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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 and CTS 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 2026?

400+

Attendees

30+

Exhibitors

30+

Speakers
400+

Attendees

30+

Exhibitors
30+

Speakers

Testimonials

See What It's All About

Featured Sponsors

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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

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

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

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

Biorce builds AI infrastructure for clinical trials. Our platform, Aika, accelerates how pharmaceutical companies, biotechs, and CROs design and execute clinical research—reducing protocol development time by at least 50% while eliminating costly amendments that delay patient access to life-saving treatments. Built on a foundation of 1 million clinical trials, Aika delivers evidence-based recommendations with complete regulatory transparency. Every decision auditable and defensible before agencies like the FDA and EMA.

Company Website

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

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Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. We work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference.

Company Website

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

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Company Information

S-CLINICA is the leader in advanced clinical supply management, specializing in Supply Forecasting, Cost and Risk Analysis, Production Planning and RTSM on a single-platform solution – ClinVision, designed to streamline trial execution.

With built-in supply demand planning and risk analysis, our system enables sponsors to evaluate multiple scenarios and make data-driven decisions to optimize production and distribution.

By supporting continuous planning and real-time updates, ClinVision ensures that supply strategies align with study needs and adapt seamlessly to changes as they happen.

Our proven technology reduces waste, minimizes risk, and accelerates trial timelines, helping biopharma companies execute clinical studies with greater efficiency and confidence.

Company Website

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

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Company Information

Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com. 

Company Website

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

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Company Information

At TRI, we make RBQM work. Deployed on over 450 clinical trials, we understand the challenges and how to overcome them. Our industry-leading RBQM platform, OPRA, is built by operational experts to support Risk Assessment, Risk Management, and Central Monitoring—all in one intuitive system.

With real-world clinical trial experience, our RBQM team provides the guidance you need to meet regulatory requirements (ICH E6/E8) and confidently embed RBQM at the heart of your trials. That’s why leading global players trust TRI.

We’re not called The RBQM Experts for nothing.

Company Website

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

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Coquelle Consulting supports pharma and biotech companies and service providers across the full Clinical Outcome Assessment (COA) journey – from endpoint strategy and instrument selection to licensing, translations and eCOA implementation in global trials. 

Combining COA expertise with hands-on clinical operations support, we help sponsors navigate complexity, maintain consistency and protect the quality of outcome data from early planning through patient data collection. 

Company Website

To learn more, please visit our website - coquelle-consulting.com

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Company Information

Evestia Clinical is the specialist CRO for biotech running oncology, rare disease, and neurodegenerative trials. Your program is never a low priority for us. You get direct access to senior leaders from day one. The same team starts and finishes your trial. Your science deserves nothing less.
evestiaclinical.com

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Company Information

HEMEX is a European CRO supporting pharmaceutical, biotech, and MedTech SMEs with clinical development solutions. Headquartered in Basel and operating globally, we manage multinational trials. Our services include clinical operations, regulatory support, quality assurance, BA/BE and PK studies, patient recruitment, and advanced medical imaging

Company Website

To learn more, please visit our website - https://hemex.ch/

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Company Information

Founded in 2017, Collective Minds is a medical imaging platform connecting hospitals, scientists, and doctors, which helps organisations running clinical trials and research generate high-quality evidence faster and more efficiently. Headquartered in Stockholm, Collective Minds is built by a specialised team of 40 experts with deep experience in medical imaging and research operations.

Company Website

To learn more, please visit our website - https://collectiveminds.health/

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Company Information

The CCL Clinical Business Unit is the global specialist of CCL Industries Inc. for products and services in the clinical trials sector. Leveraging over two decades of expertise and operating across various manufacturing sites, we stand poised as your premier partner for clinical trial labeling. With a combined portfolio, worldwide reach, and dedicated local assistance, CCL Clinical emerges as your ultimate destination for excellence in clinical trial labeling services.

Company Website

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

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Company Information

EstiMates is a Finnish biometrics consultancy specializing in biostatistics, clinical data management, statistical programming, and data science. With strong expertise in clinical trials, we provide flexible, high-quality solutions across the biometrics lifecycle, from strategic oversight and management to hands-on technical execution, tailored to the needs of each project.

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    Agenda

    • 20 Oct 2026
    • 21 Oct 2026
    Expand All

    Streams

    Stream one

    OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

    Stream two

    CLINICAL TRIAL SUPPLY

    8 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    Alexander Booth
    Host, Lab to Lives

    9 AM

    Optimising Combined Study Approvals Across Clinical Trial, IVD and Medical Device Regulatory Frameworks

    • Sharing practical learnings and experiences from Phase 1 of the “all-in-one” pilot
    • Exploring what is changing in Phase 2 and what sponsors can expect from the expanded framework
    • Understanding how coordinated assessment could simplify studies involving medicinal products, IVDs and medical devices
    • Looking ahead at the wider COMBINE programme and how its learnings could inform future approaches to combined studies

    Speakers

    Ditte Zerlang Andersen
    Strategic Business Program Manager, Danish Medicines Agency

    9:30 AM

    Implementing the New UK Clinical Trial Regulation: What Sponsors Need to Do Differently

    • Understanding how the new UK framework is working in practice 6 months after implementation
    • Identifying key operational changes, including approvals, consent, and trial setup
    • Clarifying how sponsors can take advantage of faster pathways while staying compliant

     

    Speakers

    Tanya Turgoose
    Head of Industry Engagement, NIHR UK Clinical Research Facilities (UKCRF) Network

    10 AM

    THE SCIENCE IS YOURS. IS THE TIMELINE?

    Taking control of development to accelerate proof of concept and maximize value.

    • Is your strategy accelerating development—or delaying it? Align regulatory and operational planning from day one
    • Your sites can make or break your timeline
    • Case study: Spend less. Move faster. Prove more

    Speakers

    Dr. Claudia Hesselmann
    Founder & CEO, ARENSIA Exploratory Medicine

    10:30 AM

    Morning refreshments and networking break

    11 AM

    PANEL DISCUSSION: Debating Ownership and Risk Sharing in Sponsor and Vendor Partnerships

    • Exploring the meaning of risk sharing across roles
    • Supporting balance between procurement and R&D priorities
    • Strengthening partnership models through transparency

    Moderator

    Alexander Booth, Host, Lab to Lives Podcast

     

     

    Speakers

    Alexander Booth
    Host, Lab to Lives
    Robin Emmanuel
    Sourcing & Contract Manager, Coloplast
    Morten Bang Norgaard
    Outsourcing Manager, Ascendis Pharma

    11:30 AM

    If Lewis Hamilton Ran Your Clinical Trial

    Formula One solved twenty years ago what clinical trials are still working on: designing the pressure out before the lights go on. This talk explores what we can learn from the fastest teams on earth, how our industry can adjust and how those lessons apply to cell and gene therapy in neuroscience and rare disease.

    • Live data, live decisions: moving from retrospective reporting to real-time operational intelligence so enrollment, safety and site performance data can guide decisions while they still make a difference.
    • Designed handovers, not heroic firefighting: rehearsing the sequence across regulatory, contracts, drug supply and training before the study starts so site activation becomes fast, predictable and scalable across regions.
    • Adaptive by default, efficient by design: treating adaptability and cost discipline as one engineering problem rather than a trade-off in cell and gene therapy for neuroscience and rare disease where every patient counts.

    Speakers

    Åsa Carlsheimer
    Vice President, Head of Internal Medicine and Neuroscience, TFS Health Science

    12 PM

    Live from Ukraine: Running Clinical Trials During Disruption and Lessons for Global Studies

    • Understanding how clinical trials continue during war and infrastructure disruption
    • Managing patient safety supply chain and data integrity under extreme conditions
    • Applying lessons from Ukraine to improve resilience and contingency planning

    Speakers

    Ivan Vyshnyvetskyy
    Managing Director Ukraine, FutureMeds

    12:30 PM

    Beyond RBQM: How Intelligent RBQM Gives Sponsors and CROs a Measurable Edge

    Most Sponsors and CROs have made the move to RBQM at an operational level – but is the approach actually intelligent, or is it still driven by manual review cycles, static risk thresholds and teams buried in reporting?

