Small Biopharma Strategies

2025 ARCHIVES

The 3rd Annual Small Biopharma Strategies stream provides clinical operational executives with targeted strategies, real-world case studies, and actionable takeaways to help you excel in running clinical trials from start to finish. Discover how to build strategic partnerships that drive success, plan trials tailored for smaller biotech and manage your data independently. Learn when to build in-house capabilities versus outsourcing and navigate the complexities of pharma acquisitions with confidence. You’ll also explore how to effectively demonstrate the value of clinical operations to the C-suite and tackle the operational challenges of outsourcing from start to finish.

The stream is divided into two focused parts: "Partner Selection and Trial Design" and "Vendor Oversight & Resource Management." Each part is designed to equip you with practical tools and insights to elevate your clinical operations and ensure your company thrives in a competitive market. Don't miss this chance to advance your expertise and drive success in your clinical trials.

Part 1: Partner Selection and Trial Design

Part 2: Vendor Oversight & Resource Management

Monday, February 3

6:30 amGolf Check-In & Breakfast Buffet (Sponsorship Opportunities Available)

8:00 amSCOPE's 4th Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)

Connect with your peers and colleagues at SCOPE's 4th Annual Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.
*Limited space available. Separate registration and fee required for golf.

9:00 amRegistration Open

12:00 pmGolf Lunch Buffet (Sponsorship Opportunities Available)

12:00 pm– 4:00 pm WORKSHOP 1: Innovation Day with IQVIA Technologies: Hear the vision. See the products. Join the journey.

Clinical trial sponsors are invited to join digital product leaders and industry colleagues for an afternoon of discussions, demos, and networking. This interactive event has been carefully curated to help clinical trial professionals crack key challenges across the clinical trial lifecycle: from participant and site user journeys to data security and workflows. Pharmaceutical executives with various roles in clinical operations, innovation, technology, finance/budgeting, data analytics, strategic sourcing, trial managers, medical directors, or patient and site engagement will enjoy an industry panel, interactive roundtables, live demos with product experts, and more! Pre-registration is requested, and IQVIA reserves the right to decline requests that don’t fall within attendee guidelines above: Learn more and register here.

1:00 pm– 1:45 pm WORKSHOP 2: Exploring ClinEco—SCOPE’s Growing Online B2B Clinical Trial Community

PRESENTERS:
Marina Filshstinsky, MD, Executive Director, SCOPE Summit; Co-Founder, ClinEco
Micah Lieberman, Executive Director and Team Lead, SCOPE Summit; Co-Founder, ClinEco
Erik Yorke, Marketing Lead and Scientific Writer, ClinEco

Discover how you can stay connected and extend your SCOPE conference conversations year-round in this interactive workshop focused on ClinEco—the dynamic online B2B marketplace bringing together sponsors, CROs, site networks, and innovative solution providers to streamline partnering.

This workshop will help you understand how to take full advantage of ClinEco’s capabilities. Through real-world case studies, we'll demonstrate how ClinEco members streamlined their outsourcing processes, discovered new partners, and expanded their global reach. Whether you're a sponsor seeking new collaborations or a vendor looking to stand out, this session will provide actionable insights to boost your success.

Join us to experience the future of clinical trial networking and collaboration!

1:00 pm– 2:30 pm WORKSHOP 3: The Path towards Sustainable Clinical Trials: Reducing the Environmental Impact of Global Clinical Trials

INSTRUCTORS:

Michael J. Cohen, Senior Director, Lead, Environmental Sustainability, PPD/Thermo Fisher Scientific

Thierry Escudier, Portfolio Lead, Pistoia Alliance

Hannah Sieber, Co-Founder, CEO, Artyc

Diana Steinbuesch, BioX Operations Portfolio Lead (Oncology), Roche

While developing leading and innovative therapies, we must not lose sight of the environmental impacts and greenhouse gas emissions. We can reduce the environmental impact of our studies by prioritizing remote visits and monitoring, by reducing kit wastage, and working together to find ‘greener’ solutions. This workshop will provide a brief overview of research and introductory strategies for reducing emissions as well as a 'Sustainability 101' to help anyone in our industry get started towards developing more environmentally responsible clinical trials. Open to all SCOPE attendees. Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.

1:00 pm– 2:30 pm WORKSHOP 4: Efficient Importation of Biological Materials into the U.S.

INSTRUCTORS:
Jessica Hammes, Branch Chief, Biological Threat Exclusion, Agriculture Safeguarding and Risk Management, Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Jennifer Merriman, Senior Manager, Strategic Biospecimen & Vendor Logistics, Consent, Biospecimens, & Imaging, Global Development Operations, Bristol Myers Squibb Co.
Brandy Porter, Assistant Director, Pharmaceuticals, Health, and Chemicals Center of Excellence & Expertise, U.S. Customs and Border Protection
U.S. Customs and Border Protection and partner government agencies regulate the importation of biological materials into the United States. The efficient importation of these items can be challenging, as Clinical Trial landscape is ever-evolving. The purpose of this workshop is to discuss current challenges, best practices, and possible solutions to navigate this landscape.

