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Why Attend?

This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. Combining our OCT, CTS and Medical Devices events, this is the perfect platform for professionals from across a range of clinical trial functions to meet, network, and hear about latest developments.

WHAT TO EXPECT FOR 2025?

200+

Attendees

30+

Exhibitors

30+

Speakers
200+

Attendees

30+

Exhibitors
30+

Speakers

Testimonials

See What It's All About

2025 Sponsors Included:

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Company Information

GBA CLS, part of the GBA Group, is your independent partner for clinical trial lab services (Phases I–IV).
From study planning to final data reporting, we deliver end-to-end laboratory support—globally. Backed by decades of experience and a strong international network, our expertise ensures consistency, reliability, and scientific excellence throughout every clinical development phase.

Company Website

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

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Company Information

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

KLIFO is a leading international drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development projects. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

We offer multidisciplinary consulting and operational solutions spanning all areas of clinical research, clinical trial supply, QA, CMC development, regulatory affairs, pharmacovigilance, and the development of pharmaceutical and biotech products and medical devices.

Company Website

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

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Company Information

Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

Company Website

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

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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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Company Information

Worldwide Clinical Trials (Worldwide) is a global CRO serving development-driven biopharmaceutical companies, with more than 4,400 professionals operating across more than 70 countries. The company delivers therapeutically dedicated expertise in neuroscience, oncology, rare disease, and internal medicine, with comprehensive support across every development phase – from early-stage and first-in-human studies through Phase III registration trials.

The company’s flexible service model – spanning full-service trial management to functional service partnerships through Worldwide Flex – is powered by a people‑first, partnership‑driven outsourcing approach that strengthens collaboration, enhances data transparency, and supports more informed decision‑making. This provides sponsors with tailored, adaptable solutions that keep pace with the evolving demands of clinical research. Learn more at www.worldwide.com

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Company Information

TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

Company Website

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

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Company Information

4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

Company Website:http://www.4gclinical.com/

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Company Information

Clario is a leading provider of endpoint data solutions that generate high-quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2012.

Company Website

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

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Company Information

Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Company Website

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

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Company Information

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

Company Website

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

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    Agenda

    • 21 Oct 2025
    • 22 Oct 2025
    Expand All

    Streams

    Stream one

    CLINICAL TRIAL SUPPLY

    7:30 AM

    Registration and refreshments

    8:15 AM

    Chairperson’s opening remarks

    Speakers

    Sonnika Lamont
    Senior Analyst, GlobalData

    8:30 AM

    CTS sourcing and procurement trends and challenges – external manufacturing as the “procurement´s operational arm”

    Accelerate, cultivate, innovate!

    • Managing relationships with the modern supplier
    • How Bayer's external relationship governance model adds value to the business ensuring a reliable partnership and complements the sourcing & procurement functions within CTS scope
    • Trends on procurement roles and the necessity to have an operational perspective
    • Different approaches from different business necessities
    • Trends on how to best manage CMOs, 3PLs and clinical trials partners

    Speakers

    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer

    9 AM

    Gamification in clinical trials: A proven path to better engagement, retention, and data integrity (Stream A room onsite)

    Consistent patient engagement is vital to clinical trial success, yet dropout and non-compliance remain persistent challenges. This session introduces gamification as a scientifically grounded strategy to boost retention, enhance adherence, and streamline trial execution.

    • Understand the Science: Explore the behavioral and psychological foundations that make gamification a powerful tool for sustaining patient motivation
    • See Real Results: Review real-world case studies where gamification significantly improved retention, compliance, and trial timelines
    • Apply Proven Methods: Learn practical strategies and best practices for integrating gamified elements into clinical trial protocols

    Speakers

    Christer Nilsson
    Chief Executive Officer, Replior

    9:30 AM

    Fireside Chat: Integrating both clinical supply and clinical team perspectives for end to end supply chain efficiency

    • Optimising supply chain demand forecasting to minimise waste
    • Considering AI, tools and technologies to assist in end to end supply chain planning, management and visibility
    • Creating a more joined up approach through communication with clinical teams

    Speakers

    Sonnika Lamont
    Senior Analyst, GlobalData
    Arnaud Dourlens
    Global Head of Clinical Supply Chain Operations, Sanofi

    10 AM

    1,000 Trials: A decade later – what’s worked, what’s new, and what’s next in RTSM?