    • Moving from operational RBQM to AI-enabled RBQM that learns, adapts and surfaces the right signals before they become issues
    • Identifying where operational RBQM is still leaving value on the table and where AI can create a step change in quality and efficiency
    • Examining what the data shows about improvements in speed, accuracy and cost
    • Achieving real-time inspection readiness for Sponsors and building a quality capability that helps CROs win and retain business

    Speakers

    Tim Collard
    Senior Vice President Sales, TRI

    1 PM

    Lunch and networking

    2 PM

    INTERACTIVE SESSION: China in Global Clinical Development: A Sponsor’s Decision Framework

    China has become a major source of biopharma innovation, clinical assets, and evidence. For global sponsors, the practical question is where China can add value to a program, what limitations need to be considered, and what it takes for China-generated evidence to support development decisions in other regions.

    Drawing on recent discussions with biotech and pharma leaders in China and the United States, this session will offer a sponsor-side framework for:

    • Understanding the sources of China’s development speed and how much the potential advantage depends on the asset, indication and development stage
    • Determining where China can add value in a global program: as a location for clinical development, a source of assets and evidence, or a strategic partner
    • Examining the factors that shape EMA and FDA assessments of China-generated evidence, including patient population, dose and exposure, standard of care, comparators, treatment sequencing and data integrity
    • Choosing the next development step: using the existing package, adding a focused bridging component, or designing a multiregional clinical trial
    • Defining the clinical, CMC, quality, and data governance requirements for a cross-regional program

     

    Speakers

    Kamil Sitarz
    Chief Operating Officer, Ryvu Therapeutics

    3 PM

    Faster by Design: Turning Development Strategy into Accelerated Study Delivery

    • Translating development strategy into protocols that are scientifically robust, operationally feasible and easier for sites to deliver
    • Reducing protocol complexity through earlier input from medical, operational, regulatory and site stakeholders
    • Applying country and site intelligence to accelerate start-up, strengthen recruitment planning and maintain momentum during execution
    • Considering how AI can accelerate delivery across the clinical development lifecycle

    Speakers

    Rosa Gonzalez
    Managing Director EU Biotech, Syneos Health

    3:30 PM

    Afternoon refreshments, networking & Prize Draw

    4 PM

    ASK THE EXPERT SESSION: Understanding The Key Criteria Investors Use When Selecting Biotech to Fund

    • Identifying how clinical strategy and data quality impact investment decisions
    • Translating investor expectations into practical changes in trial design and execution
    • Applying these insights to improve funding strategy in a tougher market

    Moderator: Alexander Booth, Host, Lab to Lives Podcast

    Speakers

    Stephan Christgau
    Founding Partner, Eir Ventures
    Alexander Booth
    Host, Lab to Lives

    4:30 PM

    TECH SPOTLIGHT: From Oversight to Foresight: The Intelligent Future of Clinical Outsourcing

    Clinical outsourcing generates more data than ever—but are we actually getting smarter at using it? This session explores how intelligence can transform the vendor management lifecycle: enabling smarter sourcing and category strategies, continuous governance and performance management, stronger ICH E6(R3) compliance, and greater inspection readiness. We’ll look beyond the AI hype to practical ways of connecting data, context, and human expertise to anticipate risk, improve decisions, and move clinical outsourcing from reactive oversight to proactive foresight.

    Speakers

    Anca Copaescu
    CEO & Founder, Clinical Maestro

    4:45 PM

    TECH SPOTLIGHT: Strategies for Preserving Valuable Biomarkers in Blood

    • Addressing logistical challenges in clinical trials for blood sample processing.
    • Implementing solutions to stabilize biomarkers at collection and simplify workflows.

    Speakers

    Astrid Provoost
    EMEA Sales Development Manager - CROs & Biotech BD Medical Essentials‚ Specimen Management, BD

    5 PM

    STANDUP COMEDY: Taking a light-hearted look at the realities of working in clinical trials and life sciences

    Speakers

    Ivanna Rosendal
    Vice President of Business Digitalization, Ascendis

    5:20 PM

    NETWORKING DRINKS SPONSORED BY TFS Health Science

    8:50 AM

    Chairperson’s Opening Remarks

    Speakers

    Wafaa Hassan
    Senior Strategic Intelligence Pharma Analyst, GlobalData

    9 AM

    Session reserved for Featured Sponsor

    9 AM

    KEYNOTE PANEL DISCUSSION: Building Resilient Clinical Supply Chains in An Era of Constant Disruption

    • Understanding how recent disruptions including natural events and geopolitical challenges have impacted supply chains
    • Learning how sponsors adapted routes suppliers and timelines to keep trials running
    • Identifying practical strategies to build flexibility visibility and faster decision making into supply operations

     

     

    Speakers

    Kamal Amin
    Head of Clinical Supplies Management, Galderma
    Michel David
    VP CMC & Clinical Supply, Noema Pharma
    Jonathan Pritchard
    Director Product Growth & Market Strategy, 4G Clinical

    9:30 AM

    Choosing the Right CDMO – Practical Lessons for Building Partnerships That Keep Clinical Trials on Track

    • Selecting the right CDMO for your program balancing speed, quality, flexibility, and long-term scalability
    • Building collaborative partnerships that improve communication, accountability, and execution across clinical supply
    • Common pitfalls in sponsor–CDMO relationships and how to avoid delays before they happen

    Speakers

    Michel David
    VP CMC & Clinical Supply, Noema Pharma

    10 AM

    The Case for Unifying Supply Forecasting and RTSM

    Clinical supply forecasting and RTSM systems have traditionally operated as separate entities. This session examines the compelling case for unifying these systems and the benefits that can accrue. Is this the future of clinical supply management? What does this imply for your studies.

    In this session we will look at:

    •  Operational challenges encountered in forecasting and RTSM systems seen as discrete solutions
    • Common integration models and why they fall short
    • The unified solution and its closed-loop capabilities
    • Business benefits including efficiency; cost savings and risk reduction

    Join us to explore how this unification can transform clinical supply management from a reactive, manual process into a proactive, data-driven capability that reduces costs and risk and optimises clinical supply.

    Speakers

    Jasvinder Osan
    Vice President Business Development, S-Clinica
    Irena Seredina
    Executive Director, S-Clinica

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Risk Management and Compliance in Pharma Air Freight: Navigating Through Regulatory Challenges

    • Understanding where compliance and operational risks most commonly arise in pharma air freight supply chains,
    • Managing regulatory challenges, including Good Distribution Practice (GDP), and the role of CEIV Pharma in mitigating risks and ensuring compliance.
    • Applying practical risk mitigation tools and planning strategies during transportation to avoid disruption and temperature excursions

    Speakers

    Mateusz Zawadzki
    Product Manager Special Cargo Certification, International Air Transport Association

    11:30 AM

    TECH SPOTLIGHT: Delivering Medication to Patients Quicker Through the Use of Digital Display Labels in Clinical Trials Operations & Supply Chain

    •  Exploring the practical benefits of Digital Display Labels for improving clinical trial supply operations
    • A demonstration of the functionality of DDLs; just-in-time labelling, lot & expiry update, multiple page count
    • Implementing the operational framework to securely manage remote content and language updates across global clinical trials
    • Key considerations for implementing DDLs across different IMP formats, including vials, bottles and blisters

    Speakers

    Brian Sheridan
    Vice President Global Adherence & Clinicals, Smurfit Westrock

    11:45 AM

    Digital Technologies in Clinical Trial Supply Packaging: Improving Compliance, Medicine Integrity and Patient Experience

    • Improving patient adherence through smart packaging and digital reminders
    • Protecting medicine integrity with real-time monitoring and traceability
    • Supporting clinical trials through connected packaging solutions
    • Lessons learned from implementing digital technologies in clinical trials

    Speakers

    Alexander Debets
    Lead Clinical Supply Innovation, Former MSD

    12:15 PM

    Navigating U.S. Import Compliance and Documentation Requirements

    • Understanding the key import compliance and documentation requirements when bringing products into the U.S.
    • Navigating the different requirements that may apply depending on the product being imported
    • Understanding the role of partner government agencies and when their requirements may come into play
    • Knowing where to find the right guidance and which agencies or resources to turn to when questions arise

    Speakers

    Gina Reneau
    Biological Threat Exclusion Coordinator, U.S. Customs & Border Protection

    1 PM

    Lunch and networking

    2 PM

    INTERACTIVE BOARDROOM: Responding to Changing Trial Demand Without Increasing Supply Risk

    • Understanding how demand impacts clinical supply operations
    • Improving responsiveness during changing enrolment and country expansion
    • Reducing overproduction, waste and unnecessary shipments
    • Managing data for real-time supply planning
    • Sharing practical lessons from global studies

    Speakers

    Kamal Amin
    Head of Clinical Supplies Management, Galderma

    2:30 PM

    Lessons from Early-Stage Biotech – Aligning Clinical Operations, Vendors and Clinical Supply

