SCOPE Summit for Clinical Ops Executives

Break

Golf Check-In & Breakfast Buffet

Other

SCOPE's 4th Annual Masters of Clinical Research Golf Tournament

Break

Golf Lunch Buffet

Workshop

WORKSHOP 1: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.

Workshop

WORKSHOP 2: Exploring ClinEco—SCOPE’s Growing Online B2B Clinical Trial Community

Workshop

WORKSHOP 3: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials

Workshop

WORKSHOP 4: Efficient Importation of Biological Materials into the U.S.

Workshop

WORKSHOP 5: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing

Other

Organizer's Welcome Remarks & 4th Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Cambridge Healthtech Institute

Keynote

Fast-Forward to 2035: What Success Could Look like in Converging Clinical Research and Care—And How to Get There

Janice Chang, TransCelerate Biopharma Inc

Other

Tips for Getting the Most out of SCOPE

Micah Lieberman, Cambridge Healthtech Institute

Panel

What Do Real Patients Actually Talk About?

T. Hephner, Inspire · Emily McCormack, New York Blood Center · Fabian Sandoval, Emerson Clinical Research Institute · Quynh Tran, Cystic Fibrosis Foundation

Panel

SCOPE's 9th Annual Participant Engagement Awards

Micah Lieberman, Cambridge Healthtech Institute · Tricia Barrett, Praxis · Brian Burkhardt, Oliver Patch Project · Michelle Everill, Alnylam Pharmaceuticals · Gretchen Goller, Pfizer Inc. · Jen Horonjeff, Savvy Cooperative · Stacy Hurt, Parexel Intl · Kim Ribeiro, Inside Edge Consulting Group

Networking

SCOPE's Kickoff Reception: A Luau to Remember!

Other

SCOPE's 5K Rise and Shine Fun Run!

Break

Morning Coffee

Other

Grab Your Seat: Early-Bird Seat Raffle & Prize Giveaway!

Other

Welcome to SCOPE 2025—Who’s Here and Why, What’s New, Annual Awards

Micah Lieberman, Cambridge Healthtech Institute

Keynote

Exquisite Clinical Trial Delivery in an Ever-Changing World—Evolution and Opportunity for Sustained Performance

Andrew Lee, Merck & Co

Talk

Beyond the Real-World Data, What Are Patients Saying?Special LIVE Episode with Studio Audience–Patient Contestants will be Announced Onsite!

Brett Kleger, Inspire

Panel

How Patients Can—and Must—Disrupt Traditional Pharma Clinical Trials

Craig Lipset, Decentralized Trials & Research Alliance DTRA · Deirdre BeVard, CSL · Heidi Bjornson-Pennell, Chan Zuckerberg Initiative LLC · Nasha Fitter, Citizen Health · Craig Martin, The Orphan Therapeutics Accelerator · Tracey U. Sikora, Natl Organization for Rare Disorders

Break

Grand Opening Coffee & Refreshment Break in the Exhibit Hall—Best of Show Voting Opens

Talk · AI for Clinical Trials

Scalable AI-Powered Approaches

Jonathan Crowther, Merck KGaA, Darmstadt, Germany

Talk · Decentralized & Hybrid

Accelerating Drug Development through Clinical Trial Delivery Innovation

Kim O'Day, Eli Lilly & Co

Talk · Biomarkers & Precision Medicine Trials

Biospecimen Industry Collaboration: Pioneering Best Practices to Standardize, Accelerate, and Transform Clinical Research

Brenda Yanak, Clinical Transformation Partners

Talk · Quality & Monitoring

RBQM Revealed: A Decade of Discovery & the Blueprint for Tomorrow’s Breakthroughs

Joanne Benedict, Gilead

Talk · Clinical Supply & Logistics

Unlocking IRT Potential for Maximum Leverage

Alminaz Noorani, Ultragenyx Pharmaceutical Inc

Talk · Budgeting & Resources

Budgeting for Patient-Centric Solutions to Alleviate Patient Burden

Marina Malikova, Boston Medical Ctr

Talk · Data

Optimizing Clinical Data Integration: A Path to Efficiency

Narayanarao Pavuluri, Merck

Talk · Small Biopharma Strategies

Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma

Peter Ronco, Emmes

Panel · Outsourcing

Macro Trends in Pharma: AI, Innovation, and the Impact on Outsourcing Strategy

Rene Stephens, Danforth Advisors · Lynette Bojko, Pfizer

Talk · Patient-Centric Trial Design & Inclusive Research

Can You Hear Me Now? Amplifying the Patient Voice in Trial Design

Whitley Albright, Sanofi Grp

Panel · Real World Evidence

Regulatory Initiatives to Enable Pragmatic Trials

Gracy Crane, Roche Products Ltd · Melodi McNeil, Abbvie Inc · Henry Wei, Regeneron Pharmaceuticals Inc · Stephanie Derbyshire, Roche · Kevin Bugin, Amgen

Talk · Recruitment & Engagement

Early Patient Advocacy Group Engagement: Best Practices for Establishing Efficient Partnerships

Patricia Roselle, Sanofi

Talk · Feasibility & Study Start-Up

Mapping the Evolving Global Landscape of Investigative Site Models

Joan Chambers, Tufts CSDD

Talk · Site Engagement & Enablement

Establishing Long-Term Partnerships for Study Success: AstraZeneca's Biopharmaceuticals Partners in Care Network and Site Engagement Model

Joshua Hershelman, AstraZeneca Pharmaceuticals Inc

Talk · Digital Health Technologies

Harnessing Digital Biomarkers and Data Science: Paving the Way for Accelerated Drug Development in Parkinson’s Disease

Marissa Dockendorf, Merck

Talk · Biomarkers & Precision Medicine Trials

Operationalizing Precision Medicine: Best Practice from Protocol Design through Study Start-Up

Nancy DeFusco, Merck Sharp & Dohme, LLC

Talk · Decentralized & Hybrid

Statistical Considerations for Effective Decentralized Clinical Trials

Charmaine Demanuele, Pfizer

Talk · Quality & Monitoring

In Pursuit of Adoption: Risk-Based Quality Management and ICH E6 R3

Vimi A. Shukkoor, Eli Lilly & Company

Talk · Data

Practical Governance Strategies for Large-Scale R&D Data & Analytics

Gian Prakash, AbbVie Inc

Talk · Small Biopharma Strategies

Strategic Partnerships for Accelerating Biotech Startups: From Pre-Clinical to Clinical Success

