Small Biopharma Strategies
Building Smart Trial Foundations
Scaling Operations with Impact

The 4th Annual Small Biopharma Strategies stream is designed for Senior Clinical Operations Executives at emerging and mid-sized biopharma and biotech companies, tackling the unique challenges of running trials with limited resources, lean teams, and complex pipelines. 

Gain actionable insights into overcoming key obstacles—including budget constraints, vendor dependence, strategic partner selection, and internal capability building. Learn how to navigate regulatory complexity, scale operations effectively, and communicate the strategic value of clinical operations to leadership and investors. You’ll also explore solutions for data integration, patient recruitment, and acquisition readiness

Whether you're scaling your first trial or refining a growing portfolio, this stream equips you to lead with confidence, deliver operational excellence, and drive success in a competitive landscape. 





Monday, February 2

SCOPE'S 5TH ANNUAL MASTERS OF CLINICAL RESEARCH GOLF TOURNAMENT

Golf Check-In & Breakfast Buffet*

SCOPE's 5th Annual Masters of Clinical Research Golf Tournament* SOLD OUT (Sponsorship Opportunities Still Available)

Network on the greens at SCOPE's 5th Annual Golf Tournament!  Visit the SCOPE Summit website for player and sponsorship opportunities. 

Registration Open

Golf Lunch Buffet (Sponsorship Opportunities Available)*

PRE-CONFERENCE WORKSHOPS & USER GROUPS (IN-PERSON ONLY)

– 4:00 pm IQVIA Technologies Innovation Day

– 3:30 pm MaxisAI: INSPIRE Agentic AI Summit

– 3:30 pm Using Data and AI to Accelerate Trials: WCG User Group and Product Roadmap Discussion

– 3:30 pm OPEN WORKSHOP: Modernizing Informed Consent: AI, Automation, and Ethics in Global Clinical Trials

​For more details on Pre-Conference Events, please visit: Workshops/User Groups

Close of the Masters of Clinical Research Golf Tournament

*Limited spots available. Separate registration and fee apply.

SCOPE'S PICKLEBALL NETWORKING SESSION

– 3:45 pm SCOPE'S Pickleball Networking Session: Paddles & Partnerships

Kick off the SCOPE 2026 conference with food, fun, and pickleball! Whether you're a pickleball pro or have never picked up a paddle, this event is perfect for everyone. Limited spots available. Register Here

Monday Kickoff Plenary Keynote and Participant Engagement Awards

MONDAY AFTERNOON PLENARY SESSION:
PATIENT PANEL, SITE INNOVATION AWARD, PARTICIPANT ENGAGEMENT AWARD

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

*Must be present to win.

Organizer's Welcome Remarks & 5th Annual Masters of Clinical Research Golf Tournament Awards and Jacket Signing

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

FIRESIDE CHAT:
Hope: The Double-Edged Sword of Patient Experience

Lindsay Guentzel, Multimedia Journalist & Patient Advocate , multimedia journalist & advocate , n/a

Jane Myles, Program Director, Decentralized Trials & Research Alliance (DTRA); Board Member, The Myositis Association (TMA) , Program Director , Decentralized Trials & Research Alliance (DTRA) ·

Brad Watts, CAR T Recipient and Patient Advocate, Emily Whitehead Foundation , CAR T Recipient and Patient Advocate , Emily Whitehead Foundation

In this fireside chat, two CAR T trial participants and a patient advocate/clinical research professional unpack the journey: find the trial, fight the insurer, cross state lines, then live the trial reality, along with your family. Careful research, long consent forms, and great care teams can still miss key things that matter. For clinical researchers, we share a clear look at what we ask—and what patients still can’t see.

Tips for Getting the Most out of SCOPE

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

Visit our FAQ page! We hope this page answers some of your questions related to SCOPE. It consolidates a lot of info for speakers, attendees, and vendors into one page. We look forward to seeing you at SCOPE on February 2-5, 2026, at the Rosen Shingle Creek in Orlando, Florida! https://www.scopesummit.com/faq-how-to-succeed-at-scope

SCOPE's 3rd Annual Site Innovation Awards

Wouter Daniels, Clinical Trial Patient & Site Engagement Lead, Boehringer Ingelheim Pharma GmbH & Co KG , Clinical Trial Patient & Site Engagement Lead , Boehringer Ingelheim Pharma GmbH & Co KG

Angela DeLuca, Associate Vice President, Global Study Operations, Amgen , AVP, Global Study Operations , Amgen

Irfan Khan, CEO, Circuit Clinical , CEO , Circuit Clinical

Mara Kramer, Feasibility Transversal Projects Lead, Global Clinical Early Operational Strategy, Sanofi , Feasibility Transversal Projects Lead , Sanofi

Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS , Senior Vice President , Society for Clinical Research Sites (SCRS)

Amanda Wright, Co-Founder & Senior Vice President, Healthcare Alliance, Javara , Co-Founder & SVP , Healthcare Alliance , Javara

We are excited to announce our 3rd Annual Site Innovation Award, recognizing sites and partnerships pioneering new approaches to improve clinical trials. This is an opportunity to highlight your successes and be recognized by your peers for your dedication to advance clinical research. By sharing your actionable solutions, you will inform the broader Clinical Operations Community at SCOPE. Our definition of innovation is inclusive of low-tech or high-tech solutions, or any site operations-related process improvements that effectively reduce site burden and improve a site’s ability to advance clinical research while providing patient-centered care. The Site Innovation Awards program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/site-innovation-award

Panel Moderator:

KEYNOTE INTERACTIVE PANEL:
SCOPE's 10th Annual Participant Engagement Awards

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

Kelly McKee, Head, Innovative Patient Recruitment, Evinova, an AstraZeneca Company; Co-Creator of the SCOPE Participant Engagement Award , Head of Innovative Patient Recruitment , Evinova, an AstraZeneca Company

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC; Co-Creator of the SCOPE Participant Engagement Award , President & CEO , Marketing , Patient Enrollment Advisors LLC

Panelists:

Beth Brooks, Head of Patient Insights & Behavioral Sciences, Patient Informed Development & Health Value Translation, Sanofi , Head of Patient Insights & Behavioral Sciences , Patient Informed Dev & Health Value Translation , Sanofi

Mark Evans, Managing Director, Patient Recruitment, Faze , Managing Dir , Patient Recruitment , Faze

Jameka Hill, Senior Director, Clinical Trial Health Equity, Moderna, Inc. , Senior Director, Clinical Trial Health Equity , Patient Engagement & Advocacy , Moderna

Neha Shah Londono, Director, Clinical Trial Diversity and Community Engagement Lead, Pfizer Inc. , Director , Global Clinical Trial Diversity Equity & Inclusion , Pfizer

Jessica Perry, Senior Director, Trial Optimization, Kymera Therapeutics , Senior Director , Trial Optimization , Kymera Therapeutics

Samantha Rogers, Director, Patient Engagement & Patient-Centered Innovation, Raven (RA Ventures) , Director , Patient Engagement & Patient-Centered Innovation , Raven (RA Ventures)

Brad Watts, CAR T Recipient and Patient Advocate, Emily Whitehead Foundation , CAR T Recipient and Patient Advocate , Emily Whitehead Foundation

SCOPE's Winter Games Opening Reception (Sponsorship Opportunities Available)

Break out your coolest Winter Games—inspired look—no snow required! Think country flag t-shirts, Olympic colors, or your favorite team gear. While we may be in sunny Florida, let’s ignite the spirit of unity, energy, and excitement—as we toast to teamwork and triumph!

Close of Day

Tuesday, February 3

Sunrise Yoga: In Gratitude for Clinical Research Participants

Join us at sunrise for a restorative yoga session celebrating the invaluable contributions of clinical research participants. Led by a trained instructor, this all-levels practice will focus on mindful movement, breath, and grounding—no experience necessary. Yoga mats and towels will be provided by the hotel; just wear comfortable clothing. During this yoga session, CISCRP asks participants to join us in showing gratitude for the individuals who have participated in clinical research. Each ticket includes a complimentary breakfast and a branded CISCRP yoga towel. Proceeds from this event help support CISCRP's mission. Yoga begins at 6:30 am.

Registration Link: https://www.ciscrp.org/sunrise-yoga

SCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)

Lace up and join SCOPE’s Coordinators for the Fun Run on Tuesday, February 3! Sprint, jog, walk, or talk-your-way-through—ALL abilities are welcome. This informal event is all about getting moving together. New meet-up location for 2026! Meet outside at the back of the Gatlin Terrace by the paved path. We will do three loops around the property, do as few or as many as you have time for, but we will start promptly at 6:30 am!

Registration Open

Morning Coffee (Sponsorship Opportunities Available)

Fuel your morning with made-to-order coffee and sweet bites, courtesy of our sponsors.

Tuesday Morning Opening Plenary Keynotes

TUESDAY MORNING PLENARY SESSION

Grab Your Seat—Early Bird Seat Raffle & Prize Giveaway!* (Sponsorship Opportunity Available)

Don’t miss your chance to win! Arrive early, grab your seat, and take part in SCOPE’s Early Bird Seat Raffle & Prize Giveaway. Exciting prizes are up for grabs—must be present to win!