    • Building strong cross-functional alignment before first patient in
    • Identifying and addressing operational risks early to avoid costly delays
    • Creating effective communication between sponsors, vendors and clinical supply teams
    • Practical lessons and common pitfalls from early-stage biotech programmes

    Speakers

    Tina Karunaratne
    Founder and President, Bridge to Compassionate Care

    3 PM

    FROM UNCERTAINTY TO PREDICTABILITY: Closing the Loop Between Protocol, Planning and Clinical Supply Execution

    • Clinical supply uncertainty becomes manageable when supply considerations are introduced during protocol design and connected through a structured digital thread spanning planning, RTSM execution, and operational data
    • Endpoint demonstrates how closing the loop between forecasts and trial actuals enables teams to recognize change earlier, understand its implications faster, and act before it creates patient or study risk

    Speakers

    Nagaraja “Sri” Srivatsan
    CEO, Endpoint Clinical

    3:30 PM

    Afternoon refreshments, networking & Prize Draw

    4 PM

    INTERACTIVE SESSION: Balancing Cost Versus Quality in Clinical Supply And Making The Right Trade-Offs

    • Understanding where reducing cost versus protecting patient safety creates real tension in clinical supply
    • Exploring trade-offs between speed cost and quality versus operational risk and trial integrity
    • Debating when cost reduction is justified versus when it creates unacceptable risk
    • Defining where efficiency gains are possible versus where quality must remain non-negotiable

    Speakers

    Laurynas Dailide
    Senior Category Lead, Novo Nordisk

    4:30 PM

    Clinical Trial Supply in a Changing Global Market – Where the Risks and Opportunities Are Emerging

    • Global shifts affecting clinical trial supply and sourcing
    • Emerging geographic dependencies and areas of risk
    • What the data tells us about how the market is changing
    • Key trends sponsors should be preparing for

    Speakers

    Wafaa Hassan
    Senior Strategic Intelligence Pharma Analyst, GlobalData

    5:20 PM

    NETWORKING DRINKS SPONSORED BY TFS Health Science

    Streams

    Stream one

    OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

    Stream two

    CLINICAL TRIALS TECHNOLOGY & INNOVATION

    8 AM

    Registration and refreshments

    8:50 AM

    Chairperson’s Opening Remarks

    9 AM

    Lessons Learned from the First Years of the EU Clinical Trials Regulation

    • What have Member States done to harmonise procedures
    • Templates and Procedures developed e.g pre-CTA
    • FAST EU and Fast track for early phases

    Speakers

    Lene Grejs Petersen
    EU CT-policy adviser, Danish Medicines Agency

    9:30 AM

    Demonstrating Proof-of-Concept in 3 Days: Operational Excellence in a Selective JAK1 Inhibitor (Londamocitinib) FIH respiratory trial

    • Designing an FIH study to generate an early proof-of-concept signal alongside safety and tolerability data
    • Selecting FeNO as a practical biomarker to rapidly assess anti-inflammatory activity in asthma patients
    • Demonstrating a 50% reduction in mean FeNO after just three days of treatment while maintaining minimal systemic exposure
    • Exploring the operational decisions that enabled rapid assessment of healthy volunteers and asthma patients within the same early-phase programme
    • Translating early clinical and biomarker data into clear evidence to support the next stage of development

    Speakers

    Pablo Forte Soto, MD, MSc, DPhil, FFPM
    Director, Safety Human Pharmacology, Parexel EPCU London

    10 AM

    Maintaining Control While Working with CROs and Improving Oversight Without Slowing Trials – Lessons Learnt

    • Defining clear roles and responsibilities between sponsor and CRO to avoid duplication and gaps
    • Identifying what sponsors should actively oversee versus what can be delegated with confidence
    • Setting oversight models that focus on risk rather than excessive monitoring
    • Improving communication and escalation pathways to prevent delays and misalignment

    Speakers

    Olivia Vu Van
    Clinical Project Manager, Integrative Research Laboratories

    10:30 AM

    Morning refreshments and networking break

    11 AM

    PANEL DISCUSSION Choosing Where to Run Clinical Trials in 2027 and Balancing Speed, Quality and Access

    • Comparing timelines and setup across the UK EU and other key regions
    • Understanding trade-offs between speed cost quality and patient access
    • Deciding how to prioritise regions based on trial type and strategy

    Moderator Tina Karunaratne, Founder and President, Bridge to Compassionate Care

    Speakers

    Tina Karunaratne
    Founder and President, Bridge to Compassionate Care
    Lene Grejs Petersen
    EU CT-policy adviser, Danish Medicines Agency
    Tanya Turgoose
    Head of Industry Engagement, NIHR UK Clinical Research Facilities (UKCRF) Network
    Dr. Claudia Hesselmann
    Founder & CEO, ARENSIA Exploratory Medicine

    11:45 AM

    TECH SPOTLIGHT From Friction to Flow: The Future of Imaging in Clinical Trials

    • Automation from scan to end-point
    • Imaging biomarkers and experts
    • Site connectivity for full traceability

    Speakers

    Anders Nordell
    CEO and Co-Founder, Collective Minds

    12 PM

    Using National Trial Support Models Effectively and When They Add Value

    • Exploring initiatives like Trial Nation
    • Understanding funding structures
    • Deciding when they add value

    Speakers

    Kirsten Bødker
    Head of Business Relations and Clinical Facilitator, Trial Nation

    12:30 PM

    Lunch and networking

    1:45 PM

    Meaningful Patient Involvement in Rare Disease Trials: From Recruitment to Partnership

    • Insights from the Nordic Patient Empowerment Survey (Nordic Rare Disease Summit 2025) and the Danish Rare Disease Survey (Guldkundeunders gelsen 2025) and their relevance for clinical trial design and patient engagement
    • Building trust and improving communication to support participation in healthcare and clinical research
    • Understanding the practical barriers faced by people living with rare diseases and how they may influence clinical trial participation
    • Moving from consultation to partnership: patient perspectives on involvement and decision-making throughout the research journey
    • Leveraging insights from Nordic patient organisations to better understand patient needs and priorities in rare disease research

    Speakers

    Liselotte Wesley Andersen
    Chairperson, Rare Disease Denmark

    3:15 PM

    Afternoon refreshments, networking & Prize Draw at 15:30

    3:45 PM

    End of Conference

    8:50 AM

    Chairperson’s Opening Remarks

    9 AM

    Trial Data in 2027: The Consent and Governance Layer Pharma Can’t Outsource to a CRO

    • What changes for sponsors when EHDS, eIDAS 2.0 wallets, the Data Governance Act and the AI Act converge on clinical trial data infrastructure.
    • Why current consent and audit-trail architectures will not survive a participant's right to revoke or port their data, and what the Nordic region is already building as the working answer: consent evidence ledgers, privacy-preserving computation, and neutral data altruism intermediaries

    Speakers

    Christel Conrad
    Head of Brand, Marketing & Customer Success, DATA for GOOD Foundation
    Kristian Johnsen
    Head of Strategy and Partnerships, DATA for GOOD Foundation

    9:30 AM

    From Study Design to Operational Reality: Making Trials Work at Conception

    • Exploring why protocol amendments, slow enrolment and late feasibility surprises are often failures of execution rather than science
    • Applying real-world operational evidence to trial design decisions before problems surface
    • Identifying execution risks early to design more predictable, scalable trials
    • Including a live demonstration of Aika, Biorce’s AI-driven clinical trials assistant

    Speakers

    Mariana Spínola
    Senior Clinical Specialist, Biorce

    10 AM

    PANEL DISCUSSION: Making Clinical Trial Technology Work for Sites and Reducing System Burden

    • Understanding how multiple systems increase burden for sites and study teams
    • Identifying where technology slows down rather than supports trial delivery
    • Simplifying workflows across platforms to improve adoption and efficiency
    • Reducing friction without removing valuable data and insights

    Moderator

    Kamil Sitarz, Chief Operating Officer, Ryvu Therapeutics

    Speakers

    Rasmus Jakobsen
    Senior Manager, Digital Innovation and Execution, Genmab
    Ivan Costa Abalo
    Senior Data Manager, Zealand Pharma
    Tine Rosenberg
    Chief Nurse, Rigshospitalet
    Kamil Sitarz
    Chief Operating Officer, Ryvu Therapeutics

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Making Clinical Trial Data Work Together and Improving Visibility Across Systems Through Real-World Case Studies

