16th Annual Outsourcing in Clinical Trials Europe 2026

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

6 - 7

May

2026
  • Hyatt Regency Barcelona Tower, Barcelona, Spain
  • Complimentary
  • Why attend?
  • 2025 Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2026 Sponsors
  • Media Centre
  • Why partner?
  • Resources
  • Contact Us
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2026 Sponsors Include:

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Company Information

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

Company Website

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

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ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

Company Website

To learn more, please visit our website - http://www.arensia-em.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

IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at OrchestrateYourTrials@iqvia.com

 

Company Website

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

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Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

Company Website

To learn more, please visit our website - www.novotech-cro.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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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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Company Information

1MED, is the leading European MedTech specialized solutions provider,
offering end-to-end development expertise within the medical device, novel technology and combination products fields.

Founded in 2014, with headquarter in Agno, Switzerland, and employing 100+ professionals across the Europe, 1MED’s mission is to support all the MedTech organizations in facing the complexity associated with the development of innovative medical devices in compliance with MDR.

Such support may include providing preclinical support, regulatory advice, clinical study management, post marketing support, digital solutions and quality management systems across the clinical research continuum with a cross-functional approach which led to win the certification and certification maintenance of more than 500 different medical devices within the last 5 years.

Company Website

To learn more, please visit our website - https://www.1med.ch/

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EMIS Recruit is an integrated solution that connects Research, Life Sciences and healthcare by embedding clinical research recruitment tools directly into the point of care systems.  EMIS recruit gives research organisations clear visibility of clinically relevant patients based on your study protocol. This enables us to provide you with qualified patients that streamline your recruitment process

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Company Information

Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,000 trials across 80 countries.

Company Website

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

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    Why attend?

    Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 29th-30th April 2025!

    For the 15th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials.

    This conference will bring leading industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, and technology.

    WHAT TO EXPECT FOR 2025?

    With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. Legislations such as the CTIS review to Generative AI and leveraging our global trial footprint to accelerate clinical development, as well as building on our new and existing relationships within our industry.

    This conference will bring industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, technology and of course, patient centricity.

    This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotech’s and medical device companies, to discuss operationally efficient, specifically targeted clinical trials. The 2025 program boasts 4 full streams complete with key content.

    Stream A: Outsourcing & Clinical Operations

    Stream B: Clinical Innovation & Technology

    Stream C Day 1: Patient Centricity

    500+

    Attendees

    		80+

    Exhibitors

    		40+

    Speakers
    500+

    Attendees

    		80+

    Exhibitors
    40+

    Speakers

    Testimonials

    See What It's All About

    2025 Agenda

    • 29 Apr 2025
    • 30 Apr 2025
    Expand All

    Streams

    Stream one

    Stream A: Clinical Operations and Outsourcing

    Stream two

    Stream B: Clinical Technology & Innovation

    Stream three

    Stream C: Patient Centricity

    11:30 AM

    Enhancing Patient-Centricity in Clinical Trials: A Collaborative Approach

    This session will explore how patient centricity, engagement, and incorporating the patient voice can transform clinical trials.

    • Understanding the concept of patient centricity and its importance in designing and conducting trials.
    • Explore how patient involvement can enhance trial design, improve recruitment, and ensure adherence.
    • Highlighting the value of capturing patient insights to identify and address barriers in trial participation.
    • Discuss methods for incorporating patient feedback in protocol design, consent processes, and study execution.
    • Building Collaborative Networks, Examine the roles of investigational sites, industry sponsors, and regulators in fostering a patient[1]centric approach. • Identify best practices for stakeholder collaboration to streamline trial processes while keeping patients at the forefront

    Speakers

    Patricia Ripoll Ros
    President, Fundación Visible

    12 PM

    Smoothing the Patient Journey and Driving Trial Efficiency with eClinical Innovations

    This session will explore the patient experience within clinical trials, and how eClinical solutions can be an essential strategy for easing patient and site burdens.

    In this session, we will explore:

    • Why do patients participate in clinical trials? The statistics might surprise you.
    • The challenges patients experience during their trial journey.
    • What the recent updates to the Declaration of Helsinki mean for patient centricity.
    • How to make it easier for patients and sites to participate in trials.
    • Approaches and technological innovations that improve the trial journey and drive efficiency.

    Speakers

    Daniela Duffett
    Senior Solutions Consultant, Suvoda

    12:30 PM

    Patient Centricity in Clinical Development; what & how?

    ·       Exploring the principles and practices of patient-centric approaches in clinical trials

    ·       Discussing practical applications to enhance trial design, execution, and outcomes

    ·       Introducing EUPATI: Empowering patient involvement through education

     

    Speakers

    Estrella Garcia PhD
    Executive Director Global Clinical Operations, Almirall
    Laia Bisbal Arnal
    Open Classroom Coordinator, EUPATI

    1 PM

    Advancing Clinical Programs for Rare Diseases

    • Overview of Rare Diseases
    • Global regulatory landscape for rare diseases
    • Designing Clinical Programs for rare Diseases
    • Overcoming Challenges in Rare Disease Trials

    Speakers

    Astrid Pañeda Rodríguez
    Senior Director Clinical Operations, Forge Biologics

    1:30 PM

    Lunch and networking

    2:30 PM

    Panel Discussion Integrating the Patient Voice in Protocol Design: Balancing Rigor, Feasibility, and Centricity

    Incorporating the patient perspective into clinical trial protocol design and endpoint selection is essential for ensuring that trials are relevant and meaningful. However, this integration presents challenges, including finding common ground among stakeholders and navigating the balance between scientific rigor and feasibility. This session will explore how pharma companies can streamline protocols while maintaining their integrity and enhancing patient engagement

    • Understand the importance of the patient voice in clinical trial design and endpoint selection.
    • Identify challenges in balancing scientific and Regulatory rigor, feasibility, and patient-centricity.
    • Explore strategies for creating streamlined protocols without compromising essential data collection.
    • Discuss best practices for enhancing collaboration within trial teams to facilitate patient-centered design

    Moderator: Estrella Garcia, Executive Global Clinical Operations Director, ALMIRALL

    Panellists: Denis Costello, Director at CML Advocates Network & Board Member

    Laia Bisbal Arnal, Open Classroom Coordinator, EUPATI

    Speakers

    Estrella Garcia PhD
    Executive Director Global Clinical Operations, Almirall
    Denis Costello
    Director, CML Advocates Network & Board Member
    Laia Bisbal Arnal
    Open Classroom Coordinator, EUPATI

    3 PM

    Expanding Access: How Community-Based Research Models Improve Patient Optionality and Inclusivity in Trials

    In an increasingly complex clinical trial landscape, ensuring patient inclusivity and accessibility is critical to improving study recruitment, retention, and data quality. Traditional trial models often create barriers to participation due to geographic, financial, and logistical constraints – ultimately impacting trial outcomes. Community-based research models provide a scalable, flexible approach to engaging underrepresented populations while maintaining high levels of data integrity and protocol adherence. This session will explore how community-based research options can help sponsors and CROs design more inclusive trials. We’ll also discuss how addressing social determinants of health – such as transportation, economic stability, health literacy, and access to care – can improve patient participation and adherence, leading to more representative and meaningful trial results.

     

    Maryleen Lovell-Petronilia, Quality Manager, PCM Trials

    Speakers

    Maryleen Lovell-Petronilia
    Manager, Quality Assurance and Compliance, Global Clinical Trials, PCM Trials

    3:30 PM

    VIRTUAL SESSION: WHO’s clinical trial guidance: what do I need to know

    • Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
    • Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
    • Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
    • Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

    Speakers

    Vasee Moorthy
    Senior Advisor, R&D, World Health Organization

    4 PM

    Afternoon refreshments and networking with Apple Prize Draw

    4:30 PM

    Setting the Tone for the Patient and Site Journey

    Patient advocacy groups have more influence on study design. The industry is investing in Chief Patient Officer roles. Site networks are consolidating. CROs are expanding and buying sites.

    What’s missing, however, is a focus on enhancing the patient/site relationship.

    This session explores the state of technology that supports the patient and site experience, successes/gaps, and concrete next steps.

    Speakers

    Bruce Hellman
    Co-Founder and Chief Patient Officer, UMotif

    5 PM

    PANEL How minimizing participant burden leads to on-time enrollment and completion.

    • Where are the main hurdles patients face and how can these be removed?
    • Addressing low levels of health literacy in the patient population: how to improve communication
    • Engaging patients and advocacy groups early on in the clinical trial design process
    • Barriers to clinical trial participation from a patient perspective
    • Patient reimbursement: how to relieve financial pressures on patients participating in trials

    Speakers

    Estrella Garcia PhD
    Executive Director Global Clinical Operations, Almirall
    Jose Angel Aibar
    President, Dravet Syndrome Foundation Spain and Rare Disease Patient Caregiver
    Andrzej Szandrach
    Executive Director, Head of Study Management R&I, AstraZeneca
    Joana Claverol
    Clinical Research Director, Sant Joan de Deu Barcelona Hospital

    5:30 PM

    Chairperson’s closing remarks followed by Drinks Reception

    END OF DAY 1 AND NETWORKING DRINKS RECEPTION

    11:30 AM

    AI in Clinical Trials: Practical Implementation, Navigating Uncertainty, and Measuring Success

    This session will offer a deep dive into the practical applications of artificial intelligence (AI) within clinical trials and research settings. Moving beyond theory, we’ll focus on implementing AI solutions, addressing the challenges of navigating the unknown, and defining clear metrics to measure success.

    • Identify key AI implementation areas in clinical trials and the tools available and how can the sponsor benefit from such tools
    • Understand methods to assess and measure AI-driven initiatives’ success.
    • Learn techniques for navigating uncertainties and overcoming implementation challenges.
    • Gather and utilize feedback effectively to optimise AI solutions.

    Speakers

    Piotr Maślak
    Director, Operational Data Intelligence, AstraZeneca

    12 PM

    The Data Advantage: Integrating RWD, Historic Clinical Data, and AI for Regulatory Success and Better Patient Outcomes

    The success of clinical trials depends on selecting the correct data to answer critical questions: How can we optimize protocol design? Which patients are the best fit? What real-world impact will our treatment have? This session provides a strategic framework for leveraging historical and real-time clinical trial data, real-world data (RWD), and synthetic data—ensuring that every research decision is guided by the most relevant, high-quality evidence to drive efficiency, accuracy, regulatory success, and the best long-term patient outcomes.

