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Why Attend?

WHAT TO EXPECT FOR 2025?

Join pharma and biotech experts to discuss new trends and opportunities and learn how they optimize their clinical operations enabling you to stay ahead of the game. Find the right solution providers to partner with, allowing you to accelerate your trial timelines.

200+

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40+

Speakers

20+

Exhibitors

200+

Attendees

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Speakers

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Exhibitors

See What It's All About

Agenda

  • 3 Nov 2026
  • 4 Nov 2026
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Streams

Stream one

STREAM A: Outsourcing & Clinical Operations

Stream two

STREAM B: Data, AI & Clinical Innovation

11:30 AM

AI-Powered Knowledge Management in Complex Organisations: Transforming SharePoint into an Intelligent Collaboration Ecosystem

  • Demonstrating how SharePoint can evolve into an intelligent collaboration and knowledge-sharing ecosystem through AI agents and automation
  • Showcasing practical applications including automated content classification, intelligent search, chatbots, and workflow automation
  • Identifying how AI-enabled knowledge systems can improve information accessibility, collaboration, decision-making, and organisational agility while reducing inefficiencies and knowledge silos across teams

Speakers

Lidia Magielska
Director, Study Management, AstraZeneca

12 PM

Session reserved for event sponsor

12:30 PM

PANEL DISCUSSION Future-Proofing Clinical Trials with AI: Will Today’s AI Strategies Survive Tomorrow’s Clinical Trial Landscape?

  • Exploring how AI can support end-to-end clinical trial delivery, from protocol authoring and risk assessment through to data analysis and reporting
  • Examining how historical trial outcomes, regulatory feedback, and operational data can be leveraged to improve planning, country selection, site strategy, and database design
  • Understanding how AI-driven connectivity across departments can break down silos and create a more integrated approach to trial execution
  • Discussing how organisations can operationalise AI strategically to future-proof clinical development processes rather than applying disconnected point solutions

1 seat available for event sponsor

Speakers

Sotirios Perdikeas
Executive Director, Head of Health Data Insights & Design, Novartis
Stephan Theinert
Head Clinical Affairs, FiberSense

1 PM

Session reserved for event sponsor

1:30 PM

Lunch and networking

2:30 PM

Building Responsible AI Systems: Lessons for Life Sciences

  • Understanding the core principles of responsible AI and how trust, transparency, governance, and human oversight enable successful AI adoption
  • Navigating evolving regulatory and ethical expectations to ensure AI systems remain compliant, secure and fit for purpose
  • Mitigating AI risks by addressing bias, data quality model validation, and continuous performance monitoring throughout the AI lifecycle
  • Scaling responsible AI across clinical development and operations to drive innovation while maintaining patient trust and regulatory confidence

Speakers

Marta Batlle López
Responsible AI and GenAI Lead, Roche

3 PM

Session reserved for event sponsor

3:30 PM

LIVE DEBATE Data Hoarding or Data Sharing? Rethinking Collaboration in Clinical Research

  • Exploring the untapped potential of data sitting across academic centres, hospitals, sponsors, and research networks
  • Debating whether competitive advantage is preventing the industry from unlocking faster and more cost-effective innovation
  • Examining the operational, ethical, and commercial challenges associated with large-scale data sharing initiatives
  • Discussing whether cross-industry consortia could create shared value, reduce duplication, and accelerate clinical development for all stakeholders

Debater 1: Eric Hajjar, Project Lead – Serious Bacterial Infections, Global Antibiotic R&D Partnership (GARDP)

Debater 2: Available

Speakers

Eric Hajjar
Project Lead – Serious Bacterial Infections, Global Antibiotic R&D Partnership (GARDP)

4 PM

Afternoon refreshments, networking and prize draw

4:15 PM

PRIZE DRAW

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

4:30 PM

CASE STUDY Enhanced Pharmacovigilance Pregnancy Data Collection to Support Regulatory Requests

  • Strengthening pregnancy safety data collection to meet evolving regulatory expectations and post-marketing requirements
  • Utilising pharmacovigilance processes to improve the quality, completeness, and consistency of pregnancy data
  • Examining a real-world case study demonstrating practical approaches and considerations to enhanced pregnancy data collection and regulatory compliance
  • Leveraging enhanced pregnancy data collection to support regulatory submissions, benefit-risk assessments, and patient safety