Alex Pastuszak, Paterna Biosciences

Talk · AI for Clinical Trials

Challenges in Reaching the Desired Altitude for GenAI Applications in Clinical Trials

Brian Martin, AbbVie Inc

Talk · Biomarkers & Precision Medicine Trials

Operationalizing Precision Medicine: Best Practice from Site Activation through Study Closeout and Final Disposition of the Specimen

Deborah Shepard, Pfizer Inc

Talk · Clinical Supply & Logistics

Connecting Teams and Promoting Collaboration around IRT

Dawn Sorenson, Daiichi Sankyo, Inc

Panel · Budgeting & Resources

Redesigning Site Contract and Budget Negotiations to Accelerate Study Start-Up

Debora Sobral, Kyowa Kirin · Jennifer Sydney Goldman, Individual Consultant

Talk · Patient-Centric Trial Design & Inclusive Research

Challenges of Including Patient Voice in EU CTR Materials

Tricia Buchheit, Alnylam Pharmaceuticals

Talk · Recruitment & Engagement

Advancing Clinical Research Through Strategic Partnerships: The SGM Alliance SOGI Business Case

Jimmy Bechtel, Society for Clinical Research Sites (SCRS)

Talk · Feasibility & Study Start-Up

Opportunities for AI, RWD, and People to Power Trial Optimization

Desiree Abu-Odeh, Merck

Talk · Site Engagement & Enablement

AZ (AstraZeneca) & MGB (Mass General Brigham): Innovative Partnership to Deliver Clinical Trials of the Future

Christopher Herrick, Mass General Brigham

Talk · Digital Health Technologies

Variability in Human Signal Device Readings: An Analysis of Contributing Factors and Experimental Design

Sherrine M. Eid, SAS Institute Inc

Panel · Real World Evidence

Data, Data Everywhere, and Not a Byte to Use

Robert DiCicco, TransCelerate BioPharma Inc. · Su Chen, MITRE · Jesper Kjaer, Novo Nordisk AS · Trevan Locke, Amgen · Chris Decker, CDISC

Talk · Decentralized & Hybrid

From Concept to Reality: Innovation and Use Cases in Trials with Decentralized Approaches

Isaac R. Rodriguez-Chavez, 4Biosolutions Consulting

Talk · Quality & Monitoring

Critical-to-Quality Factors (CTQs)—Beginning with the End in Mind

Cilla Mistry, GSK

Talk · Data

Help Is Here: Interpreting the New ICH E6 R3 Data Governance Requirements

Arlene Lee, Medidata

Talk · Small Biopharma Strategies

Scaling Efficiency in Clinical Vendor Identification and Selection Processes

Marina Filshtinsky, Cambridge Healthtech Institute

Panel · Digital Health Technologies

eCOA BYOD: Exploring the Pros and Cons

Melissa Sesi, Merck & Co Inc · Valerie Balosso, GSK · Lynne Cesario, Pfizer Global R&D Groton Labs · Dan Kearney, CNS Healthcare · Pankaj Shukla, Clario

Talk · AI for Clinical Trials

Implementing Gen AI in Clinical Research

Janie Hansen, Daiichi Sankyo Inc

Panel · Biomarkers & Precision Medicine Trials

Biospecimen Industry Collaboration Q&A

Brenda Yanak, Clinical Transformation Partners · Nancy DeFusco, Merck Sharp & Dohme, LLC

Talk · Clinical Supply & Logistics

Automating Invoice Reconciliation for Clinical Trial Material Distribution

Anamika Sarkar, Regeneron Pharmaceuticals Inc

Talk · Patient-Centric Trial Design & Inclusive Research

Harnessing Generative AI for Enhanced Protocol Planning: Empowering the Site and Patient Voice

Erin Reynolds, AbbVie, Inc.

Talk · Recruitment & Engagement

Patient, Community, Academia, and Industry Partnerships to Promote Clinical Trial Diversity

Edward J. Bentlyewski, Herbert Irving Comprehensive Cancer Center- Columbia University

Talk · Feasibility & Study Start-Up

Using Advanced Methods to Improve Study Planning

Andrew Coates, AbbVie Inc

Talk · Site Engagement & Enablement

Site Partnerships—Developing Site Relationships beyond Study-Level Engagement

Sven Knapinski, CSL

Talk · Quality & Monitoring

Right From the Start: Story on How Risks Identified at the Study Design Phase Foster Cross-Functional Early Engagement and Pay Off during the Study Conduct Phase

Maha Raheb, AstraZeneca

Talk · Small Biopharma Strategies

Optimizing CRO Partnerships for Small Biopharma Success

Melanie Goodwin, Immunocore LLC

Talk · Decentralized & Hybrid

ROI: Return on Innovation – a Model for Avoiding Distraction in a World of BSOs (Bright Shiny Objects)

Alex Simmonds, Bristol Myers Squibb Co

Talk · Data

Clinical Data Democratization Through Data Products

Sophia Nuijens, Bristol Myers Squibb Co

Break

Sponsored Networking Luncheon

Break

Networking Coffee & Dessert Break in the Exhibit Hall

Other · Biomarkers & Precision Medicine Trials

Chairperson's Remarks

Maria Gujral, Bristol Myers Squibb Co

Other · Clinical Supply & Logistics

Chairperson's Remarks

Lisamarie Georgen, GuidedPath Consulting, LLC

Talk · AI for Clinical Trials

Project GAIA: Structured Content Authoring Using a Generative AI Assistant

Mark F. Ciaccio, AbbVie Inc

Talk · Decentralized & Hybrid

Double Jeopardy! When Oncology DCTs Are Not the Answer, Are We Asking the Right Question?