    • Exploring why, in fully outsourced clinical trial models, visibility across data systems can be less a technology question than a process one
    • Understanding where data signals can fall through the gaps when multiple CROs and vendors have their own internal processes, review cadences and timelines
    • Case study: a pharmacokinetic protocol deviation that never reached the sponsor because it fell between chairs in the communication chain
    • Case study: a screen failure cleaning exercise where a site misinterpretation of instructions led to an irreconcilable discrepancy
    • Exploring how stronger oversight frameworks and clearer agreement on what is expected, and from whom, could prevent these issues
    • Asking what we should be considering before adopting a new digital tool – recognising that a tool can integrate systems, but not always processes

    Speakers

    Ivan Costa Abalo
    Senior Data Manager, Zealand Pharma

    11:30 AM

    From Patient Experience to Digital Measures: Capturing What Matters and Keys to Successful Implementation in Clinical Trials

    • How patient centered digital measures can capture meaningful changes in health and daily life that traditional, episodic clinical assessments may miss
    • How continuous, real-world wearable data can help assess whether improvements during standardized in-clinic tests translate into meaningful changes in patients’ daily live
    • Real world case examples demonstrating how fit for purpose digital measures can reveal treatment signals, functional changes, and patient relevant outcomes that standard approaches may not fully capture
    • Why successful patient-centered digital measurement requires thoughtful study design, fit-for-purpose algorithms, continuous compliance monitoring, and high-quality data
    • Practical guidance for advancing digital measures from exploratory use toward clinically meaningful endpoints while maintaining patient relevance throughout clinical development

    Speakers

    Jen Blankenship
    Director of Science, VivoSense

    12 PM

    Mapping Nordic R&D Innovation and the Next Wave of Drug Development

    • Identify where Nordic R&D innovation is concentrating across therapy areas, development stages and emerging modalities
    • Compare Denmark, Sweden, Finland and Norway to reveal distinct innovation profiles and emerging areas of specialisation
    • Benchmark Nordic R&D against the global pipeline to identify where the region is over-indexing and which therapeutic areas and emerging modalities could shape the next wave of drug development

    Speakers

    Eleni Tokali
    Senior Pharmaceutical Analyst, GlobalData

    12:30 PM

    Lunch and networking

    1:45 PM

    Using AI Tools in Clinical Trials and What Works for Small and Mid-Sized Biotech

    • Sharing practical examples of what has worked (and what hasn’t)
    • Highlighting key challenges and how to overcome them
    • Comparing tools in terms of ease of implementation, cost, and impact for smaller teams
    • Exploring which solutions are realistically adoptable within limited resources and existing systems

    Speakers

    Rasmus Jakobsen
    Senior Manager, Digital Innovation and Execution, Genmab

    2:15 PM

    The End of Fragmented Clinical Data & Decision-Making

    • Explore what becomes possible when clinical data and decisions are connected across study design, country strategy, feasibility, and site selection
    • Hear the Novo Nordisk + H1 story and how the organizations are working together toward a more connected clinical development ecosystem
    • Learn how to move beyond fragmented systems, spreadsheets, and data sources toward a trusted foundation that helps teams make faster, more informed decisions
    • Discover how connecting sponsor intelligence with site-level insights and feedback can strengthen feasibility and site selection while reducing disconnects across the trial lifecycle
    • See why connected, mastered data is critical to unlocking the potential of AI in clinical development, and why the future requires more than another point solution

    Speakers

    Abhishek Chatterjee
    GVP Product, Insights & Analytics, Clinical and Site Lead, Denmark, H1

    2:45 PM

    INTERACTIVE WORKSHOP: Recognising Patient Communication Styles and Adapting Your Approach

    • Concept: This session explores how different patient personalities, preferences and behaviours can shape the way they receive information, ask questions and engage with a clinical trial. Through guided discussion and practical examples, participants will identify common communication styles and consider how to recognise individual needs without relying on assumptions.
    • Takeaway: Attendees will leave with a practical framework for recognising different communication preferences and adapting their approach to build understanding, trust and engagement with patients.

    Speakers

    Roel van der Heijde
    Facilitator & Trainer, Patient Experience Association The Netherlands

    3:15 PM

    Afternoon refreshments, networking & Prize Draw at 15:30

    3:45 PM

    End of Conference

    Speakers

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    Laurynas Dailide
    Senior Category Lead, Novo Nordisk

    Laurynas is a senior procurement and category management professional with more than 12 years of experience across the pharmaceutical, energy, and industrial sectors. In his current senior leadership role at Novo Nordisk, he helps shape strategic sourcing priorities, strengthen stakeholder and supplier partnerships, and drive sustainable business value. His broader expertise includes category strategies, negotiations, change management, and cross-functional collaboration.

    Session Details:

    INTERACTIVE SESSION: Balancing Cost Versus Quality in Clinical Supply And Making The Right Trade-Offs

    2026-10-20, 4:00 PM

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    Ivan Vyshnyvetskyy
    Managing Director Ukraine, FutureMeds

    Dr. Ivan Vyshnyvetskyy is a seasoned expert in clinical trials with over 20 years of experience. His expertise spans over 70 clinical trials, including more than 50 as Principal Investigator. As the Managing Director Ukraine, he leads a growing Ukrainian unit of FutureMeds, a top-ranked European professional site network. Dr. Vyshnyvetskyy also serves as the Chair of the Ukrainian Association of Clinical Trials, where he works to enhance cooperation with regulatory bodies, harmonize legislation, and improve clinical trial awareness.  As an Associate Professor at O.O. Bohomolets National Medical University, Dr. Vyshnyvetskyy teaches courses in Research Methodology, Healthcare Management, and Strategic Management.  He holds a PhD in Cardiology from Donetsk National Medical University and a Master of Global Management from American University Kyiv.

    Session Details:

    Live from Ukraine: Running Clinical Trials During Disruption and Lessons for Global Studies

    2026-10-20, 12:00 PM

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    Ivanna Rosendal
    Vice President of Business Digitalization, Ascendis

    Ivanna Rosendal is the VP of Digitalization at Ascendis Pharma, a behavioral economist and stand-up comedian. She has worked towards optimizing R&D in large and small biopharmaceutical companies the past 15 years. Now she focuses on leveraging technology to enhance the work of scientists, clinicians and medical teams, ensuring they can make a significant impact on patient outcomes. Through initiatives like my podcast, Lab to Lives, I aim to make life sciences more accessible and foster collaboration to drive meaningful change. Reach out to Ivanna on LinkedIn.

    Session Details:

    STANDUP COMEDY: Taking a light-hearted look at the realities of working in clinical trials and life sciences

    2026-10-20, 5:00 PM

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    Rasmus Jakobsen
    Senior Manager, Digital Innovation and Execution, Genmab

    Rasmus Jakobsen is a digital innovation leader with extensive experience at the intersection of clinical development, artificial intelligence, and life sciences. As Senior Manager of Trial Digital Innovation at Genmab, he leads the development and implementation of AI-enabled solutions that support clinical trial operations, including applications for risk-based quality management, knowledge management, and digital transformation.

    Throughout his career at Genmab, LEO Pharma, and NNIT, Rasmus has driven the adoption of AI, data analytics, and agile ways of working in highly regulated pharmaceutical environments. He has led cross-functional teams and strategic initiatives spanning clinical operations, R&D, and digital innovation, with a strong focus on translating emerging technologies into compliant, practical solutions that create measurable value.

    With a background in Pharmaceutical Design & Engineering from the Technical University of Denmark, Rasmus combines technical expertise with hands-on experience in clinical research, digital transformation, and organizational change. As a speaker, he shares practical insights on AI in clinical development, digital innovation, and how sponsors can successfully navigate the opportunities and challenges of modernizing clinical trials.

    Session Details:

    Using AI Tools in Clinical Trials and What Works for Small and Mid-Sized Biotech

    2026-10-21, 1:45 PM

    Session Details:

    PANEL DISCUSSION: Making Clinical Trial Technology Work for Sites and Reducing System Burden

    2026-10-21, 10:00 AM

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    Olivia Vu Van
    Clinical Project Manager, Integrative Research Laboratories

    Olivia Vu Van is a Clinical Project Manager at Integrative Research Laboratories (IRLAB), a Swedish company, rooted in Nobel Prize-winning research, focusing on CNS disorders, and especially Parkinson’s Disease. She has worked within clinical operations for the past 10 years from hands-on clinical trial leadership in large biopharmaceutical companies to cross-functional coordination in small biotech organizations. For the last years, as the main point of contact for the CROs conducting IRLAB’s trials, Olivia has been responsible for end-to-end trial delivery, ensuring vendor/CRO oversight, regulatory readiness and operational consistency within the organization.