    What the audience will gain from your presentation:

     

    ·       Data Selection Framework: Determining which type of data—historical clinical trial data, cross-industry operational data, RWD, or synthetic data—best answers specific clinical research questions.

    ·       Risk vs. Reward: Understanding the trade-offs of each data type, including data quality, generalizability, and potential biases.

    ·       Regulatory & Scientific Considerations: How different data types align with regulatory expectations and scientific rigor.

    ·       Real-World Applications: Case studies illustrating how the right data choices have led to better trial outcomes and faster regulatory approvals.

     

    Speakers

    Ruthanna Davi
    Senior Vice President, Medidata Solutions

    12:30 PM

    A Fit-for-Purpose Framework for Effective Technology Strategies in Clinical Trials

    Discover a 5-step framework to define, design, cross-check, measure, and analyze the right technology and operational execution for your clinical trials. This session highlights the eConsent Fit-for-Purpose Study Framework, developed by the non-profit European Forum GCP eConsent initiative in collaboration with over 50 organizations. Additionally, we will explore the importance of harmonized terminologies, study documents requirements, and insights into Ethics Committees’ expectations for eConsent. While focused on eConsent, this approach can be re-used for developing similar frameworks tailored to any technology or Decentralized Clinical Trial Element

    Speakers

    Hilde Vanaken
    Head EFGCP, eConsent Initiative, European Forum for Good Clinical Practice (EFGCP)

    1 PM

    Technology Solutions for Reducing Hidden costs in Clinical Supply and Trial Changes

    Inefficiencies in investigational medicinal product (IMP) management can significantly impact trial timelines and budgets. We'll explore strategies to optimize the clinical supply chain, focusing on advanced forecasting strategies to minimize waste without compromising patient access. Discover how to build a robust, long-term supply plan that enhances overall trial efficiency and ensures secure, cost-effective IMP delivery.

    Speakers

    Neta Bendelac
    Senior Director, Strategy, 4G Clinical

    1:30 PM

    Lunch and networking

    2:30 PM

    Panel Discussion Embracing Innovative Technologies in Clinical Trials: Opportunities and Challenge

    Exploring how new technologies are transforming clinical trial processes, improving efficiency, and addressing challenges. The session will focus on real-world applications, benefits, potential risks, and future implications.

    • Why, historically is Pharma so slow to adopt new technologies? Averaging up to 7 years according to a 2022 Tufts Study
    • Current Innovations in Clinical Trials; How technologies like General AI and Large Language Models, prognostic and predictive deep learning, and direct data transfer (or EHR to EDC) are enhancing trial efficiency and patient outcomes.
    • Overcoming Challenges; Regulatory hurdles: How are agencies responding to new technologies?
    • Ethical considerations: Ensuring patient data privacy and compliance.
    • Operational barriers: Integration with existing trial frameworks (or do we need to adapt?)
    • Future Outlook: What technologies will dominate in the next 5–10 years? (perhaps 7-14 years considering the tech adoption cycle)
    • How can stakeholders (pharma, CROs, tech companies, regulators) collaborate effectively??

     

    Speakers

    Nina Skorytchenko
    CEO , Avenna
    Dr. Fabian Kreimendahl
    Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine
    Sonja Weiser
    Senior Director Clinical Operations, Insmed
    Daniel Martínez
    Clinical Services & Strategy Coordinator, Exeltis

    3 PM

    Addressing the challenge of digital adoption in clinical trials

    Case Study: streamlining the implementation of multiple solutions

     

    ·       Making a case for digitization – a Sponsors perspective

    ·       Implementation, planning and design considerations

    ·       Establishing standards and SMEs

    ·       Refining and looking to the future

    Speakers

    Kevin Landells
    Vice President, Business Head of IRT, IQVIA Technologies

    3:30 PM

    Cybersecurity in Vendor Qualification

    This session will highlight the importance of cybersecurity in vendor qualification, discussing current challenges, and provide practical strategies to safeguard clinical trial data and processes.

    Speakers

    Martin Rodriguez
    Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

    4 PM

    Afternoon refreshments and networking with Apple Prize Draw

    4:30 PM

    Connect What Matters: Making RTSM Integration Work for Your Trial

    Clinical trials rely on an interconnected ecosystem—RTSM, EDC, CTMS, eCOA, and more—but integrating these systems can become a bottleneck. Disconnected tools lead to inefficiencies, manual workarounds, and increased risk of errors, all of which slow down decision-making and trial execution.

    This webinar explores the critical role of RTSM integration, highlighting best practices for eliminating data silos, reducing workflow disruptions, and improving automation across your tech stack. Learn how smarter integration can improve data flow, reduce site burden, and support a more efficient trial experience.

     

    Key Learning Objectives

    • Understand why RTSM integration is a common challenge and how disconnected systems create inefficiencies and risks
    • Learn how point-and-click integrations enable seamless data exchange across EDC, CTMS, eCOA, and more
    • Explore how real-time synchronization strengthens data integrity and audit readiness
    • Discover strategies to reduce workflow disruptions and make RTSM integration seamless for study teams
    •  Gain a forward-looking view of RTSM’s role in building a more connected, responsive clinical trial ecosystem

     

     

    Speakers

    Joanna Tait
    Solutions Consultant, Endpoint Clinical

    5 PM

    PANEL Sharing experience & Lesson Learned with EU CTR for clinical trial approval

     

    ·       How is the European region ranked in competition to North America, Latin America, and APAC for being selected to conduct clinical trials – since EU CTR in place?

    ·       How best to avoid delays in study approval in Europe compared to other regions in global trials?

    ·       Experience & Lesson Learned with patient recruitment material & eCONSENT in EU study approval since EU CTR is in place?

     

    Speakers

    Sonja Weiser
    Senior Director Clinical Operations
    Dr. Fabian Kreimendahl
    Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine
    Michael Zörer
    Head of Clinical Operations

    5:30 PM

    Chairperson’s closing remarks followed by Drinks Reception

    END OF DAY 1 AND NETWORKING DRINKS RECEPTION

    7:45 AM

    Registration and refreshments

    8:20 AM

    Chairperson’s opening remarks

    Speakers

    Revati Tatake
    Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

    8:30 AM

    KEYNOTE PRESENTATION: The Patient’s Perspective: ‘Why are patients’ voices so important in clinical development?’

    • Discussing the personal experiences of the patient
    • Co-create clinical development & clinical trials with the perspective of the patients in mind
    • Evaluate Patient burdens for participation in Clinical trials.
    • Patient access to drug post study

    Speakers

    Jose Angel Aibar
    President, Dravet Syndrome Foundation Spain and Rare Disease Patient Caregiver

    9 AM

    Optimising Drug Development through effective Paediatric Strategies

    ·       Why Paediatric Developments?

    ·       The Regulatory Landscape

    ·       Current Situation for Paediatric Research – Challenges and Possible Solution

    ·       Early Integration of Paediatric Considerations

    ·       Insights and Outcomes from Combined Adolescent-Adult Clinical Trials

    ·       Conclusion

    Speakers

    Dr Martine Dehlinger-Kremer
    Dr. Martine Dehlinger-Kremer, PhD, MS, Vice President Scientific Affairs, Pediatric Subject Matter Expert, ICON

    9:30 AM

    KEYNOTE PANEL Where is the clinical trial industry headed this year and beyond?

    • Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to
      participate in?
    • Navigating new regulations around clinical trials smoothly and successfully
    • Technological developments into 2025 and beyond: what changes can we expect to see in the next 3-5
      years?
    • The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?

     

    Speakers

    Revati Tatake
    Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc
    Andrzej Szandrach
    Executive Director, Head of Study Management R&I, AstraZeneca
    Dr Martine Dehlinger-Kremer
    Dr. Martine Dehlinger-Kremer, PhD, MS, Vice President Scientific Affairs, Pediatric Subject Matter Expert, ICON
    Dr. Kate Dokukina
    Head of clinical trials, Eilean Therapeutics

    10:15 AM

    PROOF-OF-CONCEPT: Bold Moves, Big Wins, and Lessons Learned

    Fast, Furious, or Never-Ending: Entertaining Case Studies on Accelerating and Unexpectedly Inflating Phase Ib/II Trial Timelines and Budgets. A Site Team Perspective

    Speakers

    Dr. Claudia Hesselmann
    Founder & CEO, ARENSIA Exploratory Medicine

    10:45 AM

    Morning Networking & Refreshment break

    11:30 AM

    Transforming Sponsor-CRO Partnerships for Clinical Trial Success: Innovation, Transparency and Agility

    This session will delve into innovative approaches to sponsorCRO partnerships, with a focus on building stronger stakeholder relationships, enhancing transparency, and managing teams effectively.

    • Identify innovative processes and partnership strategies to elevate sponsor-CRO collaborations.

    • Understand the role of transparency and centralised data in fostering trust and alignment.

    • Learn how AGILE team management can improve efficiency and responsiveness in clinical trials.

    • Gain insights from a case study of a successful sponsor-CRO partnership.

    Speakers

    Andria Wilk
    Global Head of Quality, Argenx and Board Member, EFGCP

    12 PM

    PANEL: Navigating Uncertainty: Mitigating the Impact of External Factors on Clinical Trials in Europe

    External factors, including geopolitical tensions and global conflicts, can significantly disrupt clinical trials in Europe, affecting timelines, budgets, and patient recruitment. This session will analyze the implications of these external influences on clinical research and discuss strategies that pharma and biotech companies can employ to mitigate risks and maintain trial integrity.

    This session will also cover the EFPIA paper which states “60,000 fewer clinical trial places for Europeans, despite global surge in research projects. "For Europe to be competitive, it needs to function as a unified region" says Nathalie Moll.

     

    ·       Understand the impact of global conflicts and external factors on clinical trials in Europe.

    ·       Identify specific challenges posed by geopolitical events, regulatory changes, and market dynamics.

    ·       Explore strategies and best practices for mitigating risks associated with external factors.

