Feasibility & Study Start-Up

2024 ARCHIVES

Protocol Development, Feasibility, and Global Site Selection

Improving Study Start-up and Performance in Multi-Center and Decentralized Trials

Identifying the most appropriate sites, and effectively partnering to streamline site activation, start-up, and operations is a daunting task. The convergence of the pandemic, regulation changes, patient- and site-centricity, DEI, real-world data, new analytics capabilities, digital and decentralized site and patient partnership models are challenging traditional feasibility methodologies. SCOPE’s Feasibility & Study Start-Up track will explore new approaches to overcome these challenges. The Feasibility and Global Site Selection track will explore analytics-driven global site selection, patient- and site-centric approaches to planning and execution, and creative solutions to reduce site burden. The Site Activation, Study Start-up & Performance Optimization track will delve into strategies to support sites through operational hurdles, new approaches to support DEI goals, and technologies and processes to improve study deployment.

Part 1: Feasibility and Global Site Selection

Part 2: Site Activation, Study Start-Up and Performance Optimization

Sunday, February 11

Part 1: Feasibility and Global Site Selection

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

Kris MacDermant, Senior Vice President, Sales, Mid-Market, Advarra

10:50 am

Feasibility: Process Update to Ensure Active Site Engagement

Michele Teufel, Site Management & Monitoring Therapy Area Strategy & Portfolio Delivery, Development Operations, AstraZeneca Pharmaceuticals, Inc.

During this discussion, you will learn how AstraZeneca has made process changes and shifted the mindset of the feasibility process. We will share the process and template changes we have implemented to ensure we are actively engaged from our first interaction through site selection.

11:20 am PANEL DISCUSSION:

Increasing Transparency & Trust in Site Selection: A Conversation with Sponsors and Sites

PANEL MODERATOR:

Marcy Kravet, Head, Oncology Strategy, Inato

Join this insightful panel discussion to explore topics such as what sponsors and sites need from each other to accelerate site selection, How to increase transparency and accuracy in enrollment and startup projections, and assessing diverse enrollment potential.

PANELISTS:

Lilly Frohlich, Director, Clinical Operations, Cerevel Therapeutics

Jennifer Matson Hunter, CCRP, BAAS, Director of Research Operations, Mary Crowley Cancer Research

Ade Lawrence, MD, MSc, Founder/CEO, Bioluminux Clinical Research

Jonathan Salazar, Development Feasibility Manager, Global Study Operations, Amgen

11:50 am PANEL DISCUSSION:

Modernizing Site Engagement and Enablement for the Trials of the Future

PANEL MODERATOR:

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)

Revolutionizing site engagement and enablement for the trials of tomorrow is essential for the future of our trials and their success. Learn how technology, data-driven approaches, and collaborative strategies are transforming the clinical research landscape. Explore successful examples, share insights, and be part of the conversation shaping the future of efficient and patient-centric trials. Drive innovation in site engagement for long-term success.

PANELISTS:

Cerdi Beltre, COO, Innovo Research

Savine DaCosta, Health Equity Lead, Biogen

Brad Hightower, CEO, Hightower Clinical

Ryan Jones, CEO, Florence Healthcare

12:20 pm

CO-PRESENTATION:Leveraging Data and Analytics to Drive More Efficient and Diverse Trials

Ann Koehler, Product Strategy Lead, Intelligent Trials, Medidata

Jason Josie, Director, Site Management, BeiGene

Clinical Trials are growing in volume and complexity as patient enrollment rates trend downward and site competition increases. Meanwhile, new regulatory guidelines have introduced challenging, yet essential, requirements to improve clinical trial diversity.

This discussion will teach you how to leverage industry-wide, site-level data to make more informed site selection decisions and deliver faster, more representative trials. Key takeaways will include an overview of complexities in the clinical trial landscape today, current industry trends, and data that can be leveraged to address challenges. This session will also consider methods to meet regulatory requirements around diversity while taking into account operational needs. Finally, it will discuss tools pharmaceutical companies and CROs can utilize leveraging operational and clinical data to accelerate trial enrollment and achieve diversity goals.