2:00 pm– 3:30 pm WORKSHOP 5: Sponsor and Site Perspectives: Addressing Current Challenges and Exploring Future Opportunities in Clinical Trial Financing

INSTRUCTORS:
Dawn Anderson, Partner, Consulting, Deloitte LLP
Ming Shen, Managing Director, Deloitte Consulting LLP
This workshop will explore sponsor and site perspectives on current challenges and future opportunities in clinical trial financing. It will address complexities in managing trial finance including estimation, budgeting, forecasting, invoicing, payments, reconciliation and others in clinical trial management. The workshop aims to identify innovative solutions to enhance finance management in clinical trials, fostering more accurate projections. Through discussions and interactive sessions, it seeks to provide insights for future opportunities to improve clinical trial finance.

3:50 pm

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

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

3:58 pm

Chairperson's Introduction

Jenny Denney, Executive Vice President, Global Head Parexel FSP, Parexel

4:00 pm KEYNOTE PRESENTATION:

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

Janice Chang, CEO, TransCelerate Biopharma, Inc.

Mark McClellan, MD, PhD, Director, Duke-Margolis Institute for Health Policy; Former Commissioner, FDA

On this stage in 2024, we spoke about our mission to converge clinical research and clinical care for the benefit of patients worldwide. We envision a world in which patients participate in research at the point of care as seamlessly as possible. And although we’ve set our vision, and organized the work we are undertaking accordingly, the real fruits of those efforts will not be seen in the short term. We will use this session to talk about where we hope we will be by 2035. What might we reasonably achieve? What does success look like? And what will it take to get there? This session is designed to help us all to raise our gaze beyond the near-term and find inspiration in the future possibilities.

4:25 pm

Tips for Getting the Most out of SCOPE

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

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 3-6, 2025, at the Rosen Shingle Creek in Orlando, Florida!

https://www.scopesummit.com/faq-how-to-succeed-at-scope

4:33 pm

Chairperson's Introduction

Fiona Geiger, Vice President, Operational Delivery, Operations, Endpoint Clinical, Inc.

4:35 pm INTERACTIVE KEYNOTE PANEL:

What Do Real Patients Actually Talk About?

PANEL MODERATOR:

T. Hephner, CRO, Inspire

Whether at an industry event, a focus group, or another venue, we’ve all heard “real” patients share stories of their conditions, treatment journeys, and lives. But how accurate is what you’ve heard? Are the patients who speak on the podium or in a focus group truly representative of the majority of patients, or do they represent just a small sample? Our panel of patient engagement experts from some of the country’s leading patient advocacy groups and other representative organizations will give the story of what it’s like for most patients to live with illness, including rare and chronic diseases. Join us and learn about the true challenges of disease burden, unmet needs, treatment progression, the challenges–and rewards–of clinical trials, and more.

PANELISTS:

Emily McCormack, Social Media Director, New York Blood Center Enterprises

Fabian Sandoval, PhD, President & CEO, Emerson Clinical Research Institute

Quynh Tran, Director of Patient Activation, Cystic Fibrosis Foundation

5:05 pmSCOPE's 9th Annual Participant Engagement Awards Introduction (Sponsorship Opportunity Available)

5:10 pm

SCOPE's 9th Annual Participant Engagement Awards

PANEL MODERATORS:

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

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

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

Now in its 9th 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 2025 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award

PANELISTS:

Tricia Barrett, CEO, Praxis

Brian Burkhardt, Co-Founder & Executive Director, Oliver Patch Project, Inc.

Michelle Everill, Vice President, Global Trial Optimization, Alnylam Pharmaceuticals

Gretchen Goller, Head, Enrollment Strategy, Oncology, Pfizer Inc.

Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative

Stacy Hurt, Chief Patient Officer, Patient Engagement, Parexel International

Kim Ribeiro, Chief Client Officer, Inside Edge Consulting Group

5:45 pmSCOPE's Kickoff Reception: A Luau to Remember!

Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, we're turning up the tropical vibes with a luau theme.

DRESS CODE: Hawaiian shirts are encouraged! Show off your brightest, boldest, most tropical attire (grass skirts optional!) Let's bring the aloha spirit to life as we kick off another amazing SCOPE conference experience. Join us to reconnect with your old friends, make some new ones, and soak up the Florida sunshine in style!

7:00 pmClose of Day

Tuesday, February 4

6:30 amSCOPE's 5K Rise and Shine Fun Run! (Sponsorship Opportunities Available)

Join SCOPE’s Coordinators on Tuesday, February 4 for our 5K Rise and Shine Fun Run! Don’t forget to pack your sneakers.
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 6:30 am sharp!
RUN COORDINATORS:
Eileen Murphy, Conference Producer, Production, Cambridge Healthtech Institute
Steve Wimmer, Vice President of Partnerships, 1nHealth

7:30 amRegistration Open

7:30 amMorning Coffee (Sponsorship Opportunities Available)

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

8:25 amGrab Your Seat: Early-Bird Seat Raffle & Prize Giveaway! * (Sponsorship Opportunity Available)

*Must be present to win.