    From IVRS to RTSM: a decade of evolution, innovation, and lessons learned

    • Insights from 1,000 studies: what we have consistently seen, what has worked (and hasn't)
    • Emerging trends and innovations shaping the next generation of RTSM
    • What sponsors are asking for: future expectations from RTSM providers

    Speakers

    Jonathan Pritchard
    Director Product Growth & Market Strategy, 4G Clinical

    10:30 AM

    Morning refreshments and networking sponsored by Hiro

    11 AM

    Fireside Chat: Overcoming Import of Record and distribution challenges in clinical supplies

    • Finding a vendor who can be your importer of record
    • Understanding packaging and labelling differences between countries
    • Reviewing if and when you can reclaim VAT: which European countries support reclaiming R&D activities
    • Considering advantages of a central distribution model vs standard local model

    Speakers

    Kamal Amin
    Head of Clinical Supplies Management, Galderma

    11:30 AM

    Agentic AI use cases in clinical trials

    • Evolution of Agentic AI in clinical trials
    • A framework to select the right use cases to implement Agentic AI
    • Practical examples of building agentic AI use cases across clinical development
    • Deep dive into AI implementation around RTSM activities

    Speakers

    Nagaraja “Sri” Srivatsan
    CEO, Endpoint Clinical

    12 PM

    Sharing challenges and best practice in cell therapy trials from a small biotech perspective

    • Setting up a local trial in Sweden: considerations and actions
    • Communicating with multiple stakeholders
    • Considering logistical requirements for personalized cell therapy: manufacturing, sites and patients
    • Providing a small company perspective on cell therapy trial execution

    Speakers

    Andrea Salmen
    Chief Operating Officer, NEOGAP Therapeutics AB

    12:30 PM

    Technology Spotlight: 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

    12:45 PM

    Lunch and networking sponsored by Hiro

    2 PM

    Enhancing trial resilience and success by forging strong relationships through common goals, from a clinical supply perspective

    • Leveraging insights of human dynamics to deliver IMP to clinical trials.
    • Exploring how Clinical Supply Professionals can reinforce a common goal and collaboration that can break down silos.
    • Bridging the gap between clinical supply, CMC, quality, regulatory, clinical operations and other stakeholders.
    • Utilizing robust relationships to navigate challenges and enhance trial success.

    Speakers

    Malene Gantzhorn Pedersen
    Senior Clinical Supply Specialist, Lundbeck

    2:30 PM

    Strong safety, lean teams: Practical pharmacovigilance strategies for biotech and pharma (Stream A room onsite)

    • Understand how pharmacovigilance roles and responsibilities align across sponsors, CROs, vendors, and investigators, and why clear roles prevent inefficiencies and issues
    • Learn how biotech and specialty pharma can develop scalable pharmacovigilance strategies that adapt to dynamic pipelines
    • Discover how hybrid outsourcing balances in-house oversight with external expertise for global coverage
    • Explore methods to enhance partnerships so pharmacovigilance can support both compliance and operational delivery
    • Recognize how a well-designed pharmacovigilance model can accelerate progress from early development to marketing approval

    Speakers

    Kristiane Thaysen
    Associate Director, Safety, TFS HealthScience

    3 PM

    Panel Discussion: Monitoring temperature control throughout supply chain lifecycle

    • Ensuring temperature maintenance throughout packing, shipping and at sites
    • Considering monitoring tools and loggers to assist in temperature tracking
    • Complying with regulatory auditing guidelines
    • Discussing trial product quality once it reaches the patient: who should be responsible?

    Speakers

    Sonnika Lamont
    Senior Analyst, GlobalData
    Tine Bülow
    Supply Chain Project Manager, Novo Nordisk
    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer

    3:30 PM

    Afternoon refreshments, networking and prize draw sponsored by Dr Vince Clinical Research

    4 PM

    Building resiliency in supply chains: Trends to watch

    • Opportunities for CDMOs, sponsors, and suppliers
    • Clinical trials: what to expect?
    • Impact of the Biosecure Act
    • Trends in outsourcing clinical trials – supply chain disruption

    Speakers

    Floriane Reinaud
    Senior Director, Databases and Analytics, GlobalData

    4:30 PM

    Applying product launch strategy to clinical trials: A reimagined approach to recruitment and retention (Stream A room onsite)

    • Competition for patients in clinical trials is fierce, and putting the trial at the front of mind of PIs, site teams, referral networks, and patients is crucial to win in patient engagement​
    • A successful recruitment and retention strategy has to reach target HCPs and patients with accelerated precision through an engagement campaign that starts with an evidence-based point of reference, builds confidence in the trial, delivers a resonating call to action, and evolves as clinical insights start flowing in​
    • A new approach to recruitment and retention takes inspiration from ways of working within Medical and Commercial teams and produces durable outputs that evolve into the essentials of a product launch toolkit, facilitating organizational efficiency

    Speakers

    Natalia Barkalina
    Medical Director, Syneos Health

    5 PM

    Panel Discussion: Reviewing geopolitical impact on supply chain: minimizing disruption through effective risk mitigation planning

    • Identifying latest geopolitical challenges and impact on supply chain
    • Building contingency protocols from the start of trial to be better prepared for the unexpected
    • Incorporating risk assessment into project management plans

    Speakers

    Sonnika Lamont
    Senior Analyst, GlobalData
    Kamal Amin
    Head of Clinical Supplies Management, Galderma
    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    Sonnika Lamont
    Senior Analyst, GlobalData