Peter O'Neill, TuHURA Biosciences

Talk · Biomarkers & Precision Medicine Trials

Optimizing Specimen Reconciliation to Improve Compliance and Data Integrity

Maria Gujral, Bristol Myers Squibb Co

Talk · Quality & Monitoring

Integrating Data Science at-Scale: Lessons Learned in RBQM and Anomaly Detection for Clinical Operations

Numan Karim, AbbVie Inc

Talk · Clinical Supply & Logistics

Partnering with Internal Stakeholders and Vendors

Luis Vargas, Genmab US Inc

Talk · Budgeting & Resources

Contractual and Legal Implications when Working with AI Suppliers and How to Address Them

Jennifer Trevor, Astellas Pharma US Inc

Talk · Data

Clinical Content Reuse (CCR) with Development Data Flow (DDF): Key Considerations for Success

Siddharth Shah, BeiGene

Talk · Small Biopharma Strategies

Adopting a Hybrid FSP Model and eISF in a Fast-Paced Clinical Trial Environment

Katherine Barboza, Galderma

Talk · Outsourcing

Intelligent Automation in Clinical Trial Vendor Selection

Matthew Failor, MAIA Biotechnology

Panel · Patient-Centric Trial Design & Inclusive Research

Diversity Action Planning: From Study Design to Site Execution

Magnus Franzen, Wavestone · Jodie Allen, AstraZeneca

Talk · Real World Evidence

Patients, Connection, Clinical Trials

Sara Pierson, Pfizer Inc

Talk · Feasibility & Study Start-Up

Expanding Horizons: Site Selection Strategies and Training for Diverse Enrollment Success

Marland May, AbbVie

Panel · Site Engagement & Enablement

Enhancing Patient and HCP Engagement for Improved Accessibility, Enrollment, Retention, and Outcomes

Angela Bilkhu, Roche · Mary Brantner, Insmed Inc

Other

Organizer's Welcome Remarks

Talk · Clinical Trial Venture, Innovation & Partnering

Co-Chair Welcome Remarks

Jessica J. Federer, Angelini Ventures

Talk · Digital Health Technologies

Digital Health Technology (DHT)-Derived Physical Activity and Performance in Cancer Cachexia

Carrie A. Northcott, Pfizer Inc

Talk · Clinical Trial Venture, Innovation & Partnering

Session Moderator's Remarks

Shwen Gwee, (Former) Bristol Myers Squibb

Panel · Clinical Trial Venture, Innovation & Partnering

Identifying and Addressing Pharma's Unmet Needs: Strategic Insights for Investment

Jodi Akin, Hawthorne Health · David Apfel, Johnson & Johnson · Nils Bottler, Angelini Ventures · Brian Matesic, Norwest Venture Partners · Sam Srivastava, WCG

Panel · Small Biopharma Strategies

Trial Planning for Small- & Mid-Sized Biotechs: Free of Legacy Systems and Processes—But Short on Time and Money

Suzanne Vyvoda, Concordia BioStrategies · Tim Foley, Scailyte · Malika Pasha, Secretome Therapeutics · Robert Goldman, Contraline, Inc · Jeffrey S. Yablon, Ubuntu Research Inc

Talk · AI for Clinical Trials

Transforming Regulatory Document Authoring: The Promise of Human-Led Generative AI

Rogier Landman, Pfizer

Talk · Data

It’s Been a While—10 Years of Data Sharing and Reuse: Highs, Lows, and What’s Next

Medha Patel, Amgen

Talk · Real World Evidence

Multi-Stakeholder Digital Health Partnerships and Collaborations: Gravitate-Health, a Public-Private Partnership Funded by EU Innovation Health Initiative

Kelly H. Zou, Viatris

Talk · Biomarkers & Precision Medicine Trials

Deploying a Modernized Enterprise-Level Biospecimen Lifecycle Management System

Roger Craveiro, MSD

Talk · Decentralized & Hybrid

Using Innovation and Hybrid Approaches in Oncology to Lessen Site and Patient Burden

Laurie Berry, Pfizer

Talk · Budgeting & Resources

Lessons from a Small Biotech to Large Pharma: Streamlining the Contracting Process and Minimizing Change Orders

Richard O'Hara, OncoC4

Talk · Recruitment & Engagement

Competitive Enrollment: Has This Strategy Run Its Course?

William Smith, Alliance For Multispecialty Research LLC

Talk · Site Engagement & Enablement

Optimizing Our Focus on Site-Facing Training

Mette Flindt Heisterberg, Novo

Talk · Digital Health Technologies

LLS Sponsored Use of a Medical-Grade Wearable into the Beat AML Master Trial—The Oncology Journey

Len Rosenberg, Blood Cancer United (formally LLS)/BAML

Talk · AI for Clinical Trials

Accelerate Clinical Content Generation and QC with GenAI and Knowledge Graphs

Jenny Wei, Kite Pharma

Talk · Data

Streamlining Secondary Analysis of Clinical Studies—Lessons Learned

Radhesh Nair, AbbVie

Talk · Real World Evidence

EHR to EDC: Shared Astellas Experience

Thanh Tran, Astellas Pharma US Inc

Talk · Small Biopharma Strategies

Streamlining Trial Planning for Small Biotechs: Key Lessons to Maximize Impact on a Tight Budget

Malika Pasha, Secretome Therapeutics

Talk · Biomarkers & Precision Medicine Trials

Specimen Lifecycle Management: Overcoming Challenges to Launch Biospecimen Management Technology

Nancy DeFusco, Merck Sharp & Dohme, LLC

Fireside chat · Clinical Trial Venture, Innovation & Partnering

FIRESIDE CHAT: Driving ROI in Clinical Trials with Real-World Data Innovation

David Apfel, Johnson & Johnson · Brigham Hyde, Atropos Health

Talk · Quality & Monitoring

Using Audit Trail Data to Ensure Fit-for-Purpose Data for Clinical Trials

Nechama Katan, Wicked Problem Wizards

Talk · Clinical Supply & Logistics

To Outsource or Not to Outsource, That Is the Question

Lisamarie Georgen, GuidedPath Consulting, LLC

Talk · Real World Evidence

Integrated Evidence Teams—Top or Flop?

Dorothee B. Bartels, HeDa-Advisors

Talk · Digital Health Technologies

Digital Health Solutions & Digital Accessibility

Stephen Framil, Merck & Co, Inc.

Talk · Biomarkers & Precision Medicine Trials

Using Gen AI for Content Extraction from ICFs to Ensure Compliance for Individual Site and Country to Meet Sample Destruction Timelines

Lisa Hersh, Regeneron

Panel · Clinical Trial Venture, Innovation & Partnering

Start-Up Company Showcase

Shwen Gwee, (Former) Bristol Myers Squibb

Talk · Quality & Monitoring

Elevating Quality Management through Analytics

Kevin Richards, AstraZeneca

Panel · Digital Health Technologies

Building the Business Case for Adopting Digital Endpoints in Clinical Trials

Rachel Chasse, AbbVie · Stephen Ruhmel, Sanofi · Sarah Valentine, Digital Medicine Society (DiMe) · Elisabeth Piault-Louis, Evinova An AstraZeneca Healthtech Co · Rinol Alaj, Kardigan Bio

Talk · AI for Clinical Trials

Lessons Learned on Realizing GenAI/LLM Values for Clinical Document Automation

Lily Xu, Vertex Pharmaceuticals

Panel · Decentralized & Hybrid

Innovation and Hybrid Approaches for Oncology DCTs

Gretchen Goller, Pfizer Inc. · Peter O'Neill, TuHURA Biosciences · Laurie Berry, Pfizer · Rochelle Williams-Belizaire, Boehringer-Ingelheim

Talk · Budgeting & Resources

Environmental Impact of a Phase 1 Study—A Carbon Accounting Journey

Michael J. Cohen, Thermo Fisher Scientific

Talk · Data

Catalyzing Clinical Study Data Collection

Paul Jacobs, Regeneron Pharmaceuticals

Talk · Small Biopharma Strategies

Blueprints for Success: Trial Planning & Design Insights from a Small Biopharma Leader

Kevin Eisenfrats, Contraline, Inc.

