16th Annual Outsourcing in Clinical Trials East Coast 2025

Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget

20 - 21

May

2025
  • Valley Forge Casino Resort, King of Prussia, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Resources
  • Contact Us
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2025 Sponsors Include:

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Company Information

Frontage is a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. We are focused on helping our client’s to address their most significant and complex drug discovery and development challenges. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to turn our services into your solutions.

Company Website

To learn more, please visit our website - www.frontagelab.com

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Company Information

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

Company Website

To learn more, please visit our website - https://www.iconplc.com/sectors/biotech

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Company Information

PCM Trials has been at the forefront of decentralized clinical research since 2008, leading mobile visits and recently introducing community-based research sites. We are driving the shift to patient-centric clinical trials, giving individuals the flexibility to engage in research studies in ways that work best for them. Our approach expands opportunities for participation, resulting in greater patient diversity, reduced patient dropout, and faster study results.

Company Website

To learn more, please visit our website - http://www.pcmtrials.com/

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Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Company Website

To learn more, please visit our website - https://www.worldwide.com

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Company Information

ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

Company Website

To learn more, please visit our website - www.ACMGlobalLab.com

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Company Information

Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences.  Visit our website to learn more about how we deliver a Better Clinical Experience.

Company Website

To learn more, please visit our website - https://www.advancedclinical.com/

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Company Information

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

Company Website

To learn more, please visit our website - https://www.almacgroup.com

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Company Website

To learn more, please visit our website - atreo.io

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Company Information

BSI Life Sciences offers smart eClinical software for CTMS, eTMF and more. BSI makes life science software for people – and has done so for over 25 years. BSI’s software solution is made in Switzerland, Germany, USA and anywhere else clients need to be, and focused on being innovative and user-friendly. They focus on staying ahead of the industry trends and delivering a functional, compliant, and leading edge eClinical solution. This way, BSI helps its customers continuously optimize and accelerate the clinical development process. And that’s what they love! www.bsi-lifesciences.com

Company Website

To learn more, please visit our website - www.bsi-lifesciences.com

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With over 40 years’ experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services.

Company Website

To learn more, please visit our website - http://www.celerion.com

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Company Information

LabConnect is the world’s most agile central laboratory solutions partner supporting clinical trials of all sizes and complexity. With modern operations and strategic alliances with world-leading laboratories, LabConnect is uniquely positioned to provide access to the latest innovation and automation. LabConnect is the trusted partner for biotechnology, pharmaceutical, and clinical research organizations.

 

Follow LabConnect on LinkedIn

Learn more at labconnect.com

Company Website

To learn more, please visit our website - http://www.labconnectllc.com/

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Company Information

MedNet is a leading eClinical technology company specializing in electronic data capture and clinical study management systems. Since 2001, MedNet’s proven cloud-based solutions have successfully supported research initiatives worldwide. Visit our booth to see iMedNet eClinical…an agile, efficient and, effective solution that allows sponsors and CROs to easily build studies.

Company Website

To learn more, please visit our website - http://www.mednetsolutions.com

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Company Website

To learn more, please visit our website - http://www.medpace.com/

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Company Information

Miller Tanner Associates is a WBENC-certified, full-service global corporate event planning company specializing in the life sciences industry for 26+ years (15+ in virtual events). We deliver exceptional experiences for face-to-face, virtual, and hybrid meetings and events as well as tailored event management technology solutions including proprietary tools – EPIC™, Attend™, and VALTs™. We offer a broad spectrum of products and services to support event planning needs, including security and compliance (21CFR Part 11), engagement strategies, technology support, robust pre- and post-event reporting, and more. To learn more about Miller Tanner Associates, visit https://www.millertanner.com/

Company Website

To learn more, please visit our website - millertanner.com

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Company Information

Myonex provides tailored services and solutions to advance medicine through clinical to commercial stages with tailored drug sourcing and ancillary supply, to packaging, labeling, and distribution. With ten global locations, we offer flexible, efficient, and cost-effective support for clients across the pharmaceutical and biotech sectors.

 

Company Website

To learn more, please visit our website - www.myonex.com

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Company Information

Prevail InfoWorks improves the probability of clinical trial success by providing stakeholders real-time actionable intelligence to effectively manage endpoints and key deliverables with the Single Interface™, its patented cloud-based tool that aggregates, reconciles, analyzes and single-view reports/visualizes all clinical, operational and project accounting data, regardless of the source or format.

Company Website

To learn more, please visit our website - www.prevailinfoworks.com

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Company Information

Versiti Clinical Trials Services support biopharma and cell therapy companies through central laboratory, logistics, biomaterials provision, and IRB services. We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications.

Company Website

To learn more, please visit our website - www.versiticlinicaltrials.org

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Company Information

Founded in 2005, Inspire connects life sciences organizations with the voices that matter most—patients and caregivers. With 10 million unique annual visitors across over 3,000 disease states, Inspire leverages its engaged patient communities to accelerate clinical trial recruitment, uncover real-world evidence, deliver actionable market research, and provide targeted advertising solutions for health-focused audiences.  By bridging the gap between patients and life sciences, Inspire enables smarter decision-making and a deeper understanding of the communities it serves.

Company Website

To learn more, please visit our website - https://inspireresearch.com/

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Company Information

Mural Health is a participant management platform that helps manage & streamline the trial experience for patients and caregivers. Using modern payment, transportation, and communication solutions we help drive retention, compliance, and data quality.

Company Website

To learn more, please visit our website - https://www.muralhealth.com/

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Company Information

Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. For more than 30 years, Rho has been a trusted partner to  leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence,  innovative technologies, and  therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience.

Company Website

To learn more, please visit our website - http://www.rhoworld.com/

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    Why attend?

    Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget  

    Join us for a two day event filled with case studies, panel discussion and face to face networking opportunities around clinical operations, technology and innovation, and data management.

    This year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, Otsuka and Endo Pharmaceuticals, we have a keynote presentation from Craig Lipset, Advisor and Founder at Clinical Innovation Partners. Craig will be discussing “Can patients out innovate pharma?”

     

    WHAT TO EXPECT FOR 2025?