    NETWORKING DRINKS RECEPTION SPONSORED BY TFS HEALTH SCIENCE

    Streams

    Stream one

    CLINICAL TRIALS TECHNOLOGY & INNOVATION

    8:15 AM

    Registration and Refreshments

    8:30 AM

    Chairperson’s Opening Remarks

    Speakers

    Libbi Rickenbacher
    VP, Marketing & Partnerships, 4G Clinical

    8:45 AM

    Improving clinical supply chain with digital display labelling

    • Enhancing real-time data visibility and accuracy
    • Streamlining compliance and regulatory adherence
    • Boosting flexibility and efficiency in clinical supply management

    Speakers

    Alexander Debets
    Lead Clinical Supply Innovation, Former MSD

    9:15 AM

    Smartsheet for clinical trials

    For clinical trials leaders and managers, Smartsheet is the Intelligent Work Management platform that optimizes clinical trial processes by reducing administrative burden, breaking down communication silos, and centralizing fragmented information. This talk will focus on key challenges from industry, outcomes that Smartsheet facilitates, capabilities and stories from existing customers

    Speakers

    Nick Tee
    Senior Value Strategist, Smartsheet
    Abdellah Lazaar
    Senior Solution Engineer, Smartsheet

    9:45 AM

    Patient experience data: EMA reflection paper and beyond – from a data management perspective

    What is Patient Experience Data (PED)?

    With a focus on clinical trials, and a data management perspective, Ane will cover study design considerations, patient burden, missing data and other challenges

    Speakers

    Ane Jensen
    Former Principal Data Manager

    10:15 AM

    Morning refreshments and networking sponsored by Hiro

    10:45 AM

    Navigating the complexities of clinical trials

    Discussing the status quo of clinical trials in Denmark and beyond including factors influencing country selection

    • Considering barriers of success for site-set up and patient recruitment/screening
    • Considering types of data that can be utilized to assist with patient recruitment challenges
    • Incorporating data findings into development of eligibility criteria
    • Using secondary health data to identify sites and patient cohorts

    Speakers

    Lill-Brith Wium von Arx
    RWE Lead Northern European Hub, Eli Lilly and Company
    Hanne Joergensen
    Clinical Trial Lead Northern European Hub, Eli Lilly and Company

    11:15 AM

    Transform procurement: Harnessing AI for strategic sourcing

    In the rapidly evolving landscape of procurement, staying ahead of the curve is more critical than ever.

    This session will explore the transformative role of Artificial Intelligence (AI) in revolutionizing clinical business operations. Attendees will gain insights into how AI is reshaping strategic sourcing, vendor management, and cost optimization, enabling organizations to achieve unprecedented levels of efficiency and agility.

    Through real-world use cases we’ll delve into AI-driven tools that enhance decision-making, streamline workflows, and predict study cost with unparalleled accuracy. Whether you’re an outsourcing manager, a clinical operations or R&D finance professional, this session will equip you with the knowledge and strategies needed to harness the power of AI for smarter, more effective procurement leveraging Clinical Maestro powerful engine.

    Speakers

    11:45 AM

    Panel Discussion: Clinical trial innovation: insights into new technology and strategy

    • Incorporating digitalization and new technologies into your clinical trials
    • Collaborative platforms: improving communication and efficiency among stakeholders
    • Success stories, transformative cases and key takeaways

    Speakers

    Libbi Rickenbacher
    VP, Marketing & Partnerships, 4G Clinical
    Alexander Debets
    Lead Clinical Supply Innovation, Former MSD
    Dr. Claudia Hesselmann
    Founder & CEO, ARENSIA Exploratory Medicine
    Yarhy Flores
    Human-AI Collaboration Researcher, Former Harvard

    12:30 PM

    Lunch and networking sponsored by Hiro

    1:30 PM

    Lessons learned from implementing Digital Health Technologies into clinical trials

    • Examples from integrating DHTs, such as wearable devices, into clinical trials
    • Device burden and patient-related factors
    • Challenges faced by sites during DHT implementation

    Speakers

    Charlotte Sauter
    Principal Digital Health Scientist, Lundbeck

    2 PM

    Creating the first protocol design with AI: Shortening protocol design processes to less than 3 months (Stream A room onsite)

    • How AI optimizes clinical trial protocols to reduce errors, streamline processes, and enhance data quality
    • A Real-world case study of reduced timelines and improved trial outcomes using Biorce’s platform
    • Insights into leveraging predictive analytics for trial success

    Speakers

    2:30 PM

    Fireside Chat: Discussing insights on use of Real World Evidence within clinical trials

    • Integrating RWE into clinical trial design
    • Using RWE to enhance or compliment traditional evidence generation
    • Sharing successes and lessons learned

    Speakers

    Pernille Fevejle Cromhou
    Global Trial Manager RWE, Novo Nordisk

    3 PM

    Afternoon refreshments, networking and prize draw

    3:30 PM

    ROUNDTABLE SESSIONS

    During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

    Roundtable 1
    Progressing your planning as a small biotech whilst in funding mode
    Judi Simonsen, CEO and Co-Founder, MERODZ

