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
  • King of Prussia, PA, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
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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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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 - http://www.iconplc.com/

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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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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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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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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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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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LabConnect provides global central laboratory services including routine and esoteric lab testing, kit building, sample management, biostorage and scientific support services for our biopharmaceutical clients. LabConnect’s unique combination of state-of-the-art technology, world-class laboratories, easy access to emerging markets and extensive specialized testing expertise means the drug development industry can rely on a single provider for all of their central lab needs.

Company Website

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

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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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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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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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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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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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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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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

    10:30 AM

    Morning Refreshments & Networking

    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

    11:30 AM

    Reserved for session sponsor

    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

    Reserved for session sponsor

    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

    2:30 PM

    Reserved for session sponsor

    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

    4:30 PM

    Reserved for session sponsor

    7:30 AM

    Registration & Refreshments

    8:20 AM

    Chairperson’s opening remarks

    Speakers

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

    8:30 AM

    Emerging sourcing needs and models of a new biopharmaceutical company in women’s healthcare

    As a newly spun-off biopharma company focusing on unmet medical needs in Women’s Health, our clinical R&D
    sourcing needs and models have evolved over the past couple of years. We 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 Women’s Health sourcing, pros and cons of different sourcing models will be discussed.
    Mohan Bangalore, PhD, Director, Global R&D Procurement and Supplier Management, Organon

    9 AM

    Reserved for featured sponsor

    9:30 AM

    PANEL: Diversity Action Plans: how to ensure your clinical study has diverse representation

    • Meeting FDA guidelines around diversity: how will new regulations impact you?
    • 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

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

    PANELLISTS:
    Patrick Floody, Executive Director, Global Clinical Trial Services, Regeneron
    Lucas Goren, Senior Project Manager, CISCRP
    Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

    Speakers

    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals
    PATRICK FLOODY
    Executive Director, Global Clinical Trial Services, Regeneron Pharmaceuticals
    RAM RAJU
    Former CEO, NYC Health & Hosptials Corporation

    10 AM

    Reserved for featured sponsor

    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

    11:30 AM

    Reserved for ICON Plc

    Speakers

    Aamir Jaka
    Global Vice President, Customer Experience and Success, Saama

    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:
    Moderator to be confirmed

    PANELLISTS:
    Albert A Siha, Director, Oncology Unit Management Office, Procurement and Supplier Relationship Manager, Pfizer
    Nupur Modi Murali, Director, Clinical Operations, Bausch Health Kathleen Cohen, Head of Clinical Development Operations, Marinus Pharma

    12:30 PM

    Reserved for session sponsor

    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

    2:30 PM

    Reserved for session sponsor

    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

    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

    4:30 PM

    Reserved for session sponsor

    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

    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

    9:30 AM

    Reserved for session sponsor

    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

    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

    11:45 AM

    Analyzing the advantages of using e-requisitions in lab collections

    • How eReqs can improve data accuracy, streamline data flow and reduce errors
      • Compliance with regulatory standards for data handling and reporting, and how eReqs can help
      • Additional benefits of implementing eReqs for lab collections

    Bryan Fulop, Associate Director, Laboratory Services, Global R&D Procurement, Teva Pharmaceuticals

    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

    9:30 AM

    Reserved for session sponsor

    10 AM

    FIRESIDE CHAT: Achieving diversity in clinical trials

    • The importance of mindset and outlook when it comes to clinical trial diversity
    • How Endo have exceeded diversity goals and beaten timelines: factors for success
    • The role of site selection in enhancing diversity

    Carrie Lewis, Executive Director, Clinical Program
    Optimization, Endo
    Senior representative, ICON

    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

    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

    MODERATOR:
    Judyth Zahora, Senior Director, Clinical QA and Process
    Improvement, Zentalis Pharmaceuticals
    PANELLISTS:
    Audrey Hill, Associate Director, Data Management, Insmed
    Pending confirmation: Cristina N. Monastero, Director of
    Clinical Document Management and Inspection Readiness,
    Larimar Therapeutics
    Further panellists to be confirmed

    12:15 PM

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

    • Gurdyal Kalsi, Chief Medical Officer, Asklepion Pharmaceuticals

    12:45 PM

    Lunch and Networking

    1:45 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

    Amanda Murphy, Senior Director, Data Intelligence and Solutions, GlobalData

    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

    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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    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.