8:30 am

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

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

8:40 am

Chairperson's Introduction

Jonathan Rowe, Principal & Head, R&D Quality Operations & Risk Management, ZS Associates, Inc.

8:42 am KEYNOTE PRESENTATION:

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

Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.

This talk focuses broadly on Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. More specifically, how has Merck decided to optimize clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams? What are key considerations for clinical trial planning, site selection, and protocol design? And, what and why did Merck keep many core capabilities “in-house”?

9:10 am THE CLINICAL TRIAL DATING GAME:

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

Brett Kleger, CEO, Inspire

The Bachelor: Kristopher Sarajian, Vice President, Marketing, Trialbee

SCOPE’s Gameshow Host: Brett Kleger, a man whose dream it was to be a wedding singer or gameshow host

In today’s episode of “The Clinical Trial Dating Game” we have our pharma industry bachelor looking for a volunteer for his trial. He must question and choose from among three patients, who are hidden from view. He has access to all of their data, but there is more to this person than data, so how will he know which questions to ask? How will he avoid bias? How will he recruit on time? Knowing how important patient centricity is to the clinical research industry and with so much on the line, will our bachelor land a date? What could go wrong?

9:20 am KEYNOTE PANEL DISCUSSION:

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

PANEL MODERATOR:

Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)

Should biopharma companies be the only "sponsors" for clinical trials of new medicines? Does the current model limit opportunities for unmet needs in small populations or leveraging repurposed drugs? This panel will gather leaders demonstrating ways that patient-led non-profit organizations are challenging assumptions and taking a leadership position in medicine development. No longer can we think of patients as guests at pharma's table—is the next transformation in medicine development going to be entirely patient-led?

PANELISTS:

Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL

Heidi Bjornson-Pennell, Senior Program Manager, Science in Society and Lead, Rare As One Network, Chan Zuckerberg Initiative LLC

Nasha Fitter, Co-Founder & CEO, FOXG1 Research Foundation

Craig Martin, Founder, CEO, The Orphan Therapeutics Accelerator

Tracey U. Sikora, Vice President, Research & Clinical Programs, National Organization for Rare Disorders; Co-Founder, Every Cure

9:50 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall—Best of Show Voting Opens

Join us for the Grand Opening Networking Coffee break in our biggest SCOPE Exhibit Hall ever! Mingle with friends, forge new connections, and exchange ideas over your morning cup of joe. Visit exhibitors and learn about their latest and greatest innovations and products...voting opens for our Best of Show awards so don’t forget to vote.

Part 1: Partner Selection and Trial Design

11:00 am Chairperson's Remarks

Antoinette Frankum, Vice President & Head of Clinical Development, North America Clinical Development, ClinChoice, Inc.

11:05 am

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

Peter Ronco, CEO, Emmes

This presentation will dive into the critical factors that small biopharma companies must consider when selecting partners for clinical trials. Peter will share insights on making the right choices to enhance efficiency, reduce risks, and drive growth, drawing from his extensive experience in the life sciences sector. His leadership and operational expertise will be invaluable as we enter our next phase of growth.

11:30 am

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

Alex Pastuszak, MD, PhD, Co-Founder & CEO, Paterna Biosciences

Gain insight into advancing pre-clinical biotech startups to clinical-stage companies through strategic partnerships from an industry leader with firsthand experience in the successes and challenges of these processes. In the biotech landscape, these collaborations, along with thoughtful vendor selection, are crucial for a startup's success. Partnering with reliable, niche top-tier service providers (contract research organizations) and specialized vendors allows startups to leverage cutting-edge technologies and regulatory expertise, facilitating seamless transitions between development stages. Early engagement with trusted partners streamlines research, optimizes resources, mitigates risks, and establishes a strong foundation for accelerated clinical progress. These partnerships not only drive operational efficiency but also spark innovation, positioning biotech startups for long-term success in a very competitive market with rigorous regulatory requirements.

11:55 am

Scaling Efficiency in Clinical Vendor Identification and Selection Processes

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

Tina Karunaratne, Executive Advisor, Biopharma Relations, ClinEco

The clinical research industry is undergoing a rapid transformation. Sponsor needs are evolving quickly, in step with new strategies and technologies that promise to improve every aspect of how we conduct clinical trials. Both new and established technology vendors and service providers are competing to meet the changing needs of sponsors, but older outsourcing models stand in the way of continuous innovation. While companies likely feel comfortable with their current partners and processes, the “tried-and-true” days of preferred vendor lists don’t go nearly far enough in an industry where, now, new ideas are critical for success. This presentation will feature several case studies of ClinEco’ s capabilities and innovative approaches for connecting clinical research stakeholders, ranging from vendor comparative analysis to tracking information and obtaining informed referrals.

12:15 pm

Optimizing CRO Partnerships for Small Biopharma Success

Melanie Goodwin, Director, Clinical Outsourcing, Immunocore

Choosing the right (CRO) is critical for the success of clinical operations, especially for small biopharma companies. This presentation outlines a strategic approach to CRO selection, beginning with a comprehensive set-up of requirements and a thorough landscape analysis. By narrowing down potential CROs, and rigorously questioning to ensure alignment with your company's goals, we reveal how to streamline the selection process. Discover how taking a methodical and tailored approach can lead to a partnership that meets your specific needs.