Transition to Lunch12:50 pm

12:55 pm

LUNCHEON PRESENTATION:An Ecosystem Approach to Site Tech Overload

PANEL MODERATOR:

Melissa Easy, Vice-President, Digital Products & Solutions, IQVIA Technologies

Facing staffing shortages, clinical research sites are turning down studies they find unworkable. How can we get the clinical trial ecosystem in balance so that everyone benefits, most importantly the patients we serve? In this panel discussion, leaders across the clinical trial ecosystem will discuss viable strategies that move beyond single-vendor and single-sponsor solutions to make a real impact on site centricity and tech overload.

PANELISTS:

Matthew Jones, Senior Product Owner - Study Start Up, Site Engagement & Trial Operations, R&D Technology, GSK

Aruna Adhikari Thapa, Senior Director, Product Strategy, IQVIA Technologies

Sharlene Carnegie, Senior Vice President Medidata Platform, Medidata

Brad Hightower, CEO, Hightower Clinical Research

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

William B. Smith, CEO, Alliance for Multispecialty Research (AMR)

2:25 pm

Discover How Human Intelligence Is Potentialized by Artificial Intelligence to Target the Best Sites

Sarah McClure, Global Data Engagement Lead, Feasibility Management, R&D, Sanofi

Sanofi is leveraging AI to rethink how to transform trials including accelerating the process of finding the most relevant trial sites: in addition of globally improving patients’ enrollment, we enlarge the scope to also address the enrollment of underrepresented populations. The AI-powered data and analytics approach has become a real springboard to reach this challenging but so important goal. It informs and empowers teams in their decisions around clinical trial country and site identification and support the enrollment modeling.

2:55 pm CO-PRESENTATION:

Using Data Science to Accelerate Feasibly, Site Selection & Study Start-Up—Site Intelligence Hub

Sheela Iyer, Director Associate, Janssen R&D Data Science

Monica Jain, Director, R&D Data Science, Johnson & Johnson Innovative Medicine

This presentation will explore how the data stewardship processes within clinical trials feasibility can be enhanced with data science and technology. Gain insight into how Janssen developed and deployed new tools to accelerate and improve clinical trial feasibility.

3:25 pm

CO-PRESENTATION:How BioPharma Can Overcome Stakeholder Challenges through the Use of AI and an Integrated Platform

Dennis Akkaya, Chief Commercial Officer, Commercial, myTomorrows

Danny den Hamer, Product Manager, Software Engineering, myTomorrows

This presentation highlights how innovative technology is elevating clinical trial recruitment. The myTomorrows platform introduces a 'Green Wave', enhancing stakeholder engagement. It addresses key challenges in patient and physician journeys, introducing TrialSearch AI as a solution. This approach significantly helps BioPharma in effectively recruiting a larger pool of patients, optimizing the entire recruitment process.

3:55 pm PANEL DISCUSSION:

Empowering Predictable & Representative Clinical Trial Planning: Trustworthy and Scalable AI for Enhanced Feasibility and Site Selection

PANEL MODERATOR:

Ronald Du, Associate Principal, ZS Associates

In the rapidly evolving landscape of clinical trials, the integration of trustworthy and scalable AI tools, including machine learning and deep learning, is revolutionizing standard feasibility methodologies. These advanced data analytics techniques not only enhance trial planning but also facilitate the identification of diverse patient populations and provide a deeper understanding of site performance, both past and future. Leading industry organizations are already harnessing these AI-driven insights, ensuring more robust and reliable outcomes. Join four industry experts and members of the ZS Sponsored Clinical Feasibility Consortium as they delve into real-world success stories, discuss the challenges and triumphs of implementing AI, and explore how these innovations are paving the way for the next generation of therapies.

PANELISTS:

Michael Dawson, Director, Study Feasibility, AbbVie, Inc.

