around the hall and enjoy time with your newfound friends and partners.

4:30 pm Chairperson's Remarks

Colleen Hoke, CEO, ObjectiveHealth, Inc.

4:35 pm CO-PRESENTATION:

From Barriers to Best Practice: Increasing the Participation of Underrepresented Populations in U.S. Clinical Trials

Jodie Allen, PhD, Senior Director, Clinical Trial Diversity, AstraZeneca

Magnus Franzen, Partner, Wavestone

Paris Johnson, Senior Local Study Associate Director, AstraZeneca

AstraZeneca conducted research into the barriers and opportunities to increase the participation of underrepresented populations in AZ clinical trials in the United States. We conducted a review of internal processes and engaged >50 site staff with the aim of identifying practical and impactful ways to increase the recruitment, retention, and trial experience of underrepresented populations. This presentation will share actionable insights, and cover the ways in which we are further developing capabilities to improve clinical trial diversity.

5:05 pm PANEL DISCUSSION

Diversity Action Plans—The Expectation, Development, Implementation, and Feedback

PANEL MODERATOR:

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

As an industry, we have been solving for solutions to address the lack of diversity in clinical trials for a long time. The Draft FDA Guidance on Diversity Plans and the 2022 FDORA Act have brought the issue of diversity in clinical trials front and center. The goal of this conversation is to learn from each other as we implement this new requirement to advance inclusive research.

PANELISTS:

Monique Adams, PhD, MS, Executive Director, Global Head Diversity & Inclusion in Clinical Trials, Sanofi

Kelly Clark, Head of US Partnerships and Global Site Development, Merck

Tony Pearson, Senior Director, Diversity & Inclusion in Clinical Trials, Eli Lilly & Co.

5:35 pm Using Technology to Build and Adhere to Patient-Centric Trial Design

Emily Jordan, Senior Director of Sponsor Transformation at OneStudyTeam, OneStudyTeam

For clinical trials to be successful, it’s critical to not only reach patients and ensure easy access to trials, but also to make it as easy as possible for patients to continue participating in those trials. By building patient centricity into trial design, we can improve patient recruitment, engagement, and retention for better outcomes. Hear about best practices for achieving this with technology.

Close of Day6:05 pm

Evening Shuttles to Pointe Orlando6:30 pm

Shuttles will be available Monday and Tuesday 6:30-10:30 pm (last pick up), bringing you to and from Pointe Orlando.
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.
Look for SCOPE shuttle signage at each of the SCOPE hotels: Rosen Shingle Creek, DoubleTree by Hilton Hotel Orlando at SeaWorld, Element Orlando International Drive, Residence Inn Orlando at SeaWorld, and Hotel Kinetic (soon being named Hotel Landy).

Wednesday, February 14

Registration Open7:15 am

7:45 am

BREAKFAST PRESENTATION:Empowering Clinical Operations Professionals: Harnessing AI to Enhance Outcomes

Scott Chetham, CEO & Co-Founder, Faro Health, Inc.

Generative AI, machine learning, and large language models are all over the news and have the potential to impact every aspect of Clinical Development. As Clinical Development professionals, how can we differentiate the hype from reality and have an educated voice to assess the risk and rewards of these rapidly evolving technologies? Join Faro to explore current, upcoming, and hyped trends. Understand the challenges in adopting these technologies in Clinical Development.

Transition to Sessions8:15 am

8:25 am Chairperson's Remarks

Tate Stubbs, COO, Executive, HealthMatch

8:30 am PANEL DISCUSSION:

Inclusivity for the LGBTQIA+ Community: Count Me In

PANEL MODERATOR:

Garo Kiledjian, Founder & CEO, SGM Alliance

Join us for a thought-provoking session as we kick off with the introduction of SGM Alliance who's paving the way in addressing health inequities faced by the LGBTQIA+ community who are often overlooked in clinical research. Hear from sexual and gender diverse individuals as they share their lived experiences encountering barriers in healthcare systems and clinical research, including restrictive eligibility criteria, stigma and mistreatment, lack of culturally responsive care, and incomplete and inaccurate data collection of sexual orientation and gender identity (SOGI).  Gain valuable insight into the health disparity challenges faced by SGM (sexual and gender minorities) to link to the collaborative efforts aimed at pioneering solutions. Together, let’s build a foundation for more inclusive and equitable healthcare.