    Session Details:

    Maintaining Control While Working with CROs and Improving Oversight Without Slowing Trials – Lessons Learnt

    2026-10-21, 10:00 AM

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    Kirsten Bødker
    Head of Business Relations and Clinical Facilitator, Trial Nation

    Kirsten Bødker is Head of Business Relations and Clinical Facilitator for several disease area networks at Trial Nation, a role she has held since 2020. Trial Nation is a non-profit organisation, primarily publicly funded, working to promote public-private partnership and strengthen the framework conditions for conducting clinical trials in Denmark, in close collaboration with authorities, hospitals, patient organisations, and life science companies.

    Prior to joining Trial Nation, Kirsten spent twelve years in Medical Affairs at a multinational pharmaceutical company, much of that time in Nordic-wide positions. Before this, she led a clinical research unit at Copenhagen University Hospital, Hvidovre, for more than a decade.
    With over three decades of experience spanning clinical research, medical affairs, and clinical trial facilitation, Kirsten brings deep expertise in bridging academia, healthcare,

    Session Details:

    Using National Trial Support Models Effectively and When They Add Value

    2026-10-21, 12:00 PM

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    Roel van der Heijde
    Facilitator & Trainer, Patient Experience Association The Netherlands

    Roel van der Heijde lives in Rotterdam, The Netherlands. He has a MA in International Business, is an international acknowledged NLP trainer, executive team coach and a certified death and grief counsellor.

    He is a driven and experienced trainer and facilitator in:

    • - Patient Fear Reduction (for all caregivers);
    • - Team Collaboration;
    • - Vulnerability & Leadership;
    • - Discrimination & Inclusion.

    Roels motivation: “Acknowledgement and recognition of the fears and emotions of our patients are the basis for excellent patient experience and patient safety”.

    “Working with Groups I experience as thoroughly fascinating and inspiring. In interaction with groups I am every time amazed by the enormous potential of practical knowledge and direct experience that lies hidden in groups and that is so easily overlooked. Herein lies the basis for excellent vulnerable leadership.

    Session Details:

    INTERACTIVE WORKSHOP: Recognising Patient Communication Styles and Adapting Your Approach

    2026-10-21, 2:45 PM

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    Kamil Sitarz
    Chief Operating Officer, Ryvu Therapeutics

    Kamil Sitarz is Chief Operating Officer and Management Board Member at Ryvu Therapeutics, a European clinical-stage oncology company advancing a diversified pipeline of innovative therapies. He leads corporate strategy, enterprise governance, capital planning, and cross-functional clinical development execution across a diversified oncology portfolio.

    He has been instrumental in transforming Ryvu into a multi-program clinical-stage organization, embedding disciplined portfolio governance and architecting development pathways designed to enhance execution predictability in complex, high-risk oncology settings. His leadership integrates clinical strategy with capital allocation discipline, ensuring alignment across scientific ambition, regulatory positioning, operational design, and financial planning to drive sustainable enterprise value.

     

    Under his direction, Ryvu has built and scaled a robust clinical development organization capable of delivering international Phase I/II programs across challenging hematologic indications and multi-country site networks. He has also played a key role in establishing and governing strategic clinical collaborations with leading global oncology partners, strengthening Ryvu’s development footprint and reinforcing its credibility within the international biotech ecosystem.

     

    With a PhD in Medical Genetics and an Executive MBA, Kamil combines scientific depth with enterprise-level strategic and operational leadership to advance innovation with rigor, accountability, and long-term growth orientation.

    Session Details:

    INTERACTIVE SESSION: China in Global Clinical Development: A Sponsor’s Decision Framework

    2026-10-20, 2:00 PM

    Session Details:

    PANEL DISCUSSION: Making Clinical Trial Technology Work for Sites and Reducing System Burden

    2026-10-21, 10:00 AM

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    Mateusz Zawadzki
    Product Manager Special Cargo Certification, International Air Transport Association

    Mateusz Zawadzki is a professional respected for his experience in special cargo supply chain management. In his previous roles, he managed special cargo operations and fostered key account management. Mateusz's prior experience showcased exemplary proficiency in driving impactful product strategy for specialized product units. The skill set he possesses also to encompass complex air freight problem-solving and risk analysis. Mateusz's proven track record in customer service and special cargo operations.

    Session Details:

    Risk Management and Compliance in Pharma Air Freight: Navigating Through Regulatory Challenges

    2026-10-20, 11:00 AM

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    Navid Arshad
    Supply Chain Clinical Trial Study Lead, AstraZeneca
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    Liselotte Wesley Andersen
    Chairperson, Rare Disease Denmark

    Liselotte Wesley Andersen is Chair of Rare Diseases Denmark (Sjældne Diagnoser). At the OCT & CTS Nordics Conference, she represents SBONN – Rare Diseases Nordic Network, bringing a Nordic perspective on patient involvement in rare disease research.

    Liselotte holds a PhD in population genetics and worked as a research scientist for more than 30 years before moving into patient advocacy. Today, she works to strengthen the voice of people living with rare diseases in research, healthcare and health policy, with a particular focus on patient empowerment and meaningful involvement in clinical research.

    Session Details:

    Meaningful Patient Involvement in Rare Disease Trials: From Recruitment to Partnership

    2026-10-21, 1:45 PM

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    Eleni Tokali
    Senior Pharmaceutical Analyst, GlobalData

    Eleni Tokali, MPharm, MPH, is a Drug Intelligence Analyst at GlobalData. Her primary responsibilities include managing and maintaining GlobalData’s Drugs Database, analyzing drug pipeline information and producing analytical market insight reports. Additionally, Eleni provides timely client support and performs database quality checks. Prior to joining GlobalData, Eleni worked as a registered pharmacist under the General Pharmaceutical Council (GPhC). Eleni has a firm knowledge of pharmaceutical industry dynamics as well as global public health perspectives. Eleni holds a Master of Pharmacy from the University of Brighton and a Master of Public Health from King's College London.

    Session Details:

    Mapping Nordic R&D Innovation and the Next Wave of Drug Development

    2026-10-21, 12:00 PM

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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:

    KEYNOTE PANEL DISCUSSION: Building Resilient Clinical Supply Chains in An Era of Constant Disruption

    2026-10-20, 9:00 AM

    Session Details:

    INTERACTIVE BOARDROOM: Responding to Changing Trial Demand Without Increasing Supply Risk

    2026-10-20, 2:00 PM

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    Ivan Costa Abalo
    Senior Data Manager, Zealand Pharma

    Ivan Costa Abalo is a Senior Clinical Data Manager at Zealand Pharma, where he drives data management activities across fully outsourced clinical trials, overseeing CRO collaboration, trial-specific deliverables, and data management workflows. He works closely with cross-functional teams to ensure data quality, compliance, and alignment with internal standards throughout the trial lifecycle.

    Prior to joining Zealand Pharma, Ivan worked at Novo Nordisk as a Clinical Trial Data Manager, where he contributed to process optimisation initiatives and helped establish clearer responsibilities and procedures in omics data management.

    With experience spanning both large-scale pharma and a focused clinical-stage biotech, Ivan brings a practical perspective on what it takes to make clinical trial data work across complex, multi-vendor environments.

    Session Details:

    Making Clinical Trial Data Work Together and Improving Visibility Across Systems Through Real-World Case Studies

    2026-10-21, 11:00 AM

    Session Details:

    PANEL DISCUSSION: Making Clinical Trial Technology Work for Sites and Reducing System Burden

    2026-10-21, 10:00 AM

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    Stephan Christgau
    Founding Partner, Eir Ventures

    Stephan Christgau is a founding partner of the Nodic life science venture fund Eir Ventures, and an experienced life science investor with a strong background in both preclinical and clinical development. With a proven track record across the European and US biotech landscapes, he brings deep expertise from academia and industry alike. His career is grounded in scientific excellence, reflected in over 60 peer-reviewed publications and more than 30 patent applications. With almost two decades as a life science venture investor, Stephan has been involved in formation and financing of more than 25 biotech companies that have advanced innovative project through to clinical validation.