    450+

    Attendees

    		70+

    Exhibitors

    		30+

    Speakers
    450+

    Attendees

    		70+

    Exhibitors
    30+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 20 May 2025
    • 21 May 2025
    Expand All

    Streams

    Stream one

    Clinical Operations and Outsourcing

    Stream two

    Clinical Technology and Innovation

    12:45 PM

    Innovations in patient recruitment, powered by AI

    • Understand how AI is revolutionizing how content is rated and qualified by enhancing precision and accelerating the speed of communication
    • Experience a real-life AI application used to optimize patient recruitment materials
    • Gain insights into future trends and opportunities in AI-powered translation for the life sciences sector, including regulatory compliance for labeling

    Speakers

    Stephane Millet
    Director, Clinical and Patient Engagement Solutions, Acolad Life Sciences
    Kathleen O’Brien
    Head of Sales, Acolad Life Sciences

    10:30 AM

    Morning refreshments and networking break

    Streams

    Stream one

    Clinical Technology and Innovation

    9:45 AM

    TECHNOLOGY SPOTLIGHT: Establishing data governance as a best practice in your clinical eco-system

    Join for an insightful session on the world of data governance and security for the modern biotech. In this session, we will provide invaluable insights and practical strategies to help you optimize your clinical trial operations while ensuring the security of your sensitive data. Gain insight into areas such as mastering your data, the role of data governance in life sciences, and solving challenges in implementing data governance within your organization.

    Speakers

    Cat Hall
    Head of GXP Assurance, Egnyte

    Streams

    Stream one

    Clinical Operations and Outsourcing

    Stream two

    Clinical Technology and Innovation

    11 AM

    PANEL: Innovation and technology in clinical trials: exploring emerging and upcoming trends

    • Is decentralization of clinical trials still relevant in 2025?
    • Incorporating remote monitoring tools such as wearables into clinical trials
    • An overview of new tools and solutions available on the market
    • The growth of GenAI: when will this become widely used in clinical research?
    • Balancing new techno

    MODERATOR:
    Rich Polgar, Managing Director, Danforth Advisors

    PANELLISTS:
    Ashlyn Jose, Director, Clinical Operations, Kyowa Kirin, Inc
    Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health
    Kristen Olszyk, Vice President, Clinical Operations, Neuraptive Therapeutics
    Stefanie Kuhner, Head of Clinical Technology, Innovation and Patient Recruitment, Bristol Myers
    Squibb

    Speakers

    Rich Polgar
    Director Global Procurement, Bristol-Myers Squibb
    Ashlyn Jose
    Director, Clinical Operations, Kyowa Kirin, Inc
    Ram Raju
    Senior Vice President and Community Health Investment Officer, Northwell Health
    Kristen Olszyk
    Senior Director, Clinical Scientist, Neuraptive Therapeutics
    STEFANIE KUHNER
    Global Head Of Clinical Technology, Innovation & Patient Recruitment – Strategic Sourcing & Procurement, Bristol Myers Squibb

    11:30 AM

    Community is the new site: redefining trial footprints to expand access

    As the clinical research industry pushes toward innovative solutions to increase inclusivity and access, it’s time to look beyond traditional site-based trial models and digital platforms. Expanding access isn’t just about technology-centered solutions – it’s about rethinking where and how trials happen. This session explores how community-based research models, including mobile research sites, mobile clinicians, and flexible visit options, are redefining what it means to bring research to patients. This session will explore how building trust and presence in local communities leads to better enrollment, stronger retention, and more representation data.

    Speakers

    Nancy Lizzul
    Director, Site Operations, EmVenio Research

    12 PM

    CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

    • Top tips for working with and supporting naïve physicians in order to ensure their success
    • The importance of new study sites as a way of meeting FDA diversity requirements
    • Lessons learned for the future: what should you consider when working with naïve doctors?

    Carrie Lewis, Executive Director, Clinical Program
    Optimization, Endo
    Suzy Montanye, Site Relationship Manager, Endo

    Speakers

    Carrie Lewis
    Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
    Suzy Montanye
    Site Relationship Manager, Endo Pharmaceuticals

    12:30 PM

    Achieving submission excellence with Certara’s regulatory operations solutions

    • Defining the full lifecycle of clinical and regulatory documents
    • Identifying practical actions authors can take to facilitate compliance with electronic regulatory submission requirements
    • Describing how technology tools are used to ensure efficient workflows and regulatory compliance

    Speakers

    Evan Richardson
    Senior Director, Regulatory Operations and Clinical Disclosure, Certara

    1 PM

    Lunch and networking

    2 PM

    PANEL: AI and machine learning in clinical trials: where are we in 2025?

    • Opportunities for incorporating AI into clinical research: where should the industry be focusing?
    • Why has pharma been relatively slow to utilize AI in clinical research?
    • Understanding limitations of GenAI: what do you need to be wary of?
    • Real case studies on AI in the clinical trial industry: where has there been progress and success?
    • What does the future hold for AI in clinical trials?

    MODERATOR:
    Judyth Zahora, Senior Director, Clinical QA and Process Improvement, Zentalis Pharmaceuticals

    PANELLISTS:
    Rosanne Petros, Associate Director, Clinical Research, Merck Research Laboratories
    Bryan Clayton, Clinical Systems Consultant, Alnylam Pharmaceuticals
    Paresh Patel, Head of Global Clinical Intelligence, Otsuka

    Speakers

    Rosanne Petros
    PMP, Associate Director, Clinical Research, Merck Research Laboratories
    Bryan Clayton
    Chief Commercial Officer, Endpoint Clinical
    Paresh Patel
    Head Of Global Clinical Intelligence, Otsuka
    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus

    2:30 PM

    Expanding the patient universe: transforming clinical trials through inclusive, data-driven design

    • Discover how integrating health equity & SDoH data improves patient representation and accessibility in clinical trials
    • Learn how H1 supports sponsors in designing inclusive, patient-centric trials to meet diversity action plan requirements and feasibility benchmarks
    • Explore real-world applications of inclusive research strategies that have successfully expanded patient diversity and engagement