    Roundtable 2
    Selecting and managing sites: key considerations
    Catharina Östberg, Head of Site Management Nordics, Bayer

    Roundtable 3
    Considering sustainability throughout the clinical supply chain: where can we improve?
    Kamal Amin, Head of Supply Chain Management, Galderma

    Roundtable 4
    Integrating AI into clinical operations
    Pietro Belligoli, Researcher, Former Roche

    Speakers

    Judi Simonsen
    CEO and Co-Founder, MERODZ
    Catharina Östberg
    Head of Site Management Nordics, Bayer
    Kamal Amin
    Head of Clinical Supplies Management, Galderma
    Pietro Belligoli
    Researcher, Former Roche

    4:30 PM

    End of conference

    Speakers

    Select a speaker to learn more

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    Karin Nordbladh
    Director, Clinical Operation, Immune Oncology, Alligator Bioscience

    Clinical Operations professional leader with 18+yrs experience in Clinical Drug Development from both Big Pharma & small immunoncology biotech settings. Motivated by developing medicinal products that improves patient’s quality of life. Key competencies includes but are not limited to ICH-GCP, clinical trial regulations & guidelines, Global Clinical Project Management phase 1-4, CRO outsourcing & management, Sponsor Oversight, Risk Management, Quality & Compliance, People leadership, management & mentoring. Currently leading ongoing immunoncology clinical trials in phase 1 & 2, and phase 3 planning for continued clinical development of key assets.

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    Lisbet Groes
    Associate Director Clinical Operations, Ascendis Pharma

    Lisbet Groes, Ph.D., e*MMBS, is Associate Director, Clinical Operations at Ascendis Pharma. With over 25 years in clinical development, she brings deep expertise in global trial execution, including leading Phase III programs in Japan. Lisbet has hands-on experience with CRO selection, PMDA interactions, trial execution, and inspection readiness. She is known for her strategic mindset, cross-cultural collaboration, and ability to foster high-performing sponsor-CRO partnerships.

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    Catharina Östberg
    Head of Site Management Nordics, Bayer

    Session Details:

    ROUNDTABLE SESSIONS

    2025-10-22, 3:30 PM

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    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer
    • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
      Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
    • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
    • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
    • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
    • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
    • Solid team management skills, as well as Customer Service relationship and management
    • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

    CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

    Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

    Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

    Session Details:

    CTS sourcing and procurement trends and challenges – external manufacturing as the “procurement´s operational arm”

    2025-10-21, 8:30 AM

    Session Details:

    Panel Discussion: Reviewing geopolitical impact on supply chain: minimizing disruption through effective risk mitigation planning

    2025-10-21, 5:00 PM

    Session Details:

    Panel Discussion: Monitoring temperature control throughout supply chain lifecycle

    2025-10-21, 3:00 PM

    View In Agenda
    Next speaker
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    Lene Grejs Petersen
    EU CT-policy adviser, Danish Medicines Agency
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    Päivi Susanna Worsøe
    Project Manager and Special Adviser in Clinical Trials, Danish Medicines Agency

    Päivi is Project Manager in the Clinical Trials Unit at the Danish Medicines Agency, where she has been involved in the approval of clinical trials for the past four years. Prior to this role, she held various regulatory positions within competent authorities and the pharmaceutical industry.

    Next speaker
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    Lill-Brith Wium von Arx
    RWE Lead Northern European Hub, Eli Lilly and Company

    Session Details:

    Navigating the complexities of clinical trials

    2025-10-22, 10:45 AM

    View In Agenda
    Next speaker
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    Hanne Joergensen
    Clinical Trial Lead Northern European Hub, Eli Lilly and Company

    Session Details:

    Navigating the complexities of clinical trials

    2025-10-22, 10:45 AM

    View In Agenda
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    Nagaraja “Sri” Srivatsan
    CEO, Endpoint Clinical

    Nagaraja Srivatsan ("Sri") is CEO of Endpoint Clinical, a global leader in Randomization and Trial Supply Management (RTSM). With more than 30 years of experience spanning AI, digital transformation, analytics, technology, and operations, he has led growth and innovation across healthcare and life sciences. Prior to Endpoint, Sri held executive leadership roles at IQVIA, EXL, and Cognizant. Recognized by PharmaVOICE as one of the industry's 100 Most Inspiring People, he is a frequent speaker on AI, digital transformation, and innovation in life sciences.

    Session Details:

    Agentic AI use cases in clinical trials

    2025-10-21, 11:30 AM

    View In Agenda
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    Libbi Rickenbacher
    VP, Marketing & Partnerships, 4G Clinical

    As Vice President of Marketing and Partnerships, Libbi drives enterprise growth through data-driven strategy, integrated marketing leadership, and high-value alliance development. She combines deep expertise in e-clinical innovation and life sciences with a collaborative, cross-functional approach to guide strategic decisions, cultivate impactful partnerships, and translate market insights into measurable outcomes.