    ·       Discuss the importance of adaptability and contingency planning in clinical trial management.

    Speakers

    Revati Tatake
    Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc
    Christine Mohlberg
    Vice President of Project Management, Novotech
    Sandra Sistiaga Hernando
    Site Engagement Lead, GSK
    Júlia Rodríguez-Comas, PhD
    Chief Scientific Officer, Sycai Medical

    12:30 PM

    Strategic Site Selection: Identifying the Right Sites, People, and Advocates for Trial Success

    Selecting the right sites and investigators is critical for successful clinical trials, especially in multidisciplinary studies. This session will explore strategies for targeting sites that align with study goals, investing in investigators who not only have the skills but also believe in the product, and leveraging key opinion leaders (KOLs) who can enhance the trial’s impact. We’ll cover key factors in recruitment, including site capability, investigator influence, and alignment with product objectives.

    • Learn strategies for identifying and selecting sites that align with trial needs and patient demographics.
    • Understand the importance of choosing investigators who are both competent and product advocates.
    • Explore the role of KOLs in influencing trial outcomes and enhancing product credibility.
    • • Discover best practices for collaborating with the study startup team to ensure smooth trial initiation.

    Speakers

    Carlos Palacios
    Associate Director, Clinical Operations, Oncology, Gilead Sciences

    1 PM

    Beyond Boundaries – Unlocking the Potential of Cross-Border Enrollment in Clinical Trials

    Clinical trials are the backbone of medical innovation, but one of the biggest challenges we face is patient recruitment. In an era where diseases know no borders, why should access to potentially life-saving treatments be limited by geography? Cross-border enrollment offers a powerful solution—expanding trial access, accelerating recruitment, and improving diversity. But it’s not without challenges. This session will

     

    • Give a background on cross border enrollment and why it is a beneficial tool in clinical trial recruitment
    • Discuss some regulatory and logistical challenges when implementing cross border enrollment
    • Provide case studies of Worldwide Clinical Trials successful implementation of cross border enrollment strategies

    Speakers

    Nathan Chadwick
    Senior Director, Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

    1:30 PM

    Lunch and networking

    2:30 PM

    Panel Discussion Unravelling the Impact of ICH E6 Revision 3: Implementing New Standards in Good Clinical Practice

    ICH E6 (R3) introduces significant updates to Good Clinical Practice guidelines, emphasizing risk-based quality management, patient centricity, and flexibility in trial design and execution. This panel discussion will address the impact of ICH E6 (R3) on clinical trials, comparing it to the previous ICH E6 (R2), discussing approaches to implementation, and considering varied interpretations among stakeholders.

    • Understand the key changes in ICH E6 (R3) and their implications for clinical trial conduct.
    • Explore different approaches to implementing the new guidelines in diverse trial settings.
    • Analyse the challenges, opportunities, and interpretations associated with ICH E6 (R3).
    • Highlight meaningful differences between ICH E6 (R2) and ICH E6 (R3) and their practical impacts.

    Speakers

    Joanna Florek-Marwitz
    Head Risk Management and Data Quality, UCB
    Juan Ruiz
    VP, Medical Affairs, Forge Biologics
    Olga Martinez-Casares
    Director Risk Management and Management Monitoring Europe and Emerging Markets, GSK

    3 PM

    AI in trial master file management: The good, the bad, and real-world use cases.

    ·       Use Cases: How AI has already improved efficiency and compliance in TMF operations with numbers and KPIs we all love

    ·       The Pitfalls and Limitations: Where AI still falls short

    ·       Human + AI = Better TMF: Why the most effective setups are hybrid — combining AI speed with human oversight

    ·       What’s Next? A look into emerging trends and how sponsors and CROs can start preparing for AI-enabled TMF strategies

     

    Speakers

    Evgenia Michalcuk-Vrablik
    Global Director of Growth, Flex Databases

    3:30 PM

    Interactive Workshop: Navigating the Maze: Regulatory Submissions in Clinical Trials

     

    • Building a Global Regulatory Strategy: Insights, Pitfalls, and Lessons Learned
    • Setting the Standard: Best Practices for Successful Regulatory Submissions
    • Fast-Tracking Innovation: Accelerating Regulatory Pathways in Special Contexts
    • Understanding Delays: Challenges in the Evaluation of High-Risk Clinical Trials
    • Patient-Centric Strategy in Regulatory Submissions: The Role of Sponsors and Regulators

    Speakers

    Astrid Pañeda Rodríguez
    Senior Director Clinical Operations, Forge Biologics
    Maria Matilde Urdaneta Abate
    Head of Medical Assessment - Clinical Investigations & Trials - MHRA
    Nathan Chadwick
    Senior Director, Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials
    Emma Blasi Bosch
    Director, Global Regulatory Strategy, Alexion Pharmaceuticals

    4 PM

    Afternoon refreshments and networking with Apple Prize Draw

    4:30 PM

    Rethinking Clinical Operations: A Smarter, Faster Playbook for Trial Success

    The CRO-Sponsor model is broken. This session will explore a fresh approach to clinical trial outsourcing, addressing inefficiencies in the traditional CRO-Sponsor model. Learn how to enhance collaboration, improve trial execution, and accelerate timelines with a results-driven framework.

     

    •         Discover a smarter outsourcing model that boosts agility, transparency, and accountability.

    •         Learn how the “High-Retention” Trial Strategy—powered by AI-driven recruitment and patient engagement—helps achieve enrolment targets faster.

    •         Explore real-world case studies showcasing optimized trial execution across high-risk indications.

    •         Gain insights into the biggest shifts shaping clinical operations over the next five years—and how to stay ahead

     

    Speakers

    Ara Vinuesa
    Director Project Management, TFS Healthscience

    5 PM

    PANEL The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Europe

    • New regulations and guidance around clinical trials in the EU: how will this impact you?
    • Staff turnover and layoffs: handling changes in the industry in order to ensure success
    • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
    • An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

    Speakers

    Marcin Rzepus
    Strategic Procurement Manager, R&D, Polpharma
    Dr. Claudia Hesselmann
    Founder & CEO, ARENSIA Exploratory Medicine

    5:30 PM

    Chairperson’s closing remarks followed by Drinks Reception

    END OF DAY 1 AND NETWORKING DRINKS RECEPTION

    Streams

    Stream one

    Stream A: Clinical Operations and Outsourcing

    Stream two

    Stream B: Clinical Technology & Innovation

    8:50 AM

    Chairperson’s opening remarks

    9 AM

    Transforming Clinical Trials with AI and Real-World Data (RWD): A New Era of Innovation

    Key Topics Covered:

    • Introduction to the Transformative Landscape: Overview of how AI, ML, and RWD are fundamentally changing the structure and execution of clinical trials.
    • Advanced Trial Design & Digital Integration: Detailed discussion of Federated HER platforms and eSource-supported trials, showcasing their impact on operational efficiency and trial accuracy
    • AI-Driven Patient Recruitment Strategies: Exploration of unstructured data integration (clinical notes, lab reports) and its role in precise patient identification and accelerated recruitment timelines.
    • Case Studies and Real-World Applications: Presentation of practical examples, including AI-driven recruitment solutions for pharmaceutical trials and data quality improvements within the European Health Data Space (EHDS).
    • Outlook and Future Developments: Insights into emerging trends, such as increased cross[1]border collaboration, patient-centric approaches, and the evolution of AI applications in enhancing trial efficiency and global healthcare outcomes

    Speakers

    Mats Sundgren
    PhD, European Institute of Innovation through Health Data (i-HD)

    9:30 AM

    Technology Spotlight: Unlocking the potential of healthcare data


    We will explore how AI  and Real-World Data (RWD) are reshaping clinical trials. We will delve into how our Data Space Platform addresses industry challenges by ensuring efficient, secure, and structured access to clinical data within the framework of the European Health Data Space (EHDS). Our technology, powered by Artificial Intelligence and Natural Language Processing (NLP), extracts, structures, and harmonizes unstructured clinical data, enabling seamless interoperability and maximizing its value for research. As data mediators, we bridge the gap between data providers and the industry, accelerating patient identification, optimizing recruitment, and enhancing data quality in clinical trials.
    Through concrete use cases, we will demonstrate how our platform has driven the success of clinical trials by providing fast and reliable access to clinical data while aligning with European regulations and standards.

    Speakers

    António Valente
    Senior Director Business Development, Iomed

    9:45 AM

    The Digital Revolution in Clinical Trials: Relabelling with Digital Display Labels

    The landscape of clinical trials is undergoing a transformative shift as digital technologies continue to permeate every aspect of the healthcare industry. One potential transformation could be the replacement of traditional paper-based relabelling in clinical trials with digital display labels. The integration of digital display labels into clinical trials represents a significant leap forward in the industry. As this technology matures and becomes more widely adopted, it could impact the way clinical trials are conducted and managed especially in the areas of remote monitoring, adaptive trials, and patient engagement. In this session, we will explore the challenges associated with traditional relabelling processes in clinical trials, the advantages of adopting digital display labels, and the potential impact on the future of healthcare research.

    Speakers

    Brian Sheridan
    Vice President Global Adherence & Clinicals, Smurfit Westrock

    10 AM

    An overview of high-fidelity synthetic data applications

    • Defining high-fidelity synthetic data
    • MHRA approach to synthetic data generation
    • Can synthetic data be used to validate ML algorithms?
    • Can synthetic data be used for sample boosting?
    • Can synthetic data address biases due to underrepresentation?
    • Can synthetic data be used to enhance clinical trials (CTs)?
    • Regulatory considerations

    Speakers

    Puja Runa Myles
    Director, Clinical Practice Research Datalink (CPRD), MHRA

    10:30 AM

    Transforming Patient Engagement in Clinical Trials: The Power of Gamification

    The success of clinical trials is critically dependent on consistent patient participation, yet challenges in engagement continue to extend study timelines and drive escalating costs. This educational session delves into gamification as an innovative and scientifically validated method to enhance patient retention and improve protocol adherence throughout the clinical research lifecycle.

    Gamification, the strategic integration of behavioral science principles with interactive elements, motivates sustained patient engagement, directly addressing participant dropout and non-compliance. By deploying thoughtfully designed incentive structures and compelling engagement mechanisms, clinical research teams can notably elevate data quality, expedite study timelines, and reduce associated costs.