    Session Details:

    ASK THE EXPERT SESSION: Understanding The Key Criteria Investors Use When Selecting Biotech to Fund

    2026-10-20, 4:00 PM

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    Lene Grejs Petersen
    EU CT-policy adviser, Danish Medicines Agency

    Session Details:

    Lessons Learned from the First Years of the EU Clinical Trials Regulation

    2026-10-21, 9:00 AM

    Session Details:

    PANEL DISCUSSION Choosing Where to Run Clinical Trials in 2027 and Balancing Speed, Quality and Access

    2026-10-21, 11:00 AM

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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:

    Digital Technologies in Clinical Trial Supply Packaging: Improving Compliance, Medicine Integrity and Patient Experience

    2026-10-20, 11:45 AM

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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:

    TECH SPOTLIGHT: Delivering Medication to Patients Quicker Through the Use of Digital Display Labels in Clinical Trials Operations & Supply Chain

    2026-10-20, 11:30 AM

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    Anders Nordell
    CEO and Co-Founder, Collective Minds

    Anders Nordell is the CEO and Co-Founder of Collective Minds. With a career spanning medical imaging science at Stanford and Karolinska to leadership roles at GE Healthcare, Anders now leads Collective Minds in its mission to break down healthcare silos. His work focuses on leveraging secure, cloud-native platforms to connect hospitals and researchers, accelerating the development of AI-powered diagnostics and therapies through real-world imaging data

    Session Details:

    TECH SPOTLIGHT From Friction to Flow: The Future of Imaging in Clinical Trials

    2026-10-21, 11:45 AM

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    Tanya Turgoose
    Head of Industry Engagement, NIHR UK Clinical Research Facilities (UKCRF) Network

    With more than 20 years' experience across industry, the NHS and the NIHR, Tanya brings extensive experience in commercial clinical research, spanning CRO, NHS R&D, research delivery and national NIHR roles. Throughout her career, she has focused on strengthening collaboration between industry, the NHS and the UK's clinical research infrastructure to improve the UK's attractiveness for commercial research.

    As a member of the UKCRF Network Senior Leadership Team, Tanya leads the Network's strategic engagement with industry and works through the NIHR Industry Hub to support a more coordinated national approach to commercial research. She works with pharmaceutical and biotechnology companies, CROs and partners across the UK research system to accelerate commercial experimental medicine research by improving feasibility, study set-up and delivery.

    Working across the wider NIHR infrastructure, Tanya helps develop a more coordinated national offer for industry, supporting sponsors to navigate the UK research landscape and access the expertise, facilities and capabilities required to deliver innovative early-phase and complex clinical trials. Her work supports the UK's wider life sciences ambitions by improving the speed, predictability and attractiveness of commercial research delivery.

    Tanya represents the NIHR Industry Hub and UKCRF Network at national and international industry meetings and conferences, building relationships with life sciences companies and partners and promoting the UK's capabilities in commercial clinical research and experimental medicine.

    Session Details:

    Implementing the New UK Clinical Trial Regulation: What Sponsors Need to Do Differently

    2026-10-20, 9:30 AM

    Session Details:

    PANEL DISCUSSION Choosing Where to Run Clinical Trials in 2027 and Balancing Speed, Quality and Access

    2026-10-21, 11:00 AM

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    Alexander Booth
    Host, Lab to Lives

    Alex is a podcast host, consultant, and coach helping companies explore and implement more effective ways of getting their drugs and devices out of the lab, and into patients' lives. As a co-host of the Lab to Lives podcast he uses his 18 years in healthcare innovation to explore the topics at the forefront of advancing how drugs and devices are developed and successfully commercialised. Outside of this he can regularly be found working with companies on their product strategy and implementation, helping companies put these ideas into practice to improve the health of patients worldwide.

    Session Details:

    PANEL DISCUSSION: Debating Ownership and Risk Sharing in Sponsor and Vendor Partnerships

    2026-10-20, 11:00 AM

    Session Details:

    Chairperson’s opening remarks

    2026-10-20, 8:50 AM

    Session Details:

    ASK THE EXPERT SESSION: Understanding The Key Criteria Investors Use When Selecting Biotech to Fund

    2026-10-20, 4:00 PM

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    Michel David
    VP CMC & Clinical Supply, Noema Pharma

    Michel is responsible for CMC and Clinical Supply at NOEMA Pharma, a late-stage Biotech start-up developing new central nervous system (CNS) therapies.

    He is responsible for the Phase 2/3 product portfolio, covering the E2E Supply Chain, from Drug Substance to Clinical Supply and Market Launch Readiness. This requires establishing effective partnerships with all service providers.
    Michel has over 25 years of experience in Pharmaceutical Development, Manufacturing and Supply, at Roche, Aventis and in Biotech Start-ups.

    Michel is a MSc. Chemist, Chemical Engineer and holds an MBA from INSEAD.

    Session Details:

    KEYNOTE PANEL DISCUSSION: Building Resilient Clinical Supply Chains in An Era of Constant Disruption

    2026-10-20, 9:00 AM

    Session Details:

    Choosing the Right CDMO – Practical Lessons for Building Partnerships That Keep Clinical Trials on Track

    2026-10-20, 9:30 AM

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    Tina Karunaratne
    Founder and President, Bridge to Compassionate Care

    Tina Karunaratne is a global clinical operations and program management executive with over two decades of leadership experience across the healthcare, biotechnology, and pharmaceutical industries. She is recognized for her expertise in strategic clinical operations, program leadership, vendor governance, patient advocacy, and operational excellence.

    Tina is the Founder and President of Bridge to Compassionate Care (BCC), a 501(c)(3) non-profit organization dedicated to improving access to healthcare, clinical trials, education, and support for underserved patient populations, caregivers, and rare disease communities. Through BCC, Tina works to bridge gaps between patients, advocacy groups, healthcare providers, and the clinical research ecosystem to advance equitable participation and compassionate care.

    She is also the Founder and CEO of Karuna Integrated Clinical Services (KICS), a wholly biopharma consulting company that supports small and emerging biopharmaceutical companies through high-touch, strategic clinical operations and consulting services.

    In addition to her entrepreneurial leadership, Tina serves in advisory and board roles across multiple biopharma organizations and is actively involved in initiatives focused on clinical trial innovation, patient engagement, diversity in clinical research, and operational strategy.

    Tina holds a Doctorate in Law and Policy from Northeastern University and a Master’s degree in Regulatory Affairs from Regis College.

    Session Details:

    PANEL DISCUSSION Choosing Where to Run Clinical Trials in 2027 and Balancing Speed, Quality and Access

    2026-10-21, 11:00 AM

    Session Details:

    Lessons from Early-Stage Biotech – Aligning Clinical Operations, Vendors and Clinical Supply

    2026-10-20, 2:30 PM

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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:

    FROM UNCERTAINTY TO PREDICTABILITY: Closing the Loop Between Protocol, Planning and Clinical Supply Execution

    2026-10-20, 3:00 PM

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    Mariana Spínola
    Senior Clinical Specialist, Biorce

    Mariana Spínola is a Sr Clinical Specialist at Biorce, where she helps teams use Aika, an AI-powered operating system that orchestrates clinical development from end-to-end, to accelerate clinical trials. She works closely with Pharmas, Biotechs and CROs, guiding them through the platform's workflow, and integrating AI in their workflows. Before joining Biorce, Mariana worked as a CRA, both on Sponsor and CRO side, ensuring trials are conducted in line with the approved protocol, data are reliable, and participant safety remains a top priority. Mariana is also a Nutritionist, with experience both in clinical and community nutrition and research

    Session Details:

    From Study Design to Operational Reality: Making Trials Work at Conception

    2026-10-21, 9:30 AM

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    Ditte Zerlang Andersen
    Strategic Business Program Manager, Danish Medicines Agency

    Ditte Zerlang Andersen joined the Danish Medicines Agency (DKMA) in 2015 as a clinical trial assessor. She now leads strategic projects in our national and EU regulatory landscape as a senior strategy project lead. Ditte recently led the work of the EU ‘COMBINE’ project analysing the interface between clinical trials and the device and in vitro diagnostic area. Prior joining DKMA, Ditte worked 5 years in the pharmaceutical industry and have a PhD in neuroscience.

    Session Details:

    Optimising Combined Study Approvals Across Clinical Trial, IVD and Medical Device Regulatory Frameworks

    2026-10-20, 9:00 AM

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    Robin Emmanuel
    Sourcing & Contract Manager, Coloplast

    Robin Emmanuel is a Sourcing & Contract Manager at Coloplast, where he leads strategic sourcing, contracting, and vendor governance activities supporting global clinical development programs. He brings extensive experience in sponsor-CRO partnerships, clinical trial outsourcing, and contract strategy, with a strong focus on building collaborative operating models that enable efficient, compliant, and high-quality clinical trial execution.