    Session Details:

    Chairperson’s Opening Remarks

    2025-10-22, 8:30 AM

    Session Details:

    Panel Discussion: Clinical trial innovation: insights into new technology and strategy

    2025-10-22, 11:45 AM

    View In Agenda
    Next speaker
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    Jonathan Pritchard
    Director Product Growth & Market Strategy, 4G Clinical

    Jonathan is a seasoned leader with a proven track record in driving sales, product growth and market strategy across diverse sectors within the Clinical trials space, including Medical Devices, Biostatistics, and Contract Research Organizations (CROs). As Senior Manager, Product Growth and Market Strategy at 4G Clinical, he leverages his extensive background in sales and operations to identify and capitalize on market opportunities within the Randomization and Trial Supply Management (RTSM) space. Jonathan's strategic vision and data-driven approach are instrumental in accelerating product adoption and expanding market share, ultimately contributing to the advancement of clinical research and the development of innovative medical solutions.

    Session Details:

    1,000 Trials: A decade later – what’s worked, what’s new, and what’s next in RTSM?

    2025-10-21, 10:00 AM

    View In Agenda
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    Kamal Amin
    Head of Clinical Supplies Management, Galderma

    Kamal is a trained Chemist who decided to pursue a career in supply chain management and quality. In this role, he was tasked to supervise commercial and clinical trial products. Kamal has worked in the pharmaceutical and device industries for over 15 years in different size organisations ranging from large multinational to small virtual companies. He is currently leading a global team at Galderma to develop an integrated clinical supply chain organisation within the company.

    Session Details:

    Panel Discussion: Reviewing geopolitical impact on supply chain: minimizing disruption through effective risk mitigation planning

    2025-10-21, 5:00 PM

    Session Details:

    Fireside Chat: Overcoming Import of Record and distribution challenges in clinical supplies

    2025-10-21, 11:00 AM

    Session Details:

    ROUNDTABLE SESSIONS

    2025-10-22, 3:30 PM

    View In Agenda
    Next speaker
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    Sonnika Lamont
    Senior Analyst, GlobalData

    Sonnika Lamont, MRes, is a Clinical Trials Senior Analyst at GlobalData, where her primary responsibilities include the review and update of clinical trial information presented on GlobalData’s Trials Intelligence Platform, the production of analytical reports and insights, testing database releases, and providing comprehensive conference coverage. She has a firm understanding of all aspects of clinical research, and the drug development process. Prior to joining GlobalData, Sonnika worked as a Clinical Trials Research Assistant at University College London’s Cancer Institute. Sonnika holds a Master of Research in Drug Design with a concentration in rare diseases from University College London, and a Bachelor of Science in Biochemistry from Nottingham Trent University.

    Session Details:

    Fireside Chat: Integrating both clinical supply and clinical team perspectives for end to end supply chain efficiency

    2025-10-21, 9:30 AM

    Session Details:

    Chairperson’s closing remarks

    2025-10-21, 5:30 PM

    Session Details:

    Panel Discussion: Reviewing geopolitical impact on supply chain: minimizing disruption through effective risk mitigation planning

    2025-10-21, 5:00 PM

    Session Details:

    Chairperson’s opening remarks

    2025-10-21, 8:15 AM

    Session Details:

    Panel Discussion: Monitoring temperature control throughout supply chain lifecycle

    2025-10-21, 3:00 PM

    View In Agenda
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    Elisabeth Ahlmann-Ohlsen
    Director Quality Assurance, Hemispherian AS
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    Kira Hammershoi
    Director EU/UK QPPV, LEO Pharma
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    Malene Gantzhorn Pedersen
    Senior Clinical Supply Specialist, Lundbeck

    Malene holds a MSc in Pharmacy from the Faculty of Pharmaceutical Sciences in Copenhagen. With over 17 years of experience in clinical supply management at Lundbeck, she has developed a deep expertise in vendor management, project management, and process optimization. Currently serving as a Senior Clinical Supply Specialist, she leads strategic initiatives and global collaborations to enhance clinical supply processes.

    In addition to her extensive professional experience, she is an ICF certified Coach from Mindjuice Academy, specializing in powerful communication, systemic thinking, and personal leadership. She holds a Master Coach certification in Team Coaching and Leadership, equipping her with the skills to transform team dynamics and inspire collective success.

    Malene is passionate about enhancing team collaboration across organizational barriers to improve clinical trials, project progress, and ultimately benefit patients with unmet needs.

    Session Details:

    Enhancing trial resilience and success by forging strong relationships through common goals, from a clinical supply perspective

    2025-10-21, 2:00 PM

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    Charlotte Sauter
    Principal Digital Health Scientist, Lundbeck

    Charlotte Sauter is a dedicated professional in digital health. As a Principal Digital Health Scientist at Lundbeck, she brings more than four years of experience in evaluating and implementing Digital Health Technologies, including wearable devices, into clinical trials. Before joining Lundbeck, Charlotte worked as a Research Associate at NTU Singapore, focusing on digital health within the field of population health science. She holds a Bachelor’s degree in Health Economics and a Master’s degree in Global Health.