    This presentation explores three foundational dimensions of gamification within clinical research: its theoretical underpinnings, rationale for implementation, and demonstrated effectiveness in real-world trial environments. Attendees will benefit from:

    ·       Insight into psychological and behavioral drivers of sustained patient motivation

    ·       Practical strategies and best practices for incorporating gamified elements into clinical trials

    ·       Real-world case studies showcasing measurable improvements in participant retention and compliance

    Speakers

    Christer Nilsson
    Chief Executive Officer, Replior

    11 AM

    Morning refreshments and networking

    11:30 AM

    AI-Powered Clinical Outsourcing: The Future of Strategic Sourcing

    In the fast-paced procurement landscape, staying ahead is crucial. AI is revolutionizing clinical business operations, from strategic sourcing to vendor management and cost optimization. AI-driven tools are enhancing decision-making, streamlining workflows, and accurately predicting study costs. Ideal for outsourcing managers, clinical operations, and R&D finance professionals, learn to leverage AI for smarter, more efficient procurement.
     

     

    Speakers

    Anca Copaescu
    Chief Executive Officer, Strategikon Pharma

    12 PM

    Clinical Trial Investigations: Looking at the trends and landscape for 2024 and what we can learn from them moving through 2025 and into 2026

    • Overview of global clinical trials for 2024
    • Assessing key sponsors, top interventions and looking at the trial landscape for 2024
    • Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status.

    Speakers

    Priya Ravisekara
    Senior Analyst, GlobalData

    12:30 PM

    Lunch and networking

    1:30 PM

    PANEL Harnessing Technology: Innovations in Patient Recruitment and Retention for Clinical Trials

    As clinical trials become increasingly competitive, utilizing technology to improve patient recruitment and retention is essential for success. This panel will explore innovative methods and tools that streamline recruitment processes, leverage AI and machine learning to accelerate timelines, and engage patients through digital platforms, including social media.

    • Understand the current challenges in patient recruitment and retention in clinical trials.
    • Explore technology-driven methods to streamline recruitment and enrollment processes.
    • Analyze the role of AI and machine learning in enhancing trial efficiency and reducing costs.
    • Discuss best practices for engaging patients through social media and other digital channels.

     

    Speakers

    Mats Sundgren
    PhD, European Institute of Innovation through Health Data (i-HD)
    Puja Runa Myles
    Director, Clinical Practice Research Datalink (CPRD), MHRA
    Ashish Bagde
    Data Management, UCB Belgium

    2 PM

    Reserved for event sponsor

    2:30 PM

    From theory to practice: practical case examples of the use of AI in the whole life of a clinical trial

    Preclinical to phase IV, from the protocol synopsis to the dossier presentation, and other strategies that have significantly reduced the time and cost of our studies.

     

     

    Speakers

    Ana Pérez Hidalgo
    Global clinical Operations & AI Director, Insud Pharma

    3 PM

    Afternoon refreshments and Apple Prize draw

    8:10 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    9 AM

    Good Clinical Practice and Bioethics

    • Put the theory into practice: from patient information to Informed Consent
    • Real application of bioethics autonomy principle.
    • Training in Good Clinical Practices: where we want to go

    9:30 AM

    Trends in clinical outsourcing and partnerships, biotech’s vs large pharma. The CRO perspective

    • The effects of R&D growth, productivity, and macro-environmental factors on clinical outsourcing strategy in biotech and large pharma
    • How is this changing the CRO Market?
    • How do biotech and large pharma sponsors view CROs and what are they really looking for in a partner?
    • What does successful partnership look like for a CRO?
    • How to leverage CRO partnerships to drive productivity through innovation – a CRO perspective

    Speakers

    Melissa Smellie, PhD
    Executive Director, Strategic Partnerships, Fortrea

    10 AM

    Navigating Phase 1 Trials: Strategies for Small Biotech’s to Overcome Financial and Resource Challenges

    Small biotech companies often face unique challenges when conducting Phase 1 clinical trials due to limited financial and human resources. This session will explore practical strategies and tools that can help these companies effectively manage their trials while navigating regulatory requirements. Attendees will gain insights into optimizing trial design, budget management, and leveraging partnerships.

    • Understand the financial challenges faced by small biotech companies in running Phase 1 trials.
    • Explore strategies for effective resource allocation and cost management in clinical trials.
    • Learn about tools and technologies that can streamline trial operations and improve efficiency.
    • Discuss regulatory considerations and compliance best practices that impact trial management.

     

    Speakers

    10:30 AM

    Medical monitoring done right: the three questions every sponsor should ask

    Ensuring the right medical monitoring (MM) approach is critical to trial success—but sponsors often overlook key factors that impact cost, efficiency, and patient safety. This session will cover three essential questions sponsors should ask: Who is on the medical team and do they have real-world expertise? Are you paying for the right level of MM or just paying more? When should MM start, and what happens if it’s too late? Attendees will gain actionable insights on how to optimize MM strategy, avoid unnecessary expenses, and enhance study outcomes.

     

    ·       Medical monitoring teams: Why indication-specific expertise matters.

    ·       Cost versus value: Avoiding unnecessary 24/7 coverage and eligibility review costs.

    ·       Early MM involvement: How proactive planning prevents protocol pitfalls.

    Speakers

    Anna Pinsky
    MD, PhD, Medical Director at Rho

    11 AM

    Morning refreshments and networking

    11:30 AM

    From setback to success: The art of clinical trial rescue

    In the complex world of clinical research, even meticulously planned trials can face unexpected hurdles that threaten to derail progress and encounter obstacles beyond the capabilities of a small-scale Clinical Research Organization (CRO). When studies falter, a well-executed rescue strategy with an experienced global CRO becomes crucial. Drawing from Parexel's extensive rescue-trial experience, this presentation unveils the blueprint for successful clinical trial transitions, focusing on four key phases:

     

    ·       Strategic Initiation & Planning - establishing a robust framework and standardized processes

    ·       Comprehensive Preparation & Due Diligence - ensuring stakeholder alignment on transition plans and timelines - Conducting thorough documentation review and gap analysis

    ·       Adaptive Execution & Transfer - How to operationalize a study transfer - Anticipating challenges and employing agile governance for real-time course corrections

    ·       Effective Closure & Delivery - defining clear transition thresholds and success metrics  - Ensuring continuity and maintaining data integrity throughout the process

    Speakers

    Suzanne McNally
    Executive Director in Portfolio Management, Parexel

    12 PM

    Fostering a Strong Sponsor-CRO relationship through knowledge sharing and innovative strategies

    • Planning for a successful sponsor/CRO relationship
    • Overview of common challenges and pitfalls when working with your CRO
    • Sharing best practices to gather market knowledge
    • Transition to strategic partnership

    Speakers

    Eva Torres Costa
    Director, Alliance Management, AstraZeneca

    12:30 PM

    Lunch and networking

    1:30 PM

    Risk-Based Quality Management in Clinical Trials: Ensuring Compliance and Efficiency

    This session will explore the principles, methodologies, and tools of Risk-Based Quality Management (RBQM) in clinical trials. It will focus on how a risk-based approach can enhance compliance, improve data quality, and optimize trial efficiency. Attendees will gain practical insights into risk assessment, monitoring, and mitigation strategies, with a particular emphasis on implementing RBQM frameworks in alignment with ICH E6(R3) guidelines.

     

    • Overview of RBQM: Concepts and Regulatory Frameworks
    • Designing a Risk Assessment and Categorization Tool (RACT)
    • Centralized and On-Site Monitoring Strategies
    • Leveraging Technology for Risk Management
    • Case Studies: Lessons Learned from Implementing RBQM
    • Future Trends and Updates in Regulatory Guidance

    Speakers

    Joanna Florek-Marwitz
    Head Risk Management and Data Quality, UCB

    2 PM

    Reserved for event sponsor

    2:30 PM

    SUSTAINABILITY SPOTLIGHT: Inspiring partnerships and action in sustainable healthcare

    Mitigating the environmental impact of clinical trials, in line with the broader imperative to address the interconnected climate and health crises.

    Speakers

    Hugh Whetherly
    Senior Environmental Specialist, Sustainable Health Coalition

    3 PM

    Afternoon refreshments and Apple Prize draw

    3:45 PM

    ROUNDTABLE DISCUSSIONS

    Interactive Roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry. Hosted by industry experts and each focused on a single issue, think tanks are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each think tank session lasts for 30 minutes, and delegates may attend up to 2.

     

    Roundtable 1: Site Selection and working relationships with your site to increase reliability.

    Sandra Sistiaga Hernando, Site Engagement Lead, GlaxoSmithKline

    Roundtable 2: The role of lived experience in Clinical Trials: Meaningful patient engagement in clinical trials is vital to develop impactful and relevant outcomes

    Cameron Keighron, Patient Advocate

    Roundtable 3: Bringing Innovation to Clinical Trials

    Laura Jiménez Robledo, Clinical Innovation Manager, Novo Nordisk

     

     

    Speakers

    Denis Costello
    Director, CML Advocates Network & Board Member
    Sandra Sistiaga Hernando
    Site Engagement Lead, GSK
    Ashish Bagde
    Data Management, UCB Belgium
    Marcin Rzepus
    Strategic Procurement Manager, R&D, Polpharma

    4:45 PM

    Chairperson’s closing remarks

    END OF CONFERENCE

    Speakers

    Select a speaker to learn more

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    Revati Tatake
    Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

    Revati Tatake, PhD, is the Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData Healthcare.  Revati has over 25 years of multidisciplinary experience in academic research and the healthcare industry, both on the client and agency sides of the business. Previously she worked as a VP of Databases and Analytics at GlobalData, where she made significant contributions to Pharma Intelligence Center. Before joining GlobalData, Revati worked at Citeline/Informa, where she was involved in competitive intelligence and analytics of clinical trials and drugs in the areas of Autoimmune/Inflammation, Central Nervous System, and Ophthalmology.  Earlier, Revati worked at Boehringer Ingelheim Pharmaceuticals for over 12 years as Senior Scientist to Senior Principal Scientist, where she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She also worked at Boehringer Ingelheim as a Director of Competitive Intelligence for projects in cardiometabolic space and research beyond borders. She is a co-inventor on many issued US patents related cell and gene therapies and has several publications in peer reviewed scientific journals. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She did her postdoctoral fellowship at the University of Connecticut Health Center and Boehringer Ingelheim.

