The European clinical trial landscape will take centre stage this October as leading voices from the biopharma and healthcare sectors convene in Copenhagen, Denmark, for the annual Outsourcing in Clinical Trials & Clinical Trial Supply Nordics 2025.
The two events, which will take place alongside each other on 21-22 October, will bring together senior executives, regulators, and innovators from the international pharmaceutical and biotech sectors to discuss the pressing topics across clinical trial outsourcing and supply chains.
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Destination Europe
The pharma landscape is undergoing immense metamorphosis via the emergence of China as a clinical trial powerhouse. The country’s meteoric rise is set to continue, with it recently surpassing the US for the annual number of clinical trials. Amid a volatile regulatory and political landscape gripping the US, eyes are currently on the EU as to whether it can maintain its historical tag as a hot bed of trial innovation and variety.
Lene Grejs Petersen, senior adviser of the Danish Medicines Agency, will present issues and feedback sponsors have faced when conducting trials in Europe, along with creating and implementing solutions.
Novotech’s executive director of clinical operations Dr Yvonne Tretter, will further dive into the European clinical trial scene in a later session on the first day. Tretter will outline the state of the research landscape, along with discussing how obtaining the right mix of countries can be a key factor to success.
One of the most successful public-private initiatives to boost clinical trial competitiveness comes in the form of Sweden’s SweTrial. Established by the Swedish government, the platform represents a move to reverse a decline in clinical trial activity in the country. SweTrial’s acting director, Gunilla Andrew-Nielsen, who is also part of the Swedish Medical Products Agency, will share the latest updates from the programme, along with how national partnerships can enhance the conditions for clinical trials.
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By GlobalDataAnother example of cross-sector initiatives is the COMBINE programme, a pilot launched by the European Commission to streamline authorisation of combined studies. On day two of the event, Päivi Susanna Worsøe, project manager and special adviser in clinical trials at the Danish Medicines Agency, will give an overview of the programme and other ongoing projects.
An international outlook
The Nordics are famous for the history of great explorers and travellers. Continuing in that vein, the event will not just focus on the European scene, with multiple sessions set to focus on other regions.
Tariffs imposed by President Donald Trump have created a disrupted global clinical trial landscape. A panel will review the geopolitical impact on the supply chain, identifying contingency protocols to help sponsors prepare for the unexpected from the start of the trial. More macro-level analysis of improving supply chain robustness also features, with a panel discussing how clinical team perspectives can improve drug supply, along with a session detailing cell therapy trial experience from a small biotech perspective.
Alligator Bioscience’s director of clinical operations, Karin Nordbladh, meanwhile will present how the US Food and Drug Administation’s (FDA) Project Optimus will be implemented. This agency initiative aims to reform the dose selection paradigm in oncology drug development. Nordbladh will cover correct dose selection in line with the guidance, how study designs and protocols enable implementation, as well as highlighting challenges.
Attention will then turn towards East Asia, with Ascendis Pharma’s associate director of clinical operations, Lisbet Groes, who will present her experience of overseeing a clinical trial in Japan. The contract research organisation (CRO) landscape has been rocky since the Covid-19 pandemic. A survey by Worldwide Clinical Trials reported that nearly 80% of respondents felt the ‘one-stop-shop’ claim of large CROs is not a cost-effective business model. Furthermore, 50% of respondents said that the instability of large CROs had impacted their willingness to partner due to project team disruptions, lack of access to top talent, poor service delivery, and more. Global CRO partnerships have therefore become a popular route to achieve trial operation flexibility.
Groes’ session will particularly focus on selecting a CRO in Japan, along with the benefits and challenges of heading to the country for trials.
CRO partnerships are further covered in two key sessions at the conference. The first, a panel, will cover the selection process along with financial considerations. An interactive session on the second day will delve into sponsor-CRO partnerships with a focus on building strong relationships.
Technology in the spotlight
Advancements in technology have helped transform the clinical trial landscape. Via the Clinical Trials Technology and Innovation stream at the conference, attention will turn toward improving clinical supply through digital means.
Alexander Debetes, lead clinical supply innovation, former MSD, will highlight how digital display labelling can improve supply chain logistics via flexibility and visibility. Former principal data manager Ane Jensen will cover Patient Experience Data (PED), the topic of a recent reflection paper published by the European Medicines Agency (EMA). The paper’s aim is to encourage stakeholders and developers to engage at an early stage with regulators to discuss inclusion of PED in programmes. Jensen will discuss study design considerations in light of this, along with patient burden and missing data.
View the full list of speakers and the complete conference agenda for 13th Annual Outsourcing in Clinical Trials Nordics 2025 here.
View the full list of speakers and the complete conference agenda for 13th Annual Clinical Trial Supply Nordics 2025 here.
Register here: https://hc.eventsonlineregister.com/tc-events/13th-annual-outsourcing-in-clinical-trials-clinical-trial-supply-nordics-2025/