PANELISTS:

Amanda Beasley, PhD, Director, Representation in Clinical Research (RISE), Amgen

Evan Ko, Study Management Associate, AbbVie, Inc.

Shir Netanel, Associate Director of Patient Advocacy and Clinical Trial Advocacy, Global Medical Affairs Oncology, Janssen

Jeffery Pettit-Williams, Principal Project Manager, Patient Diversity, PPD

Solomon Yakubov, Associate Director, Global Clinical Operations, GSK

Sponsored Presentation (Opportunity Available)9:30 am

9:45 am PANEL DISCUSSION:

Overcoming Access Barriers to Healthcare for the LGBTQIA+ Community: Bridging Gaps, Driving Change

PANEL MODERATOR:

Jessica Brescher, Chief Research Officer, SGM Alliance

In this dynamic follow-up session, we delve into innovative strategies to achieve inclusive clinical research that supports the LGBTQIA+ community. Explore how to directly address systemic barriers in clinical research through inclusive language, expanded demographic data collection, and culturally inclusive and responsive education for clinical site staff and healthcare providers (HCP). Join the conversation to learn about actionable measures you can take to include sexual and gender minorities (SGM) in clinical study design, spanning from protocol design through recruitment and retention. Together, let’s bridge the gaps and drive meaningful change for a more inclusive and accessible landscape in clinical research. 

PANELISTS:

Sandra Amaro, Head, Clinical Trial Diversity, Pfizer Inc.

Denise Johnson Sura, Associate Vice President, Design Hub Foundations, Eli Lilly & Co.

Shir Netanel, Associate Director of Patient Advocacy and Clinical Trial Advocacy, Global Medical Affairs Oncology, Janssen

Michel Reid, Senior Director & Head, Global Demographics & Diversity, GSK

Kim Ribeiro, Head, Diversity and Patient Inclusion, AbbVie

Networking Coffee Break10:45 am

11:05 am Chairperson's Remarks

Michael Stadler, CEO, Clariness

11:10 am CO-PRESENTATION:

We Identified the Barriers to Trial Diversity, According to 4,000 Patients across the Globe—Breaking Down the Barriers

Amy Froment, Head, Global Trial Optimization, Regeneron

Kristin Parkhurst, Associate Director, Global Trial Optimization – Diversity, Equity and Inclusion (DEI), Development Operations & Portfolio Management, Regeneron

This presentation will share six major psychological and practical barriers to trial diversity, as reported in the largest patient diversity survey run to date. The findings are drawn from the responses of nearly 4,000 patients, spanning nine countries, and a broad range of socio-economic groups, education levels, ethnic and gender identities, and ages. Gain a wholistic understanding of what prevents patients from marginalized backgrounds—socioeconomic status, poor insurance coverage, LGBTQ+ identity, and more—from participating in clinical trials and what motivates them to do so; and how simple changes to study design, site selection, study materials, terminology, and language can overcome many of the issues identified.

11:40 am

Early Insights to Support Diverse Enrollment

DeeAnn Lijfrock, RN, Patient Insights and Inclusion Lead, Sanofi

How does an organization make the transition from having a diversity plan to successfully enrolling diverse patients in their clinical trials? I will share a number of best practices in use at Sanofi to increase participation of underrepresented populations across therapeutic areas in the United States which can be modified for use in other regions and countries. COVID-19 shone a light on the need to improve on the diversity of clinical trial participants across all disease areas. Sanofi’s experience thinking outside the box to accomplish this will be of value to any organization struggling to move the needle and achieve realistic goals for diverse enrollment.