     

    Session Details:

    PANEL: Navigating Uncertainty: Mitigating the Impact of External Factors on Clinical Trials in Europe

    2025-04-29, 12:00 PM

    Session Details:

    KEYNOTE PANEL Where is the clinical trial industry headed this year and beyond?

    2025-04-29, 9:30 AM

    Session Details:

    Chairperson’s opening remarks

    2025-04-29, 8:20 AM

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    Christine Mohlberg
    Vice President of Project Management, Novotech

    Christine Mohlberg has been with Novotech (formerly EastHORN Clinical Services) since 2013, when she joined as Director of Clinical Operations, Germany. Over the years, she has advanced to roles including Director, Head of Project Management, and Country Head, Germany. She currently serves as Vice President of Project Management, where she oversees the operations of the European Project Management Department with full accountability for successful project and program delivery.

    In her role, Christine develops strategic plans to ensure optimal allocation of human, system, and financial resources within her area of responsibility. She defines the department’s strategic goals and objectives, ensuring alignment with senior management priorities. Additionally, she leads key functional initiatives and collaborates with stakeholders to drive effective implementation.

    Prior to joining Novotech, Christine held leadership roles in both CROs and pharmaceutical companies, working on international and global projects. With over 20 years of experience in clinical research, she brings a deep understanding of the industry’s structure, challenges, and evolving needs. Her expertise ensures that project teams deliver the highest quality services to clients, maintaining excellence in execution and operational efficiency.

    Session Details:

    PANEL: Navigating Uncertainty: Mitigating the Impact of External Factors on Clinical Trials in Europe

    2025-04-29, 12:00 PM

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    Sandra Sistiaga Hernando
    Site Engagement Lead, GSK

    Session Details:

    PANEL: Navigating Uncertainty: Mitigating the Impact of External Factors on Clinical Trials in Europe

    2025-04-29, 12:00 PM

    Session Details:

    ROUNDTABLE DISCUSSIONS

    2025-04-30, 3:45 PM

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    Júlia Rodríguez-Comas, PhD
    Chief Scientific Officer, Sycai Medical

    Júlia Rodríguez-Comas (CSO, Co-founder, and Board Member at Sycai Medical) holds a PhD in Biomedicine from the Universitat de Barcelona (UB), a degree in Biology from the Universitat Autònoma de Barcelona, and a master's degree in Integrative Physiology from the UB. She has over seven years of academic experience as a PhD candidate and postdoctoral researcher at leading institutions such as IDIBAPS (August Pi i Sunyer Biomedical Research Institute) and the Institute for Bioengineering of Catalonia (IBEC), where she contributed to cutting-edge projects, including the development of organ-on-a-chip technology. With an h-index of 13, she has also been involved in university teaching and academic mentoring, supervising PhD and master's students. As Clinical Director of Sycai Medical, she leads clinical investigations, ensuring the validation and integration of AI-driven solutions in healthcare.

    Session Details:

    PANEL: Navigating Uncertainty: Mitigating the Impact of External Factors on Clinical Trials in Europe

    2025-04-29, 12:00 PM

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    Andrzej Szandrach
    Executive Director, Head of Study Management R&I, AstraZeneca

    Session Details:

    KEYNOTE PANEL Where is the clinical trial industry headed this year and beyond?

    2025-04-29, 9:30 AM

    Session Details:

    PANEL How minimizing participant burden leads to on-time enrollment and completion.

    2025-04-29, 5:00 PM

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    Dr Martine Dehlinger-Kremer
    Dr. Martine Dehlinger-Kremer, PhD, MS, Vice President Scientific Affairs, Pediatric Subject Matter Expert, ICON

    Dr. Dehlinger-Kremer brings over 30 years of experience in the research industry, including 30 years with a particular focus on global regulatory affairs, medical affairs, and pediatric leadership. At ICON’s Center for Pediatric Clinical Development, she supports pediatric developments and advances in pediatric research. Additionally, as Co-Chair of ICON’s Maternal-Fetal Medicine Unit, Dr. Dehlinger-Kremer contributes to the search for innovative solutions in maternal-fetal health.

    Prior to joining ICON, Dr. Dehlinger-Kremer served in several executive leadership roles at global CROs, and has experience in global drug development in more than 40 countries. Her vision and leadership extend to service with a number of professional organizations – she is an observer member of the Coordinating Group of Enpr-EMA at the European Medicines Agency, chair of the Pediatric Working Group and also President of the European CRO Federation (EUCROF), serves as chair of the European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party and Board Member of the association, and is active in the International Children’s Advisory Network (iCAN). She is an member of the ACT EU MSP Ad Hoc Advisory Group  representatives.

    In 2015, Dr. Dehlinger-Kremer was named one of PharmaVOICE’s 100 Most Inspiring People in Life Sciences.

    Dr. Dehlinger-Kremer earned a Doctorate in Sciences from the J. W. Goethe University in Francfort on the Main, Germany;  a Diploma of Advanced Study in Neurophysiology from the University Louis-Pasteur, Strasbourg, France; and a Master of Sciences degree from University Moulin de la Housse in Reims, France.

    Session Details:

    KEYNOTE PANEL Where is the clinical trial industry headed this year and beyond?

    2025-04-29, 9:30 AM

    Session Details:

    Optimising Drug Development through effective Paediatric Strategies

    2025-04-29, 9:00 AM

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    Dr. Kate Dokukina
    Head of clinical trials, Eilean Therapeutics

    Dr. Kate Dokukina is an expert with 20+ years in the biopharmaceutical industry and medicine , specializing in clinical research, drug development, and regulatory strategy. She has led global clinical programs across oncology, autoimmune, and rare diseases, overseeing the launch of 50+ new molecules. Currently VP in clinical trials at Eilean Therapeutics(US), she has held leadership roles at BIOCAD, Shanghai Pharma and MedInvestGroup.

    Session Details:

    KEYNOTE PANEL Where is the clinical trial industry headed this year and beyond?

    2025-04-29, 9:30 AM

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    Jose Angel Aibar
    President, Dravet Syndrome Foundation Spain and Rare Disease Patient Caregiver

    Session Details:

    KEYNOTE PRESENTATION: The Patient’s Perspective: ‘Why are patients’ voices so important in clinical development?’

    2025-04-29, 8:30 AM

    Session Details:

    PANEL How minimizing participant burden leads to on-time enrollment and completion.

    2025-04-29, 5:00 PM

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    Session Details:

    PANEL The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Europe

    2025-04-29, 5:00 PM

    Session Details:

    Navigating Phase 1 Trials: Strategies for Small Biotech’s to Overcome Financial and Resource Challenges

    2025-04-30, 10:00 AM

    View In Agenda
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    Session Details:

    PANEL The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Europe

    2025-04-29, 5:00 PM

    View In Agenda
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    Marcin Rzepus
    Strategic Procurement Manager, R&D, Polpharma

    Session Details:

    PANEL The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Europe

    2025-04-29, 5:00 PM

    Session Details:

    ROUNDTABLE DISCUSSIONS

    2025-04-30, 3:45 PM

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    Dr. Claudia Hesselmann
    Founder & CEO, ARENSIA Exploratory Medicine

    Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

     

    Session Details:

    PANEL The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Europe

    2025-04-29, 5:00 PM

    Session Details:

    PROOF-OF-CONCEPT: Bold Moves, Big Wins, and Lessons Learned

    2025-04-29, 10:15 AM

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    Ara Vinuesa
    Director Project Management, TFS Healthscience

    Ara is a seasoned pharmaceutical professional with over 17 years of industry experience. She holds a Degree in Biology (2004) and a Degree in Biochemistry (2005) from Universitat Central de Barcelona. Currently serving as Senior Director of Project Management in the Internal Medicine and Neuroscience Business Unit, Ara has extensive expertise in leading and managing cross-functional teams at both national and international levels.

    Passionate about overseeing the operational and financial aspects of clinical projects, she is skilled in guiding studies from Request for Proposal (RFP) to completion. Her therapeutic area experience spans transplantation, cardiovascular diseases, nephrology, infectious diseases (including COVID-19), oncology, primary care, autoimmune and autoinflammatory diseases, respiratory diseases, dermatology, ophthalmology, and neuroscience.

    Ara has managed clinical trials across all phases, including pediatric and medical device studies, as well as Real-World Evidence (RWE) projects.

    Session Details:

    Rethinking Clinical Operations: A Smarter, Faster Playbook for Trial Success

    2025-04-29, 4:30 PM

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    Astrid Pañeda Rodríguez
    Senior Director Clinical Operations, Forge Biologics

    Session Details:

    Interactive Workshop: Navigating the Maze: Regulatory Submissions in Clinical Trials

    2025-04-29, 3:30 PM

    Session Details:

    Advancing Clinical Programs for Rare Diseases

    2025-04-29, 1:00 PM

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    Maria Matilde Urdaneta Abate
    Head of Medical Assessment - Clinical Investigations & Trials - MHRA

    Session Details:

    Interactive Workshop: Navigating the Maze: Regulatory Submissions in Clinical Trials

    2025-04-29, 3:30 PM

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    Nathan Chadwick
    Senior Director, Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

    Nathan Chadwick is a Therapeutic Strategy Lead for Rare Disease at Worldwide Clinical Trials. Nathan has over 12 years of industry experience holding progressive roles through project management and operations at multiple CROs. At Worldwide, Nathan is responsible for ensuring the right fit solutions are sought for clients working in Rare Diseases – he is passionate about patient-centric design and accelerating medications for those with unmet needs.