    Speakers

    Chris Riley
    Ph.D, Senior Product Manager, H1 Clinical

    3 PM

    Topic TBC

    Dr Thomas Hopkins, Chief Medical Officer, AccuVein

    3:30 PM

    Afternoon refreshments, networking

    4 PM

    Health literacy in clinical trials: ensuring information is clear and accessible to patients

    • Technology and innovation for addressing health literacy and how information is presented to patients
    • Integrating health literacy principles into all phases of clinical research
    • How low health literacy can

    Speakers

    Lucas Goren
    Senior Project Manager, CISCRP

    4:30 PM

    CASE STUDY: Practical aspects of running a clinical trial when repurposing an existing drug

    • Benefits of repurposing: how this can save time and money, and reduce risk to patients
    • How to effectively utilize real world data when repurposing existing drugs
    • Speeding up regulatory approval for a repurposed drug: how to navigate FDA guidelines

    Speakers

    John Seman
    Chief Executive Officer, REVITALE Pharma

    7:30 AM

    Registration & Refreshments

    8:30 AM

    Chairperson’s opening remarks

    Speakers

    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    8:45 AM

    Evolving sourcing needs and models in clinical R&D

    Clinical R&D outsourcing needs and models have evolved over the last few years. Many biopharma companies are transitioning to a function-driven sourcing model where we can have a set of fit-for-purpose preferred suppliers to bring in flexibility and agility. Challenges in sourcing needs, pros and cons of different sourcing models will be discussed.

    Speakers

    Mohan Bangalore
    PhD, Director, Global R&D Procurement and Supplier Management, Organon

    9:15 AM

    Smarter, faster, autonomous: the future of clinical data management with generative and agentic AI

    • How Generative AI can streamline clinical data review, enhance efficiency, and reduce operational burden
    • Agentic AI’s potential to elevate data management from task-based automation to intelligent, autonomous systems
    • Real-world applications demonstrating the impact of AI-powered agents in clinical trial oversight
    • What’s next in AI evolution and how to prepare your data management processes for scalable change

    Speakers

    Prasanna Rao
    Chief Product and Innovation Officer, Saama

    9:45 AM

    PANEL: Diversity in clinical trials: how to ensure your clinical study has diverse representation

    • Addressing historical issues with trial recruitment in certain populations in order to ensure diversity
    • Community outreach as a method to reduce distrust around clinical trial participation
    • Sourcing new sites in communities with high numbers of under-represented populations
    • Language and translation: how to ensure your trial materials are accessible to non English speaking participants

    Speakers

    Ram Raju
    Senior Vice President and Community Health Investment Officer, Northwell Health
    Patrick Floody
    Executive Director, Global Clinical Trial Services
    Lucas Goren
    Senior Project Manager, CISCRP
    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Innovative approaches to measure your performance and identify areas for improvement in supplier relationships

    • KPIs in clinical research: what should you be measuring to determine your performance?
    • Working collaboratively with your CROs and vendors throughout your clinical trial: where are you falling short?
    • Tools and technology available to facilitate processes around performance measurement

    Speakers

    Jim Mordaga
    MBA, MA, Senior Director, Medical Platforms and Intelligence, Novartis
    Amanda Murphy
    Senior Director, Data Intelligence & Solutions,
    GlobalData

    11:30 AM

    Reserved for ICON Plc

    12 PM

    PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

    • Priorities and considerations when working with vendors and external suppliers
    • Cultivating collaborative relationships with vendors and CROs
    • Managing procurement and outsourcing during an integration of two companies
    • Developing a plan for effective supplier relationship management to ensure your trial runs smoothly

    MODERATOR:
    John Seman, Chief Executive Officer, Revitale Pharma

    PANELLISTS:
    Albert A Siha, Group Lead Director, Oncology, Internal Medicine, and Inflammation & Immunology, Pfizer Nupur Modi Murali, Director, Clinical Operations, Bausch Health Kathleen Cohen, Senior Vice President, Clinical Development Operations, Avalo Therapeutics Susan Neal, Senior Director, Clinical Operations, Novavax

    Speakers

    John Seman
    Chief Executive Officer, REVITALE Pharma
    Albert A Siha
    Director, Oncology Unit Management Office, Procurement and Supplier Relationship Manager, Pfizer
    Nupur Modi Murali
    Director, Clinical Operations, Bausch Health
    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals
    Susan Neal
    Director, Clinical Operations, Novavax

    12:30 PM

    Trump Administration effect on healthcare through the lens of a former regulator

    • Healthcare themes in a Trump Administration
    • Update on key priorities and opportunities
    • Short and long term effects of staffing and budget cuts

    Speakers

    Patrick Ronan
    Operating Partner, ArchiMed and Board of Directors, Symbio Research

    1 PM

    Lunch and networking

    2 PM

    Marriage counseling: how two nurses from both the hospital and industry side see us resolving the site v sponsor chasm

    • What sites really want and need, and why they don’t understand sponsors
    • What sponsors really want and need, and why they don’t understand sites
    • Areas of common ground
    • How sites and sponsors can reconcile and work together to find success

    Speakers

    Linda Miller
    Senior Clinical Operations Lead, Incyte
    Todd Nicklas
    Clinical Trial Manager, Incyte

    2:30 PM

    Built different: how a BioA-rooted central lab delivers precision in a dynamic clinical landscape

    Most central labs are built to process samples. Ours was built to understand them. Evolving from a world-class bioanalytical backbone, Frontage Central Lab brings scientific depth, quality rigor, and operational discipline to every protocol, amendment, and shipment. This talk unpacks how our BioA heritage uniquely equips us to manage complex sample logistics, adapt to protocol deviations, and align with today's complex and evolving clinical trials!

    Speakers

    Dr Nan Zhang
    Senior Vice President, Central Lab, Biomarker and Biologics Services, Frontage Laboratories

    3 PM

    PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

    • Ensuring your trial is cost-conscious and efficient without compromising on quality or on patient care
    • Forecasting and budgeting in order to accurately predict costs and minimize unforeseen expenses
    • Keeping your clinical budget on track
    • Negotiating prices and contracts in order to ensure maximum benefit without going over budget

    Speakers

    Rich Polgar
    Director Global Procurement, Bristol-Myers Squibb
    Lauren Colfer
    Former Vice President, Clinical Operations at Aceragen Pharmaceuticals
    Amber Knight
    Associate Director, R&D Procurement, Organon
    Rick O’Hara
    Director, R&D Business Operations, OncoC4

    3:30 PM

    Afternoon refreshments, networking

    3:50 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

    4 PM

    What does patient centricity mean in an outsourcing context?