    Session Details:

    PANEL DISCUSSION: Debating Ownership and Risk Sharing in Sponsor and Vendor Partnerships

    2026-10-20, 11:00 AM

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    Anca Copaescu
    CEO & Founder, Clinical Maestro

    Anca Copaescu is the founder and CEO of Clinical Maestro®, bringing more than 20 years of experience in clinical operations and outsourcing. She is dedicated to helping life sciences organizations move from reactive oversight to proactive, intelligence-driven outsourcing by connecting data, operational context and human expertise. Through Clinical Maestro, Anca advances smarter sourcing strategies, continuous vendor governance, stronger performance management and greater inspection readiness. Her work focuses on translating technology and AI into practical capabilities that help clinical teams anticipate risk, strengthen compliance and make faster, better-informed outsourcing decisions.

    Session Details:

    TECH SPOTLIGHT: From Oversight to Foresight: The Intelligent Future of Clinical Outsourcing

    2026-10-20, 4:30 PM

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    Mads Kongsgaard Engelund
    Director Clinical Operations, Novo Nordisk

    Mads Kongsgaard Engelund, PhD, MSc, is Director and Head of Clinical Operations Leads at Novo Nordisk. With more than 20 years of experience in clinical research and global clinical operations, Mads has held leadership roles spanning clinical trial execution, project leadership, organizational development, and operational transformation. Prior to the current role, Mads led Clinical Operations in Novo Nordisk's Cardiovascular, Kidney and Alzheimer's Disease area, overseeing major global clinical development programs and contributing to several high-profile clinical trials. Earlier career experience includes leadership positions at IQVIA Nordics, where Mads headed the Scandinavian FSP clinical operations organization, as well as roles in trial management, clinical project leadership, and clinical research. Mads holds a PhD in Health Sciences and an MSc in Human Physiology from the University of Copenhagen.

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    Astrid Provoost
    EMEA Sales Development Manager - CROs & Biotech BD Medical Essentials‚ Specimen Management, BD

    Clinical Chemistry and Molecular Biology professional turned commercial leader, with more than a decade of experience in the life sciences industry. As EMEA Sales Development Manager at BD, I support CROs and biotech organizations with specimen management and biomarker preservation solutions, helping ensure high-quality samples for clinical research and precision medicine programs.

    Session Details:

    TECH SPOTLIGHT: Strategies for Preserving Valuable Biomarkers in Blood

    2026-10-20, 4:45 PM

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    Rosa Gonzalez
    Managing Director EU Biotech, Syneos Health

    As a senior biopharmaceutical executive with more than 30 years of experience in global clinical development, I help organizations transform scientific innovation into meaningful outcomes for patients. Throughout my career, I have built and led high-performing international teams, driven operational and commercial transformation, and developed strategic partnerships across the healthcare ecosystem.

    My experience spans leadership roles at Pfizer, ICON, and Syneos Health, where I have successfully guided complex clinical development programs from strategy through execution across multiple therapeutic areas. I am particularly passionate about immunology and inflammation, having led numerous global initiatives aimed at accelerating the development of innovative therapies.

    Beyond clinical development, I have been actively involved in shaping new business and operating models for the industry, including end-to-end product development strategies, virtual pharmaceutical organizations, pharmaceutical-CRO partnerships, decentralized clinical trials, and digital health solutions. My focus has always been on creating scalable, innovative approaches that improve performance, streamline development, and enhance patient access to life-changing medicines.
    I hold a degree in Biology and a Master's in Immunology from the University of Barcelona, complemented by postgraduate studies in Pharmaceutical Marketing and Medicine in the Pharmaceutical Industry. I have also completed executive leadership and corporate governance programs at ESADE, including Promociona and Futuras Consejeras.

    Today, my work sits at the intersection of science, business strategy, and leadership. I am passionate about fostering innovation, empowering teams, and building collaborative partnerships that accelerate the development of therapies that make a real difference in patients' lives.

    Session Details:

    Faster by Design: Turning Development Strategy into Accelerated Study Delivery

    2026-10-20, 3:00 PM

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    Pablo Forte Soto, MD, MSc, DPhil, FFPM
    Director, Safety Human Pharmacology, Parexel EPCU London

    Dr. Forte Soto is an MHRA-accredited Principal Investigator with over 25 years of experience in clinical practice and research. As Director of Safety Human Pharmacology at Parexel's London Early Phase Clinical Unit, he has led or contributed to more than 200 Phase I/II studies, including first-in-human trials, drug-drug interaction studies, bioequivalence, thorough QT, biosimilars, and proof-of-concept research.

    His therapeutic expertise spans CNS, immunology, cardiovascular, metabolism, respiratory, and dermatology. Dr. Forte Soto holds a medical degree from the University of Central Venezuela, an MSc in Clinical Pharmacology from the University of Aberdeen, and a DPhil in Clinical Pharmacology from the University of London. He completed postdoctoral training at the William Harvey Research Institute and is a Fellow of the Faculty of Pharmaceutical Medicine (FFPM).

    Session Details:

    Demonstrating Proof-of-Concept in 3 Days: Operational Excellence in a Selective JAK1 Inhibitor (Londamocitinib) FIH respiratory trial

    2026-10-21, 9:30 AM

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    Morten Bang Norgaard
    Outsourcing Manager, Ascendis Pharma

    Morten Bang Nørgaard is a senior outsourcing and strategic alliance specialist with more than 25 years of experience across the pharma and biotech industry. Throughout his career, he has held leadership roles at both small and large-scale sponsor and service provider companies, supporting drug development from early research through global clinical development and large -scale manufacturing.

    Morten is recognized for building and leading strategic partnerships, managing complex outsourcing programs, negotiating high-value contracts, and establishing effective governance models with CROs, CMOs and alliance partners. He has extensive experience in clinical development, service provider oversight, procurement and management of collaborations between international life sciences organizations.

    Session Details:

    PANEL DISCUSSION: Debating Ownership and Risk Sharing in Sponsor and Vendor Partnerships

    2026-10-20, 11:00 AM

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    Tine Rosenberg
    Chief Nurse, Rigshospitalet

    Tine Rosenberg is Head Nurse at the Cardiology Trial Unit, Rigshospitalet. She has been working in clinical research since 2010 and has extensive experience in the planning, coordination, and management of clinical trials and investigator-initiated studies all the years with a strong focus on research quality, patient safety, and evidence-based practice.

    Session Details:

    PANEL DISCUSSION: Making Clinical Trial Technology Work for Sites and Reducing System Burden

    2026-10-21, 10:00 AM

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    Gina Reneau
    Biological Threat Exclusion Coordinator, U.S. Customs & Border Protection

    Gina Reneau is a distinguished senior professional with U.S. Customs and Border Protection (CBP), bringing over 25 years of specialized expertise in agricultural safeguarding, biological threat mitigation, and international security collaboration.
    In her current role as the Biological Threat Exclusion Coordinator (BTEC) across CBP Headquarters and the New York Field Office, Ms. Reneau provides strategic guidance to tactical response teams and agriculture specialists, ensuring the safe handling, containment, and management of biological materials.

    Throughout her career, Ms. Reneau has spearheaded critical domestic and international initiatives. Her extensive portfolio includes the development of advanced agro- and biosecurity training curricula, the cultivation of robust inter-agency partnerships with federal entities such as the U.S. Department of Agriculture (USDA) and the U.S. Centers for Disease Control and Prevention (CDC), and active representation at major global conferences.

    Renowned for her operational leadership, risk management, and regulatory enforcement, Ms. Reneau is a recognized authority in biological threat assessment, dedicated to advancing international biosecurity standards and protecting global supply chains.

    Session Details:

    Navigating U.S. Import Compliance and Documentation Requirements

    2026-10-20, 12:15 PM

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    Åsa Carlsheimer
    Vice President, Head of Internal Medicine and Neuroscience, TFS Health Science

    Åsa leads TFS HealthScience’s Internal Medicine and Neuroscience teams and brings 30 years of experience in life sciences and pharmaceutical research. She has worked with pharmaceutical and biotech companies on global studies across all development phases and a wide range of indications, including asthma, COPD, diabetes, kidney diseases, wound healing, hematology, migraine, Alzheimer’s and Parkinson’s disease. She also has extensive experience with regulatory submissions to the FDA, EMA and other regulatory authorities worldwide.