Welcome to SCOPE 2026—Welcome to the Clinical Trials Factory

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

KEYNOTE FIRESIDE CHAT: Aligning Purpose, Innovation, and Operational Excellence in Clinical Development

Eliav Barr, Head, Global Clinical Development and CMO, Global Clinical Development, Merck & Co. , Head, Global Clinical Development and Chief Medical Officer , Global Clinical Dev , Merck & Co

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

Panel Moderator:

KEYNOTE PANEL DISCUSSION:
From Years to Months: Is Radical Acceleration in Clinical Research Possible?

Jeremy Goldberg, Operating Partner, Healthcare, Arsenal Capital Partners , Operating Partner , Healthcare , Arsenal Capital Partners

Panelists:

Sandeep Burugupalli, Head, Data Science & Biopharmaceuticals R&D, AstraZeneca , Head, Data Science & Biopharmaceuticals R&D , AstraZeneca

Shawne Moran, Head, In-Country Study Operations-Americas, EMD Serono/Merck KGaA Darmstadt, Germany , Head, Study Operations-Amercias , Clinical Delivery & Patient Centricity , Merck KGaA/EMD Sereno

Jared Saul, MD, CMO, Commercial Healthcare and Life Sciences, Amazon Web Services , Chief Medical Officer, Commercial Healthcare and Life Sciences , Healthcare & Life Sciences Start Ups , Amazon Web Svcs LLC

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

Step into SCOPE’s one-of-a-kind exhibit hall! With 300+ leading clinical trial technology and service companies, it’s the place to discover new partners and reconnect with familiar ones. Cast your vote for SCOPE’s Best of Show, recharge with coffee, snap a photo, and don’t forget your comfy shoes—you’ll have miles to explore!

Part 1: Building Smart Trial Foundations

AGILE CLINICAL OPERATIONS: HOW LEADERS NAVIGATE CHANGE AND DELIVER RESULTS

Biotech’s New Reality—Market Pressures and Clinical Implications for Emerging Biopharma

Photo of Scott T. Megaffin, CEO, Adiso Therapeutics , CEO , Adiso Therapeutics
Scott T. Megaffin, CEO, Adiso Therapeutics , CEO , Adiso Therapeutics

Emerging biopharma faces tougher markets, leaner budgets, and higher expectations. In this session, Scott breaks down key economic and market trends shaping clinical operations—from funding constraints to pipeline reprioritization—and shares practical strategies to navigate these challenges, forge smart partnerships, and maintain operational excellence in an unforgiving landscape.

Panel Moderator:

PANEL DISCUSSION:
Thriving through Transitions—A Clinical Operations Leadership Perspective

Photo of Valerie Reynaert, Vice President, Global Clinical Operations, Immunocore , Vice President Global Clinical Operations , R&D , Immuncore
Valerie Reynaert, Vice President, Global Clinical Operations, Immunocore , Vice President Global Clinical Operations , R&D , Immuncore

Panelists:

Photo of Ann-Marie Hulstine, Vice President, Clinical Operations, Alpheus Medical , Vice President, Clinical Operations , Clinical Operations , Alpheus Medical
Ann-Marie Hulstine, Vice President, Clinical Operations, Alpheus Medical , Vice President, Clinical Operations , Clinical Operations , Alpheus Medical
Photo of Anne Marie L. Inglis, PhD, Senior Director & Asset Lead, Clinical Operations, GSK , Senior Director & Clinical Operations Asset Lead , Clinical Operations , GSK
Anne Marie L. Inglis, PhD, Senior Director & Asset Lead, Clinical Operations, GSK , Senior Director & Clinical Operations Asset Lead , Clinical Operations , GSK
Photo of Kristi Koontz, Vice President, Global Clinical Operations, Daiichi Sankyo US , VP Global Clinical Operations , Daiichi Sankyo, Inc.
Kristi Koontz, Vice President, Global Clinical Operations, Daiichi Sankyo US , VP Global Clinical Operations , Daiichi Sankyo, Inc.
Photo of Doug Schantz, Senior Vice President, Clinical Operations, Asklepios BioPharmaceutical, Inc. , Senior Vice President Clinical Operations, Clinical Operations , Clinical Operations , Asklepios BioPharmaceutical Inc
Doug Schantz, Senior Vice President, Clinical Operations, Asklepios BioPharmaceutical, Inc. , Senior Vice President Clinical Operations, Clinical Operations , Clinical Operations , Asklepios BioPharmaceutical Inc

Clinical Clarity in a Climate of Change: Key Takeaways for Leaders in Emerging Biotech

Photo of Kelly L. Smith, CEO, V2 Clinical Inc. , CEO , V2 Clinicial Inc.
Kelly L. Smith, CEO, V2 Clinical Inc. , CEO , V2 Clinicial Inc.