    • Ensuring patients are at the forefront of conversations with CROs and vendors
    • Considering vendor selection processes with the patient in mind: what does this look like?
    • Working closely with patient advocacy groups alongside CROs and vendors to deliver a patientcentric clinical trial

    Speakers

    Amber Knight
    Associate Director, R&D Procurement, Organon

    4:30 PM

    Reserved for Harvest Integrated Research Organization (HiRO)

    5 PM

    KEYNOTE PRESENTATION AND WORKSHOP: Applying AI to our clinical operations challenges

    • What’s stopping us from using AI?
    • How to overcome barriers to AI: creative starter ideas
    • AI case studies, stories and key takeaways

    Speakers

    Dan Seewald
    Co-Founder and COO, LiviWell and Founder and CEO, Deliberate Innovation

    5:45 PM

    Chairperson’s closing remarks

    Speakers

    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    5:50 PM

    NETWORKING DRINKS RECEPTION AND END OF DAY 1

    Streams

    Stream one

    Clinical Operations and Outsourcing

    Stream two

    Clinical Technology and Innovation

    9 AM

    Medically underserved populations and the impact on rare disease clinical trials

    • Insights on the differences between represented and underrepresents populations on their barriers to care
    • Challenges and nuances of rare disease patients’ journey to receive a diagnosis
    • Mental health and well-being: the emotional toll rare diseases take on patients and caregivers
    • Exploring overall experiences individuals have had within the healthcare system: strengths and areas for improvement

    Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

    Speakers

    Harsha K. Rajasimha
    MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

    9:30 AM

    The innovation mandate: how to thrive in a rapidly evolving world of data and analytics

    • The current landscape of technology and analytics including some of the notable recent advances
    • How new technologies (eg GenAI and Predictive Modeling) can change the life sciences industry
    • What we need to do today to see tangible value and be ready to adapt to future developments

    Speakers

    Walter Boyle
    Executive Director, Biostatistics and Programming

    10 AM

    A YEAR ON UPDATE: Critical to quality factors Part 2: operationalization of the concept in a pilot study

    Jehan Poco, Associate Director, BDM Planning and Functional Excellence, Biostatistics and Data Management, Daiichi Sankyo, Inc
    Kevin Douglass, Associate Director, RBQM Center of Excellence, Biostatistics and Data Management, Daiichi Sankyo, Inc

    Speakers

    Jehan Poco
    Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc
    Kevin Douglass
    Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

    10:30 AM

    Morning Refreshments & Networking

    11:15 AM

    PANEL: Optimizing remote data capture: new trends and technology in data acquisition

    • Incorporating innovative products and tools into your clinical trial for remote data capture
    • FDA regulatory guidance around data acquisition and collecting data in remote settings
    • Easing burden on patients through remote data collection: how to utilize these tools effectively
    • How new tools such as eCOA solve patient issues

    MODERATOR:
    Terry Katz, Senior Director, Biostatistics and Data
    Management Planning and Functional Excellence, Daiichi
    Sankyo, Inc
    PANELLISTS:
    Robert Besthof, Chief Operating Officer, RiboNova
    TJ Sharpe, Patient Advocate
    Further panellists to be confirmed

    Speakers

    Terry Katz
    Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo
    Robert Besthof
    Chief Operating Officer, RiboNova

    11:45 AM

    Leveraging technology for seamless collaboration

    This session will include demonstrations and case study data illustrating how novel, effective technology-driven strategies can remove workflow friction and improve project delivery across several clinical workflows that are complex and dynamic, requiring multi-stakeholder inputs and timely, complex data exchanges. In this session, you will learn how to optimize your processes for patient eligibility review, remote monitoring and more – all in one collaboration platform!

    Speakers

    Jamie Russo
    Head of Product, AG Mednet

    8 AM

    Registration and Refreshments

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    9 AM

    PANEL: Ensuring your FSP model is a success: what do you need to know?

    • Working closely with FSP vendors: how much oversight do you need?
    • Benefits and challenges of moving to an FSP outsourcing model
    • Comparing vendor management strategies between pharma and biotechs: do you need a different
    approach?
    • Why is FSP becoming a popular outsourcing model: what benefits can this offer sponsors?

     

    MODERATOR:
    Rich Polgar, Managing Director, Danforth Advisors

    PANELLISTS:
    Melanie Goodwin, Director, Clinical Outsourcing,
    Immunocore
    Russell Bland, Director, Clinical Outsourcing and
    Innovation, Jazz Pharmaceuticals
    Terry Katz, Senior Director, Biostatistics and Data
    Management Planning and Functional Excellence, Daiichi
    Sankyo, Inc

    Speakers

    Rich Polgar
    Director Global Procurement, Bristol-Myers Squibb
    Melanie Goodwin
    Director, Clinical Outsourcing, Immunocore
    Russell Bland
    Director, Clinical Outsourcing and Innovation, Jazz Pharmaceuticals
    Terry Katz
    Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo

    9:30 AM

    What do you mean you need equipment? Demystifying the complexities of the equipment supply chain

    • Explore the critical role of equipment in enabling clinical trial success, from ensuring compliance to supporting protocol-specific needs
    • Understand key challenges in the equipment supply chain, including global logistics, maintenance, and vendor management
    • Discover practical solutions such as centralized planning, global harmonization, and the use of technology to optimize supply chain performance
    • Learn from real-world examples that illustrate how proactive equipment management can save time, reduce costs, and ensure continuity across trials

    Speakers

    Jonathan Raven
    Chief Commercial Officer, Emsere Bryan Dunlap, Business Development Manager, North America, Emsere

    10 AM

    PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

    • Reviewing last year’s FDA feedback on audits: what were the main reasons for failure?
    • Tips and tricks to ensure you are ready for inspection
    • Simplifying processes in order to prepare for an FDA inspection