12:35 pm

Small Yet Mighty: The Critical Role of Study Start-Up Tech for Small Biopharma

Ashley Davidson, Vice President, Product Lead, Advarra

Richard Buckley, Director, Site Technology Solutions, Immunovant

In this session, we will explore why site-centric study startup technology is essential for small biopharma companies, highlighting the significant ROI and streamlined workflow it offers for sites and study teams alike. Additionally, we'll emphasize the importance of site centricity, showing how focusing on site needs and challenges can enhance trial success and patient experiences. We'll delve into specific projects to show how site-centric technology helps smaller organizations achieve efficient study start-ups, demonstrating why investing in this tech is crucial for staying competitive in today's fast-paced biopharma and biotechnology landscape.

1:05 pm

Small Biopharma: Total Quality Management Lesson for Recruitment

Dan Brenner, CEO & Founder, 1nHealth

Small biopharma often faces challenges in patient enrollment due to limited resources and tight timelines. But accepting those challenges as status quo is no longer an option. By planning clear targets and executing evidence-based strategies, organizations can overcome bottlenecks and adapt to shifting enrollment dynamics. Through a Total Quality Management approach combined with data-based design-thinking, 1nHealth provides a lesson in enrollment and recruitment that actually works.

1:35 pmSponsored Networking Luncheon

Take this opportunity to refresh and refuel and network, compliments of SCOPE sponsors! Take a well-deserved break outdoors in the sun, or indoors in the air conditioning.

2:35 pmNetworking Coffee & Dessert Break in the Exhibit Hall

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!

3:20 pm Chairperson's Remarks

Donna Dorozinsky, Founder and CEO, Just in Time GCP

3:25 pm

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

Katherine Barboza, PhD, Associate Director, Process Development, Galderma Laboratories LP

Alissa Calaway, RN, MSN, Manager, Medical Device Clinical Project Management, Galderma

Galderma has implemented a hybrid Functional Service Provider (FSP) model and eISF for select clinical trials, outsourcing specific functions while still maintaining control over data and processes. This hybrid approach blends sponsor, CRO, and vendor tools and technologies. It allows increased oversight of quality and compliance and leverages in-house expertise with an expanded pool of specialized talent through the FSP provider. This presentation will highlight the pros and cons of implementing a hybrid FSP model and an eISF in a fast-paced clinical trial environment with tight timelines and lean in-house cross-functional teams.

3:40 pm PANEL DISCUSSION:

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

PANEL MODERATOR:

Suzanne Vyvoda, Independent Consultant

Each clinical trial is unique. However, something small- and mid-sized biopharma companies have in common is the need to plan and execute trials in a way that does not mimic the contracts, budgets, and processes of typical bigger pharma and CRO partners. The smaller players often have a small clinical team and they want a CRO that understands their needs and knows how they are different. These smaller companies have the freedom to innovate—what to outsource and when, what capabilities and functions to build and why, who to partner with and how to find them, etc., but with this freedom comes the burden of creating on the go.

PANELISTS:

Tim Foley, Chief Business Officer, Scailyte

Malika Pasha, Vice President, Clinical Operations, Secretome Therapeutics

Robert Goldman, Head of Clinical Operations, Contraline

Jeffrey S. Yablon, Head Business Development & Strategic Operations, Ubuntu Research, Inc.

4:10 pm

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

Malika Pasha, Vice President, Clinical Operations, Secretome Therapeutics

Ataali Shaikh, Life Scientist, Global Head- Clinical Development Strategy and Solutions

This presentation will provide practical strategies for clinical operations executives in small and mid-sized biotech companies to overcome common trial planning hurdles. Presenters will share valuable lessons learned, offering actionable insights into how small biotechs can leverage limited resources effectively. Topics include optimizing trial processes, driving clinical proof of concept, and navigating partnerships—while avoiding the inefficiencies of legacy systems. Attendees will leave with clear, implementable tactics to streamline operations, reduce costs, and accelerate trial success.

4:25 pm

Managing Your Clinical Trial Effectively: Engaging Patients and Sites for Success

Cheryl Kole, Vice President, Strategy & Commercialization, Clinical Technologies, Almac Group

Kees Van Ooik, Vice President - eClinical Development, Almac Group

Explore how small biopharma companies can achieve clinical trial success using tools that effectively engage patients and sites. Using a case study of a fully remote study, we will discuss the unique challenges faced by small biopharma, such as limited resources and short timelines, and how an integrated eClinical solution can help overcome these obstacles. Join us to learn how to transform clinical trial processes and drive success.

4:55 pm

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

Kevin Eisenfrats, Founder & CEO, Contraline, Inc.

Gain actionable insights into clinical trial planning and design from Kevin, CEO and co-founder of Contraline. With over $30M in funding and a groundbreaking product in reproductive health, Kevin will share key takeaways and lessons learned from leading a biotech startup through the journey from concept to clinical stage. This session is a must for clinical operations executives launching and running trials.