Talk · Outsourcing

Refreshing Partner KPIs and Metrics: Where Did They Come from and Where Do We Go from Here?

Kimberly Payton, Alnlyam

Talk · Patient-Centric Trial Design & Inclusive Research

Protocol Simplification Championship: Where Innovation Meets Simplification, Collaboration, and Recognition

Tuba Bas, Bristol Myers Squibb Co

Panel · Real World Evidence

Real-Time Point-of-Care Patient Identification

John D. Chelico, CommonSpirit Health · Trejeeve Martyn, Cleveland Clinic · Eirini Schlosser, Dyania Health

Panel · Recruitment & Engagement

Empowering Patients: New Sampling Technologies and Processes to Improve Recruitment and Retention

Len Rosenberg, Blood Cancer United (formally LLS)/BAML · Jas Bajwa, Roche

Panel · Feasibility & Study Start-Up

Integrating Diversity into Clinical Trial Feasibility & Site Engagement

Lauren Chazal MBA, Headlands Research Inc · Gary Cobb, Boehringer Ingelheim Pharmaceuticals Inc

Panel · Site Engagement & Enablement

Site Innovation Award: Celebrating Creativity in Site-Centric Approaches to Advance Clinical Trials for All Stakeholders

Irfan Khan, Circuit Clinical · Katherine Broecker, Eli Lilly & Company

Talk · Biomarkers & Precision Medicine Trials

FDA Regulation of LDTs: The Impact on Clinical Trials for Precision Medicine

Christine P. Bump, Penn Avenue Law & Policy

Talk · Quality & Monitoring

Analytics for Automated Outlier Detection of ePRO Data: Ensuring Data Integrity and Quality in Clinical Trials

John Samuelsson, Pfizer

Panel · Quality & Monitoring

Advancements and Challenges in Clinical Trial Data Quality Control: A Roadmap for Audit Trail Analysis

Olgica Klindworth, Medidata a Dassault Systemes Co · Jenn Krohn, Gilead · Kevin Stephenson, Karyopharm Therapeutics Inc · Simon Walsh, Johnson & Johnson Innovative Medicine

Panel · Clinical Supply & Logistics

PAIN POINTS PANEL: Peer-to-Peer Resolutions

Lisamarie Georgen, GuidedPath Consulting, LLC · Pablo Caiceo, Thermo Fisher Scientific Inc · Mia Carter, ICON Clinical Research LLC · Barbara Versage, Immunocore LLC

Networking

Welcome Reception in the Exhibit Hall

Break

Registration and Morning Coffee

Other · Biomarkers & Precision Medicine Trials

Chairperson's Remarks

Karina Bienfait, Bristol Myers Squibb Co

Other · Budgeting & Resources

Chairperson's Remarks

Rosalie Filling, Keenova Therapeutics

Other · Data

Chairperson's Remarks

Ariel Bourla, Johnson and Johnson

Other · Outsourcing

Chairperson's Remarks

Scott Sawicki, Centessa Pharmaceuticals

Other · Digital Health Technologies

Chairperson's Remarks

Shawn Mishra, Regeneron Pharmaceuticals Inc

Talk · AI for Clinical Trials

A Multi-Company Study Examining the Adoption and Use of AI

Maria Florez, Tufts University

Talk · Decentralized & Hybrid

Representation in Recruitment at Retail Pharmacy

Jim Carroll, Walgreens

Talk · Biomarkers & Precision Medicine Trials

The Other Side of the Protocol: Insights from a Clinical Research Site

Suzin Webb, Velocity Clinical Research

Talk · Quality & Monitoring

Integrating Meaningful Diversity Metrics into Clinical Monitoring

Martha Dockery, Exact Sciences

Panel · Budgeting & Resources

Investigator-Initiated Studies: Budgeting Practices for Time and Cost Savings

Meghan Harrington, Medidata a Dassault Systemes Co · Karen Hartman, Mayo Clinic

Talk · Data

"Science, Sealed, Delivered": Bringing Efficiency to Complex Oncology Trials

John Manlay, Pfizer Inc

Talk · Small Biopharma Strategies

Securing Clinical Trial Data: Navigating Cyber Threats and Regulatory Challenge

Christopher Hart, Foley Hoag LLP

Talk · Outsourcing

Evolving Sourcing Needs and Models in Clinical R&D

Mohan Bangalore, Summit Therapeutics

Talk · Patient-Centric Trial Design & Inclusive Research

Going with the (Digital Data) Flow: Reduce Time & Effort on Study Start-Up

Donald Jennings, Eli Lilly & Co

Talk · Real World Evidence

How to Tokenize a Clinical Trial to Facilitate Follow-Up with RWD

Simon Dagenais, Pfizer

Panel · Recruitment & Engagement

Empowering Partnerships: Collaborating with Patients and Advocacy Groups to Accelerate Clinical Research

Joan Chambers, Tufts CSDD · Monique Adams, Sanofi

Talk · Feasibility & Study Start-Up

Site Selection—Looking Beyond Historical Performance: Patients, Protocol, and Performance

Asma Kasuba, Johnson and Johnson Innovative Medicine

Panel · Site Engagement & Enablement

What Sites Really Want from Study Sponsors and CROs

Norman M. Goldfarb, Site Council · Lauren Chazal MBA, Headlands Research Inc

Talk · Digital Health Technologies

Analytical Validity and Clinical Evaluation of the Moticon Insole System for Assessing Gait in Parkinson’s Disease

Rolando J. Acosta Nuñez, Regeneron

Other

Organizer's Welcome Remarks

Talk · Clinical Trial Venture, Innovation & Partnering

Co-Chair Welcome Remarks

Jessica J. Federer, Angelini Ventures

Talk · Clinical Trial Venture, Innovation & Partnering

Session Moderator's Remarks

Jennifer Levin Carter, Medzown

Talk · Clinical Trial Venture, Innovation & Partnering

KEYNOTE PRESENTATION: Shaping Tomorrow's Clinical Trial Market Today: Deal Trends and AI's Role