    Session Details:

    Lessons learned from implementing Digital Health Technologies into clinical trials

    2025-10-22, 1:30 PM

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    Judi Simonsen
    CEO and Co-Founder, MERODZ

    Session Details:

    ROUNDTABLE SESSIONS

    2025-10-22, 3:30 PM

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    Alexander Debets
    Lead Clinical Supply Innovation, Former MSD

    Dr. Alexander Debets has more than 30 years of experience in analytical and pharmaceutical R&D.

    He previously worked for Organon and Schering-Plough. He held several roles of increasing responsibility in Analytical Development, Pharmaceutical Development and Clinical Supply Operations in the Netherlands. He was site head of development manufacturing sites in Germany and in Switzerland, which involved the transition of a site from research and development into commercial. He did lead the Global Clinical Supply organization at MSD in the US.

    Recently he held a position of Lead Clinical Supply Innovation, driving new opportunities to enhance the clinical supply chain for patients, sites and sponsor.

    His educational background includes a Doctor in Chemistry, and a Master’s Degree in Analytical🥾 Chemistry and Toxicology from the Free University, Amsterdam, the Netherlands.

    He was chairman of several committees and councils, including global harmonization steering committees for Analytical Chemistry, Manufacturing and Control (CMC) processes, Quality and international Procurement Improvements. He was board-member of the Analytical Section of the Royal Dutch Chemical Society and president of the Analytical Lab Managers Association.

    Session Details:

    Improving clinical supply chain with digital display labelling

    2025-10-22, 8:45 AM

    Session Details:

    Panel Discussion: Clinical trial innovation: insights into new technology and strategy

    2025-10-22, 11:45 AM

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    Andrea Salmen
    Chief Operating Officer, NEOGAP Therapeutics AB

    Session Details:

    Sharing challenges and best practice in cell therapy trials from a small biotech perspective

    2025-10-21, 12:00 PM

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    Helen Johansen Blanco
    Former Chief Operating Officer

    Helén Johansen Blanco has 24 years of clinical development experience, managing Phase I to III clinical trials leading to the successful launch of several oncology products, as Revlimid, Xofigo and a Herceptin biosimilar. She has experience in project management and financial oversight of large global clinical trials conducted in all continents of the world, mainly within oncology, but also therapeutic areas as cardiovascular and gastrointestinal. Mrs. Blanco has previously worked for large international pharma companies such as AstraZeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector, Oncoinvent, Cantargia, Cytovation and Celgene. Currently she holds a position as Chief Operating Officer at Node Pharma AS, a small medium sized Norwegian biotech company. She holds a Diploma Engineer/MSc degree in Biophysics and medical technology and a MBA.

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    Claudia Krag
    Director Clinical Operations, Novo Nordisk
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    Tine Bülow
    Supply Chain Project Manager, Novo Nordisk

    Tine Bülow is an established Supply Chain Project Manager with over 12 years of experience in clinical IT systems. She brings extensive expertise in integrating clinical technologies to optimize trial operations, with a strong focus on temperature management and data integrity throughout the temperature deviation process. Her background includes 8 years working with Interactive Response Technology (IRT) systems and 4 years dedicated to advanced temperature control solutions.

     

    Tine’s work centers on safeguarding both product and data integrity across the entire supply chain—from packaging and shipment to storage at clinical sites—ensuring that patients receive safe and effective investigational products under optimal conditions. Passionate about reliability and compliance, she is committed to driving smarter, innovative solutions that strengthen quality, trustworthiness, and integrity in clinical trial delivery—ultimately protecting patient safety and improving trial outcomes.

     

    Session Details:

    Panel Discussion: Monitoring temperature control throughout supply chain lifecycle

    2025-10-21, 3:00 PM

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    Tankred Ott
    Senior Data Scientist – AI & Analytics CoE, Novo Nordisk
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    Merete Schmiegelow
    Patient Advocate
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    Jonathan Crowther
    Former Head of Predictive Analytics, Pfizer

    With a keen eye for Strategic Vision, Jonathan has been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. With a prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies.

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    Arnaud Dourlens
    Global Head of Clinical Supply Chain Operations, Sanofi

    Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group.

    During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio.

    Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

    Session Details:

    Fireside Chat: Integrating both clinical supply and clinical team perspectives for end to end supply chain efficiency

    2025-10-21, 9:30 AM

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    Session Details:

    Transform procurement: Harnessing AI for strategic sourcing

    2025-10-22, 11:15 AM

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    Gunilla Andrew-Nielsen
    Acting Director SweTrial, Swedish Medical Products Agency

    Gunilla Andrew-Nielsen has held her current position as Head of Clinical Trial and Special Permission at the MPA in Sweden during seven years. Since the early 1990s, she has held various positions within global R&D in the pharma industry including project and training management and later as Director of Quality Assurance.