5:25 pm

Protocol and Feasibility Simulations to Optimize Trial Planning

Cheryle Evans, Senior Vice President, Global Clinical & Biometric Operations, Advanced Clinical

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

Tamara Costopoulos, Patient Recruitment Leader, Advisory Board, Individual Consultant

Leverage protocol simulations and strategic tech partnerships to enhance trial predictability and streamline planning.

5:55 pmWelcome Reception in the Exhibit Hall (Sponsorship Opportunities Available)

Wind down at the end of a busy session day with colleagues and old and new friends. Networking is always in full swing at this reception, so raise a glass with your favorite exhibitors and take a chance at winning one of our fabulous raffle prizes (must be present to win). Continue your networking over dinner at one of the Rosen Shingle Creek's fine dining or casual restaurants and eliminate the need to face Orlando traffic.

7:15 pmClose of Day

7:15 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)

The 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.

Shuttles will run a continuous loop from 7:00pm-11:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.

On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Wednesday, February 5

7:45 amRegistration Open

8:15 am

BREAKFAST PRESENTATION OPTION #1:Digital Innovation’s Role in Pediatric and Elderly Clinical Trials

Kyle Hogan, CEO, Datacubed Health

This presentation examines how targeted digital tools improve retention rates among pediatric and elderly participants. Our pediatric focus reveals how gamification can create meaningful connections and enhance the trial experience while engaging caregivers. For elderly participants, we examine the use of accessible interfaces and remote monitoring solutions to address age-specific challenges. Attendees will discover strategies for implementing these solutions within their research programs.

8:15 am

BREAKFAST PRESENTATION OPTION #2:Expanding the Patient Universe: Transforming Clinical Trials through Inclusive, Data-Driven Design

Christopher Riley, Director, Strategic Insights, Solutions, H1

In today’s complex clinical research landscape, achieving patient-centricity and inclusivity is more critical than ever. This presentation introduces Patient Universe, a groundbreaking solution designed to optimize trial feasibility while addressing health equity challenges. Attendees will learn how leveraging real-world health equity data can transform patient recruitment strategies, create inclusive trial designs, and improve participant engagement. Through actionable insights and use cases, this session will demonstrate how advanced analytics and innovative technologies can bridge gaps in representation, support diversity action planning and enhance trial outcomes.

8:15 am

BREAKFAST PRESENTATION OPTION #3:

Scaling Success: How Sanofi and Trialbee Drive Patient-Centric Recruitment and Reduce Site Burden in Global Asthma Programs

Whitley Albright, Clinical Innovation and Operations Strategy Lead, Sanofi

Gaynor Anders, Chief Delivery Officer, Trialbee

Join Whitley Albright (Sanofi) and Gaynor Anders (Trialbee) to discuss how to keep patients at the center of focus while reducing site burden in a complex global asthma program by: connecting patients to the right trials with targeted outreach and a highly efficient global process; pre-qualifying all patients with live medical secondary screening to reduce the volume sent to sites, improve trust, and increase referral-to-consent ratio; keeping disqualified patients ready to enroll with program-level rematching; centralizing activity in a Patient Recruitment Platform (PRP) to manage progress, evaluate site performance, and measure campaign ROI; building a collaborative, supportive, and meaningful relationship.

Learn how these organizations are scaling recruitment success globally while achieving diversity and inclusion goals, reducing site burden, and keeping patients at the center of care.

8:45 amTransition to Sessions

8:50 am Chairperson's Remarks

Lisa Jennings, Senior Director, Business Development, Catalyst Clinical Research - Catalyst Flex

8:55 am

Securing Clinical Trial Data: Navigating Cyber Threats and Regulatory Challenge

Christopher Hart, Partner, Co-Chair, Privacy and Data Security Group, Foley Hoag LLP

As clinical trials become more data-dependent, the risk of cybersecurity threats grows, especially in a shifting legal landscape with increasing multi-jurisdictional complexities. For clinical operations executives, staying ahead of regulatory changes is crucial to ensure data security and compliance. Chris Hart, Partner at Foley Hoag LLP, will discuss how small biopharma can proactively address cybersecurity, build robust data infrastructure, and strategically select outsourcing partners to safeguard clinical trial data.

9:15 am

What to Consider in Managing External Data for the Small Biopharma

Kara Titus, Senior Director, Procurement, Dragonfly Therapeutics

Efficient and compliant clinical trial data management is the cornerstone of successful drug development and regulatory approval. As the volume and complexity of non-clinical data continue to grow, organizations face critical decisions about whether to manage data in-house, outsource to Contract Research Organizations (CROs), or adopt hybrid approaches. This session explores the strategic and operational considerations that influence these decisions. Attendees will gain insights into the advantages and challenges of in-house data management, the benefits and risks of outsourcing to CROs, and the flexibility offered by hybrid models, helping clinical operations professionals, data managers, and decision-makers seeking to optimize their clinical trial workflows and make informed choices that align with their organization's goals and resources.