    Speakers

    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus
    Samantha Beddows
    Director, Data Management, Oncology, AstraZeneca

    10:30 AM

    Morning refreshments and networking

    11:15 AM

    Choosing CRO and vendor partners as a small biotech sponsor: priorities and key considerations

    • • How vital is knowledge of therapeutic area in CRO selection?
      • As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
      • Ensuring your CRO and vendor partners prioritize your study

    11:45 AM

    Driving success: strategies for optimal site support

    • Understand how the increasing complexity of clinical trials, higher competition, and site staff turnover are driving the need for more engaged site support
    • Learn how (CROs) provide crucial support through improved communication and tailored site resources
    • Explore how sponsors can enhance site performance through clear expectations and data-driven collaboration
    • Discover strategies for streamlining processes and improving site engagement to drive trial success

    Speakers

    Eleanor Miller
    Clinical Trial Liaison, PSI CRO

    12:15 PM

    The state of the biopharmaceutical industry in 2025

    • Key themes and technology advancements in biopharma
    • Spotlight on clinical trial technologies for drug development
    • Leveraging data to predict the outlook for 2025 clinical trial outsourcing
    • Trends, key players, opportunities and threat in biopharma
    • What the latest investment trends show for small to medium biotechs

    Speakers

    Amanda Murphy
    Senior Director, Data Intelligence & Solutions,
    GlobalData

    12:45 PM

    Lunch and Networking

    1:45 PM

    KEYNOTE PRESENTATION: Establishing a Center of Excellence for gene therapy and vaccines

    Speakers

    Gurdyal Kalsi
    Chief Medical Officer, Asklepion Pharmaceuticals

    2:15 PM

    PANEL: Navigating the outsourcing landscape for emerging therapy areas

    • An overview of emerging therapy areas including women’s health, cell and gene therapy and rare diseases
    • Designing a successful patient recruitment strategy: common challenges and how to overcome these
    • Vendor sourcing: key considerations in vendor selection
    • How important is therapeutic area knowledge when choosing CROs and partners?

    MODERATOR:
    Judyth Zahora, Senior Director, Clinical QA and Process Improvement, Zentalis Pharmaceuticals
    PANELLISTS:
    Gurdyal Kalsi, Chief Medical Officer, Asklepion Pharmaceuticals
    Mohan Bangalore, PhD, Director, Global R&D Procurement and Supplier Management, Organon
    Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
    Priya Marreddy, Vice President, Clinical Operations, OnCusp Therapeutics

    Speakers

    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus
    Gurdyal Kalsi
    Chief Medical Officer, Asklepion Pharmaceuticals
    Mohan Bangalore
    PhD, Director, Global R&D Procurement and Supplier Management, Organon
    Harsha K. Rajasimha
    MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
    Priya Marreddy
    Vice President, Clinical Operations, OnCusp Therapeutics

    2:45 PM

    Afternoon refreshments and networking

    3:05 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss 0ut!

    3:15 PM

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will focus on a different challenge within clinical operations.

    ROUNDTABLE 1: Developing a successful Diversity Action Plan for your clinical trial
    ROUNDTABLE 2: Creating an AI strategy to support clinical research
    ROUNDTABLE 3: Key considerations when selecting a CRO
    ROUNDTABLE 4: Working with advocacy groups to keep the patient voice at the heart of your trial

     

    4:15 PM

    End of conference

    END OF CONFERENCE – SEE YOU NEXT YEAR!

    Speakers

    Select a speaker to learn more

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    Dr Thomas Hopkins
    Chief Medical Officer, AccuVein
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    Amber Knight
    Associate Director, R&D Procurement, Organon

    Session Details:

    What does patient centricity mean in an outsourcing context?

    2025-05-20, 4:00 PM

    Session Details:

    PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

    2025-05-20, 3:00 PM

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    Bryan Clayton
    Chief Commercial Officer, Endpoint Clinical

    Bryan Clayton is a seasoned global commercial leader with experience across multiple functions including sales and marketing, operations, and software product design. For over 20 years, he has effectively managed cross-functional teams, created new technology solutions, managed contract negotiations, and driven revenue growth for top life sciences technology and solutions providers. Bryan is a sought-after speaker, writer and contributor to industry events and publications, and possesses a range of skills well-suited to boost commercial success and revenue growth.

    Bryan joined endpoint Clinical in 2023 as Chief Commercial Officer to lead commercial strategy and business development operations, and to further strengthen endpoint’s expertise in providing agile, patient centric IRT solutions. In his spare time, Bryan coaching and playing baseball.

    Session Details:

    PANEL: AI and machine learning in clinical trials: where are we in 2025?

    2025-05-20, 2:00 PM

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    Gurdyal Kalsi
    Chief Medical Officer, Asklepion Pharmaceuticals

    Session Details:

    KEYNOTE PRESENTATION: Establishing a Center of Excellence for gene therapy and vaccines

    2025-05-21, 1:45 PM

    Session Details:

    PANEL: Navigating the outsourcing landscape for emerging therapy areas

    2025-05-21, 2:15 PM

    View In Agenda
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    Samantha Beddows
    Director, Data Management, Oncology, AstraZeneca

    Session Details:

    PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

    2025-05-21, 10:00 AM

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    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

    Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

    Session Details:

    PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

    2025-05-20, 12:00 PM

    Session Details:

    PANEL: Diversity in clinical trials: how to ensure your clinical study has diverse representation

    2025-05-20, 9:45 AM

    View In Agenda
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    Nupur Modi Murali
    Director, Clinical Operations, Bausch Health

    Session Details:

    PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

    2025-05-20, 12:00 PM

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    Stefanie Kuhner
    Global Head Of Clinical Technology, Innovation & Patient Recruitment – Strategic Sourcing & Procurement, Bristol Myers Squibb
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    Evan Richardson
    Senior Director, Regulatory Operations and Clinical Disclosure, Certara

    Session Details:

    Achieving submission excellence with Certara’s regulatory operations solutions

    2025-05-20, 12:30 PM

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    Lucas Goren
    Senior Project Manager, CISCRP