    Session Details:

    Interactive Workshop: Navigating the Maze: Regulatory Submissions in Clinical Trials

    2025-04-29, 3:30 PM

    Session Details:

    Beyond Boundaries – Unlocking the Potential of Cross-Border Enrollment in Clinical Trials

    2025-04-29, 1:00 PM

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    Emma Blasi Bosch
    Director, Global Regulatory Strategy, Alexion Pharmaceuticals

    Emma has over 18 years of experience in the biopharmaceutical industry, spanning biotech startups, multinational companies and consultancy. She specializes in developing and implementing global regulatory strategies and successfully leading meetings with international regulatory agencies. As a global regulatory lead, she provides key insights to global programs focused on rare disease and oncology drug development, from first-in-human through late-phase clinical development and registration trials to successfully register unique, innovative, and technologically complex products.

     

    Session Details:

    Interactive Workshop: Navigating the Maze: Regulatory Submissions in Clinical Trials

    2025-04-29, 3:30 PM

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    Evgenia Michalcuk-Vrablik
    Global Director of Growth, Flex Databases

    Evgenia holds several degrees in International Economics and MBA in Digital Transformation, she is in top management of eSystem provider Flex Databases, one of the leading European software providers for Life Sciences.

    She has been in clinical research for 15+ years, 8 years in the company management, participated in digitalization of 60+ companies 15 to 50 000 employees in the US, Europe, and Asia.

    Session Details:

    AI in trial master file management: The good, the bad, and real-world use cases.

    2025-04-29, 3:00 PM

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    Martin Rodriguez
    Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

    Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

    I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

    Session Details:

    Cybersecurity in Vendor Qualification

    2025-04-29, 3:30 PM

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    Carlos Palacios
    Associate Director, Clinical Operations, Oncology, Gilead Sciences

    Highly skilled and enthusiastic drug development, clinical operations and project management Director with strong organizational skills. Used to providing and managing operational and scientific strategy, design and execution for multiple programs within Oncology (Early Phase), Immuno-Oncology, CNS, Infectious diseases, Vaccines, Respiratory, Cardio-vascular and Immunology.

    Responsible for resource management and deployment for assigned TA, including hiring and staffing. Line managing, coaching and mentoring managers. Managing and providing feedback and developmental opportunities for direct reports and staff. Focused on developing teams' clinical knowledge, decision-making skills and recognized for staff development leading to high performing teams.

    Session Details:

    Strategic Site Selection: Identifying the Right Sites, People, and Advocates for Trial Success

    2025-04-29, 12:30 PM

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    Ruthanna Davi
    Senior Vice President, Medidata Solutions

    Ruthie Davi is a Statistician and senior Vice President, Data Science at Medidata (a Dassault Systemes Company) and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics in CDER at FDA. At Medidata,  Ruthie is part of a team creating analytical tools to improve the efficiency and rigor of clinical trials, an example of which is the Synthetic Control work. Ruthie holds a Ph.D. in Biostatistics from George Washington University.

     

    Session Details:

    The Data Advantage: Integrating RWD, Historic Clinical Data, and AI for Regulatory Success and Better Patient Outcomes

    2025-04-29, 12:00 PM

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    Sonja Weiser
    Senior Director Clinical Operations

    A Clinical Research Professional (Pharmacist), PhD (Medical School - Pharmacology/Toxicology) and PMP (2016) with more than 20 years’ experience in Biotech / Health Care Industry / CRO / Drug Development / Clinical Research.

    Expertise ranging from Clinical Research/Clinical Operations experience in Pharma, Biotech and CRO with focus on Oncology, Immunology, Infectious Disease, Respiratory indications and Rare/Orphan indications.

    Focused on goal achievement, constant striving for improving processes on an international / global level, strong project management background.

    Dedication to people management as the main success factor in clinical research/clinical development – foster open & trustful communication on a global level.

    Strong believer in "Manage by example" as key to success in drug development

    Session Details:

    PANEL Sharing experience & Lesson Learned with EU CTR for clinical trial approval

    2025-04-29, 5:00 PM

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    Dr. Fabian Kreimendahl
    Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine

    Session Details:

    PANEL Sharing experience & Lesson Learned with EU CTR for clinical trial approval

    2025-04-29, 5:00 PM

    Session Details:

    Panel Discussion Embracing Innovative Technologies in Clinical Trials: Opportunities and Challenge

    2025-04-29, 2:30 PM

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    Michael Zörer
    Head of Clinical Operations

    Michael is responsible for a team of 11 people and the overall delivery of the conducted studies. The group runs several studies in different indications with a clear focus on rare diseases. In 2016 AOP Orphan received approval for one new product (RAPIBLOC®). In 2019 AOP received the marketing authorization for their first biological (BESREMi®), after completing a series of clinical studies and successfully passing a series of EMA inspections under Michael’s responsibility.

    Before joining AOP Orphan Michael has been operations manager for Haemophilia at Baxter.
    Michael has many years of experience as a project manager and learned the job in clinical research from scratch starting as CRA at Amgen.
    Michael received his Ph. D in biochemistry from the University of Vienna.

    Session Details:

    PANEL Sharing experience & Lesson Learned with EU CTR for clinical trial approval

    2025-04-29, 5:00 PM

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    Nina Skorytchenko
    CEO , Avenna

    Nina is the co-founder and CEO of Avenna Ltd. Her mission is to make healthcare for chronic inflammatory disease (CIDs) more preventive and personalised. By developing more effective, affordable, and accessible precision medicine solutions we can enable early detection and treatment personalisation for variety of CIDs. Nina has background in finance, business, and healthcare and worked in large multinational companies including Nomura, Bloomberg and Schlumberger, as well as several entrepreneurship ventures.

    Nina’s main ability and expertise is to connect the worlds of scientific research and business. She uses this experience to translate the most promising, research-grade technologies into practical solutions for individuals, clinicians, and biopharma. Nina works in collaboration with leading scientists, clinicians, and patients to translate R&D stage technologies into practical clinical solutions. This includes design and execution of clinical studies and trials, development of bioinformatics infrastructure to facilitate the translation of precision health programs for chronic disease prevention into clinical practice.

    Session Details:

    Panel Discussion Embracing Innovative Technologies in Clinical Trials: Opportunities and Challenge

    2025-04-29, 2:30 PM

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    Sonja Weiser
    Senior Director Clinical Operations, Insmed

    A Clinical Research Professional (Pharmacist), PhD (Medical School - Pharmacology/Toxicology) and PMP (2016) with more than 20 years’ experience in Biotech / Health Care Industry / CRO / Drug Development / Clinical Research.

    Expertise ranging from Clinical Research/Clinical Operations experience in Pharma, Biotech and CRO with focus on Oncology, Immunology, Infectious Disease, Respiratory indications and Rare/Orphan indications.

    Focused on goal achievement, constant striving for improving processes on an international / global level, strong project management background.

    Dedication to people management as the main success factor in clinical research/clinical development – foster open & trustful communication on a global level.

    Strong believer in "Manage by example" as key to success in drug development

    Session Details:

    Panel Discussion Embracing Innovative Technologies in Clinical Trials: Opportunities and Challenge

    2025-04-29, 2:30 PM

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    Daniel Martínez
    Clinical Services & Strategy Coordinator, Exeltis

    Daniel Martínez studied Biochemistry at the Universidad Autónoma de Madrid and spent two years in basic research in genomics and transcriptomics. On November 2018, he started working as a CRA and, in 2022, he moved to Exeltis for globally managing Clinical Trials. Daniel focuses on implementing AI and innovative technologies throughout clinical trials to shorten timelines, improve data quality, and enhance participant experience. He collaborates with various companies and leads internal projects where AI promises to improve clinical trials.

    Session Details:

    Panel Discussion Embracing Innovative Technologies in Clinical Trials: Opportunities and Challenge

    2025-04-29, 2:30 PM

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    Suzanne McNally
    Executive Director in Portfolio Management, Parexel

    Suzanne McNally is an Executive Director in Portfolio Management with over 20 years of leadership experience in clinical trial management. She holds a BA (Hons) in Nursing and brings strong financial acumen, innovation, and a proven track record in overseeing multi-therapeutic, global Phase I-IV drug trials. Suzanne has clinical research experience in oncology, neurology, ophthalmology, GI, general medicine, and infectious diseases, managing complex global projects with high quality.

    As a proactive leader, Suzanne excels in navigating challenging operational complexities and site dynamics, providing innovative solutions to meet tight timelines and budgets. She is a certified PMP, Lean Six Sigma, and a member of the global Women in Leadership alumni.

    Session Details:

    From setback to success: The art of clinical trial rescue

    2025-04-30, 11:30 AM

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    Kevin Landells
    Vice President, Business Head of IRT, IQVIA Technologies

    Kevin has over 24+ years of experience in the IRT/ RTSM industry, having worked across many technical and project management leadership roles.  Experienced with developing and leading global teams delivering managed services spanning Operations, Project Management, Client Partnerships and Business Transformation.  Kevin is passionate about improving healthcare and utilizing technology that makes a real difference to patients’ lives.

    Kevin holds a Bachelors’ Degree in Computer Science from Hertfordshire University in the UK.

    Session Details:

    Addressing the challenge of digital adoption in clinical trials

    2025-04-29, 3:00 PM

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    Joanna Florek-Marwitz
    Head Risk Management and Data Quality, UCB

    Session Details:

    Panel Discussion Unravelling the Impact of ICH E6 Revision 3: Implementing New Standards in Good Clinical Practice

    2025-04-29, 2:30 PM

    Session Details:

    Risk-Based Quality Management in Clinical Trials: Ensuring Compliance and Efficiency

    2025-04-30, 1:30 PM

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    Juan Ruiz
    VP, Medical Affairs, Forge Biologics

    Session Details:

    Panel Discussion Unravelling the Impact of ICH E6 Revision 3: Implementing New Standards in Good Clinical Practice

    2025-04-29, 2:30 PM

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    Olga Martinez-Casares
    Director Risk Management and Management Monitoring Europe and Emerging Markets, GSK

    More than 20 years experience in the pharmaceutical industry. Passionate about clinical research. Apply this passion and the ability to integrate personal and cultural differences, to create high performing teams in a respectful environment. Constantly perform above and beyond the limits of a role. Natural developer as motivate others on the same principles. Comfortable working out of the comfort zone. Top performer. Continuous improvement mindset, I embrace the change quickly as an opportunity to move things forward from the status quo. Critical thinker. Agile learner looking for motivating and challenging opportunities.