9:35 am

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

Gaelan Ritter, Executive Director, Innovation and Digital Health Analytics, Bristol Myers Squibb Co.

The evidence generation required for clinical development is evolving rapidly. Many trials include various data types and sources, labs, biomarkers, wearable devices, real world EHR, and others. It is critical to understand the opportunities and risks inherent with those new sources, and know how to utilize and manage them effectively. Gaelan will discuss the current and future state of these data types, how to think about strategic partnerships with vendors in these areas, and how to navigate the evidence planning required to drive value in the integrated data future.

9:55 am

Sponsors, CROs & Tech Providers: A Triple Threat

Andrea Valente, Chief Operating Officer, uMotif

In basketball, being able to execute a Triple Threat can be a game-changer – but it requires flexibility and adaptability.

As in basketball, even the best-designed clinical trial can be unpredictable and require quick decisions.

This presentation discusses how sponsors, CROs and technology providers can team up to build a playbook of practical guidance and lessons learned, to create a Triple Threat that optimizes even the most complex clinical trials by building in flexibility and adaptability.

10:25 amCoffee Break in the Exhibit Hall

SCOPE is ALL about networking—with clients, colleagues, sponsors and exhibitors. Take this chance to visit booths you haven't been to, build new relationships, and fuel up with coffee for the rest of the busy day ahead. Last chance to vote for the Best of Show award! Make your vote count!

10:45 amSpecial Book Signing

Fundamentals of Decentralized Clinical Trials
Editors: Isaac R. Rodriguez-Chavez & Anna Yang

Location: Gatlin Foyer, ClinEco Booth #1

11:20 am

Chairperson's Remarks

Collier Wright, Vice President of Solutions, Sales, TruTechnologies

11:25 am PANEL DISCUSSION:

Requirements for Managing Clinical and Non-Clinical Data

PANEL MODERATOR:

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

PANELISTS:

Stacey Arrambide, Senior Vice President, Functional Service Solutions, Advanced Clinical

Leila Cupersmith, CEO, Principal Consultant and Patient Advocate, Choice ClinOps LLC, Independent Consultant

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

Gaelan Ritter, Executive Director, Innovation and Digital Health Analytics, Bristol Myers Squibb Co.

12:25 pm

Empowering Success in Small Pharma/Biotech: Leveraging People and Process for Optimal Results

Sheila Gwizdak, Vice President, Head of Consulting, Halloran Consulting Group

This session will provide insights on how best to align people with process, essential for fostering innovation and sustainable growth. Learn how to strategically integrate human capital with process optimization, a cornerstone for success in the small pharma sector. Leveraging real-world examples and best practices, learn how organizations can effectively harness the potential of their teams—promoting a culture of collaboration and continuous improvement. We will focus on process-driven strategies that streamline operations, enhance quality control, and expedite time-to-market, all while maintaining high standards of quality and regulatory compliance.

12:55 pmSponsored Networking Luncheon

Once again, join us for lunch, courtesy of our generous sponsors.

1:55 pmNetworking Coffee & Dessert Break in the Exhibit Hall—Best of Show Winner Announced

SCOPE's Networking Coffee and Dessert Break is the perfect time to pick up a sweet treat, courtesy of our sponsors, and fuel up for the afternoon with a cup of coffee or soft drink. Visit our Game Card Sponsors to fill your Game Card with stickers and get in a little more networking time before afternoon sessions!

2:30 pm

SCOPE around the World, Faces from the Community

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

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

2:35 pm

Chairperson's Introduction

Brad Stefanovic, PhD, Head Clinical Innovation, Pro-ficiency, a Simulations Plus Company

2:37 pm KEYNOTE PRESENTATION:

Fostering Clinical Innovation in a Large Pharmaceutical Organization

James Gallagher, Senior Director, Innovative Health, Johnson & Johnson Innovative Medicine

This presentation explores strategies for fostering innovation within a large pharmaceutical organization by focusing on four key areas: developing a clear mandate and compelling vision to guide innovation efforts; designing and engineering an infrastructure that supports creativity and collaboration; building a high-performance, diverse team empowered to drive innovation; and seeking opportunities for true patient-centricity and sponsor-agnostic innovation. By aligning these elements, the organization can create a sustainable innovation ecosystem that prioritizes patient outcomes and drives transformative breakthroughs in healthcare.

3:00 pm KEYNOTE PRESENTATION:

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

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

Sponsors can leverage increasing technology capabilities to enhance quality by integrating advanced data analytics, AI, and automation into their drug development and manufacturing processes. These technologies enable real-time monitoring, predictive analytics, and streamlined workflows, ensuring higher precision and consistency in product quality. Additionally, digital tools facilitate better compliance with regulatory standards and more efficient management of clinical trials, ultimately accelerating time-to-market while maintaining rigorous quality standards.