Shane C. Senior, Crosstree Capital Partners Inc

Panel · Decentralized & Hybrid

Decentralized Clinical Trial Elements to Improve Participant Access and Representation

Marjorie Zettler, Conjugate Group · Aneta Woroniecka-Osio, Bayer Healthcare · Brad Hightower, Hightower Clinical · Abigail Dirks, Tufts University

Talk · Quality & Monitoring

Leveraging RBQM Technologies to Achieve Diversity Action Plan Goals

Damalie Akuamoah, Merck

Talk · Data

Technology and Data-Driven Solutions for Increasing Enrollment of Diverse Patients in Oncology Trials

Ariel Bourla, Johnson and Johnson

Talk · Small Biopharma Strategies

What to Consider in Managing External Data for the Small Biopharma

Kara Titus, DragonFly Therapeutics

Talk · Patient-Centric Trial Design & Inclusive Research

This, Not That: Data Collection, Optimized

Laura Galuchie, Merck

Other · Clinical Supply & Logistics

Chairperson's Remarks

Lee Buckler, Blood Centres of America

Panel · AI for Clinical Trials

Overcoming Challenges and Managing Costs in Industrializing Generative AI

Nagaraja "Sri" Srivatsan, Endpoint Clinical, Inc. · Prasanna Rao, Saama · Kannan Natarajan, Pfizer Inc

Panel · Biomarkers & Precision Medicine Trials

Biospecimen Management Consortium: Driving Sample Excellence in Clinical Research

Amy Ripston, Biospecimen Management Consortium · Karina Bienfait, Bristol Myers Squibb Co · Mark Melton · Roshan Yadama, Profound Research

Talk · Clinical Supply & Logistics

Cell Therapy Patient Operations: Enhancing Customer Experience Through Data-Driven Support

Michael Mehler, AstraZeneca

Talk · Outsourcing

Best Practices in Adaptability in Outsourcing Models and Relationships: A Biotech Perspective

Richard Scaife, Windward Bio AG

Talk · Real World Evidence

Challenges and Key Considerations while Conducting a Trial Tokenization Study across the US, EU, and UK

Thomas Dougherty, Novo Nordisk

Talk · Recruitment & Engagement

Patient Remuneration: Results from a Review across IRB Types and Potential Impact on DEI and Recruitment

Tricha Shivas, Foundation for Sarcoidosis Research

Talk · Feasibility & Study Start-Up

Towards an Automated Site Feasibility with Use of Ontologies

Thierry Escudier, Pistoia Alliance

Panel · Site Engagement & Enablement

What Sponsors Don't Seem to Understand about Site Costs

Norman M. Goldfarb, Site Council · Stephanie Berger, Urology Clinics of North Texas

Talk · Digital Health Technologies

Internal Development to Phase 1 Clinical Validation of Bend Ease, a Novel Digital Measure of Morning Stiffness in Axial Spondyloarthritis

Dee-Dee Shiller, AbbVie

Talk · Quality & Monitoring

Debate: Fraud and Misconduct in Clinical Trials: Marginal Nuisance or Major Problem?

Marcin Makowski, GlaxoSmithKline

Talk · Data

Key Considerations for Utilizing AI/ML Screening Algorithms to Identify Patients with Immunotherapy

Usama Javed, Merck & Co

Talk · Small Biopharma Strategies

Navigating the Diverse Future of Trial Data: Real World Data & Devices

Gaelan Ritter, Sanofi

Talk · Patient-Centric Trial Design & Inclusive Research

Designing and Operationalizing Double-Blind RCTs with Sham Controls in Digital Therapeutics

Gazal Vakili, Sumitomo Pharma

Panel · Clinical Trial Venture, Innovation & Partnering

Where Are Investors Placing Their Bets? An Oxford-Style Debate

Jessica J. Federer, Angelini Ventures · Sofia Guerra, Bessemer Venture Partners · Christina L. Jenkins, Convergent Ventures LLC · Sunny Kumar, Informed Ventures · Carrie Williams, McKesson Ventures · Blake Wu, New Enterprise Associates NEA

Talk · Real World Evidence

Complexities and Solutions Used to Conduct a Global RWE Program in COVID-19 and Immunocompromised Indications

Catia Ferreira, AstraZeneca

Panel · Clinical Trial Venture, Innovation & Partnering

Fueling Innovation: How Pharma Venture Arms Are Transforming Clinical Trials

Jeremy Goldberg, Arsenal Capital Partners · Konstantina Katcheves, Teva Pharmaceuticals · John R. Pavletic, Lilly Ventures · Dave Stevenson, Merck · Kindra Tatarsky, Cerity Partners Ventures

Break

Coffee Break in the Exhibit Hall

Other

Special Book Signing

Break

Networking Coffee Break

Other · Decentralized & Hybrid

Chairperson's Remarks

Isaac R. Rodriguez-Chavez, 4Biosolutions Consulting

Other · Biomarkers & Precision Medicine Trials · Digital Health Technologies

Chairperson's Remarks

Karina Bienfait, Bristol Myers Squibb Co

Other · Quality & Monitoring

Chairperson's Remarks

Leslie Sam, Leslie Sam & Associates LLC

Other · Budgeting & Resources

Chairperson's Remarks

Richard Scaife, Windward Bio AG

Other · Site Engagement & Enablement

Chairperson's Remarks

Norman M. Goldfarb, Site Council

Talk · AI for Clinical Trials

Gaining 70% Efficiencies by Using AI in Clinical Study Data Conformance

Daniel Bachalis, Bristol Myers Squibb Co

Talk · Decentralized & Hybrid

Through the Looking Glass of the Site Journey: Navigating Decentralized Clinical Trials

Deena Bernstein, TPS Global

Talk · Biomarkers & Precision Medicine Trials · Quality & Monitoring · Digital Health Technologies

IC-Scope: Use of LLMs to Evaluate Local Consent Scope and Enable Additional Research Use of Clinical Data and Samples

Dmitri Mikhailov, Novartis Institutes for BioMedical Research Inc

Talk · Clinical Supply & Logistics

Ensuring Precision and Safety: Vein-to-Vein Tracking in Cell and Gene Therapy

Christine M. Fernandez, Cell & Gene Therapy

Talk · Budgeting & Resources

FIRESIDE CHAT: How Are Companies Preparing and Upskilling Their Workforce to Innovate in the Changing AI Landscape?