Speakers

Robert Corbé
Associate Director, Patient Safety Scientist, AstraZeneca

5 PM

Evidence Generation and Endpoint Strategy in Biotech Clinical Trials

  • Developing evidence generation strategies that align with regulatory expectations and clinical development goals
  • Selecting meaningful clinical and patient-centred endpoints to support efficient trial design and execution
  • Integrating innovative trial designs, biomarkers, and real-world evidence to strengthen development decisions
  • Optimising endpoint strategies to reduce development risk, accelerate approvals, and improve trial outcomes

Speakers

Florian Vogl
Fractional, CMO, Stealth Mode Biotech

5:30 PM

Why Innovation Fails to Scale at the Pilot Stage

  • Defining clear ownership, success metrics, and decision points at every stage of implementation
  • Exploring how sponsors, CROs, and technology partners can better align expectations and timelines
  • Is the industry too risk-averse to innovate properly?
  • Identifying when to pivot, pause, or scale innovations based on measurable impact and long-term feasibility

Speakers

Ana Rita Delgado
Global Medical Development Engagement Lead, Sanofi

8 AM

Registration and Refreshments

8:45 AM

Chairperson’s opening remarks

9 AM

KEYNOTE: What Really Changes After a $100 Million Financing Round?

  • How should clinical trial sponsors allocate resources to accelerate clinical development without compromising quality?
  • Making strategic investment decisions across people, technology, quality and partnerships
  • Deciding where to build internal capabilities versus leveraging external partners
  • Balancing speed, quality and capital efficiency while preparing for the next stage of growth

Speakers

Dominik Hart
Chief Medical Officer, Granite Bio
Sofia Ribeiro Forte
VP, Head Clinical Operations, Granite Bio

9:30 AM

Session reserved for featured sponsor

10 AM

PANEL DISCUSSION How Shifting Geopolitical and Regulatory Dynamics Are Reshaping Clinical Trial Destinations and How to Bring the Focus Back to Europe

  • Looking at why Europe is losing competitiveness and risks falling behind in trial attractiveness and patient access despite advanced healthcare systems and strong research reputations
  • What must change for Europe to remain desirable, including initiatives shaping the future European landscape (FAST‑EU, COMBINE, EU Biotech Act)
  • Examining the rise of emerging trial destinations, from China to the Middle East, alongside the ethical responsibilities and more favourable regulatory approvals
  • Exploring the role of ISO 18969 in harmonising clinical investigation processes and supporting more efficient trial delivery across Europe

1 seat available for event sponsor

Speakers

Pilar de la Rocha Mur
VP, Head of EMEA, Global Clinical Operations, BeOne Medicines
Simona Berardi Vilei
Head of GCP/GVP Inspectorate, Swissmedic

10:30 AM

Session reserved for featured sponsor

11 AM

Morning refreshments and networking break

11:30 AM

The Clinical Development Paradox: Trial Timelines Are Becoming Increasingly Rigid, But Trial Complexity Keeps Growing

  • Why faster development timelines are colliding with increasing trial complexity
  • Understanding how accelerated pathways are reshaping expectations across sponsors, CROs and regulators
  • Assessing whether traditional operating and outsourcing models can keep pace with today's demands
  • Adapting to rolling submissions, real-time oversight and compressed development timelines
  • Building operational resilience without compromising speed, quality or compliance

Speakers

Maria Koutsopoulou
SVP, Head of Global Development Operations, Merck

12 PM

Session reserved for event sponsor

12:30 PM

Site Engagement in a Competitive Trial Landscape: How Sponsors Can Become a Preferred Partner

Speakers

Pilar de la Rocha Mur
VP, Head of EMEA, Global Clinical Operations, BeOne Medicines

1 PM

Session reserved for event sponsor

1:30 PM

Lunch and networking

2:30 PM

PATIENT ADVOCATE SPOTLIGHT Avoiding Turbulence: How Early Patient Research Partner Involvement Keeps Clinical Development on Course

  • Understanding the evidence and recommendations for meaningful Patient Research Partner (PRP) involvement in clinical research: Review the 2023 EULAR recommendations and explore why involving PRPs from the inception of a research programme can improve the relevance, feasibility and quality of clinical development.
  • Recognising the impact of early patient partnership on clinical trial success: Examine how PRP involvement can influence protocol design, patient burden, recruitment, retention, study execution and ultimately support regulatory decision-making and approval readiness.
  • Identifying practical approaches to implementation and measurement: Discuss how sponsors, CROs and research teams can operationalise PRP involvement throughout outsourced clinical development programmes, assess current levels of adoption, and measure the value and impact of patient partnership.