Amid biotech's ongoing transformation, fueled by tighter capital markets, shifting board expectations, and increasingly complex partnership models, leaders are under pressure to do more with less—and faster. This presentation distills the strategic and operational insights shared throughout the session, spotlighting the critical takeaways every clinical leader should walk away with. From investor-driven execution metrics to the ripple effects of M&A and IPO events on trial continuity, we'll explore how small and mid-sized biotechs can stay agile while maintaining quality. We'll also briefly address the role of "one BBB", tariffs, and their influence on acquisition preparedness and operational predictability.

Sponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break, whether you prefer Florida sunshine or the cool comfort of indoor seating.

Networking Coffee & Dessert Break in the Exhibit Hall

Keep the conversations going in the Exhibit Hall with coffee and dessert, courtesy of SCOPE sponsors. Network with colleagues, explore new products and services, and don’t forget—Best of Show Award voting is still open, so be sure to cast your vote!

DELIVERING RESULTS: BUIDLING A SUCESSFUL CLINICAL TRIAL

Chairperson's Remarks

Sheri Lee, CEO, Principal Consultant, Premier Regulatory Consulting (PRC); Former National Program Expert, FDA , CEO , Premier Regulatory Consulting

Risk-Based Monitoring as Your Early Warning System: Detecting and Addressing FDA Compliance Gaps

Photo of Sheri Lee, CEO, Principal Consultant, Premier Regulatory Consulting (PRC); Former National Program Expert, FDA , CEO , Premier Regulatory Consulting
Sheri Lee, CEO, Principal Consultant, Premier Regulatory Consulting (PRC); Former National Program Expert, FDA , CEO , Premier Regulatory Consulting

Risk-based monitoring (RBM) has evolved from a resource optimization strategy into a powerful compliance tool that can predict and prevent FDA inspection findings before they occur. This presentation demonstrates how organizations can transform their RBM programs into proactive early warning systems that detect regulatory vulnerabilities in real-time. 

Drawing on FDA inspection trends and common 483 observations, we explore how strategic risk indicators—including consent process deviations, data integrity issues, protocol non-compliance, and safety reporting delays—can be systematically monitored through centralized and onsite activities. Attendees will learn how to design risk thresholds and triggers that align with FDA expectations, enabling study teams to identify compliance gaps before they escalate into formal findings. 

The presentation provides a practical framework for translating RBM signals into effective mitigation strategies, targeted corrective actions, and preventive measures that strengthen overall trial quality. Real-world case examples illustrate how early detection through RBM has enabled sponsors to address potential findings proactively, resulting in cleaner inspections and improved regulatory outcomes. 

Participants will leave equipped to enhance their monitoring programs to serve dual purposes: optimizing operational efficiency while safeguarding regulatory compliance.

Panel Moderator:

PANEL DISCUSSION:
Blueprint for Growth: Core Strategies for Lean, Scalable Clinical Ops

Photo of Robert Goldman, Global Head of Clinical Operations, Contraline, Inc. , Head of Clinical Operations , Contraline, Inc
Robert Goldman, Global Head of Clinical Operations, Contraline, Inc. , Head of Clinical Operations , Contraline, Inc

Panelists:

Photo of Allison Billups, Executive Vice President, Client Solutions, ClinLab Solutions Group , Executive Vice President, Client Solutions , ClinLab Solutions Group
Allison Billups, Executive Vice President, Client Solutions, ClinLab Solutions Group , Executive Vice President, Client Solutions , ClinLab Solutions Group
Photo of Christine Cornwell, Senior Director Clinical Operations , Head of Clinical Operations US , Oblenio Bio
Christine Cornwell, Senior Director Clinical Operations , Head of Clinical Operations US , Oblenio Bio
Photo of Matthew Failor, Director & Head, Clinical Operations, MAIA Biotechnology , Head of Clinical Trials , Clinical Operations , MAIA Biotechnology
Matthew Failor, Director & Head, Clinical Operations, MAIA Biotechnology , Head of Clinical Trials , Clinical Operations , MAIA Biotechnology
Photo of Michael Hickey, Vice President, Clinal Operations, Processa Pharmaceuticals , VP Clinical Operations , Processa Pharmaceuticals, Inc
Michael Hickey, Vice President, Clinal Operations, Processa Pharmaceuticals , VP Clinical Operations , Processa Pharmaceuticals, Inc

SCALING CLINICAL OPS WITH AI, DATA, AND AGENTIC AI

Next-Gen Clinical Operations: Empowering Clinical Teams with AI Teammates

Photo of Paulius Ojeras, Vice President, Clinical Operations, Perceive Biotherapeutics , VP Clinical Operations , Clinical Operations , Perceive Biotherapeutics
Paulius Ojeras, Vice President, Clinical Operations, Perceive Biotherapeutics , VP Clinical Operations , Clinical Operations , Perceive Biotherapeutics

Clinical trials are entering a new era—one defined not by automation alone, but by the integration of Agentic AI into daily operations. This session features a real-world case study showcasing how AI teammates are transforming clinical development from manual coordination to intelligent, self-driving systems that adapt, learn, and act across study activities. Attendees will explore where Agentic AI creates the greatest impact, gain practical insights into implementation and validation, and learn how to navigate key adoption challenges in this rapidly evolving field. Join us to see what’s working today and how to prepare for tomorrow’s AI-driven clinical operations.

