DAY 1
12.00 Registration, networking and exhibition
12.50 Welcome, background and practicalities. Mia Bengtström Lecturer, University of Helsinki and Associate professor, Åbo Akademi University
13.00 Using RWE and AI in the development of medicine to solve patient’s unmet medical needs and improving the competitiveness of EU. Anders Rething Borglykke, Vice President, Real World Evidence, Novo Nordisk A/S
- The talk will be an introduction to how Novo Nordisk uses RWD throughout the value chain with a focus on clinical development. The talk will include a call to action for using better and appropriate data in order to increase the usefulness of the results necessary to achieve the ambition of using RWE to all aspects of clinical drug development including regulatory submissions.
13.25 Empowering data-driven medicines regulation in the EU: unlocking the power of real-world data and AI. Luis Pinheiro, Senior Epidemiology Expert, Data Analytics and Methods Taskforce
Implementation of EHDS – how to improve the competitiveness of the Nordic Region by using the excellent RWD assets
13.50 TEHDAS2 and VALO Value from Nordic health data – VALO – Sitra Markus Kalliola, Program Director, Coordinator of Joint Action Towards TEHDAS 2 and VALO projects
14.15 European Health Data Space – a stealth revolution. Richard Bergström, Vice President European Affairs, IQVIA
Use of RWD and AI towards value based decision making and healthcare (1/2)
14.40 The global value of Nordic data – pharma perspective. Emmi Tikkanen, RWE Scientist, Global RWE Platform, Pfizer
15.00-15.35 Coffee, exhibition and networking.
15.35 The global value of Nordic data – selected use cases. Emilie Toresson Grip, Director, Head of RWE and Analytics, Quantify Research
- Overview of the key comparative advantages of the Nordic RWD landscape, compared to other US/EU RWD assets. Illustrated by highlighting examples of pan-Nordic research in collaboration with global pharma stakeholders, including the added value of Nordic data in international, multi-country studies
15.55 Secure Processing Environment (SPE) – Your Gateway from Individual Level RWD to RWE. Erkki Soini. CEO, ESiOR Oy. Chairman on the Board, Kuopio Health
- SPE can provide a secure platform for collecting, transferring, managing, analysing, presenting, and storing social, health, trial, and other sensitive real-world data (RWD) for research, knowledge management, and education purposes used in research, development, decision making, market access, and value-based healthcare. In addition, some examples of SPE use in cardiovascular and other diseases with Nordic perspectives will be presented.
16.15 Nordic data landscape today and tomorrow. Riikka-Leena Leskelä, Research Director and Senior Partner at Nordic Healthcare Group
- Current possibilities to conduct Nordic RWE studies and how future changes in the data landscape will make data utilization easier
16.35 Use of RWD/RWE in medicines development and regulatory decision making. Sini Eskola, PhD Candidate at University of Utrecht and WHO Centre for Pharmaceutical Policy and Regulation; Director, Regulatory Strategy, EFPIA
16.55 Using Federated Data Networks and Common Data Models for Health Technology Assessment. Ravinder Claire, Scientific Advisor – Science Policy and Research Programme, National Institute for Health and Care Excellence
17.20 Comparative effectiveness of first line pembrolizumab vs. chemotherapy in advanced non-small cell Lung-cancer after approval and reimbursement: A Norwegian Population-Based Cohort Study. Simon Boge Brant, PhD, NordicRWE
17.40 Thank you for the Day and walking to the City Hall
18.00- 19.30 The Networking Reception
DAY 2
Chairs: Martta Ranta, Head of Medical Research, Abbvie and Juha Laine, Nordic HEOR Manager and RWD Advisor, Roche
Use of RWD and AI towards value based decision making and healthcare (2/2)
9.00 Value based healthcare. Irene Eriksson, EMEA Partnership Lead, J&J
9.25 Building a Foundation for Evidence-Based Healthcare: The Impact of Real-Time Data in clinical decision making, Real-World Evidence Generation and on building Registries. Joakim Söderberg, Head of Business Development, BCB Medical
- Traditionally, real-world data (RWD) has been derived from static extracts of registries, electronic medical records (EMRs), and similar systems. However, with the disease-specific registries used in the daily clinical work, RWD is generated from continuously updated, dynamic, “living” datasets. With the dynamic datasets, the ability to capture trends, assess interventions, and make adjustments in real-time becomes feasible, bridging the gap between research and day-to-day clinical care.