Speakers

Karen Cheng
Patient Advocate, EULAR PARE

3 PM

Session reserved for event sponsor

3:30 PM

LIVE DEBATE Are large CRO operating models equipped to support the agility and priorities of small biotechs?

  • Navigating traditional and niche CRO models as an emerging biotech
  • Understanding the key differences between big pharma and biotech approaches to clinical trial execution and outsourcing strategy
  • Examining how niche and specialist vendors are addressing sponsor pain points with more tailored, flexible solutions
  • Identifying how sponsors and providers can better align expectations, communication models, and operational support for successful partnerships

Debater 1: Juliet Dizon, Director, Pre-Clinical and Clinical Quality Assurance, ARTBIO

Debater 2: Available

Speakers

Juliet Dizon
Director, Pre-Clinical and Clinical Quality Assurance, ARTBIO

4 PM

Afternoon refreshments, networking and prize draw

4:15 PM

PRIZE DRAW

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

4:30 PM

Streamlining Contracts and Approvals to Accelerate Site Activation for Study Start-Up

  • Optimising contracting across the clinical trial ecosystem
  • Adapting vendor oversight and management models to evolving regulatory requirements
  • Strengthening sponsor–CRO partnerships to improve accountability and execution
  • Reducing approval bottlenecks to accelerate study start-up and trial delivery

Speakers

Piotr Slawik
Assistant General Counsel, Spur Therapeutics

5 PM

PATIENT ADVOCATE AND SITE SPOTLIGHT Cultural Change in Clinical Trial Development with a Patient and Sites Expert Panel

Speakers

Robina Weermeijer
Global Clinical Trials Patient & Site Engagement Lead, Boehringer Ingelheim
Estelle Jobson
Patient Advocate

5:30 PM

CLOSING PANEL DISCUSSION The Feasibility Crisis: Are Sponsors Pushing Sites Beyond Capacity?

  • Why recruitment forecasts and feasibility assessments across the DACH region continue to miss targets despite strong research infrastructure and healthcare systems
  • How increasing study competition, protocol complexity, and limited patient availability are placing growing pressure on sites
  • The operational challenges impacting recruitment and patient access across the region
  • How sponsors, CROs, and sites can work together to create more realistic feasibility strategies and more sustainable approaches to patient recruitment and site engagement

2 seats available for biotech/ pharma

1 seat available for event sponsor

Speakers

Sabine de Ducla
Clinical Operations Country Head – Switzerland, Roche

6 PM

Chair’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

Best 3 LinkedIn posts from day 1 with hashtag #OCT and @Outsourcing in Clinical Trials Event Series tagged will win a prize in day 2 morning’s prize draw during chair’s opening remarks. Deadline end of drinks reception day 1. You must be present to win!

8:15 AM

Registration and refreshments

8:20 AM

Chair’s opening remarks

8:30 AM

Interactive Speaker-Hosted Breakfast Breakout Discussions

With drinks and refreshments, interactive breakout sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will run for 30 minutes and be led by a table moderator and will focus on a different challenge within clinical trials. Breakout discussions are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Discussion 1 What Types of Challenges Are Best to Be Solved with Technology and AI, and What Are the Best Ways to Operationalise?
Discussion 2 Exploring How Evolving FDA and EMA Guidance Is Shaping the Next Phase of Global Clinical Trials
Discussion 3 Mastering Next-Generation Outsourcing Models: Assessing Competing Strategies to Optimize Clinical Efficiency and Costs for Maximum ROI
Discussion 4 What Sponsors Still Get Wrong About Patient-Centred Clinical Research

9 AM

KEYNOTE: Insights from Swissmedic Inspections: Common GCP Findings and Practical Lessons for Sponsors and CROs

  • Key recurring GCP findings identified in recent Swissmedic inspections
  • A Swissmedic perspective on ICH E6(R3), Real-Time Monitoring and evolving regulatory expectations
  • Common gaps in oversight, documentation, and trial master file (TMF) management
  • Frequent issues in vendor/CRO oversight and delegated responsibilities
  • Practical recommendations to strengthen inspection readiness and quality systems

Speakers

Simona Berardi Vilei
Head of GCP/GVP Inspectorate, Swissmedic

9:30 AM

Session reserved for event sponsor

10 AM

PANEL DISCUSSION Preventing the Preventable: Why Patients Still Walk Away from Clinical Trials

  • Tackling the hidden drivers of patient dropout
  • Understanding how participant-focused engagement strategies can improve recruitment, trust, and long-term retention
  • When is enough enough, and how much is excessive data collection driving the patients away?
  • Identifying why participants disengage during studies and what sponsors and sites can do proactively to reduce attrition

2 seats available for biotech/ pharma

1 seat available for event sponsor

Speakers

Karen Cheng
Patient Advocate, EULAR PARE

10:30 AM

Morning refreshments and networking break

11 AM

Are We Designing the Right Clinical Trials or Just the Safest Ones?