Jade Dennis, Executive Director, Clinical Trial Design Capabilities, Eli Lilly and Company

Sylvia Marecki, PhD, Head, Operational Design Center (ODC), Global Development Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Dana Iommazzo, Global Head, Clinical Operations Program Management, Novartis

4:25 pm

Speed to Access—Simplifying Study Start-Up for All Clinical Users

Martin O'Malley, Director Life Sciences/Health IT Business Solutions, Exostar

Join us as we discuss innovative strategies to empower sponsors to streamline study start-up processes, enhance the clinical site experience, and eliminate the technology burden that often hinders research efficiency. Uncover practical solutions that will drive smoother operations, enhance collaboration, and ultimately accelerate advancements in clinical research. Don't miss this opportunity to explore options that elevate the sites experience and help speed drugs to market.

4:40 pm

CO-PRESENTATION:Leveraging Scaled Patient Insights to Inform Trial Strategy

April Lewis, Associate Principal, ZS

Kevin Hudziak, Clinical Trial Design Capabilities, CoDESIGN Clinical Design Delivery & Analytics, Eli Lilly

As an industry we lack a mature programmatic approach to ensure the voice of our key end-user—the patient—is integrated in real-time across the clinical development life cycle. This interview with Eli Lilly will share innovation in the use of scaled, quantified and representative insights in line with patient-informed drug development.

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

Donna Hanson, Vice President, Strategy & Optimization, Advanced Clinical

9:15 am

Data-Informed Investigator Selection That Drives Patient Enrollment and Health Equity

Katherine Broecker, Senior Director, Design Hub Data Insights, Eli Lilly & Co.

There is much data available to inform historical site performance, however, the world of clinical trials is changing. We must have a patient focus during investigator selection. This presentation will explore the use of multiple data sources and analytics that give insight into geographies, investigators, and novel opportunities to reach patients. All this with an emphasis on diversity of patient population to have a positive impact on health equity.

9:45 am PANEL DISCUSSION:

Making Diversity, Equity, and Inclusion an Integral Part of Feasibility

PANEL MODERATOR:

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)

Join our expert panel as they explore key strategies to infuse diversity, equity, and inclusion into the core of clinical trial feasibility assessments. Discover innovative approaches to enhance participant recruitment, improve study design, and address disparities. You will gain insights into the evolving landscape of inclusive research practices. Don't miss this vital discussion shaping the future of clinical research.

PANELISTS:

Denise Bronner, PhD, Director, Diversity, Equity and Inclusion in Clinical Trials, Immunology, Johnson & Johnson Innovative Medicine

Shafaat Ali Khan, Associate Director – Investigator Engagement Clinical Research Lead (CRL), Eli Lilly and Company

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

10:15 am

Site Activation and Start-Up Optimisation: Reducing Operational Burden

Tamara Hughes, Vice President, Study Start-Up, ICON Clinical Reserach

Reducing operational burden during the site activation and start-up phases is essential to ensuring that clinical trials start efficiently and run smoothly. Explore ways to enable greater transparency in study start-up processes and workflows to enhance collaboration, manage risk, and align stakeholder expectations for more successful initiation of clinical trials.

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

Sidd Bhattacharya, Principal, PwC

11:45 am

Practical Tactics for Diversity in Clinical Trial Implementation

Zoma Foster, Head of Strategic Feasibility, UCB Biosciences, Inc.

The presentation will focus on the strategic steering of planning, tracking, and reporting for diversity in clinical trials. We will detail some practical approaches to consider at different stages to enhance diversity in clinical trials; e.g., during site selection, patient recruitment, diversity vendor considerations, etc.