9.45 Use of natural language processing and machine learning to extract smoking status from patient texts in Finnish data lakes: lung cancer outcomes related to smoking as case example. Olivia Hölsä, Data Scientist, Medaffcon Oy
- Finnish data lakes provide endless RWE opportunities especially in oncological indications with access to deep clinical data. However, many clinically relevant variables such as smoking status are widely recorded in free text format, and natural language processing methods are required to include them in RWE studies.
10.00 Why does the Nordics exceed in RWE – or could we do better?
Real-time hospital-level clinical cost-effectiveness RWD production and reporting at HUS/HUCH. Sami Pakarinen, Chief Medical Officer of Clinical Auditing (deputy) at HUS/HUCH
- Nordic Case: Valo and EU Case: Oncovalue, implementing value-based oncology care at European cancer hospital
EU Case: IHI Prominent, digital platform for precision medicine. Linus Jönsson, Professor, Karolinska Institute
Fireside discussion moderated by Lisse-Lotte Hermansson, Country Director Medaffcon AB. Discussion with Sami Pakarinen and Linus Jönsson:
- What are the challenges in RWD for cost effectiveness analysis?
- Why is collaboration, data harmonization and interoperability important?
- How can we avoid data access delays and continue to lead in the health data space?
10.40 Networking break
11.00 Harnessing the Finnish national registers to generate RWE. Anna-Maija Tolppanen, Professor, University of Eastern Finland
- Possibilities and challenges of using Finnish national registers are discussed through examples of previous multi-country and single-site studies and ongoing projects including Real4Reg https://www.real4reg.eu/
11.25 The Power of Next-Gen Anonymization: Secure, Compliant, and Accessible Data. Tuomo Pentikäinen, CEO, VEIL.AI
- AI-enhanced next-generation anonymization technology is transforming the data landscape. It improves access to real-world data for evidence generation, facilitates secure cross-border sharing of clinical research data, and enables privacy-compliant datasets for AI training.
11.45 HealthHub Finland EDIH – Auria Clinical Informatics – Agile Path for RWD Research. Arho Virkki, Chief Analytics Officer, Wellbeing Services County of South-West Finland (Varha)
12.05 Real World Evidence Reveal Unjustified Antibiotic Use for the treatment of acne. Johanna Vinblad, Manager HEOR, Market Access & Healthcare Consulting, PharmaLex (part of Cencora)
12.30-13.30 Lunch
Use of RWD and AI in Drug discovery and development
13.30 Transforming drug development in the future using Large Scale Data to find novel treatments for understudied medical needs. William Hennah, Senior Scientist Genomics at Orion Pharma Oy
- How do you gain RWE to support drug development when the medical need is poorly defined in health records, and how do you get that precious RWE into the hands of research scientists? I’ll present Orion’s work on co-developing the DeepPheWAS R package, that allows for dynamic phenotype creation to address lacking information in large scale population datasets, and the POD3 platform, that brings public and proprietary data into one place supporting collaborative multidisciplinary research.
13.55 The power of combining Norwegian Healthdata and AI: A case example from Novartis and Akershus University Hospital. Novartis
- Intro – 5 min: Nicolas Vaugelade-Baust, Nordic Evidence Generation Director – Novartis
- Case example: Tatjana Bosnjak-Olsen – Medical Lead Norway – Novartis, Jesper Ravn – Senior Advisor Technology and ehealth – Akershus University Hospital
- International perspective: Benjamin Gmeiner – Head of Medical Data Strategy & Science Germany – Novartis
14.30 Transforming Clinical Trial Practices through Real-World Data. Tero Ylisaukko-oja, CEO, founder, MedEngine Oy
- Real-world data (RWD) have great potential to revolutionize clinical development, particularly in rare diseases. By leveraging RWD in natural history studies, researchers can gain valuable insights into disease progression and identify key factors—such as demographic, genetic, and environmental influences—that shape patient outcomes under current standards of care. These insights are crucial for designing clinical trials with optimal duration, meaningful endpoints, and the possibility of incorporating external control arms. Data from the Nordic countries provide a uniquely robust foundation for conducting these transformative studies.
14.50 Can you outsource data interpretation to AI? Paavo Raittinen, PhD, Head of Commercial Data Services, Oriola
15.10-15.20 Next steps. Thank you for participating and funding, Mia Bengtström