  • Have clinical trials become over-engineered for predictability at the expense of speed, feasibility, and patient access
  • Are protocols optimised for regulatory comfort rather than real-world execution and site capacity
  • Is clinical trial eligibility criteria too stringent?
  • Can adaptive designs, simulation, and AI shift trial design from risk avoidance to smarter decision-making

Speakers

Daniel McVeigh
Director, Clinical Operations, Alexion Pharma

11:30 AM

Session reserved for event sponsor

12 PM

NEW FOR 2026! INDUSTRY HOT TAKES

1 stage, a variety of rapid-fire opinions, bold predictions and myth-busting from experts across the industry. Audience members will vote, agree or disagree, on each hot take! There’ll be a chance for the audience to pose some questions to the panel too.

The panel will answer the following:

  • Biggest mistake in clinical trials today
  • One thing pharma should stop doing
  • One prediction for 2030
  • What’s overhyped and what’s worth the hype
  • What vendors misunderstand
  • Where trials fail most often
  • Biggest recruitment mistake
  • Hot takes from the audience

2 seats available for biotech/ pharma

1 seat available for event sponsor

Speakers

Eric Hajjar
Project Lead – Serious Bacterial Infections, Global Antibiotic R&D Partnership (GARDP)

12:30 PM

Session reserved for event sponsor

1 PM

Lunch and networking

2 PM

Rethinking How Patients Contribute to Drug Development: How Servier Embed Patient Engagement Across R&D

Speakers

Laura Risueño Ayerbe
Global Patient Affairs, Patient Engagement R&D, Servier

2:30 PM

Session reserved for event sponsor

3 PM

Afternoon refreshments, networking and prize draw

3:15 PM

PRIZE DRAW

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

3:30 PM

Biosimilar Development: New FDA and EMA Regulations Are a Paradigm Shift After 20 Years of Biosimilars

  • Reducing development costs through leaner clinical strategies
  • Navigating evolving regulatory expectations for biosimilars in Europe and globally
  • Understanding how outsourcing models differ for biosimilar programs versus innovative therapies

Speakers

Karsten Roth
Senior Director Clinical Research and Development, Polpharma Biologics

4 PM

CLOSING KEYNOTE – EUPATI Switzerland: Advancing Meaningful Patient Engagement in Healthcare R&D

  • Embedding patients as equal partners across the medicines development lifecycle
  • Building trust through education, transparency and collaborative decision-making
  • Strengthening patient engagement to improve clinical research and regulatory decisions
  • EUPATI case study: Practical examples of how meaningful patient involvement creates lasting impact

Speakers

Ivo Schauwecker
President of EUPATI Switzerland and Head of Research Ethics at ETH Zürich

4:30 PM

END OF CONFERENCE

Speakers

Select a speaker to learn more

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Daniel McVeigh
Director, Clinical Operations, Alexion

A Clinical Research Professional with over 13 years’ experience across various settings such as Site, CRO, Small Biotech and Pharma. Expertise in various therapeutic areas from Oncology and Rare/Orphan Disease. Experience from early phase first in human to late phase and Nov Intervention RWE generation and Registries. Focused on Clinical Operations excellence and process improvements for the benefit of the patients we serve. Currently Director, CPL at Alexion, AZ Rare Disease leading a Cross Functional clinical team.

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Juliet Dizon
Director, Pre-Clinical and Clinical Quality Assurance, ARTBIO

I am a Clinical Research professional with more than 20 years of combined experience across the pharmaceutical, biotechnology, and medical devices industries. My background includes 17 years as a Quality Professional in Switzerland and 3 years in Singapore where I managed clinical monitoring and operations, directly overseen drug-device combination trials across 13 Asia-Pacific countries including Japan, Australia/New Zealand, China, Japan, South Korea, India, and others.