12:15 pm

SITE INNOVATION AWARD: Celebrating Creativity in Site-Centric Approaches to Advance Clinical Trials for All Stakeholders

PANEL MODERATORS:

Irfan Khan, CEO, Circuit Clinical

Amanda Wright, Vice President, Partnership Development, Javara

PANELISTS:

Denise Bronner, PhD, Director, Diversity, Equity and Inclusion in Clinical Trials, Immunology, Johnson & Johnson Innovative Medicine

Joe Dustin, Founder & Managing Partner, eClinical Consulting

Brad Hightower, CEO, Hightower Clinical

Marisa Rackley, Vice President, Clinical Site Start Up, Site Engagement, Trial Optimization, Takeda

Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS

Transition to Lunch12:45 pm

12:50 pm

LUNCHEON PRESENTATION:A Novel Framework for Quantifying Site Burden in Protocol Complexity Assessment

Eddie Valaitis, Director, PwC

Marigrace Ambrosia, Director, PwC

While clinical trial sponsors have invested in capabilities to reduce protocol complexity by lowering patient burden and streamlining inclusion/exclusion criteria and endpoints, site perspectives have not been generally incorporated into the protocol complexity assessment processes. We propose a novel quantitative framework for evaluating site burden as part of protocol complexity assessment; and show how it relates to other protocol complexity dimensions and downstream operational 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: Site Activation, Study Start-Up and Performance Optimization

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

Suzanne Caruso, SVP, Product Strategy, Citeline

4:35 pm CO-PRESENTATION:

Transforming Operations to Cut Time out of the Development Continuum

Nikki Amaratunge, Vice President, Clinical Development Operations, Aesthetics & Eyecare & Specialty, AbbVie, Inc.

Lorena Gomez, Global Head, Study Start-Up, COA, and Digital Implementation, AbbVie, Inc.

Hear from AbbVie clinical leadership on how they are forming specialized functional groups, compressing tasks, and applying AI solutions to improve operational outcomes and accelerate clinical development. Explore the impact of organizational change with a focus on key areas including study planning, study start-up, and site engagement.

5:05 pm CO-PRESENTATION:

Journey to Industry-Leading Predictive Analytics

Alyson Higgins, Director, Study Feasibility and Patient Platform, AbbVie, Inc.

Li Wang, PhD, Senior Director & Head, Statistical Innovation, AbbVie, Inc.

Trial enrollment timeline prediction is a crucial aspect of clinical development, Our presentation will outline the key steps in building a predictive enrollment model using machine learning and NLP. We will also introduce a combined approach based on a Quasi-Poisson model that integrates the domain knowledge of experts, together with the machine learning model to build an ensemble model structure. Internal validation results will be discussed as well.

5:35 pm

CO-PRESENTATION:The Perfect Technology Combination to Maximize Your Clinical Trial Platform — From Start-Up to Close Out

Mark Laney, Sales Engineering & Product Partnerships Lead, Business Development, Merative

Jan Nielsen, Community Manager, BSI Life Sciences

It’s hard to find a “one size fits all” platform that meets your clinical trials technology needs, but the collaboration between BSI Life Sciences and Zelta brings you one step closer to building an integrated system. Join us for a session to learn how proven CTMS, eTMF and CDMS solutions are accessible in one established ecosystem and how you can easily navigate the modules you need throughout your trial.

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

Dennis McMillan, Vice President, Global Feasibility, Parexel

8:30 am CO-PRESENTATION:

Transforming Trials: Actionable EHR-to-EDC Strategies for Sites, Sponsors, and Evaluating Success

Amy Cramer, Focus Area Leader: Capitalizing on Data Assets, The Janssen Pharmaceutical Companies of Johnson & Johnson

Joe Lengfellner, Senior Director, Clinical Research Informatics, Memorial Sloan Kettering Cancer Center

This presentation offers pragmatic EHR-to-EDC strategies for sites, sponsors, and CROs. We will illuminate the essential steps for EHR-to-EDC implementation, underlining its immediate applicability and moving beyond theoretical discussions. Participants will be presented with the initial outcomes of collaboration between Memorial Sloan Kettering, Janssen, and IgniteData. This session is crucial for clinical research experts who are eager to quickly and efficiently update their data integration strategies.