3:20 pm

SCOPE Award Winners & Announcements

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

3:25 pmSponsored Presentation (Opportunity Available)

3:30 pm KEYNOTE PANEL DISCUSSION:

The Unleashing of Gen AI: Revolutionizing Healthcare and Beyond

PANEL MODERATOR:

Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Johnson & Johnson

Gen AI, a groundbreaking approach that seamlessly merges artificial intelligence into our daily lives, holds immense potential for transforming the pharmaceutical and healthcare industries. This paradigm shift not only demands a thorough understanding of the ethical implications, potential biases, and social consequences of AI systems— it also requires a steadfast focus on creating tangible value that benefits individuals and society at-large. By harnessing advanced AI technologies, Gen AI can pave the way for unparalleled breakthroughs, elevating patient care, enabling personalized medicine, streamlining processes, and revolutionizing the way we approach healthcare as a whole. Join the debate on the real value-based use cases and explore the endless possibilities that Gen AI brings to the table.

PANELISTS:

James Gallagher, Senior Director, Innovative Health, Johnson & Johnson Innovative Medicine

Andrew Lee, Senior Vice President & Head, Global Clinical Trial Operations, Merck & Co.

Brian Martin, Chief AI Product Owner, BTS; Head of AI, R&D Information Research; Senior Research Fellow, AbbVie, Inc.

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

4:00 pmBooth Crawl & Refreshment Break in the Exhibit Hall (Sponsorships Available) Last Chance for Exhibit Viewing

We know you're tired, we know the Exhibit Hall is huge, and we know you still have some booths to visit, some connections to make, some networking to do. SCOPE's Networking Booth Crawl is the time to do it! Crawl if you must, but be sure to visit our sponsored booths for some food, drinks, and enough energy to finish SCOPE strong! Our final Networking Exhibit Hall break is the final time to see the exhibits you haven't seen and meet the people you haven't yet met. The break ends with another amazing raffle prize, so be sure to get your Game Cards in and the lucky winner (must be present to win) could be you!

5:00 pmClose of Day

5:00 pmEvening Courtesy Shuttles to Pointe Orlando (Sponsorship Opportunities Available)

The 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.

Shuttles will run a continuous loop from 5:00pm-9:00pm (last pick up 30 minutes before end time) between Rosen Shingle Creek, Rosen Plaza, Residence Inn Orlando and Pointe Orlando.

On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Thursday, February 6

7:15 amRegistration Open

7:45 am

BREAKFAST PRESENTATION:What Sites Really Need to Deliver Successful Patient Engagement Strategies

Leslie Ives, Senior Director, Patient Recruitment, Patient Strategy and Insights, Parexel International

Brittany Harvey, Clinical Project Mgr, Clinical Operations, UCB Inc

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

Sites have shared that delivering successful patient recruitment is arguably one of the most persistent challenges they face. Despite this being well-known, not enough of the right support is provided to them, causing more than half of sites to pay out of pocket for unreimbursed recruitment expenses, all while the one-size-fits-all recruitment materials provided to them collect dust. By rethinking how we support sites in their patient engagement activities, sponsors and CROs can shift the paradigm to make patient enrollment delays and declining retention rates outliers, instead of the norm. This breakfast session will discuss strategies to transform patient engagement by leveraging site experience, incorporating patient insights and motivations, as well as AI solutions, to improve patient retention and deliver better study outcomes.

8:15 amTransition to Sessions

Part 2: Vendor Oversight & Resource Management

8:20 am

Chair Person's Remarks

Leila Cupersmith, CEO, Principal Consultant and Patient Advocate, Choice ClinOps LLC, Independent Consultant

8:25 am

Mastering Acquisitions: A Clinical Ops Guide to Successful Biopharma Transitions

Scott T. Megaffin, CEO, Adiso Therapeutics

oin a seasoned C-level leader as they outline the key steps clinical operations executives need to navigate when a small biopharma company is acquired. This session will cover how to evaluate and integrate acquisition opportunities, manage operational transitions, and ensure data continuity. Gain practical strategies for maintaining clinical trial integrity, optimizing resources, and leveraging acquisitions to strengthen your company’s market position and drive sustainable growth.

8:55 am PANEL DISCUSSION:

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

PANEL MODERATOR:

Valerie Reynaert, Vice President, Global Clinical Operations, Immunocore

Join us for an insightful session on navigating the turbulent waters of change in the biotech industry. From mergers and acquisitions to going public, dramatic portfolio shifts, and new co-development ventures, learn how to build robust strategies to manage these significant transitions. Gain practical insights and actionable strategies from clinical operations experts who have successfully steered their organizations through these challenges. Don’t miss this opportunity to equip yourself with the tools to thrive amidst the drama of change!

PANELISTS:

Kristi Koontz, Vice President, Global Clinical Operations, Daiichi Sankyo US

Ann-Marie Hulstine, Vice President, Clinical Operations, Alpheus Medical

Anne Marie L. Inglis, PhD, Senior Director & Asset Lead, Clinical Operations, GSK

Doug A. Schantz, Senior Vice President, Clinical Operations, Asklepios BioPharmaceutical, Inc.