    Session Details:

    If Lewis Hamilton Ran Your Clinical Trial

    2026-10-20, 11:30 AM

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    Jen Blankenship
    Director of Science, VivoSense

    Jen Blankenship is the Director of Science at VivoSense, where she leads scientific strategy and supports the development and implementation of digital measures in clinical research. She works closely with pharmaceutical sponsors and cross-functional teams to design studies that integrate wearable sensors and digital measures in ways that are scientifically meaningful and fit for purpose. In her role, Jen helps sponsors evaluate how digital measures can strengthen clinical development programs, from early exploratory research through later-stage studies, with a focus on generating interpretable evidence that can inform clinical development decisions.

    Session Details:

    From Patient Experience to Digital Measures: Capturing What Matters and Keys to Successful Implementation in Clinical Trials

    2026-10-21, 11:30 AM

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    Irena Seredina
    Executive Director, S-Clinica

    Irena Seredina’ background is medicine, economics and management. She holds an MD, honors diploma and a MSc in Health Economics. During her medical practice,  Irena  worked in clinical research as a researcher and an investigator. The results of her research have been published in a number of articles and she is a recognized speaker at several industry forums and international conferences.  Irena worked at Amgen, and then joined S-Clinica in 2004. Now, as  Executive Director Irena gives direction for the product strategy and customer relationships.

    Session Details:

    The Case for Unifying Supply Forecasting and RTSM

    2026-10-20, 10:00 AM

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    Jasvinder Osan
    Vice President Business Development, S-Clinica

    Jas started his career in the 90s, as a data manager within clinical trials when these were done predominantly on paper - and has over the years seen the industry change and evolve.

    He has a degree in Applied Physics, and has worked over the last 25 years within eClinical technologies and solutions, with global responsibilities in project management, solutions consulting and sales. Jas's role within S-CLINICA is to bring new business, and build strategic relationships with customers.

    Session Details:

    The Case for Unifying Supply Forecasting and RTSM

    2026-10-20, 10:00 AM

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    Tim Collard
    Senior Vice President Sales, TRI

    Tim Collard is Senior Vice President of Sales at TRI, where he has spent eight years helping Sponsors and CROs get more value from Risk-Based Quality Management (RBQM). He partners with pharma, biotech, and CRO teams to implement OPRA, TRI's Intelligent RBQM platform, so it fits their existing processes and drives more efficient trials with stronger data quality and patient safety. Tim brings a practical, client-first view of what makes RBQM work in the real world.

    Session Details:

    Beyond RBQM: How Intelligent RBQM Gives Sponsors and CROs a Measurable Edge

    2026-10-20, 12:30 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:

    THE SCIENCE IS YOURS. IS THE TIMELINE?

    2026-10-20, 10:00 AM

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    PANEL DISCUSSION Choosing Where to Run Clinical Trials in 2027 and Balancing Speed, Quality and Access

    2026-10-21, 11:00 AM

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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:

    KEYNOTE PANEL DISCUSSION: Building Resilient Clinical Supply Chains in An Era of Constant Disruption

    2026-10-20, 9:00 AM

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    Christel Conrad
    Head of Brand, Marketing & Customer Success, DATA for GOOD Foundation

    Leading brand, growth, stakeholder engagement and customer success for DATA for GOOD's ethical data ecosystem.

    Responsible for positioning, partnerships, adoption and communication across citizens, businesses, public institutions and research organizations.

    Led the international CRANE healthcare pilot across Sweden, Norway and Spain, demonstrating how citizen-controlled and privacy-preserving data sharing can improve healthcare outcomes and enable trusted digital innovation.

    Session Details:

    Trial Data in 2027: The Consent and Governance Layer Pharma Can’t Outsource to a CRO

    2026-10-21, 9:00 AM

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    Wafaa Hassan
    Senior Strategic Intelligence Pharma Analyst, GlobalData

    Wafaa Hassan, MSc, is a Senior Pharma Analyst in the Digital team at GlobalData’s London office. Her responsibilities involve writing reports and providing insights on digital strategy across disease areas and channels. Prior to working in the digital team, Wafaa worked in the thematic research team at GlobalData, where she contributed to quantitative and qualitative analysis reports on disruptive themes and technologies, with a focus on Pharma, Healthcare and Medical Devices sectors. Prior to joining GlobalData, Wafaa studied for an MSc in Healthcare Management at City, University of London.

    Session Details:

    Chairperson’s Opening Remarks

    2026-10-20, 8:50 AM

    Session Details:

    Clinical Trial Supply in a Changing Global Market – Where the Risks and Opportunities Are Emerging

    2026-10-20, 4:30 PM

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    Abhishek Chatterjee
    GVP Product, Insights & Analytics, Clinical and Site Lead, Denmark, H1

    Abhishek has over 14 years of experience in the Healthcare industry, leading digital, business & process departments across Clinical Development & Operations. He has been instrumental in redefining and conceptualizing Planning as a Product and has driven concept designs and delivery for digital Products across Portfolio acceleration, Trial Design, Site Selection, Competitive intelligence, Patient-Centric Solutions, Gen AI, and LLM-based use cases across Drug Development.

    Session Details:

    The End of Fragmented Clinical Data & Decision-Making

    2026-10-21, 2:15 PM

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    Dr Ulf Forssmann
    Vice President, Medical Head of Early Development, Genmab

    Prof. Dr. med. Ulf Forssmann is a physician-scientist and senior biopharmaceutical leader with more than 25 years of experience spanning translational medicine, clinical pharmacology, early clinical development, and oncology drug development. His career has focused on translating innovative biology into differentiated medicines and advancing novel therapeutic concepts from preclinical development through first-in-human studies and proof of concept.

    He is currently Vice President, Medical Head of Early Development at Genmab, where he provides strategic medical leadership across the early development portfolio. His work spans multiple therapeutic modalities, including immuno-oncology, bispecific antibodies, antibody-drug conjugates, and next-generation antibody technologies. He has contributed to the clinical development of programs including acasunlimab (PD-L1x4-1BB), HexaBody-DR5/DR5, enapotamab vedotin, and several emerging immuno-oncology programs.

    Before joining Genmab, Ulf held senior roles in exploratory medicine, oncology, and clinical pharmacology at Bayer Pharma and Merck Serono/Merck KGaA. Across these positions, he led multidisciplinary international teams and early development strategies covering cancer immunotherapy, bispecific antibodies, antibody-drug conjugates, cancer vaccines, immunocytokines, kinase inhibitors, and other targeted therapies. His scientific roots are in immunology, chemokine biology, and translational pharmacology.

    Ulf is an Associate Professor at Hannover Medical School and has authored and co-authored numerous peer-reviewed publications spanning immunology, inflammation, translational research, and oncology. His recent work reflects a strong focus on the clinical translation of next-generation antibody therapeutics and on understanding how target biology, pharmacology, and biomarker strategies can inform early development decisions.

    Today, his work sits at the intersection of science, medicine, and portfolio strategy. He is particularly passionate about building strong translational bridges between discovery and the clinic, designing development strategies that generate early biological and clinical insight, and advancing innovative therapeutics that can deliver meaningful benefit for patients with cancer.

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    Kristian Johnsen
    Head of Strategy and Partnerships, DATA for GOOD Foundation

    A strategic healthcare and innovation leader with 30 years of executive experience across public administration, life sciences, and philanthropy. Currently Head of Strategy and Partnerships at the DATA for GOOD Foundation, their previous roles include Academic Director at the Danish Diabetes Association, Director of APOVAC, and Deputy Director within the Capital Region of Denmark. They have directed multi-billion-kroner healthcare initiatives, notably the establishment of the Steno Diabetes Center Copenhagen (DKK 3 billion), the creation of Denmark's national clinical-trial alliance Trial Nation, and the founding of the Eastern Denmark EU Office. Their earlier career includes policy roles at the Danish Ministry of Science and Ministry of Business, as well as private-sector management at F.L. Smidth A/S.

    Session Details:

    Trial Data in 2027: The Consent and Governance Layer Pharma Can’t Outsource to a CRO

    2026-10-21, 9:00 AM

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    OCT Advisory Board

    Select a member to learn more

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    Dr Alison McMorn
    Head of Clinical Strategy and Development, LifeArc

    Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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    Behtash Bahador
    Senior Director, Community Engagement & Partnerships, Center for Information & Study on Clinical Research Participation (CISCRP)

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

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    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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    Aditya Kotta
    VP Business Development, Novotech

    Aditya Kotta is the VP of Business Development for Novotech. He has been with the company since 2018. He has 14 years of experience in the clinical trial industry, working in both Clinical Operations and Business Development. He holds degrees in Biomedical Engineering from Johns Hopkins University and Medical Science from Boston University.

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

    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 .

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

    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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    Edwin van Vulpen
    Executive Director and Head of Clinical Business Development Euro-Asia
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