Sol Babani, Symbiosis Advisors

Talk · Data

Interoperability Being a Value for Product Companies Enables the Patient Value and Delivery Agility to Sponsor Organizations

Donald Thampy, Merck

Panel · Small Biopharma Strategies

Requirements for Managing Clinical and Non-Clinical Data

Lorenzo Balsamo, Tango Therapeutics · Stacey Arrambide, Advanced Clinical · Leila Cupersmith, Choice ClinOps: Oncology, Rare Disease, and CGT Fractional Clinical Operations · Manny Lazaro, Kailera Therapeutics · Gaelan Ritter, Sanofi

Talk · Outsourcing

CASE STUDY: Driving Success in a Complex Partnership

Jodi Coughlin, Deciphera

Panel · Patient-Centric Trial Design & Inclusive Research

Diversity in Clinical Trials: The Homework and the Homeruns

Bianca Green, UCB Biosciences, Inc. · Monique Adams, Sanofi

Panel · Real World Evidence

Conducting Effective Global RWD Studies

Aaron W. Kamauu, Navidence LLC · Catia Ferreira, AstraZeneca · Thomas Dougherty, Novo Nordisk

Talk · Recruitment & Engagement

Bridging Barriers in Patient Recruitment

Kendal Whitlock, Walgreens Co.

Panel · Feasibility & Study Start-Up

Balancing Innovation Options to Enable Adoption: Perspectives from Sponsors, CROs, and Sites

Jane Myles, Decentralized Trials & Research Alliance (DTRA) · · Nicholas Focil, FOMAT Medical Research

Panel · Site Engagement & Enablement

Interoperability Will Slash the Technology Burden on Sites

Norman M. Goldfarb, Site Council · Michelle Hartmann, South Broward Research

Panel · Clinical Trial Venture, Innovation & Partnering

Leading the Future of Clinical Trials: CEO and Founders' Perspectives on Innovation and Transformation

Rana Lonnen · Liz Beatty, Inato, Inc. · Scott Chetham, Faro Health · Zach Taft, IgniteData · Emmanuel Walckenaer, Yseop

Talk · AI for Clinical Trials

CATALYST Trial Timeline Planning—Enhancing Predictions with Advanced Machine Learning and Large Language Models

Sheng Zhong, AbbVie Inc

Talk · Data

Modern Clinical Data Management: Data Enablement for Tiered Clinical Data Review

Aman Thukral, AbbVie Inc

Talk · Biomarkers & Precision Medicine Trials · Quality & Monitoring · Digital Health Technologies

Leveraging AI to Codify Informed Consent

Cristin Freeman, Bristol Myers Squibb

Talk · Clinical Supply & Logistics

Innovative Strategies for a More Robust (Yet Adaptable, Accessible, and Cost-Effective) Global Advanced Therapies Supply Chain

Lee Buckler, Blood Centres of America

Talk · Outsourcing

Leveraging External Partners & Capabilities to Deliver on Organizational Transformation Goals

James Chennells, Bayer Plc

Panel · Real World Evidence

Advancements in the Use of GenAI in Real-World Research

John Cai, Merck · Thomas Dougherty, Novo Nordisk · Hua Xu, Yale University

Talk · Feasibility & Study Start-Up

Effective Strategies for Pharma to Engage Naive Sites in Clinical Research

Carrie Lewis, Keenova Therapeutics

Panel · Site Engagement & Enablement

Real AI at Real Sites Today

Norman M. Goldfarb, Site Council · Todd Albin, Cedar Health Research

Talk · AI for Clinical Trials

Data -Driven Evaluation of Clinical Trial Inclusion and Exclusion Criteria to Optimize Study Design

Brandon Rufino, Sanofi

Panel · Decentralized & Hybrid

Decreasing Site Burden to Adopt DCT Methods

Jane Myles, Decentralized Trials & Research Alliance (DTRA) · · Jimmy Bechtel, Society for Clinical Research Sites (SCRS) · Sylvie Kruyner, Bayer Pharmaceuticals · Caroline Redeker, StuffThatWorks · Joe Dustin, Sanofi

Panel · Clinical Supply & Logistics

Scaling CGT: Cracking the Supply Chain Code

Lee Buckler, Blood Centres of America · Christine M. Fernandez, Cell & Gene Therapy · Michael Mehler, AstraZeneca

Break

Networking Luncheon

Break

Sponsored Networking Luncheon

Talk · Clinical Trial Venture, Innovation & Partnering

Session Moderator's Remarks

Raolat M. Abdulai, Galvani Bioelectronics

Fireside chat · Clinical Trial Venture, Innovation & Partnering

Driving Innovation in Clinical Trials: Insights for Investors from Industry Leaders

Jennifer Levin Carter, Medzown

Break

Networking Coffee & Dessert Break in the Exhibit Hall—Best of Show Winner Announced

Roundtable

FACILITATED ROUNDTABLE DISCUSSIONS

Other

SCOPE around the World, Faces from the Community

Marina Filshtinsky, Cambridge Healthtech Institute

Panel · Clinical Trial Venture, Innovation & Partnering

Investing in AI for Clinical Trials: Navigating Risk and Maximizing ROI

Mitesh Rao, OMNY · Dana Callow, Boston Millennia Partners · JILL JOHNSTON, WCG Clinical · Brian Martin, AbbVie Inc · Prasanna Rao, Saama

Keynote

Fostering Clinical Innovation in a Large Pharmaceutical Organization

James Gallagher, Johnson & Johnson Innovative Medicine

Keynote

Harnessing Tech & AI for Quality and Performance in Clinical Trial Operations

Angela DeLuca, AstraZeneca

Fireside chat · Clinical Trial Venture, Innovation & Partnering

Visionary Leadership in Clinical Trial Innovation: A Fireside Chat with Miruna Sasu

Miruna Sasu, COTA Inc · Lori Ellis, BioSpace

Other

SCOPE Award Winners & Announcements

Micah Lieberman, Cambridge Healthtech Institute

Panel

The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond

Disa Lee Choun, Johnson and Johnson · James Gallagher, Johnson & Johnson Innovative Medicine · Andrew Lee, Merck & Co · Brian Martin, AbbVie Inc · Demetris Zambas, Pfizer Inc

Panel · Clinical Trial Venture, Innovation & Partnering

Unlocking the Patient Recruitment Puzzle: A Smart Investment in Enhancing the Patient Experience and the Future of Trials