9:25 am

Faster Submissions, Smarter Workflows: Lessons from Sanofi’s AI-Powered Translation Strategy

Georges Tavares, Clinical Translation Services Global Manager, Sanofi

Denise Mayes-Gascard

In this session, learn how Sanofi has transformed its translation processes using centralized management by expert project managers, automated workflows, and integration of TransPerfect’s GlobalLink platform with Veeva eTMF. You’ll gain insights into Sanofi’s pragmatic, phased approach, including leveraging automation and AI-powered workflows. The result is a dynamic digital ecosystem that captures feedback, drives continuous improvement, and achieves over 30% savings in time and resources. Join us to hear actionable strategies you can take back to your teams to accelerate timelines, enhance inspection-readiness, and cut costs.

9:40 am

Advanced Therapies: C-Suite Considerations for Navigating Development Challenges

Amanda Moore, Vice President, Program Leadership & Clinical Operations, Abeona Therapeutics

Shaheen Limbada, COO, Operations, WEP Clinical

Atalah Haun, Vice President, Medical Affairs, Medical Affairs, WEP Clinical

The development of advanced therapies, such as cell and gene therapies, presents unparalleled opportunities and challenges for biotech companies. This presentation will focus on how the C-suite can effectively navigate the complexities of advanced therapy development, including manufacturing scalability, logistics complexity, regulatory requirements and commercialization planning. As part of the discussion, we’ll touch on the critical role of vendor selection, exploring how to identify and engage partners with the expertise required to address the unique demands of advanced therapies.

Key topics include:

•Overcoming technical and operational challenges in advanced therapy development.

•Managing logistical complexities and regulatory intricacies.

•Integrating patient perspectives

•Incorporating vendor selection into a broader operational strategy.

•Preparing for the commercial launch of advanced therapies.

10:10 am PANEL DISCUSSION:

Advocating for Clinical Operations before Clinical Development

PANEL MODERATOR:

Dawn Buchanan, Vice President, Clinical Development Operations, AffyImmune Therapeutics, Inc.

Join our panel discussion on educating the C-suite about the critical role of clinical operations. Learn strategies to demonstrate value, manage expectations, and grow support. Gain insights on effective outsourcing and communicating complex details to executives and investors. Elevate your influence and drive operational excellence in your biopharma company.

PANELISTS:

Nithiya Ananthakrishnan

Ed Tumaian, Senior Vice President, Clinical Operations, Cyclo Therapeutics, Inc.

Caro Unger, Clinical Trial Strategy & Management Leader, Asher Biotherapeutics

11:10 amNetworking Coffee Break

11:50 am

Chairperson's Remarks

Akhil Rachamadugu, Director, Life Sciences Industry Solutions, ServiceNow

11:55 am

Strengthening Sponsor-Site Partnerships in Outsourced Trials

Liza Micioni, Senior Director, Head of Clinical Operations, Tris Pharma

In fully outsourced trials, sponsor-site relationships might seem less critical—but are they? For small biopharmas, especially new players, these relationships can be pivotal. Shouldn't the CRO handle this? Why should sites care? Discover why building strong sponsor-site connections still matters and how it can make a difference in your trial's success.

12:25 pm

Creating and Leveraging an Outsourcing Strategy for Smaller Biotechs

Kelly L. Smith, AD, Operations, Viracta Therapeutics, Inc.

How do you leverage vendors to engage while not being able to rely on a book of business? This will advise on step-by-step approaches, engagement strategies, and considerations for your own study.

12:55 pm PANEL DISCUSSION:

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

PANEL MODERATOR:

Carrie Lewis, Executive Director, Clinical Program Optimization, Endo

The pharmaceutical industry has faced a number of challenges related to hiring the right candidates with the right skills and retaining them since the COVID pandemic introduced a whole new way of working. How can pharma and biotech companies think outside the box and hire candidates interested in entering clinical research but may not have the industry experience? How do these companies then retain these employees and grow their careers? How can hiring, training, and growing employees be done in a way to minimize the impact to ongoing trials? This case study will explore how Endo utilized a bridge program to find employees that ultimately thrive in the workplace.

PANELISTS:

Suzy Montanye, Site Relationship Manager, Endo

Joan Ramella, Associate Director, Oversight & Training, Endo

Krista Wilson, Director, Clinical Operations, ICON

1:25 pmTransition to Lunch

1:30 pm

LUNCHEON PRESENTATION: Clinical Trials Outside of a Vacuum: Leveraging ServiceNow and Generative AI to Transform End-to-End Trial Delivery

Akhil Rachamadugu, Director, Life Sciences Industry Solutions, ServiceNow

As the clinical trial landscape grows more complex, the need for integrated, intelligent solutions has never been more critical. This session explores how ServiceNow, combined with cutting-edge generative AI capabilities, is reshaping the way trials are planned, executed, and managed—bridging silos, streamlining operations, and fostering seamless collaboration across sponsors, CROs, and sites. Attendees will discover how to unlock efficiency and agility in trial delivery, from accelerating patient recruitment to enhancing data management and regulatory compliance. Learn from real-world case studies that showcase the transformative power of generative AI in breaking down operational barriers, reducing cycle times, and driving innovation across the entire clinical trial lifecycle.

2:00 pmSCOPE Summit 2025 Adjourns