    Session Details:

    PANEL: Diversity in clinical trials: how to ensure your clinical study has diverse representation

    2025-05-20, 9:45 AM

    Session Details:

    Health literacy in clinical trials: ensuring information is clear and accessible to patients

    2025-05-20, 4:00 PM

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    Walter Boyle
    Executive Director, Biostatistics and Programming

    Session Details:

    The innovation mandate: how to thrive in a rapidly evolving world of data and analytics

    2025-05-21, 9:30 AM

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    Terry Katz
    Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo

    Terry Katz is Senior Director of Biostatistics and Data Management Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA International, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician and Certifications as a Quality Engineer and a Six Sigma Green Belt. He is Chair of DIA's GCP-QA Community; formerly he was a Core Committee member for NJ CDISC User Group and Chair of the Statistical Taskforce for the Animal Health Institute. Terry also completed a 3-month Fellowship in Kenya to improve capacity and capability for the local hospitals to run oncology clinical trials.

    Session Details:

    PANEL: Ensuring your FSP model is a success: what do you need to know?

    2025-05-21, 9:00 AM

    Session Details:

    PANEL: Optimizing remote data capture: new trends and technology in data acquisition

    2025-05-21, 11:15 AM

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    Kevin Douglass
    Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

    Kevin Douglass, Associate Director, RBQM Center of Excellence, Biostatistics & Data Management (BDM), Daiichi Sankyo, Inc.

     

    Kevin is an Associate Director in the Risk-Based Quality Management Center of Excellence (RBQM COE) at Daiichi-Sankyo.  The RBQM COE partners within BDM, with cross-functional stakeholders, and CRO partners to optimize RBQM processes and tools.  The RBQM COE has central (e.g., as process owners developing and delivering tools and training) and Program/Study-level responsibilities (providing guidance to study teams).

     

    Kevin has 40+ years of industry experience working for numerous companies in various positions (Data Management, Quality & Compliance, Operational Excellence/Change Management, and RBQM).  He received a BS in Biology from Ursinus College, an MS in Biology from Villanova University, and is certified in Lean Six Sigma and multiple Change Management methodologies.

     

    Kevin can be contacted at kdouglass@dsi.com.

    Session Details:

    A YEAR ON UPDATE: Critical to quality factors Part 2: operationalization of the concept in a pilot study

    2025-05-21, 10:00 AM

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    Jehan Poco
    Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc

    Jehan, Associate Director, Functional Excellence, Biostatistics & Data Management (BDM), Daiichi Sankyo, Inc.

     

    Jehan is an Associate Director in the Biostatistics & Data Management Functional Excellence at Daiichi-Sankyo.  In this role, Jehan partners with BDM and R&D teams on functional initiatives, system roll outs, and committee as well as supporting key partners like the RBQM COE as a member.

     

    Jehan has 18+ years of industry experience working for numerous companies in various positions (TMF, Clinical Monitoring, Quality & Compliance, Operational Excellence/Change Management, Metrics/Benchmarking and RBQM).  He received a BA in Cell Biology & Neuroscience from Rutgers College, an MBS in Biomedical Science from the University of Medicine and Dentistry NJ (UMDNJ), and is certified Auditing and Change Management methodologies.

     

    Jehan can be contacted at jpoco@dsi.com

    Session Details:

    A YEAR ON UPDATE: Critical to quality factors Part 2: operationalization of the concept in a pilot study

    2025-05-21, 10:00 AM

    View In Agenda
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    Rich Polgar
    Director Global Procurement, Bristol-Myers Squibb

    NULL

    Session Details:

    PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

    2025-05-20, 3:00 PM

    Session Details:

    PANEL: Ensuring your FSP model is a success: what do you need to know?

    2025-05-21, 9:00 AM

    Session Details:

    PANEL: Innovation and technology in clinical trials: exploring emerging and upcoming trends

    2025-05-20, 11:00 AM

    View In Agenda
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    Dan Seewald
    Co-Founder and COO, LiviWell and Founder and CEO, Deliberate Innovation

    Session Details:

    KEYNOTE PRESENTATION AND WORKSHOP: Applying AI to our clinical operations challenges

    2025-05-20, 5:00 PM

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    Jonathan Raven
    Chief Commercial Officer, Emsere Bryan Dunlap, Business Development Manager, North America, Emsere

    Session Details:

    What do you mean you need equipment? Demystifying the complexities of the equipment supply chain

    2025-05-21, 9:30 AM

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    Bryan Dunlap
    Business Develop Manager, North America, Emsere

    Bryan brings over nine years of experience in clinical trial support, having held diverse roles at Emsere in logistics, equipment preparation and testing, project management, and business development. His multifaceted career has provided him with a comprehensive understanding of the clinical trial landscape, including the numerous factors and touchpoints that can influence trial success. Bryan’s cross-departmental expertise enables him to identify potential challenges, anticipate real-world implications of decisions, and provide actionable insights to ensure smoother trial operations.

    Next speaker
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    Nancy Lizzul
    Director, Site Operations, EmVenio Research

    Session Details:

    Community is the new site: redefining trial footprints to expand access

    2025-05-20, 11:30 AM

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    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

     

    Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

     

    Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

     

    Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

     

    Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

    Session Details:

    Chairperson’s opening remarks

    2025-05-20, 8:30 AM

    Session Details:

    Chairperson’s closing remarks

    2025-05-20, 5:45 PM

    Session Details:

    Chairperson’s opening remarks

    2025-05-21, 8:50 AM

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    Carrie Lewis
    Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

    Carrie Lewis has over 20 years of varied Clinical Research experience.  Carrie is currently an Executive Director, Clinical Program Optimization at Endo USA, Inc. where she oversees Clinical as well Business Operations, eTMF/inspectional readiness, and Training/Oversight.  Prior to Endo, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO.  She has a Master’s Degree in Clinical Research Administration and has experience in multiple therapeutic areas.