From Agentic AI and Data Analytics to Precision Clinical Trials

Photo of Iman Tavassoly, Associate Director of Quantitative and Systems Pharmacology, Alnylam Pharmaceuticals , Associate Director of Quantitative and Systems Pharmacology , Alnylam Pharmaceuticals
Iman Tavassoly, Associate Director of Quantitative and Systems Pharmacology, Alnylam Pharmaceuticals , Associate Director of Quantitative and Systems Pharmacology , Alnylam Pharmaceuticals

Attendees will gain a clear understanding of how Agentic AI and advanced data analytics can transform clinical trials from static, protocol-driven processes into adaptive, precision-focused frameworks. They will learn practical approaches for integrating AI-driven insights into trial design, patient recruitment, and operational decision-making. The session will also highlight real-world examples, emerging best practices, and future trends that can help organizations accelerate innovation and improve patient-centric outcomes.

Welcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)

Wrap up the day with colleagues, friends old and new at SCOPE’s Welcome Reception in the Exhibit Hall. Enjoy drinks, network with exhibitors, and enter to win fabulous raffle prizes (must be present to win). Keep the evening going with dinner at Rosen Shingle Creek’s restaurants—no Orlando traffic required!

Close of Day

SCOPE Out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

SCOPE out the restaurants and shops at Pointe Orlando, via our courtesy Shuttle
*Times subject to change. More details closer to the event.​

Wednesday, February 4

Sunrise Yoga: In Gratitude for Clinical Research Participants

Join us at sunrise for a restorative yoga session celebrating the invaluable contributions of clinical research participants. Led by a trained instructor, this all-levels practice will focus on mindful movement, breath, and grounding—no experience necessary. Yoga mats and towels will be provided by the hotel; just wear comfortable clothing. During this yoga session, CISCRP asks participants to join us in showing gratitude for the individuals who have participated in clinical research. Each ticket includes a complimentary breakfast and a branded CISCRP yoga towel. Proceeds from this event help support CISCRP's mission. Yoga begins at 6:30 am.

Registration Open

BREAKFAST PRESENTATIONS

– 9:00 am WORKING GROUP BREAKFAST: Pharma Leadership Forum: Overcoming Geopolitical Challenges in Clinical Development (Invite Only)

MODERATOR: 
Demetris Zambas, Vice President & Global Head, Clinical Data Sciences, Pfizer Inc.

Global clinical development is increasingly vulnerable to geopolitical forces. Sponsors face rising risks in running global trials, requiring proactive and diversified strategies to maintain momentum and safeguard patients. A group of top clinical research leaders from biopharma companies will get together at SCOPE to exchange ideas and case studies and to explore opportunities for sponsor companies to unify their efforts. Some of the challenges to be discussed include regulatory divergence, supply chain disruptions, patients recruitment in global trials, data security & sovereignty, IP protection, and cyber threats.

Transition to Sessions

OPTIMAL TRIAL DESIGN: MANAGING PARTNERSHIPS, CO-DEVELOPMENT, AND CRO OVERSIGHT

What Happens When a Sponsor–CRO Partnership Goes Terribly Wrong (but Actually RIGHT)?

Photo of Theresa R. Devins, PhD, Vice President, Clinical Ooperations, Cognition Therapeutics, Inc. , VP , Clin Ops , Cognition Therapeutics Inc
Theresa R. Devins, PhD, Vice President, Clinical Ooperations, Cognition Therapeutics, Inc. , VP , Clin Ops , Cognition Therapeutics Inc
Photo of Krista Armstrong, PhD, Senior Vice President & Head of Neurosciences, Medical & Clinical Development, Premier Research , Senior Vice President & Head of Neurosciences , Medical & Clinical Dev , Premier Research
Krista Armstrong, PhD, Senior Vice President & Head of Neurosciences, Medical & Clinical Development, Premier Research , Senior Vice President & Head of Neurosciences , Medical & Clinical Dev , Premier Research

Panel Moderator:

PANEL DISCUSSION:
Selecting the Right CRO and Optimizing Bid-Defense Strategy

Photo of Manny Lazaro, Senior Vice President, Clinical Development Operations, Kailera Therapeutics , Senior Vice President , Clinical Development Operations , Kailera Therapeutics
Manny Lazaro, Senior Vice President, Clinical Development Operations, Kailera Therapeutics , Senior Vice President , Clinical Development Operations , Kailera Therapeutics

Panelists:

Photo of Krista Armstrong, PhD, Senior Vice President & Head of Neurosciences, Medical & Clinical Development, Premier Research , Senior Vice President & Head of Neurosciences , Medical & Clinical Dev , Premier Research
Krista Armstrong, PhD, Senior Vice President & Head of Neurosciences, Medical & Clinical Development, Premier Research , Senior Vice President & Head of Neurosciences , Medical & Clinical Dev , Premier Research
Photo of Theresa R. Devins, PhD, Vice President, Clinical Ooperations, Cognition Therapeutics, Inc. , VP , Clin Ops , Cognition Therapeutics Inc
Theresa R. Devins, PhD, Vice President, Clinical Ooperations, Cognition Therapeutics, Inc. , VP , Clin Ops , Cognition Therapeutics Inc
Photo of Stephanie Pfister, Vice President, Clinical Operations, Biohaven , VP, Clinical Operations , Clinical Operations , Biohaven
Stephanie Pfister, Vice President, Clinical Operations, Biohaven , VP, Clinical Operations , Clinical Operations , Biohaven
Photo of Millie A. Shultz, Global Head of Clinical Operations, Galderma , Global Head of Clinical Operations , Galderma
Millie A. Shultz, Global Head of Clinical Operations, Galderma , Global Head of Clinical Operations , Galderma

Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)

Fuel up and connect at SCOPE’s Coffee Break in the Exhibit Hall! Visit booths you haven’t seen, network with colleagues and exhibitors, and cast your final vote for the Best of Show Award—make your vote count!

BUILD VS BUY, OR THE HYBRID APPROACHES FOR SMALL OPS TEAMS

The Hybrid Advantage: Building Small Ops Teams That Deliver

Photo of Randy Brown, Vice President, Clinical Operations, Altimmune, Inc. , VP Clinical Operations , Clinical Ops , Altimmune Inc
Randy Brown, Vice President, Clinical Operations, Altimmune, Inc. , VP Clinical Operations , Clinical Ops , Altimmune Inc

The hybrid approach might be right for you! As a small biopharma/biotech we might be enticed to hand off all of the work to an outsourcing partner, but I encourage you to think differently. Can you, with compliance in mind, take on this work internally? You can build an operational team that can—and will—deliver. I will share three or four success stories over the last 10 years.

Panel Moderator:

PANEL DISCUSSION:
Agile Trials, Smarter Data: Strategies for Lean Biopharma Success from Informatic Experts

Photo of Lorenzo Balsamo, Director, Clinical Informatics & Innovation, Tango Therapeutics , Director, Clinical Informatics & Innovation , Clinical Informatics , Tango Therapeutics
Lorenzo Balsamo, Director, Clinical Informatics & Innovation, Tango Therapeutics , Director, Clinical Informatics & Innovation , Clinical Informatics , Tango Therapeutics

Panelists:

Photo of Stacey Arrambide, Senior Vice President, Functional Service Solutions, Advanced Clinical , Sr VP Functional Svc Solutions , Functional Svc Solutions , Advanced Clinical
Stacey Arrambide, Senior Vice President, Functional Service Solutions, Advanced Clinical , Sr VP Functional Svc Solutions , Functional Svc Solutions , Advanced Clinical
Photo of Tina Henderson, Head of Life Sciences Consulting, Just in Time GCP , Head of Life Sciences Consulting , Life Sciences Consulting , Just in Time GCP
Tina Henderson, Head of Life Sciences Consulting, Just in Time GCP , Head of Life Sciences Consulting , Life Sciences Consulting , Just in Time GCP
Photo of Derek Lawrence, Strategy & Transformation Lead, Product, Saama , Strategy & Transformation Lead , Product , Saama
Derek Lawrence, Strategy & Transformation Lead, Product, Saama , Strategy & Transformation Lead , Product , Saama
Photo of Iman Tavassoly, Associate Director of Quantitative and Systems Pharmacology, Alnylam Pharmaceuticals , Associate Director of Quantitative and Systems Pharmacology , Alnylam Pharmaceuticals
Iman Tavassoly, Associate Director of Quantitative and Systems Pharmacology, Alnylam Pharmaceuticals , Associate Director of Quantitative and Systems Pharmacology , Alnylam Pharmaceuticals

Sponsored Networking Luncheon

Recharge, refuel, and connect over lunch—compliments of SCOPE sponsors! Enjoy a well-deserved break, whether you prefer Florida sunshine or the cool comfort of indoor seating.