I am a highly skilled Quality Professional with focus on Quality Assurance, end to end Quality Strategy, Risk Management and Compliance. Recognized for work ethics and passionate leadership. Strategic and with extensive experience driving global pharmaceutical development and regulatory success. Expert in integrating end-to-end quality principles across cross-functional R&D programs and implementing Quality by Design (QbD) aided by data analytics.

Specializing in GCP, GLP, GMP, Pharmacovigilance (GVP), and Computerized System Validation (CSV). Led global audits, inspection readiness, and Health Authority inspections for high-priority NDAs. Expertise in Risk-Based Quality Management, Quality Strategy, Quality Narratives and regulatory compliance across major global health authorities.

An empathetic People Leader who champions growth and development of team members to help them reach their full potentials, mentored cross functional teams and coached direct reports globally, recognised for stakeholder engagement and effective collaboration across diverse, multi-cultural environment in both big pharma and start-up biotechnology environments.

Session Details:

LIVE DEBATE Are large CRO operating models equipped to support the agility and priorities of small biotechs?

2026-11-03, 3:30 PM

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Lidia Magielska
Director, Study Management, AstraZeneca

Global clinical trials, teams leader with extensive experience in pharmaceutical business. Innovative, agile, proactive mindset with hands on experience in leading multiply projects, teams and people development. Cross department knowledge with business acumen. Project management of global clinical trials, site management and monitoring, CRO management. Line management, coaching, leadership. Pharmaceutical sales & marketing with projects delivery for generic and innovative products with proven achievements track. Working experience in clinical trial management in China.
Passionate about medicines development, strategic management and multicultural environment.
Interested in new solutions and innovation in project and program management in clinical trials with a global scope.

Session Details:

AI-Powered Knowledge Management in Complex Organisations: Transforming SharePoint into an Intelligent Collaboration Ecosystem

2026-11-03, 11:30 AM

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Robert Corbé
Associate Director, Patient Safety Scientist, AstraZeneca
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Pilar de la Rocha Mur
VP, Head of EMEA, Global Clinical Operations, BeOne Medicines

Global Drug Development Executive | Board Member | Founder
Strategic Leader in Oncology and Global Clinical Operations.
22+ Years Building and Governing High-Impact Teams Across 6 Continents
Driving Innovation, Scale, and Long-Term Enterprise Value

Session Details:

Site Engagement in a Competitive Trial Landscape: How Sponsors Can Become a Preferred Partner

2026-11-03, 12:30 PM

Session Details:

PANEL DISCUSSION How Shifting Geopolitical and Regulatory Dynamics Are Reshaping Clinical Trial Destinations and How to Bring the Focus Back to Europe

2026-11-03, 10:00 AM

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Robina Weermeijer
Global Clinical Trials Patient & Site Engagement Lead, Boehringer Ingelheim

Patient & Site Engagement Lead focused on representation in clinical trials at Boehringer Ingelheim, passionate about transforming healthcare. With 10+ years of experience in the pharmaceutical industry, I connect and collaborate with patients & healthcare professionals worldwide, to help make our clinical trials more accesible. Let's work together to make clinical research more inclusive!

Session Details:

PATIENT ADVOCATE AND SITE SPOTLIGHT Cultural Change in Clinical Trial Development with a Patient and Sites Expert Panel

2026-11-03, 5:00 PM

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Stephan Theinert
Head Clinical Affairs, FiberSense

Stephan Theinert holds a Ph.D.of the Charité- University Medicine Berlin, Germany in immunology since 2007. He studied biology at the Humboldt-University in Berlin, Germany with an emphasis on microbiology, genetic and biochemistry. In 2006 he joined the PAREXEL GmbH in Berlin, Germany as a project manager clinical phase I. In 2008 he joined the Momentum Pharma Services GmbH in Hamburg, Germany as a manager business development. In 2009 he became director business development. Since end of 2009 he, as Head Clinical Affairs at the EyeSense GmbH, is mainly responsible for the clinical studies inlc. parts of regulatory and medical affairs.

Session Details:

PANEL DISCUSSION Future-Proofing Clinical Trials with AI: Will Today’s AI Strategies Survive Tomorrow’s Clinical Trial Landscape?