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    Gurdyal Kalsi
    Chief Medical Officer, Asklepion Pharmaceuticals
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    Samantha Beddows
    Director, Data Management, Oncology, AstraZeneca
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    Nupur Modi Murali
    Director, Clinical Operations, Bausch Health
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    STEFANIE KUHNER
    Global Head Of Clinical Technology, Innovation & Patient Recruitment – Strategic Sourcing & Procurement, Bristol Myers Squibb
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    Lucas Goren
    Senior Project Manager, CISCRP
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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.

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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

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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.

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    Rich Polgar
    Director Global Procurement, Bristol-Myers Squibb

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

    PANEL: Diversity Action Plans: how to ensure your clinical study has diverse representation

    2025-05-20, 9:30 AM

    Session Details:

    Chairperson’s opening remarks

    2025-05-20, 8:20 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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    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.

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    Melanie Goodwin
    Director, Clinical Outsourcing, Immunocore
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    Linda Miller
    Senior Clinical Operations Lead, Incyte
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    Todd Nicklas
    Clinical Trial Manager, Incyte
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    Harsha K. Rajasimha
    MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
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    Audrey Hill
    Senior Director, Data Management, Advaxis
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    Russell Bland
    Director, Clinical Outsourcing and Innovation, Jazz Pharmaceuticals
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    Ashlyn Jose
    Director, Clinical Operations, Kyowa Kirin, Inc
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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.

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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.

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    Anka G. Ehrhardt
    Director, Cell-Based Sciences, AR&D, 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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    Rosanne Petros
    PMP, Associate Director, Clinical Research, Merck Research Laboratories

    Rosanne Petros is a US Sr. Clinical Research Manager currently working in the vaccine therapy area.  She has 35 years of experience in Clinical Research primarily in clinical project management and is a PMP.   She has been at Merck for 18 years.  Prior to Merck, Rosanne had her own clinical research consulting company and began her career in clinical research at Pharmaco (then PPD).  Rosanne received her degree in Chemistry from University of Virginia and was a bench chemist prior to moving into clinical research. She lives outside of Washington DC with Kevin, her husband of 35 years and 4 of her 5 children (one moved out!) and two shih tzu mix dogs.  Her children range in age from 30 to 13 years old. Rosanne enjoys cooking, crafting and being with her family.  She also enjoys collecting and restoring Victorian and Art Deco jewelry and collecting and repairing vintage quilts.

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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.

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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.

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    Jim Mordaga
    MBA, MA, Senior Director, Medical Platforms and Intelligence, Novartis
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    Rick O’Hara
    Director, R&D Business Operations, OncoC4
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    Priya Marreddy
    Vice President, Clinical Operations, OnCusp Therapeutics
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    Mohan Bangalore
    PhD, Director, Global R&D Procurement and Supplier Management, Organon
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    Amber Knight
    Associate Director, R&D Procurement, Organon
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    PARESH PATEL
    Director Data Science & Technologies,Otsuka
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    TJ Sharpe
    Patient #1, Blogger and Cancer AdvocateJen Horonjeff, CEO
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    Albert A Siha
    Director, Oncology Unit Management Office, Procurement and Supplier Relationship Manager, Pfizer
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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.

    Session Details:

    PANEL: Diversity Action Plans: how to ensure your clinical study has diverse representation

    2025-05-20, 9:30 AM

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    Robert Besthof
    Chief Operating Officer, RiboNova
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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
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