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    Brian Sheridan
    Vice President Global Adherence & Clinicals, Smurfit Westrock

    Brian as Vice President Global Adherence & Clinicals leads a team focused on providing Adherence focused, patient centric and Child Resistant Senior Friendly (CR-SF) packaging & service solutions to the Pharmaceutical, Biotech & Clinical Trial industries. Working in companies such as Cardinal Health, Catalent and other businesses Brian has gained invaluable insights and a thorough understanding of the demanding requirements, operating systems & ethos of these markets. Brians global team focuses on best-in-class supply infrastructure with an expanded focus on digital platforms, these solutions encompass electronic measure and monitor packaging solutions together with Cere®Screen Digital Display Labels.

    Session Details:

    Technology Spotlight: The digital revolution in clinical trials: relabelling with digital display labels

    2025-10-21, 12:30 PM

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    Cornelia Baumgartner
    Head of Clinical Operations, T-CURX
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    Lihua Deng
    Senior Clinical Supply Manager, Radiometer Medical
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    Floriane Reinaud
    Senior Director, Databases and Analytics, GlobalData

    Floriane Reinaud started her carrier in pharmaceutical pricing, reimbursement and market access. She has oversees several datasets including prices of medicines, costs of treatments, HTA decisions, International Reference Pricing. Over the years she has expanded her expertise into clinical trials, manufacturers, sales forecasts and is now the Senior Director of the Databases and Analytics at GlobalData.

    She studied biology and holds a Master of Science in biochemistry, as well as a Master of Science in healthcare marketing. She co-authored a peer-reviewed article that was published in The Journal of Biological Biochemistry.

    She speaks English and French (her mother tongue).

    Session Details:

    Building resiliency in supply chains: Trends to watch

    2025-10-21, 4:00 PM

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    Pietro Belligoli
    Researcher, Former Roche

    Session Details:

    ROUNDTABLE SESSIONS

    2025-10-22, 3:30 PM

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    Ane Jensen
    Former Principal Data Manager

    Passionate about new technology and their ability to change the way we conduct clinical trials. Has worked at different positions in Novo Nordisk between 2008 and 2020. Since 2020 employed at Zealand Pharma. Previous experiences include RTSM, training, process improvements, logistics, clinical trials supplies and eLearning development.

    Session Details:

    Patient experience data: EMA reflection paper and beyond – from a data management perspective

    2025-10-22, 9:45 AM

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    Pernille Fevejle Cromhou
    Global Trial Manager RWE, Novo Nordisk

    Session Details:

    Fireside Chat: Discussing insights on use of Real World Evidence within clinical trials

    2025-10-22, 2:30 PM

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    Nick Tee
    Senior Value Strategist, Smartsheet

    Nick brings deep experience in quantifying Smartsheet's transformative impact on its customers' priorities. As a member of the Customer Outcomes organization, Nick focuses on providing industry insights, value perspectives, outcome success stories, and journey roadmaps with Enterprises in the EMEA Region.

    Session Details:

    Smartsheet for clinical trials

    2025-10-22, 9:15 AM

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    Abdellah Lazaar
    Senior Solution Engineer, Smartsheet

    Abdel is a Senior Solution Engineer at Smartsheet in London, with over 10 years of experience in customer engagement and SaaS products across EMEA. He holds a master's degree in Economics from the University of Montpellier 1 and has worked in energy Forecasting, Business Intelligence, and Retail Data Software. Abdel has supported major clients like EDF, Deutsche Bank, Monoprix, and L'Oréal. He is also the Chairman of FC Vauvert (France), reflecting his passion for football.

    Session Details:

    Smartsheet for clinical trials

    2025-10-22, 9:15 AM

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    Advisory Board

    Select a member to learn more

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    Chris Wallace
    Head of Distribution EMEA, Argenx

    Chris has over 35 years’ varied supply chain experience, having worked for several blue chip companies in a number of industries including 3rd party logistics services, automotive, medical device, nuclear fuels and biotech/pharmaceuticals.

    Originally from the UK but now based in Switzerland, he has been involved in life science - biotech/pharmaceuticals & medical device - for over 20 years of his career and has latterly been SVP Global Supply Chain at Clover Biopharmaceutical before last year moving to Argenx as Head of Distribution EMEA.

    He has developed, implemented and managed global healthcare supply chain strategies and operations on 6 continents. This has included different set-ups in multiple countries, including many in the Emerging Markets as well as the developed world.

    Chris has a degree in economics from Manchester University, an MBA from Aston University and a postgraduate diploma from London University. In his spare time, he plays golf badly and loves to sample great Italian food and red wines!