9:00 am CO-PRESENTATION:

Research Site Technology: Fostering Understanding and Collaboration

Nan Croy, Associate Director, Site Partnerships, CLS Behring

Mark King, Vice President, Research & Innovation, Novant Health

Denise Snyder, Associate Dean, Clinical Research, Duke University School of Medicine, Duke Office of Clinical Research

The session will feature site and sponsor leadership perspectives on how we can collaborate to address common challenges that slow study start-up. The audience will gain an understanding of how sites, sponsors, and CROs are working together to solve longstanding process and workflow challenges while improving patient centricity and bringing treatments to market safely and efficiently.

9:30 am

CO-PRESENTATION:Trust in Innovation: Site & Patient Education Driving Change in Clinical Trial Quality, Efficiency, and Engagement

Philip Bedrin, Vice President, Medical & Clinical Solutions, ScienceMedia, Inc.

Malachi Bierstein, Chief Commercial Officer, ScienceMedia, Inc.

Dawn Furey, Senior Vice President, Enterprise Client Delivery Operations, Signant Health

Colleen Graham, Vice President, Head of Clinical Operations, Mediar Therapeutics

Effective education of study staff and diverse patient populations is crucial for your study’s conduct. Old ways of burdensome documents and PPT training cause slow enrollment, staff turnover, and a lack of common training language. It is time to trust innovative training solutions that produce high-quality data, reduce risk, time, and cost, while improving engagement and patient experience. With so many options available, how do you determine a high-quality training solution?

9:45 am CO-PRESENTATION:

The Secret to Recruitment Success Starts with Site Selection: How to Supercharge Site Selection in the UK to Deliver Results

Alex Hammond, Business Development Manager, National Institute of Health and Care Research (NIHR)

Nicola Yallup, National Head, Business Development & Marketing, National Institute of Health and Care Research (NIHR)

Recently implemented initiatives are putting the UK back on the map as a world-leading research destination. Working in partnership is achieving better “speed and spread” of research, inclusive recruitment and faster set up times. This session explores how sponsors and sites are embracing new ways of working including the UK’s approach to costing and contracting and increased recruitment of patients in general practice - the NHS (National Health Service) front line.

10:05 am

Effective Start-Up and Trial Optimization

Stephanie Abbott, Clinical Research Program Director, Clinical Trials, Western Washington Medical Group

The information that will be presented is from over two decades of innovation at the site level to improve the efficiency by which trials are deployed and run. We will review tips and tricks for streamlining the start-up process, leveraging key technologies to facilitate optimization of the trial deployment process, and creating integrated workflows that simplify trial conduct.

10:25 am

Sorting through the Noise to Accelerate Study Start-Up

Asma R. Kasuba, Senior Director, R&D Data Science Global Development, Johnson and Johnson Innovative Medicine

To accelerate clinical trials, JNJ Innovative Medicine has built an Intelligence Hub platform of internal and external RCTs. To accelerate site selection, the Hub provides daily updates on the "feasibility Flow" until selection and insights to the progress/roadblocks to site activation. The objective is to democratize the access to the data and have an integrated site engagement strategy from the central and local study teams. Unique, first in industry approach to bring benchmark and actual study start up data into an intelligence hub. The hub provide data reasoning and visualization to an individual country and site level to understand local needs. Learning from one trial to inform proactively future studies, and aid in the development of AI enrollment models.

Networking Coffee Break10:45 am

11:05 am Chairperson's Remarks

Akiko Shimamura, Senior Vice President, Trial Design & Optimization, Clinical Sciences, TriNetX

11:10 am PANEL DISCUSSION:

Examining Site Activation and Patient Enrollment Benchmarks among Sponsors and CROs

PANEL MODERATOR:

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

Sponsors and CROs are encountering significant challenges identifying and activating investigative sites and recruiting and retaining study volunteers. This session will examine some of the study and site-level metrics that Tufts has gathered on patient enrollment and site activation rates as well as global recruitment and retention tactics. A panel of sponsor companies will provide insights on the study results and discuss innovative practices and approaches being implemented.