    Session Details:

    CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

    2025-05-20, 12:00 PM

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    Suzy Montanye
    Site Relationship Manager, Endo Pharmaceuticals

    Session Details:

    CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

    2025-05-20, 12:00 PM

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    Cole Eshbach
    Sr. Clinical Trial Manager, Endo

    Cole Eshbach is a clinical research professional with experience managing Phase 1-4 trials, driving innovation, and fostering collaboration.  With over six years dedicated to Endo projects, along with previous roles at Global CROs, have further enriched his skill set.  Before entering the clinical research industry, Cole conducted assessments for Autism (ADOS-II) in the greater Philadelphia area and completed behavioral consulting.

    Next speaker
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    Dr Nan Zhang
    Senior Vice President, Central Lab, Biomarker and Biologics Services, Frontage Laboratories

    Session Details:

    Built different: how a BioA-rooted central lab delivers precision in a dynamic clinical landscape

    2025-05-20, 2:30 PM

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    Amanda Murphy
    Senior Director, Data Intelligence & Solutions,
    GlobalData

    Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

    Session Details:

    Innovative approaches to measure your performance and identify areas for improvement in supplier relationships

    2025-05-20, 11:00 AM

    Session Details:

    The state of the biopharmaceutical industry in 2025

    2025-05-21, 12:15 PM

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    Chris Riley
    Ph.D, Senior Product Manager, H1 Clinical

    Session Details:

    Expanding the patient universe: transforming clinical trials through inclusive, data-driven design

    2025-05-20, 2:30 PM

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    Melanie Goodwin
    Director, Clinical Outsourcing, Immunocore

    Session Details:

    PANEL: Ensuring your FSP model is a success: what do you need to know?

    2025-05-21, 9:00 AM

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    Linda Miller
    Senior Clinical Operations Lead, Incyte

    Session Details:

    Marriage counseling: how two nurses from both the hospital and industry side see us resolving the site v sponsor chasm

    2025-05-20, 2:00 PM

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    Todd Nicklas
    Clinical Trial Manager, Incyte

    Session Details:

    Marriage counseling: how two nurses from both the hospital and industry side see us resolving the site v sponsor chasm

    2025-05-20, 2:00 PM

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    Harsha K. Rajasimha
    MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

    Session Details:

    PANEL: Navigating the outsourcing landscape for emerging therapy areas

    2025-05-21, 2:15 PM

    Session Details:

    Medically underserved populations and the impact on rare disease clinical trials

    2025-05-21, 9:00 AM

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    Russell Bland
    Director, Clinical Outsourcing and Innovation, Jazz Pharmaceuticals

    Session Details:

    PANEL: Ensuring your FSP model is a success: what do you need to know?

    2025-05-21, 9:00 AM

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    Mario D’Achille
    Senior Director, GCDO Clinical Operations, Neuroscience Lead, Jazz Pharmaceuticals
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    Ashlyn Jose
    Director, Clinical Operations, Kyowa Kirin, Inc

    Session Details:

    PANEL: Innovation and technology in clinical trials: exploring emerging and upcoming trends

    2025-05-20, 11:00 AM

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    Jessica Truscello
    Senior Vice President, Clinical Operations, Lava Therapeutics
    Next speaker
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    Lauren Colfer
    Former Vice President, Clinical Operations at Aceragen Pharmaceuticals

    Lauren joins us with over 25 years of pharmaceutical development experience in both large and small pharmaceutical company settings.  Her career started as a clinical monitor with Covance which eventually led to oversight of clinical and medical affairs operations teams at Wyeth, Pfizer, Cephalon and Teva across multiple therapeutic areas.  Her biotech experience includes Head of Clinical Operations and Project Management at Recro Pharmaceuticals and, most recently, Head of Clinical Operations at Aceragen Pharmaceuticals (formerly Idera Pharmaceuticals).

    Lauren holds a BS in Biology from the University of Scranton and an MBA in Biotechology and Health Industry Management from Pennsylvania State University.

    Session Details:

    PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

    2025-05-20, 3:00 PM

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    Jamie Russo
    Head of Product, AG Mednet

    Session Details:

    Leveraging technology for seamless collaboration

    2025-05-21, 11:45 AM

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    Anka Ehrhardt
    Director Cell-Based Assays / Analytical Research & Development, Merck

    Dr. Ehrhardt is a biophysicist with a Ph.D. in human physiology. Throughout her career, she focused on driving biomedical research through efficient application of innovative technologies and strategies. She built and led successful teams in industry, including at Merck, where she headed a laboratory providing leading technologies for cell-based research from early discovery through manufacturing; and at BMS where Dr. Ehrhardt led and grew an international clinical assay team to robustly cover large scale registrational and translational clinical analysis generating clinical decision-driving data and mechanistic insights for immuno-oncology, cardiovascular, immunology, metabolic and rare disease studies. Before returning to Merck, Dr. Ehrhardt fulfilled one of her scientific aspirations at CHDI Foundation, designing and implementing successful clinical biomarker discovery and development strategies for Huntington’s disease. Currently, at Merck, Dr. Ehrhardt is providing strategic and technical leadership for the development and implementation of industry-leading and QC-friendly cell-based assays and models for potency determination that reflect the unique mechanisms of biologics products in clinical studies and beyond.

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    Kristen Olszyk
    Senior Director, Clinical Scientist, Neuraptive Therapeutics

    Kristen Olszyk joined Neuraptive in March 2020 and is the Acting Head of Clinical Operations.  She brings with her 20 years in the pharmaceutical industry.  Kristen’s areas of expertise include data science, clinical development, clinical operations and regulatory affairs, and she has been involved with several successful regulatory submissions in multiple therapeutic areas.  Prior to joining Neuraptive, Kristen held positions at Wyeth Pharmaceuticals/Pfizer, Endo Pharmaceuticals and Paratek Pharmaceuticals.

     

    Kristen earned her Bachelor of Science degree in Biochemistry from The Pennsylvania State University and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.