Laura Hilty, HealthX Ventures · Sean Lynch, Novartis Pharmaceuticals · Denise Bronner, Empactful Ventures · Eirini Schlosser, Dyania Health · Delmonize Smith, Acclinate

Networking

Booth Crawl & Refreshment Break in the Exhibit Hall Last Chance for Exhibit Viewing

Talk · Clinical Trial Venture, Innovation & Partnering

Co-Chair Closing Remarks

Sunny Kumar, Informed Ventures

Other

Close of Summit

Other · Biomarkers & Precision Medicine Trials · Clinical Supply & Logistics

Chairperson's Remarks

Jarod Prince, Amgen

Other · Quality & Monitoring

Chairperson's Remarks

Jenn Krohn, Gilead

Other · Budgeting & Resources · Small Biopharma Strategies · Outsourcing

Chair Person's Remarks

Leila Cupersmith, Choice ClinOps: Oncology, Rare Disease, and CGT Fractional Clinical Operations

Other · Real World Evidence

Chairperson's Remarks

Demissie Alemayehu, Pfizer Inc

Other · Digital Health Technologies

Chairperson's Remarks

Kai Langel, DEEP Measures

Talk · AI for Clinical Trials · Data

Content Generation and Knowledge Extraction for Clinical Documents

Vaishali Goyal, AstraZeneca Pharmaceuticals

Talk · Decentralized & Hybrid

Incorporation of Decentralized Clinical Trial Components in Early Clinical Trial Planning

Jessica Marer, Teva Pharmaceutical Industries Ltd

Talk · Biomarkers & Precision Medicine Trials · Clinical Supply & Logistics

Logistics Considerations in a Global Clinical & Biospecimen Supply Chain

Thomas J. McDonald, Amgen

Talk · Quality & Monitoring

Protecting Data Quality: Implementing and Demonstrating the Value of Centralized Monitoring

Jenn Krohn, Gilead

Talk · Budgeting & Resources · Small Biopharma Strategies · Outsourcing

Mastering Acquisitions: A Clinical Ops Guide to Successful Biopharma Transitions

Scott T. Megaffin, Adiso Therapeutics

Panel · Patient-Centric Trial Design & Inclusive Research

Actionable Strategies to Promote Diversity in Clinical Research Participation

Katie Shaw, IQVIA · Brittany Gerald-Lewis, Moderna Inc · Neha Londono, Pfizer · Casey Orvin, Alcanza Clinical Research

Talk · Real World Evidence

Challenges and Recent Developments in RWD—Augmented Study-Control Arms

Demissie Alemayehu, Pfizer Inc

Talk · Recruitment & Engagement

Enhancing Diversity in Clinical Trials through External Partnerships

Kemi Williams, Independent Consultant / Fractional Leader

Talk · Feasibility & Study Start-Up · Site Engagement & Enablement

Streamlined Clinical Trial Feasibility with Technology, Tools, and Process Excellence

John Yannone, Johnson & Johnson Innovative Medicine

Talk · Digital Health Technologies

The Future of Regulatory Acceptance of Digital Measures Is Happening Now: Continuing the Journey

Martha Azer, Johnson & Johnson Innovative Medicine

Panel · Decentralized & Hybrid

Recognizing, Classifying, and Mitigating Patient and Site Burden Induced by Digital Health Technologies in Clinical Trials

Krista Russell, Evinova · Sophie Bartram, Ohio State University · Andrea Paraboschi, Takeda

Panel · Digital Health Technologies

Driving DHT Adoption and Utility through Advocacy and Multi-Organizational Collaboration

Kai Langel, DEEP Measures · Martha Azer, Johnson & Johnson Innovative Medicine · Scottie Kern, Critical Path Institute · Carrie A. Northcott, Pfizer Inc · Bola Grace, University College London

Talk · Biomarkers & Precision Medicine Trials · Clinical Supply & Logistics

Exploratory Biomarkers in Clinical Trials: Right Clinical Site, Right Lab, Right Data, Right Time, and Right Quality

Arkady Gusev, Novartis Institutes for BioMedical Research Inc

Talk · Quality & Monitoring

A Unique Transition from Outsourced Centralized Monitoring to an in-House Process in a Very Short Timeframe

Anne Smith, Regeneron Pharmaceuticals Inc

Panel · Budgeting & Resources · Small Biopharma Strategies · Outsourcing

Weathering the Drama of Change in Biotech: A Clinical Operations Perspective

Valerie Reynaert, Immuncore · Kristi Koontz, Amgen · Ann-Marie Hulstine, Alpheus Medical · Anne Marie L. Inglis, GSK · Doug Schantz, Asklepios BioPharmaceutical Inc

Talk · Real World Evidence

Historical Placebo Controls to Characterize Event Rates in Ongoing RCTs

Chris Schneiderman, AbbVie Inc

Talk · Recruitment & Engagement

LLMs and the Science of Diversity in Clinical Trials: Case Studies from an American Heart Association's Strategically Funded Research Network

Muhammed Idris, Morehouse School Of Medicine

Talk · Feasibility & Study Start-Up · Site Engagement & Enablement

Optimizing Clinical Strategy with Innovative Technology in a Dynamic Organization

Amy McCormick, Regeneron Pharmaceuticals Inc

Talk · AI for Clinical Trials · Data

How AI Document Automation Can Support Our Clinical Trials for EU Submissions: EU-CTR Synopsis Case Study

Marie Kromplewski, Bristol Myers Squibb Co

Talk · Biomarkers & Precision Medicine Trials · Clinical Supply & Logistics

Tissue and Blood Biospecimen Journey: Strategies to Avoid Logistical Uncertainty

Michael Tanen, Merck & Co

Talk · AI for Clinical Trials · Data

Evaluating Generative AI in Regulated Environments: A Statistical Rigorous Framework for Regulatory Compliance and Safety

Venky Iyer, Pfizer

Panel · Decentralized & Hybrid

Access for All: How HCPs Are the Key to Changing Clinical Trial Participation

Craig Lipset, Decentralized Trials & Research Alliance DTRA · Shelly Barnes, UCB, Inc · Joe O'Rourke, Walgreens · Hassan Kadhim, Vertex Pharmaceuticals

Talk · Quality & Monitoring

The Many Faces of Clinical Data Integrity

Bartosz Wylot, AstraZeneca

Panel · Budgeting & Resources · Small Biopharma Strategies · Outsourcing

Advocating for Clinical Operations before Clinical Development

Dawn Buchanan, Immatics · Nithiya Ananthakrishnan, Precision for Medicine · Ed Tumaian, Cyclo Therapeutics Inc · Caro Unger, Asher Biotherapeutics