PANELISTS:

Amanda Decoker, Senior Director, Head of Patient Recruitment and Retention, Takeda

Saartje Vansteenkiste, Executive Director, Clinical Portfolio Execution, CDO, CSL

Jacklynn Wong, Associate Director, Investigator and Patient Engagement, Johnson & Johnson

11:40 am

The Power of Adaptability: Engagement and Retention in Majority-Minority Communities

Don Harder, Head of Trial Solution Design, Care Access

If we are going to reach majority-minority communities with opportunities for research, it needs to be done on a grass-roots level with leadership from the communities of interest. Engagement must start with community leadership and be focused on a long-term commitment to the community. I will discuss the multiple levels of engagement that must be employed in order for any diversity-focused enrollment strategy to be effective.

12:10 pm

Patient Burden, and Net-Zero: How Environmentally-Friendly Patient Solutions Can Also Be Patient-Friendly

Michael J. Cohen, Senior Director, Environmental Sustainability, Strategy & Innovation, Thermo Fisher Scientific

Here we will discuss a pilot using self-driving, electric vehicles for patient travel to and from a site in a clinical trial through multiple lenses as we explore strategies for simultaneously reducing patient burden and carbon footprint. Bringing together experts from multiple stakeholders, we look forward to exploring key performance across environmental sustainability, patient and site experience as well as regulatory and other important factors uncovered in this pilot. The goal is to highlight lessons learned as we attempt to decarbonize patient travel while also improving patient experience in clinical trials.

Transition to Lunch12:40 pm

12:45 pm

LUNCHEON PRESENTATION:Unlocking Enrollment Success: Study Support to Accelerate Timelines

Seth Halvorson, General Manager, Site Solutions, Clinical Research Solutions, WCG

As protocols become increasingly complex, a persistent challenge arises when the capacities and timelines of sites do not synchronize with the study timelines envisioned by sponsors. Additional study support is often necessary to accelerate enrollment of participants to meet the study demands.

In this session, we will explore a range of strategies aimed at reducing the gap between expected and actual enrollment timelines while maintaining the balance between speed and quality.

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

SITE-CENTRICITY IN FEASIBILITY AND SITE SELECTION PROCESSES

DATA-DRIVEN STRATEGIES TO IMPROVE FEASIBILITY

BREAKFAST PRESENTATIONS

THE FUTURE SITE: INNOVATION, CREATIVITY & COLLABORATION TO ADVANCE CLINICAL RESEARCH

THE FUTURE SITE: INNOVATION, CREATIVITY & COLLABORATION TO ADVANCE CLINICAL RESEARCH (cont)

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

APPLYING AI TO IMPROVE OPERATIONS AND OUTCOMES

BREAKFAST PRESENTATION

TECHNOLOGY AND COLLABORATION TO STREAMLINE START-UP AND OPTIMIZE PERFORMANCE

INNOVATIVE TACTICS TO IMPROVE ENROLLMENT & RETENTION: THE FUTURE OF CLINICAL TRIALS

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

SITE-CENTRICITY IN FEASIBILITY AND SITE SELECTION PROCESSES

DATA-DRIVEN STRATEGIES TO IMPROVE FEASIBILITY

BREAKFAST PRESENTATIONS

THE FUTURE SITE: INNOVATION, CREATIVITY & COLLABORATION TO ADVANCE CLINICAL RESEARCH

THE FUTURE SITE: INNOVATION, CREATIVITY & COLLABORATION TO ADVANCE CLINICAL RESEARCH (cont)

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

APPLYING AI TO IMPROVE OPERATIONS AND OUTCOMES

BREAKFAST PRESENTATION

TECHNOLOGY AND COLLABORATION TO STREAMLINE START-UP AND OPTIMIZE PERFORMANCE

INNOVATIVE TACTICS TO IMPROVE ENROLLMENT & RETENTION: THE FUTURE OF CLINICAL TRIALS

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