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    Luiz Barberini
    Head of External Manufacturing, Latin America, Bayer
    • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
      Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
    • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
    • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
    • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
    • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
    • Solid team management skills, as well as Customer Service relationship and management
    • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

    CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

    Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

    Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

    Session Details:

    CTS sourcing and procurement trends and challenges – external manufacturing as the “procurement´s operational arm”

    2025-10-21, 8:30 AM

    Session Details:

    Panel Discussion: Reviewing geopolitical impact on supply chain: minimizing disruption through effective risk mitigation planning

    2025-10-21, 5:00 PM

    Session Details:

    Panel Discussion: Monitoring temperature control throughout supply chain lifecycle

    2025-10-21, 3:00 PM

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    Amanda Briceno
    Clinical Supply Management & Patient Centricity Unit Manager, Chiesi Farmaceutici

    Amanda Briceno is an experienced clinical supply professional with over 10 years in clinical research and supply chain operations. Originally from Venezuela, now based in Italy. She currently serves as Clinical Supply Manager and Head of the Patient Centricity Unit at Chiesi Farmaceutici, where she leads initiatives to design and deliver patient-focused clinical supply solutions that improve trial compliance and enhance the experience of both patients and site staff.

    Her career began as a Clinical Research Associate at IQVIA, where she gained extensive experience in global trial monitoring and operations. Since joining Chiesi, Amanda has held positions of increasing responsibility within the Clinical Supply department, before assuming her current leadership role.

    Amanda holds a Master’s degree in Drug Biotechnology from the Università degli Studi di Milano and a Bachelor’s degree in Medical Biotechnology. Amanda brings a strong blend of technical knowledge and operational leadership. Passionate about innovation in clinical supplies, she is dedicated to advancing more accessible, patient-centric clinical trials.

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    Paul Hingst
    Supply Chain Consultant, Crinetics Pharmaceuticals

    Paul is an experienced Clinical Supply Chain Professional with a 25-year career in the BioPharmaceutical industry.  His extensive career includes roles at major companies like Amgen and Thermo Fisher Scientific, where he honed his skills and made a significant impact.  He has served in varied roles from basic research and contract manufacturing to client services and account management.  He is a Principal Consultant and Co-Founder of Beacon BioPharm Associates, a clinical supply chain consulting firm, providing variable staffing solutions to small and mid-sized BioPharm clients.  Paul is an industry veteran and respected leader known for his expertise in clinical supply chain.

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    Amaury Jeandrain
    Strategy Advisor, Clinical Supply, N-SIDE

    Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain optimization. He joined Clinigen in 2015, then N-SIDE in 2016 where he last  held the position of VP of Strategy for clinical supply solutions.

    Over the past decade, his objective has been to make clinical trial supply chains more efficient by redefining CTS strategies and driving measurable performance improvements. His expertise also includes forecasting, planning, waste reduction, and shortage risk mitigation.

    Since 2024, while accompanying his wife on humanitarian missions abroad (Niger, then Colombia), Amaury has continued his work as a CTS advisor and trainer, partnering with pharmaceutical companies worldwide to enhance clinical supply performance.

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    Francesco Santo
    Director Clinical Supply Chain,
    Orano Med

    A highly experienced and passionate Director Clinical Supply Chain, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

    • Strategic Supply Chain Management
    • Regulatory Compliance
    • Cross-Functional Collaboration
    • Risk Management
    • Innovative Problem-Solving

    Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

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    Arnaud Dourlens
    Global Head of Clinical Supply Chain Operations, Sanofi

    Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group.

    During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio.

    Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

    Session Details:

    Fireside Chat: Integrating both clinical supply and clinical team perspectives for end to end supply chain efficiency

    2025-10-21, 9:30 AM

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    Paul Larochelle
    Senior Director Global Clinical Supply Chain,
    Takeda

    Paul Larochelle currently serves as Senior Director (Planning Team Lead) for Global Clinical Supply Chain at Takeda, where he serves as a member of the GCSC Leadership Team and is responsible for managing a team of professionals overseeing the forecasting and planning of clinical study supplies. His role encompasses the strategic and operational aspects of clinical supply chain management in therapeutic areas such as oncology, neuroscience, gastrointestinal diseases, vaccines, and rare diseases. Paul's leadership extends to cross-functional projects aimed at implementing new capabilities, conducting due diligence of potential acquisitions by the company, and improving existing processes.  

    Previously, Paul held various roles at Biogen Corporation and Genzyme, a Sanofi Company, where he honed his expertise in clinical asset planning and clinical supplies management. His contributions to these organizations included serving as a lead contact for multiple clinical programs, developing supply chain strategies, leading continuous improvement projects, and serving as Fellowship Coordinator and Student Preceptor for dozens of students.  

    Paul has a BS in Biology from Providence College, PharmD from MCPHS Boston, and an MBA from Worcester Polytechnic Institute. He also completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with MCPHS-Worcester and Genzyme Corporation. He is Chair of the Dean's Advisory Board at MCPHS School of Pharmacy – Boston,  a member of the Pharmacy Advisory Board at Western New England University, and a member of the Advisory Board for the Clinical Trial Supply global conference series.  

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