Talk · Patient-Centric Trial Design & Inclusive Research

Being Intentional About Diversity in Clinical Trials: Real-World Results

Tamara Oyejide, Apnimed

Talk · Real World Evidence

Utilizing Pharmacy Data in Observational Pharmacoepidemiology Studies

Scott Chavers, Walgreens Co

Talk · Recruitment & Engagement

The Top 5 Most-Requested Resources Patients Ask for to Support Their Continued Participation: Considerations toward Creating Equitable, Engaging Clinical Trial Participation Experiences

Rachel Melloul, CISCRP

Talk · Feasibility & Study Start-Up · Site Engagement & Enablement

Feasibility Process Update to Ensure Active Site Engagement: One Year Later

Katie Bonner, AstraZeneca

Talk · Digital Health Technologies

Magnol.AI—Shaping the Future of Connected Clinical Trials

Andrew D. Kaczorek, Eli Lilly & Co

Panel · Biomarkers & Precision Medicine Trials · Clinical Supply & Logistics

Where Are My Samples? Deconvoluting Biospecimen Supply Chain Logistics

Brenda Yanak, Clinical Transformation Partners · Christine P. Bump, Penn Avenue Law & Policy · Thomas J. McDonald, Amgen · Jarod Prince, Amgen

Panel · AI for Clinical Trials · Data

Ethical Consideration for AI Applications in Clinical Trials

Dominic De Bellis, Merck & Co., Inc. · Sheraz Khan, Pfizer · Mark F. Ciaccio, AbbVie Inc · Jonathan Shough, Parexel Intl

Talk · Decentralized & Hybrid

Decentralized Clinical Trials from the World-Saving Idea to the Inevitable Reality

Istvan Attila Kerekes, Gedeon Richter Plc

Panel · Quality & Monitoring

Challenges and Strategies for Managing Central Monitoring Action Fatigue

Olivia Feiro, CSL Behring · Kristin Stallcup, Takeda · Danilo Branco, BeOne Medicines

Panel · Patient-Centric Trial Design & Inclusive Research

Challenges of Diversity Data in Clinical Trials: Bridging Gaps for Inclusive Research

Bianca Green, UCB Biosciences, Inc. · Fenwick Eckhardt, Citeline · Samantha Shaw, TriNetX · Rita Yankyera, Elligo Health Research

Talk · Real World Evidence

Gathering RWE on Life-Saving Devices: A 5-Year Review

Barbara Fink, Philips

Talk · Recruitment & Engagement

Multichannel and Multidisciplinary Approach to Accelerating Patient Recruitment in Rare Disease Clinical Trials

Chris Cirillo, Chemomab Therapeutics

Panel · Digital Health Technologies

Unlocking New Frontiers in Alzheimer’s Disease Research through Digital Measures

Sarah Valentine, Digital Medicine Society (DiMe) · Ann M. Hake, Eli Lilly & Co · Jeffrey A. Kaye, Oregon Health & Science University · Mark Matson, Medidata Solutions

Break

Networking Coffee Break

Other · AI for Clinical Trials · Data · Real World Evidence

Chairperson's Remarks

Sina Djali, Axcellion.ai

Other · Decentralized & Hybrid · Quality & Monitoring · Digital Health Technologies

Chairperson's Remarks

Lindsay Kehoe, Clinical Trials Transformation Initiative

Talk · AI for Clinical Trials · Data · Real World Evidence

The Role of AI in Powering Digital Protocols

Yugang Jia, Verily

Talk · Decentralized & Hybrid · Quality & Monitoring · Digital Health Technologies

Applying Social Determinants of Health (SDoH) in Clinical Study Planning and Execution

Daoying Hu, Johnson & Johnson Innovative Medicine

Talk · Biomarkers & Precision Medicine Trials · Clinical Supply & Logistics · Recruitment & Engagement

Incorporating Patient-Centric Sampling into Multicenter Clinical Trials: Output from the PCSIG Workshop

Jas Bajwa, Roche

Talk · Budgeting & Resources · Small Biopharma Strategies · Outsourcing

Strengthening Sponsor-Site Partnerships in Outsourced Trials

Liza Micioni, Tris Pharma, Inc.

Talk · Patient-Centric Trial Design & Inclusive Research · Feasibility & Study Start-Up · Site Engagement & Enablement

Taking Research to the People: Decentralized Trials, Leveraging Technology to Enable Community-Based Approaches

Amy Yarker, NIHR Clinical Research Network

Panel · AI for Clinical Trials · Data · Real World Evidence

Transforming the Clinical Trial Protocol—Moving from a Document-Centric to a Data-Centric World

Chris Decker, CDISC · Amy Cramer, Johnson and Johnson Innovative Medicine · Stacy Tegan, TransCelerate Biopharma Inc · Mary Lynn Mercado, Novartis Pharmaceuticals · Donald Jennings, Eli Lilly & Co

Panel · Decentralized & Hybrid · Quality & Monitoring · Digital Health Technologies

Achieving Flexibility and Expanding Access While Preserving Data Quality

Lindsay Kehoe, Clinical Trials Transformation Initiative · Pamela Tenaerts, Medable · Jimmy Bechtel, Society for Clinical Research Sites (SCRS) · Wes Burian, Retired

Talk · Budgeting & Resources · Small Biopharma Strategies · Outsourcing

Creating and Leveraging an Outsourcing Strategy for Smaller Biotechs

Kelly Smith, V2 Clinicial Inc.

Talk · Patient-Centric Trial Design & Inclusive Research · Feasibility & Study Start-Up · Site Engagement & Enablement

Expanding the Patient Universe: Transforming Clinical Trials Through Inclusive, Data-Driven Design

Christopher Riley, H1

Talk · Biomarkers & Precision Medicine Trials · Clinical Supply & Logistics · Recruitment & Engagement

“This Won’t Work”: Establishing Study Conduct at Retail Pharmacy

Adam Samson, Walgreens Co

Panel · Budgeting & Resources · Small Biopharma Strategies · Outsourcing

Bridging the Gap: A Case Study in Hiring through Bridge Programs and the Impact on Clinical Operations Effectiveness

Carrie Lewis, Keenova Therapeutics · Suzy Montanye, Keenova Therapeutics

Talk · Patient-Centric Trial Design & Inclusive Research · Feasibility & Study Start-Up · Site Engagement & Enablement

Integrating Community Health Solutions: A Case Study

Shelly Barnes, UCB, Inc

Other

SCOPE Summit 2025 Adjourns