2026-11-03, 12:30 PM

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Eric Hajjar
Former Associate Director, Global Medical Research Operations, Biogen
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Eric Hajjar
Project Lead – Serious Bacterial Infections, Global Antibiotic R&D Partnership (GARDP)

Session Details:

LIVE DEBATE Data Hoarding or Data Sharing? Rethinking Collaboration in Clinical Research

2026-11-03, 3:30 PM

Session Details:

NEW FOR 2026! INDUSTRY HOT TAKES

2026-11-04, 12:00 PM

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Tina Taylor
Vice President of Disease Intelligence and Epidemiology, GlobalData

With over 15 years of experience at the forefront of market intelligence, currently serving as Vice President of Disease Intelligence and Epidemiology at GlobalData Healthcare. My expertise spans leadership, data, disease and competitive analytics, market research, people and project management. I am focused on empowering teams to deliver actionable insights in pharma and biotech, and dedicated to driving data-driven decisions that align with organizational goals. Known for collaborative leadership and a commitment to fostering impactful outcomes through strategic analysis and innovative disease intelligence solutions. Excited to be part of delivering cutting-edge market research and intelligence.

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Dominik Hart
Chief Medical Officer, Granite Bio

Physician Scientist with Big-Pharma & Biotech Drug Development expertise in Immunology/IBD/Cell Depletion/CAR-T/TCE/Derm/T2-Inflammation/Respiratory/Fibrosis/Renal. Advanced multiple assets from pre-clinic into clinic & from Ph1 into Ph2/3.

CMO of GRANITE-BIO: Clinical-Stage I&I Biotech developing novel Immune-Cell Depletion antibodies. FIC Innate/Myeloid immune reset (CCR2-monocyte depleting mAb Minokitug). Biomarker-guided adaptive IBD Monolith trial. NOVARTIS Option-to-Acquire deal. www.granitebio.com

Former CMO of QUELL Therapeutics: CAR-T/Treg Therapies for Autoimmune Diseases (Liver, Kidney, Tx, T1D, IBD). AstraZeneca partnership deal. www.quell-tx.com

Former Immunology/Translational Medicine Leadership roles at Roche & Novartis. Involved in various Global Drug Development programs (Ph1/2/3: B-cell depleters, ianalumab, secukinumab, iptacopan, canakinumab, NLRP3, remibrutinib, tocilizumab, JAKi/filgotinib)

MERCK Immunology advisory board member

AI-based Drug Development project RN.AI with Fabian Theis (Helmholtz)

Session Details:

KEYNOTE: What Really Changes After a $100 Million Financing Round?

2026-11-03, 9:00 AM

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Sofia Ribeiro Forte
VP, Head Clinical Operations, Granite Bio

Session Details:

KEYNOTE: What Really Changes After a $100 Million Financing Round?

2026-11-03, 9:00 AM

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Maria Koutsopoulou
SVP, Head of Global Development Operations, Merck

Session Details:

The Clinical Development Paradox: Trial Timelines Are Becoming Increasingly Rigid, But Trial Complexity Keeps Growing

2026-11-03, 11:30 AM

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Sotirios Perdikeas
Executive Director, Head of Health Data Insights & Design, Novartis

I am an enterprise data, AI and digital transformation leader in pharma R&D, currently heading Data & Analytics in Clinical Operations at Novartis, with a focus on strengthening decision quality at scale by integrating trusted data, AI-enabled capabilities and human judgment.

With over 20 years of experience at the intersection of science, technology and business, I have led global teams and enterprise programs across research, clinical development, informatics and finance. My work focuses on translating complex data, digital and AI opportunities into scalable capabilities, trusted decisions and measurable business impact.

Across Roche and Novartis, I have built and scaled AI-driven and analytics enabled capabilities supporting critical decisions across the drug development lifecycle, including study planning, protocol feasibility and design, predictive site selection, competitive intelligence and benchmarking, performance modelling and simulation, operational risk management and intelligent summarization of clinical content. These capabilities have improved decision speed, consistency, resource optimization and portfolio execution across therapeutic areas.

I bring a systems perspective to enterprise transformation, combining pharma R&D domain knowledge, technology depth, data and AI strategy, product thinking, governance and change leadership. My leadership focus is on building future ready teams and operating models that enable organizations to move from experimentation to trusted, adopted and value-generating capabilities at scale.

Session Details:

PANEL DISCUSSION Future-Proofing Clinical Trials with AI: Will Today’s AI Strategies Survive Tomorrow’s Clinical Trial Landscape?