Networking Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)—Best of Show Winner to be Announced

Recharge with coffee, dessert, and networking at SCOPE’s Exhibit Hall Break! Grab a sweet treat courtesy of our sponsors, visit Game Card Sponsors to collect stickers, and connect with colleagues before the afternoon sessions. Plus, don’t miss the announcement of the Best of Show winner!

Wednesday Afternoon Plenary

WEDNESDAY PLENARY AFTERNOON SESSION

SCOPE around the World: Community, Connection, Celebration

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

SCOPE’s Producer Team (Meet the Team!) https://www.scopesummit.com/meet-the-team

Panel Moderator:

KEYNOTE INTERACTIVE PANEL:
Clinical Is Not an Island: How Med Affairs and Access Can Transform Trial Success

Rosemary Rebuli, Global Head, Study & Site Operations, Novartis Pharma AG , Global Head Study and Site Operations , Study & Site Operations , Novartis Pharma AG

Panelists:

Karen Correa, PhD, Vice President, Development Operations, Boehringer Ingelheim , Vice President , Clinical Development Operations , Boehringer Ingelheim

Raza Zaheer, Medical Head, Next Gen Immunology, North America, Sanofi , Medical Head, Next Gen Immunology, Sanofi , Next Gen Immunology, North America , Sanofi

Jie Zhang, Head, Global Pipeline Market Access, CSL , Head, Global Pipeline Market Access , Global Market Access , CSL

Panel Moderator:

KEYNOTE INTERACTIVE PANEL:
Change Management for AI Adoption in Pharma Clinical Development Teams

Mike Sullivan, Executive Director, Global Development Operations Business Insights & Technology, Bristol Myers Squibb Co. , Executive Director , Global Development Operations Business Insights & Technology , Bristol Myers Squibb Co

Panelists:

Chris Sinclair, PhD, Vice President, Global Therapeutic Platforms, AbbVie, Inc. , VP , Global Therapeutics Platforms , AbbVie

Susie Stephens, PhD, Head of Clinical Facing Technology R&D, Amgen , Head of Clinical Facing Technology R&D , Amgen

Demetris Zambas, Vice President & Global Head, Clinical Data Sciences, Pfizer Inc. , Vice President, Global Head - Clinical Data Sciences , Clinical Data Sciences , Pfizer Inc

SCOPE's Closing Ceremony Booth Crawl (Sponsorship Opportunities Available). Last Chance for Exhibit Viewing

As the flame of another unforgettable SCOPE conference comes to a close, join us for our final reception, our infamous "booth crawl." Just like the Closing Ceremonies of the Games, we'll come together one last time to honor the moments of triumph, teamwork, and inspiration that made this week so special. Gather with friends, old and new, enjoy great food and drink, and celebrate the spirit of unity that connects us all. SCOPE 2026 may be ending, but the memories will last long after the torch goes out.

Close of Day

SCOPE out the Restaurants and Shops at Pointe Orlando, via Our Courtesy Shuttle* (Sponsorship Opportunities Available)

SCOPE out the restaurants and shops at Pointe Orlando, via our courtesy Shuttle
*Times subject to change. More details closer to the event.

Thursday, February 5

Registration Open

BREAKFAST PRESENTATION

Transition to Sessions

Part 2: Scaling Operations with Impact

Navigating Regulatory Requirements across Multiple US Agencies for Importing Biological Materials

Photo of Sean Smith, Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, US Customs and Border Protection , Biological Threat Exclusion Coordinator , US Customs & Border Protection
Sean Smith, Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, US Customs and Border Protection , Biological Threat Exclusion Coordinator , US Customs & Border Protection

CBP will provide an overview of major U.S. regulatory authorities governing biological material importations, guidelines for acceptable and unacceptable cargo descriptions, examples of non-compliant shipments of biological materials and pharmaceutical products, and provide essential resources and important contacts for support.

Shared Learnings on Methods to Decrease Temperature Excursions

Photo of Barbara Versage, Senior Manager, Supply Chain Sourcing, Immunocore LLC , Sr Mgr , Supply Chain Sourcing , Immunocore LLC
Barbara Versage, Senior Manager, Supply Chain Sourcing, Immunocore LLC , Sr Mgr , Supply Chain Sourcing , Immunocore LLC

Monitoring temperature control is a vital responsibility in clinical supply, extending beyond deep-frozen storage. Even products stored at ambient conditions require monitoring to ensure they avoid freezing or overheating. This session explains how tracking at defined supply chain touchpoints enables data collection, trending, and timely intervention. By leveraging value stream checkpoints, organizations can proactively maintain product integrity, safeguarding quality while minimizing risks across distribution and storage environments.