    Session Details:

    Panel Discussion Unravelling the Impact of ICH E6 Revision 3: Implementing New Standards in Good Clinical Practice

    2025-04-29, 2:30 PM

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    Hilde Vanaken
    Head EFGCP, eConsent Initiative, European Forum for Good Clinical Practice (EFGCP)

    Session Details:

    A Fit-for-Purpose Framework for Effective Technology Strategies in Clinical Trials

    2025-04-29, 12:30 PM

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    Estrella Garcia PhD
    Executive Director Global Clinical Operations, Almirall

    Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology.  Following this, Estrella held at post-doctoral position at ICI (now Astra Zeneca) in Macclesfield, UK. At ICI Estrella’s focus was on novel anti-tumor drugs in the pre-clinical phase. Subsequently Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, Estrella has amassed a 29 year career with the company- taking on roles of increasing demand and responsibility, including Head of Allergy Therapeutic Area and Head of Clinical Development Operations- to the role she holds today.

    Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall do not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies- particularly for pivotal studies- in-house. In this capacity Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small single centre studies to global programs involving hundreds of sites and thousands of patients. Her responsibility is covering the selecting, negotiation, contracting, managing and final evaluation of the CROs responsible for the worldwide clinical development, in order to deliver on the agreed timelines, quality and cost.

    She has been responsible for ensuring Clinical Development for Aclidinium bromide in COPD was performed worldwide from the operational point of view on time, budget and quality, among other development from Almirall.

    Now fully focus on Dermatology development, managing trials worldwide mainly in Psoriasis, Acné, Atopic Dermatitis, Actinic Keratosis, among other indications.

    Session Details:

    Patient Centricity in Clinical Development; what & how?

    2025-04-29, 12:30 PM

    Session Details:

    Panel Discussion Integrating the Patient Voice in Protocol Design: Balancing Rigor, Feasibility, and Centricity

    2025-04-29, 2:30 PM

    Session Details:

    PANEL How minimizing participant burden leads to on-time enrollment and completion.

    2025-04-29, 5:00 PM

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    Laia Bisbal Arnal
    Open Classroom Coordinator, EUPATI

    Session Details:

    Patient Centricity in Clinical Development; what & how?

    2025-04-29, 12:30 PM

    Session Details:

    Panel Discussion Integrating the Patient Voice in Protocol Design: Balancing Rigor, Feasibility, and Centricity

    2025-04-29, 2:30 PM

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    Daniela Duffett
    Senior Solutions Consultant, Suvoda

    Daniela Duffett is the European Solutions Consultant at Suvoda, based out of our Barcelona office. She consults with clients and prospects, delivering presentations and demonstrations, while acting as a Subject Matter Expert on Suvoda’s solutions. She started at Suvoda five years ago on the Project Management side of our Services Delivery organization, so can impart her hands-on delivery experience & knowledge.

     

     

    Session Details:

    Smoothing the Patient Journey and Driving Trial Efficiency with eClinical Innovations

    2025-04-29, 12:00 PM

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    Andria Wilk
    Global Head of Quality, Argenx and Board Member, EFGCP

    Session Details:

    Transforming Sponsor-CRO Partnerships for Clinical Trial Success: Innovation, Transparency and Agility

    2025-04-29, 11:30 AM

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    Piotr Maślak
    Director, Operational Data Intelligence, AstraZeneca

    With extensive experience in delivering actionable insights in global pharmaceutical R&D and Operations, Piotr is passionate about turning data into meaningful business value and changing patient outcomes by leveraging the science behind the data. He specializes in designing and executing data-driven strategies that enable senior and executive leadership to make informed decisions. Piotr's experience spans cross-functional collaboration on data science and AI implementation, data governance, product management, and leading diverse global teams to achieve their full potential.

    Session Details:

    AI in Clinical Trials: Practical Implementation, Navigating Uncertainty, and Measuring Success

    2025-04-29, 11:30 AM

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    Patricia Ripoll Ros
    President, Fundación Visible

    Session Details:

    Enhancing Patient-Centricity in Clinical Trials: A Collaborative Approach

    2025-04-29, 11:30 AM

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    Maryleen Lovell-Petronilia
    Manager, Quality Assurance and Compliance, Global Clinical Trials, PCM Trials

    Maryleen Lovell-Petronilia is a Medical Biologist specializing in Molecular Pathology, with over 13 years of experience in clinical research and healthcare. In 2022, after a decade in research and innovation, where she introduced risk management documentation in routine clinical diagnostics, Maryleen transitioned to the role of Manager of Quality Assurance and Compliance at PCM Trials. In this position, she focuses on enhancing quality oversight and ensuring compliance with regulatory requirements and country-specific regulations.

    Maryleen is committed to advancing the global adoption of patient-centric approaches and fostering collaboration among stakeholders to promote and uphold high standards in decentralized clinical trials

    Session Details:

    Expanding Access: How Community-Based Research Models Improve Patient Optionality and Inclusivity in Trials

    2025-04-29, 3:00 PM

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    Vasee Moorthy
    Senior Advisor, R&D, World Health Organization

    Dr. Vasee Moorthy is Senior Advisor, Research for Health Department, WHO Science Division, Geneva, Switzerland. Since 2008, he has held progressively senior roles at WHO in malaria vaccine policy development, Ebola vaccine phase 1-2 trials, global norms in sharing research data and results during public health emergencies, WHO R&D Blueprint for action to prevent epidemics, global consensus on clinical trials policy norms, WHO COVID-19 Research & Innovation Roadmap and the WHO Solidarity Trial of therapeutics supporting clinical trials networks in over 40 Member States in all WHO regions, and most recently, the adoption of resolution (WHA75.8) on clinical trials. Prior to joining WHO, Dr. Moorthy worked as a medical researcher at the University of Oxford, UK (2005-2008); with an NGO, PATH, in USA (2003-2005); running a clinical trials programme at MRC Laboratories in The Gambia (1999-2003), and as a government medical officer in Kwazulu/Natal, South Africa (1996-1997). He received a B.A. and M.A. from the University of Cambridge in Natural Sciences, a B.M.B.Ch medical degree and a Ph.D in malaria immunology and clinical trials both from the University of Oxford.

    Session Details:

    VIRTUAL SESSION: WHO’s clinical trial guidance: what do I need to know

    2025-04-29, 3:30 PM

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    Puja Runa Myles
    Director, Clinical Practice Research Datalink (CPRD), MHRA

    Session Details:

    An overview of high-fidelity synthetic data applications

    2025-04-30, 10:00 AM

    Session Details:

    PANEL Harnessing Technology: Innovations in Patient Recruitment and Retention for Clinical Trials

    2025-04-30, 1:30 PM

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    Melissa Smellie, PhD
    Executive Director, Strategic Partnerships, Fortrea

    Melissa has over 25 years' experience in the industry and is an Executive Director in our Strategic Partnerships team responsible for the oversight of Fortrea strategic partner accounts.

    Melissa started her CRO career as a CRA working her way through project management to senior leadership in clinical development responsible for a number of major programmes across Phase I–IV for large Top 20 large pharma customers.

    For the last 10 years Melissa has worked in alliance & partnership management, including responsibility for leading pharma accounts across the enterprise and setting up partnerships with venture capital companies. In her role she is responsible for building partnership strategy and supporting excellence in delivery.

    Prior to Fortrea, Melissa started her career in industry with a small CRO specializing in work with Biotech & Start-Up companies, managing Phase I patient and Healthy Volunteer studies. She has degree in Biomedical Sciences, a PhD in Molecular & Cellular Pharmacology and worked in the West German Cancer center.

    Melissa lives in the UK with her husband, 2 children and is the executive sponsor for WEN (Women’s Empowerment Network) for the UK at Fortrea.

    Session Details:

    Trends in clinical outsourcing and partnerships, biotech’s vs large pharma. The CRO perspective

    2025-04-30, 9:30 AM

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    Mats Sundgren
    PhD, European Institute of Innovation through Health Data (i-HD)

    Mats Sundgren, PhD, MSc, is a renowned expert in Health Data Strategy for Industry and Academia. With over 37 years in the pharma industry (Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science and Data Science & AI), Mats is at the forefront of industry technology innovation. In 2022, following a 12-year tenure as global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats’ new portfolio encompasses the roles of Senior Industry Scientific Director for the i~HD (European Institute for Innovation through Health Data); Executive Strategic Advisor for IgniteData, developer of a system-agnostic EHR-to-EDC solution for clinical trials; and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology) across Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology & Stockholm School of Business.

    Mats has authored over 70 publications, books, and patents in Science, Economics & Social Science (Health Data Science, Clinical Science, Business Modelling, Innovation & Creativity Management, and Device development).

    Session Details:

    Transforming Clinical Trials with AI and Real-World Data (RWD): A New Era of Innovation

    2025-04-30, 9:00 AM

    Session Details:

    PANEL Harnessing Technology: Innovations in Patient Recruitment and Retention for Clinical Trials

    2025-04-30, 1:30 PM

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    Joanna Tait
    Solutions Consultant, Endpoint Clinical

    I have worked in the IRT industry for over 20 years in various roles, gaining extensive experience in bridging the gap between technical capabilities and client needs. For the past nine years, I have specialized as a Solutions Consultant, helping clients design and implement tailored IRT solutions to streamline clinical trial operations.