12:10 pm CO-PRESENTATION:

Applying Modeled Population Data to Improve Diversity in Clinical Trial Recruitment in European Countries

Baris Guc, Senior Data Scientist, Roche

Johnny Wharton, Portfolio Analytics Manager, Insights and Analytics, Product Development Global Operations (PDG), Roche

In recent years, attention has been increasingly focused on trying to improve the diversity of patients recruited to clinical trials. We have been assisting clinical teams with data-driven recommendation of sites most likely to be able to diversely recruit. However, lack of data availability in European countries has made this very difficult. Here we discuss methods we are using to improve data-driven diverse patient recruitment in Europe.

Transition to Lunch12:40 pm

12:45 pm

LUNCHEON PRESENTATION:Real-Time Patient Insights: Flexible Patient Engagement, in Days Not Months

Tate Stubbs, COO, Executive, HealthMatch

The value of timely and representative patient insights is well established not just as a social but commercial imperative in the clinical development process.

Leveraging direct connection to a rapidly growing patient user base of 1.3 million users, HealthMatch’s Real-Time Patient Insights provides engagement to industry at scale.

Two case studies will be explored, on quantifying DEI in Clinical Trials and lived experience in psychiatry, conducted with Abbvie.

SCOPE Summit 2024 Adjourns1:15 pm

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

PRE-CONFERENCE WORKSHOPS

SUNDAY AFTERNOON PLENARY SESSION:
KICK-OFF MULTI-STAKEHOLDER PLENARY KEYNOTE AND PARTICIPANT ENGAGEMENT AWARDS

MONDAY MORNING PLENARY SESSION:
TRANSFORMING THE DEVELOPMENT PARADIGM & GENERATIVE AI IN CLINICAL TRIALS

INCORPORATING PATIENT AND SITE VOICE IN PROTOCOL DEVELOPMENT AND TRIAL PLANNING

NEW TRENDS IN TRIAL DESIGN TO IMPROVE PATIENT EXPERIENCE AND TRIAL OUTCOMES

BREAKFAST PRESENTATIONS

TUESDAY AFTERNOON PLENARY SESSION:
MODERNIZING TRIALS WITH FDA & INTERSECTION OF INNOVATIVE DEVELOPMENT MODELS AND INVESTMENT APPROACHES

BREAKFAST PRESENTATION

TRANSFORMING HEALTHCARE FOR THE LGBTQIA+ COMMUNITY: INNOVATIVE APPROACHES TO INCLUSIVITY

PRE-CONFERENCE WORKSHOPS

SUNDAY AFTERNOON PLENARY SESSION:KICK-OFF MULTI-STAKEHOLDER PLENARY KEYNOTE AND PARTICIPANT ENGAGEMENT AWARDS

MONDAY MORNING PLENARY SESSION:TRANSFORMING THE DEVELOPMENT PARADIGM & GENERATIVE AI IN CLINICAL TRIALS

INCORPORATING PATIENT AND SITE VOICE IN PROTOCOL DEVELOPMENT AND TRIAL PLANNING

NEW TRENDS IN TRIAL DESIGN TO IMPROVE PATIENT EXPERIENCE AND TRIAL OUTCOMES

BREAKFAST PRESENTATIONS

TUESDAY AFTERNOON PLENARY SESSION: MODERNIZING TRIALS WITH FDA & INTERSECTION OF INNOVATIVE DEVELOPMENT MODELS AND INVESTMENT APPROACHES

BREAKFAST PRESENTATION

TRANSFORMING HEALTHCARE FOR THE LGBTQIA+ COMMUNITY: INNOVATIVE APPROACHES TO INCLUSIVITY

SUNDAY AFTERNOON PLENARY SESSION:
KICK-OFF MULTI-STAKEHOLDER PLENARY KEYNOTE AND PARTICIPANT ENGAGEMENT AWARDS

MONDAY MORNING PLENARY SESSION:
TRANSFORMING THE DEVELOPMENT PARADIGM & GENERATIVE AI IN CLINICAL TRIALS

TUESDAY AFTERNOON PLENARY SESSION:
MODERNIZING TRIALS WITH FDA & INTERSECTION OF INNOVATIVE DEVELOPMENT MODELS AND INVESTMENT APPROACHES