Interactive Breakouts and Working Groups

INTERACTIVE WORKING GROUPS (IN-PERSON ONLY)

Find your Working Group

Interactive Working Groups (Sponsorship Opportunity Available)

Step away from the slide decks and into the conversation.
After a full agenda of case studies, technical talks, and panels, SCOPE’s Interactive Working Groups offer a unique chance to roll up your sleeves and engage. Choose the topic that interests you—whether it aligns with your expertise or challenges you to think differently. Each group will explore a distinct theme using collaborative formats like hackathons, open innovation challenges, or problem-solving sprints. The only requirement: jump in and contribute.

THINK TANK:
Specimen in Transit: Untangling the Complexities of Global Transport Logistics

Brenda Yanak, Founder & Principal, Clinical Transformation Partners LLC , Founder and Principal , Clinical Transformation Partners

Where in the world is . . . . .?  Have you encountered confusion or churning around supply logistics for clinical trials?  Don’t know where to turn? This is your opportunity to learn from industry experts in global transport logistics, sample tracking and management, along with customs clearance on a multitude of topics. Join a Think Tank facilitated small group discussion to share experiences and solutions.

Think Tank Report Outs: Listen and Learn

During the Think Tank Table discussions, we shared our experiences and working solutions for global supply logistics. Now, as a collective community, let’s hear from the table facilitators as they share key discussion points and strategies and provide a wrap-up of their table’s discussion. What can we take away and apply?

Networking Coffee Break

Take a break and reconnect at SCOPE’s Networking Coffee Break! Grab a cup of coffee, meet colleagues old and new, and fuel up before the next sessions. A perfect pause to spark conversations and make connections!

COLLABORATIVE OUTSOURCING MODELS: BALANCING COST, GOVERNANCE, AND SITE ENGAGEMENT ACROSS STAKEHOLDERS

Strengthening Sponsor-Site Partnerships in Outsourced Trials

Photo of Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma , Senior Director, Head of Clinical Operations , Tris Pharma, Inc.
Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma , Senior Director, Head of Clinical Operations , Tris Pharma, Inc.

In fully outsourced trials, sponsor-site relationships might seem secondary—but for small and emerging biopharmas, they can be a key differentiator. Even when using a CRO or FSP model, sites still look to sponsors for clarity, support, and partnership. This session will explore why direct sponsor-site engagement still matters, how it impacts trial success, and practical ways to build trust and alignment—regardless of your outsourcing structure.

Panel Moderator:

PANEL DISCUSSION:
Strategic Outsourcing in Biopharma: Optimizing Vendor Partnerships, Governance, and Site Engagement

Photo of Suzanne Vyvoda, Founder and Principal , Founder and Principal , Clinical Operations , Concordia BioStrategies
Suzanne Vyvoda, Founder and Principal , Founder and Principal , Clinical Operations , Concordia BioStrategies

Panelists:

Photo of Kristin M. Ferrigno, Director of Clinical Operations, Clinical Research Site Development & Operations, Veda Clinical Trials , Director of Clinical Operations , Clinical Research Site Dev & Operations , Veda Clinical Trials
Kristin M. Ferrigno, Director of Clinical Operations, Clinical Research Site Development & Operations, Veda Clinical Trials , Director of Clinical Operations , Clinical Research Site Dev & Operations , Veda Clinical Trials
Photo of Tim Foley, Chief Business Officer, Scailyte , Chief Business Officer , Scailyte
Tim Foley, Chief Business Officer, Scailyte , Chief Business Officer , Scailyte
Photo of Melanie Goodwin, Director, Clinical Outsourcing, Immunocore , Director Clinical Outsourcing , Clinical Outsourcing , Immunocore LLC
Melanie Goodwin, Director, Clinical Outsourcing, Immunocore , Director Clinical Outsourcing , Clinical Outsourcing , Immunocore LLC

Transition to Lunch

SCOPE Summit 2026 Adjourns

And that’s a wrap! Thank you for joining us at SCOPE Summit 2026. We hope you leave inspired, connected, and energized for what’s next in clinical trials. Safe travels, and we can’t wait to see you at the next SCOPE event!

POST-CONFERENCE TRAINING SEMINARS*

THURSDAY, FEBRUARY 5, 2026  2:00 – 5:00 pm | FRIDAY, FEBRUARY 6, 2026  9:00 am – 4:00 pm

TS1: Service Provider Oversight: Practical Tools for Clinical Operations Teams

TS2: Quality and Process Improvement Techniques and Tools


Thursday, February 5, 2026  2:00 – 5:00 pm | Friday, February 6, 2026  9:00 am – 12:00 pm

TS3: ICH E6(R3) and E8 Implementation Workshop: Understanding Key Points and Practical Applications​

* In-Person Only, Separate registration required.

SCOPE Track Summariese

2026 Conference Programs