    Session Details:

    Connect What Matters: Making RTSM Integration Work for Your Trial

    2025-04-29, 4:30 PM

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    Denis Costello
    Director, CML Advocates Network & Board Member

    Session Details:

    ROUNDTABLE DISCUSSIONS

    2025-04-30, 3:45 PM

    Session Details:

    Panel Discussion Integrating the Patient Voice in Protocol Design: Balancing Rigor, Feasibility, and Centricity

    2025-04-29, 2:30 PM

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    Ashish Bagde
    Data Management, UCB Belgium

    Overall accountable for delivery of all relevant data operations activities from strategy planning database
    setup to database lock.
    Demonstrated excellence in outsourced as well as in-house data management activities.
    Provide continues DM solution & leadership to team.
    Team management: hiring, goal setting, mentoring, resource utilization, performance evaluation.
    Well versed with entire data management process (project set-up, conduct and close out).
    Strong grip on creation/review/ approval of DM documents.
    Experienced in eDiary, medical device trials. Assisted pre-sales & business development team.
    Budget management (POs, Invoices)
    Excellence in CRO/vendor management and service delivery management
    Proven experience in clinical system validation.
    CRF part 11 requirement. Experienced in review of clinical system validation documentation.
    Facilitated & audited by many internal and external audits and faced inspection. Creation/review of standard operating procedure (SOP).
    Knowledge of CDISC standards (CDASH & SDTM), review of Pinnacle 21 report, SDTM package etc. Represent the organization on various data management forum.
    Presented on SCDM conference 2016 on Impact of technology in future Clinical Trials.
    Published paper on Leveraging digital technology in clinical trials (SCDM data basics 2018).
    SCDM EMEA steering committee member & SCDM COVID-19 webinar task-force member

    Session Details:

    ROUNDTABLE DISCUSSIONS

    2025-04-30, 3:45 PM

    Session Details:

    PANEL Harnessing Technology: Innovations in Patient Recruitment and Retention for Clinical Trials

    2025-04-30, 1:30 PM

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    Anca Copaescu
    Chief Executive Officer, Strategikon Pharma

    Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side.  She is currently the Founder and CEO of Strategikon Pharma, developer of Clinical MaestroTM, the industry’s only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation.

    Session Details:

    AI-Powered Clinical Outsourcing: The Future of Strategic Sourcing

    2025-04-30, 11:30 AM

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    Ana Pérez Hidalgo
    Global clinical Operations & AI Director, Insud Pharma

    Ana is a pharmacist, with a master's degree in clinical trials, pharma economics and business executive. She started her career more than 20 years ago, as a CRA, passing through different positions of higher responsibility at Novartis and GSK. He joined Insud  Pharma 4 years ago and is responsible for the execution and strategy of all trials globally, from phase I to IV, trying to implement with maximum creativity in a highly legislated world. To this end, Insud has incorporated AI in all phases of the life of the study, improving time and quality.

    Session Details:

    From theory to practice: practical case examples of the use of AI in the whole life of a clinical trial

    2025-04-30, 2:30 PM

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    António Valente
    Senior Director Business Development, Iomed

    Session Details:

    Technology Spotlight: Unlocking the potential of healthcare data

    2025-04-30, 9:30 AM

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    Bruce Hellman
    Co-Founder and Chief Patient Officer, UMotif

    Chief Patient Officer and Co-Founder - uMotif

    Bruce is the Chief Patient Officer of uMotif and co-founded the company in 2012. He and his team have designed and built a patient-centric eCOA / ePRO data capture platform for clinical and real-world research.

    Bruce began his career working in clinical trials at British Biotech before joining the UK Civil Service Fast Stream in the Department for Culture, Media and Sport. Prior to founding uMotif, Bruce worked at Serco and completed an Executive MBA from Imperial College Business School.

    Bruce has been recognized in the PharmaVoice 100 as one of the most innovative entrepreneurs in life sciences and has also been nominated as one of Computer Weekly's UKtech50 Rising Stars, won the Cisco BIG awards, and was nominated by Real Business magazine as one of the '30 to watch in mobile'.

     

    Bruce is a 3-time Ironman finisher and Head Coach of the Teddington Athletic Under 11s Sharks football team.

    Session Details:

    Setting the Tone for the Patient and Site Journey

    2025-04-29, 4:30 PM

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    Eva Torres Costa
    Director, Alliance Management, AstraZeneca

    Session Details:

    Fostering a Strong Sponsor-CRO relationship through knowledge sharing and innovative strategies

    2025-04-30, 12:00 PM

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    Priya Ravisekara
    Senior Analyst, GlobalData

    Priya Ravisekara, MSc,is a senior analyst at GlobalData in London, UK, where her primary responsibilities include producing analytical reports, improving and maintaining database functionality through quality assurance testing, updating and monitoring Global Data’s Clinical Trials Intelligence Database, and answering queries directly from clients. Priya holds a Masters in Clinical Drug Development from Barts and The London School of Medicine and Dentistry, and a Bachelor of Science in Biochemistry from Brunel University, London.​

    Session Details:

    Clinical Trial Investigations: Looking at the trends and landscape for 2024 and what we can learn from them moving through 2025 and into 2026

    2025-04-30, 12:00 PM

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    Joana Claverol
    Clinical Research Director, Sant Joan de Deu Barcelona Hospital

     Joana Claverol , is the Clinical Research Director at Barcelona Children’s Hospital Sant Joan de Déu, Spain, where she leads the clinical trials office since 2012 and the Patients engagement in research area since 2015. The Clinical Research Unit is a reference unit for pediatric patients nationally and internationally, specializing in innovative treatments for highly complex patients with rare pediatric diseases. She has more than 13 years of experience in medical and clinical research in the pharmaceutical and biotechnology industry, with special knowledge and experience in drug development and clinical trial design, and all regulatory and methodological aspects related to clinical research. She holds a postgraduate in Senior Management Program of Health Institutions by IESE Business School, a Master in Pharmaceutical Marketing by Universitat Pompeu Fabra, a Master of clinical trials at Universitat de Barcelona and a BS Degree in Biological Sciences by Universitat Autonoma de Barcelona.

    Session Details:

    PANEL How minimizing participant burden leads to on-time enrollment and completion.

    2025-04-29, 5:00 PM

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    Hugh Whetherly
    Senior Environmental Specialist, Sustainable Health Coalition

    Hugh Whetherly is a Senior Consultant in ERM's Product Sustainability team and works very closely with The Sustainable Healthcare Coalition (SHC). Hugh was one of the co-authors of the clinical trial footprinting method and guidance documents as well as leading, from the ERM side, on the development of the clinical trials carbon calculator online tool and subsequent database. Hugh's experience in life cycle analysis covers a wide range of pharmaceutical activities from drug development through to clinical trials.”

    Session Details:

    SUSTAINABILITY SPOTLIGHT: Inspiring partnerships and action in sustainable healthcare

    2025-04-30, 2:30 PM

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    Neta Bendelac
    Senior Director, Strategy, 4G Clinical

     

    Neta Bendelac, 4G Clinical Senior Director of Strategy, has over 10 years of experience in Clinical Supply Chain Management. She headed the Clinical Supply Chain department at Teva Pharmaceuticals, where she established new and innovative approaches to managing IMPs in clinical trials, designing them with a highly acclaimed and unique patient perspective. Prior to Teva, Neta worked as an international Supply Chain consultant, providing simulations and optimization tools to clients worldwide. Neta holds a BS in Industrial Engineering  and a Master of Business Administration (MBA) from Tel Aviv University, Israel. Neta is always focused on execution, finding joy in creative solutions to help patients around the world.

    Session Details:

    Technology Solutions for Reducing Hidden costs in Clinical Supply and Trial Changes

    2025-04-29, 1:00 PM

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    Anna Pinsky
    MD, PhD, Medical Director at Rho

    Dr. Anna Pinsky, MD, PhD, has more than 12 years of experience in clinical research, specializing in CNS and psychiatric indications for the past 9 years. With extensive expertise in both clinical trial management and medical monitoring, she has consistently demonstrated her ability to ensure patient safety and maintain data integrity throughout the course of clinical trials.

    In her role as a medical director at Rho, Dr. Pinsky serves as a medical adviser, providing strategic guidance on protocol development and risk management. She is familiar with common clinical scales and assessments, as well as various methods of their administration, including paper-based formats and digital tablets with audio and video recording. Dr. Pinsky collaborates closely with clinical teams, investigators, and sponsors to address potential challenges related to patient enrollment and retention, adherence to study protocols, and the accurate assessment of safety and efficacy endpoints. She is instrumental in developing and implementing mitigation strategies to ensure both subject safety and the generation of high-quality, reliable data that supports regulatory approvals.

    Dr. Pinsky earned both her MD and PhD in Endocrinology from the Institute of Internal and Preventive Medicine in Russia.

    Session Details:

    Medical monitoring done right: the three questions every sponsor should ask

    2025-04-30, 10:30 AM

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    Christer Nilsson
    Chief Executive Officer, Replior

    Christer Nilsson is a dynamic entrepreneur and the CEO of Replior, bringing over 30 years of leadership experience in IT, Finance, and Life Sciences. Throughout his career, he has successfully launched and managed several businesses with a strong focus on innovation and customer satisfaction. At Replior, Mr. Nilsson is committed to a transparent and honest approach, ensuring that clients’ needs are at the heart of every decision. He leads the integration of cutting-edge digital endpoints, sensor technology, and gamification strategies into clinical research solutions, aimed at reducing patient dropout and increasing compliance. Under his leadership, Replior is pioneering a more patient-centric and effective model for clinical trials.

    Session Details:

    Transforming Patient Engagement in Clinical Trials: The Power of Gamification

    2025-04-30, 10:30 AM

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    Brian Sheridan
    Vice President Global Adherence & Clinicals, Smurfit Westrock

    Brian joined, the then WestRock, in 2018 as Vice President Global Adherence & Clinicals - the business unit focused on providing Adherence focused, patient centric and Child Resistant Senior Friendly (CR-SF) packaging & service solutions to the Pharmaceutical, Biotech & Clinical Trial industries.

    Having majored in marketing, business studies and finance Brians key expertise has been developing packaging solutions supplied to these key markets. Holding a wide range of increasingly elevated positions within companies such as Cardinal Health, Catalent and across several other packaging entities, Brian has gained invaluable insights and a thorough understanding of the demanding requirements, operating systems and ethos of the various market sectors that Smurfit Westrock support today.

    Within the last number of years Brian's focus, together with his globally based team, has been to strategically develop a bespoke, best in class global supply infrastructure within the Smurfit Westrock specialized field of Adherence, Clinical Trial and SMART digital & electronic platforms. These cutting-edge solutions encompass electronically enhanced SMART measure and monitor packaging solutions, such as Cere®Pak, together with developing the vision and capabilities of Cere®Screen Digital Display Labels within the Clinical Trial Supplies arena..

    Session Details:

    The Digital Revolution in Clinical Trials: Relabelling with Digital Display Labels

    2025-04-30, 9:45 AM

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    Advisory Board

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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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    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.

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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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    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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