2026-11-03, 12:30 PM

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Estelle Jobson
Patient Advocate

Member of Boehringer Ingelheim's Global Representivity Board, 2024-2025

  • EUPATI Fellow / Alumna, trained patient expert, patient peer reviewer for the British Medical Journal, lay summary editor, and more
  • Founding patient member of Partner REC (Partenariat en Recherche Clinique) working group on patient and public involvement in research at the Geneva University Hospitals (HUG), in French
  • Author with successful marketing, paperback and e-book sales for Kindle
  • Member of IMI pool of patient experts and patient representative expert within Patients Active in Research and Dialogues for an Improved Generation of Medicines (IMI-PARADIGM)

Session Details:

PATIENT ADVOCATE AND SITE SPOTLIGHT Cultural Change in Clinical Trial Development with a Patient and Sites Expert Panel

2026-11-03, 5:00 PM

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Karen Cheng
Patient Advocate, EULAR PARE

My career began at the patient’s bedside — where science meets humanity and every decision carries real consequence. Then came the most profound life lesson of all: becoming the patient myself. That experience grounded me — both as a provider and a receiver of care — and continues to shape everything I do. Every diagnosis carries a story, every therapy holds a promise, and every decision can change a life.

My passion lies in rare diseases, where patients often wait the longest for answers, and where scientific excellence and empathy must go hand in hand. I’ve had the privilege of collaborating with brilliant minds across the globe — physicians, researchers, patients, and policymakers — and I’ve seen firsthand that true progress happens when we connect ideas across borders, disciplines, and perspectives.

My experience in medical affairs, clinical development, education, patient partnership, product management, operations, and commercial strategy, was built by complex launches across geographies, challenges in evidence generation and nurturing cross-functional alliances to strengthen and advance both medical understanding and patient access to appropriate care.

My international mindset was developed from living and working in seven countries across three continents. I thrive in diverse, matrix environments where creativity, compassion, and collaboration drive performance. I’m energized by people, inspired by purpose, and committed to advancing patient care through thoughtful leadership, integrity, and innovation.

My mission is simple yet profound: to bridge patient perspectives, clinical insights, and corporate strategy to accelerate better solutions for patients. Every project, product, and partnership is an opportunity to improve a life — and breakthroughs mean nothing unless it reaches the people who need it most. To me, leadership in rare diseases is not a title, but a responsibility — to inspire, to connect, and to act with purpose.

Session Details:

PATIENT ADVOCATE SPOTLIGHT Avoiding Turbulence: How Early Patient Research Partner Involvement Keeps Clinical Development on Course

2026-11-03, 2:30 PM

Session Details:

PANEL DISCUSSION Preventing the Preventable: Why Patients Still Walk Away from Clinical Trials

2026-11-04, 10:00 AM

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Ivo Schauwecker
President of EUPATI Switzerland and Head of Research Ethics at ETH Zürich

Team oriented leadership, reliable, enthusiastic towards new challenges, result-oriented, fair, good communicator and motivator, excellent project manager – ready to take risks and propose unconventional solutions.

I am eager to take over responsibility in my positions to move tasks to successful completion. To lead in a strongly team-oriented business environment is my highest motivator. Teaching and imparting knowledge is a passion. To make patient and persons concerned involvement in human research happen is a mission.

Session Details:

CLOSING KEYNOTE – EUPATI Switzerland: Advancing Meaningful Patient Engagement in Healthcare R&D

2026-11-04, 4:00 PM

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Karsten Roth
Senior Director Clinical Research and Development, Polpharma Biologics

Pharmaceutical professional with more than 27 years of experience in the pharmaceutical industry, having held various international leading positions with focus on clinical development and medical affairs across several therapeutic areas. More than 17 years experience in Biosimilar development including:
- Successful development up to approval several Biosimilars in the EU and US
- Presentation at EMA-, FDA- and PMDA meetings of various type
- Set up of quality management systems, including SOP implementation

Serves as Vice-Chair at the Biosimilars Medicines Group at Medicines for Europe

Holds a Ph.D. in Biochemistry, a postgraduate Diploma in Pharmaceutical Medicine, and a Masters in Project Management from the George Washington University.

Session Details:

Biosimilar Development: New FDA and EMA Regulations Are a Paradigm Shift After 20 Years of Biosimilars

2026-11-04, 3:30 PM

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Marta Batlle López
Responsible AI and GenAI Lead, Roche

Leading the scaling and development of trustworthy GenAI solutions at Roche for the benefit of worldwide patients. As Responsible AI and AI Governance Lead at Roche Digital Technologies, I have deep experience designing and operationalizing AI risk, ethics & governance frameworks in healthcare.