    Session Details:

    PANEL: Innovation and technology in clinical trials: exploring emerging and upcoming trends

    2025-05-20, 11:00 AM

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    Ram Raju
    Senior Vice President and Community Health Investment Officer, Northwell Health

    Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

    Session Details:

    PANEL: Diversity in clinical trials: how to ensure your clinical study has diverse representation

    2025-05-20, 9:45 AM

    Session Details:

    PANEL: Innovation and technology in clinical trials: exploring emerging and upcoming trends

    2025-05-20, 11:00 AM

    View In Agenda
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    Jim Mordaga
    MBA, MA, Senior Director, Medical Platforms and Intelligence, Novartis

    Session Details:

    Innovative approaches to measure your performance and identify areas for improvement in supplier relationships

    2025-05-20, 11:00 AM

    View In Agenda
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    Rick O’Hara
    Director, R&D Business Operations, OncoC4

    Session Details:

    PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

    2025-05-20, 3:00 PM

    View In Agenda
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    Priya Marreddy
    Vice President, Clinical Operations, OnCusp Therapeutics

    Session Details:

    PANEL: Navigating the outsourcing landscape for emerging therapy areas

    2025-05-21, 2:15 PM

    View In Agenda
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    Paresh Patel
    Head Of Global Clinical Intelligence, Otsuka

    Session Details:

    PANEL: AI and machine learning in clinical trials: where are we in 2025?

    2025-05-20, 2:00 PM

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    TJ Sharpe
    Patient Advocate
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    Albert A Siha
    Director, Oncology Unit Management Office, Procurement and Supplier Relationship Manager, Pfizer

    Session Details:

    PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

    2025-05-20, 12:00 PM

    View In Agenda
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    Eleanor Miller
    Clinical Trial Liaison, PSI CRO

    Eleanor Miller, Clinical Trial Liaison, is an oncology certified nurse with 17 years of oncology nursing experience at academic medical centers, including both inpatient and outpatient care, most recently leading an oncology nurse navigation program. Much of her career has been in direct collaboration with investigators and research teams to improve patient access to trials through increased awareness, patient education, and coordination of care.

     

    At PSI, she uses this operational and clinical expertise to develop site specific recruitment strategies, tailored study tools and training. She can anticipate barriers to enrollment and resolve site needs with the project team. Eleanor is a strong collaborator and strategic thinker by identifying patterns, and bridging gaps between sites, clinical operations, project management, and sponsors.

    Session Details:

    Driving success: strategies for optimal site support

    2025-05-21, 11:45 AM

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    PATRICK FLOODY
    Executive Director, Global Clinical Trial Services, Regeneron Pharmaceuticals

    Patrick has over 27 years’ experience in new drug development. He joined Regeneron in March 2020. His current role is the Head of the Global Clinical Trial Services group, responsible for global site management, central monitoring, study feasibility and site selection, study/site start up and eCOA and patient technology initiatives. Prior to this, Patrick spent 25 years at Pfizer, with most of his time spent in clinical program operations but also includes GCP Quality (level 1) and Analytics. Patrick has extensive international experience in drug development. He helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. Subsequently, Patrick spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups. He was the recipient of the PGRD Achievement Award in 2007. Patrick is a former officer in the U.S. Army and is a veteran of the first Gulf War. He holds a bachelor’s degree in Biology from the University of Rhode Island and a Master of Business Administration from Temple University.

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    John Seman
    Chief Executive Officer, REVITALE Pharma

    John Seman is the CEO and Founder of REVITALE Pharma.  He began his career working in Big Pharma - Johnson & Johnson and Bristol Myers Squibb - in sales, marketing and business development.  The second half of his career was spent as a serial entrepreneur having Founded a half dozen companies that provided either products or services for the pharmaceutical industry.  John earned his bachelor's and master's degrees from the Massachusetts College of Pharmacy.

    Session Details:

    PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

    2025-05-20, 12:00 PM

    Session Details:

    CASE STUDY: Practical aspects of running a clinical trial when repurposing an existing drug

    2025-05-20, 4:30 PM

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    Robert Besthof
    Chief Operating Officer, RiboNova

    Session Details:

    PANEL: Optimizing remote data capture: new trends and technology in data acquisition

    2025-05-21, 11:15 AM

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    Haifa Tyler
    Executive Director, Head of Clinical Operations, RiboX Therapeutics
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    Prasanna Rao
    Chief Product and Innovation Officer, Saama

    Session Details:

    Smarter, faster, autonomous: the future of clinical data management with generative and agentic AI

    2025-05-20, 9:15 AM

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    Jay Madan
    Chief Financial Officer, SGN Nanopharma
    Next speaker
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    Mohan Bangalore
    PhD, Director, Global R&D Procurement and Supplier Management, Organon

    Session Details:

    Evolving sourcing needs and models in clinical R&D

    2025-05-20, 8:45 AM

    Session Details:

    PANEL: Navigating the outsourcing landscape for emerging therapy areas

    2025-05-21, 2:15 PM

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    Patrick Ronan
    Operating Partner, ArchiMed and Board of Directors, Symbio Research

    Session Details:

    Trump Administration effect on healthcare through the lens of a former regulator

    2025-05-20, 12:30 PM

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    Bryan Fulop
    Associate Director, Laboratory Services, Global R&D Procurement, Teva Pharmaceuticals
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    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus

    Session Details:

    PANEL: AI and machine learning in clinical trials: where are we in 2025?

    2025-05-20, 2:00 PM

    Session Details:

    PANEL: Navigating the outsourcing landscape for emerging therapy areas

    2025-05-21, 2:15 PM

    Session Details:

    PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

    2025-05-21, 10:00 AM

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    Advisory Board

    Select a member to learn more

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    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

     

    Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

     

    Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

     

    Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

     

    Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

    Session Details:

    Chairperson’s opening remarks

    2025-05-20, 8:30 AM

    Session Details:

    Chairperson’s closing remarks

    2025-05-20, 5:45 PM

    Session Details:

    Chairperson’s opening remarks

    2025-05-21, 8:50 AM

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    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

    Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

    Session Details:

    PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

    2025-05-20, 12:00 PM

    Session Details:

    PANEL: Diversity in clinical trials: how to ensure your clinical study has diverse representation

    2025-05-20, 9:45 AM

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    THOMAS M TREMBLAY
    Vice President Of Clinical Development, Trefoil Therapeutics, Inc

    Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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    Behtash Bahador
    Director, Health Literacy, CISCRP

    Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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    Bao Dinh
    Global Development Business Operation, Takeda

    With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

    Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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