•Proven track record implementing Enterprise-scale Responsible AI risk controls, technical guardrails and leading high-impact initiatives in partnership with Legal, Security, Ethics and Corporate AI strategy.
•Experienced in AI risk mitigation, bias mitigation and privacy-preserving technologies, building the foundations for ethical AI innovation.
•In my previous role as GenAI Product Owner, I led the development of large-scale customer-facing solutions

Session Details:

Building Responsible AI Systems: Lessons for Life Sciences

2026-11-03, 2:30 PM

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Sabine de Ducla
Clinical Operations Country Head – Switzerland, Roche

Clinical studies expert and people leader with >26 years of experience in both Pharmaceutical Industry and Academic Research Organization within Operations, Medical Affairs and Global Development as well as within Headquarter and affiliate organizations. Expertise across the product lifecycle: clinical trial design, trial conduct and read-out, health authority interactions, medical affairs strategic/scientific planning and execution – Cross-functional/matrix leadership and people management responsibilities, including leadership for self-organized and empowered teams and collaboration with a number of multicultural internal and external stakeholders – Empathetic and creative mindset with passion for developing, empowering, coaching and mentoring others – always keeping the patients at the center.

Session Details:

CLOSING PANEL DISCUSSION The Feasibility Crisis: Are Sponsors Pushing Sites Beyond Capacity?

2026-11-03, 5:30 PM

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Ana Rita Delgado
Global Medical Development Engagement Lead, Sanofi

Session Details:

Why Innovation Fails to Scale at the Pilot Stage

2026-11-03, 5:30 PM

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Laura Risueño Ayerbe
Global Patient Affairs, Patient Engagement R&D, Servier

Pharmaceutical professional with a strong background in preclinical research and a strategic focus on patient engagement. I have experience across the drug development, from early-stage research to patient-centered initiatives, allowing me to bridge the gap between science and real-world healthcare needs. My expertise includes executing preclinical studies, interpreting complex scientific data, and translating research insights into meaningful outcomes.

In recent years, I have shifted my focus toward patient engagement, working to integrate the patient voice into drug development processes. I am passionate about fostering collaboration between researchers, healthcare providers, and patients to ensure that treatments are not only scientifically sound but also aligned with patient needs and experiences. My ability to navigate both the scientific and human aspects of pharmaceutical development enables me to contribute to innovate.

Session Details:

Rethinking How Patients Contribute to Drug Development: How Servier Embed Patient Engagement Across R&D

2026-11-04, 2:00 PM

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Piotr Slawik
Assistant General Counsel, Spur Therapeutics

Internationally experienced in-house lawyer specialised in pharmaceutical law with substantial expertise and focus on the startup, conduct and legal compliance of research and development activities. Subject matter expert in full scope of contracts relating to clinical trials, informed consent forms, ethics and regulatory processess and data privacy aspects of clinical trials.

Session Details:

Streamlining Contracts and Approvals to Accelerate Site Activation for Study Start-Up

2026-11-03, 4:30 PM

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Florian Vogl
Fractional, CMO, Stealth Mode Biotech

Session Details:

Evidence Generation and Endpoint Strategy in Biotech Clinical Trials

2026-11-03, 5:00 PM

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Simona Berardi Vilei
Head of GCP/GVP Inspectorate, Swissmedic

Experienced Head Of Project Management with a demonstrated history of working in the research industry. Skilled in Business Planning, Customer Acquisition, Medical Devices, Communication, and Oncology. Strong healthcare services professional with a Diploma of advanced studies in Pharmaceutical Medicine (DAS) focused in ECPM from Universität Basel.

Session Details:

PANEL DISCUSSION How Shifting Geopolitical and Regulatory Dynamics Are Reshaping Clinical Trial Destinations and How to Bring the Focus Back to Europe

2026-11-03, 10:00 AM

Session Details:

KEYNOTE: Insights from Swissmedic Inspections: Common GCP Findings and Practical Lessons for Sponsors and CROs

2026-11-04, 9:00 AM

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OCT Advisory Board

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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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SPONSORSHIP ENQUIRIES


Senior Sponsorship Manager

Alex Purnell


+44 20 4540 7786

SPEAKER & MARKETING ENQUIRIES


Conference Producer

Ralitsa Pashkuleva


+44 20 7661 7976

DELEGATE ENQUIRIES


VIP Delegate Manager

Sunny Saikia