This conference is arranged in collaboration between The Nordic Trial Alliance (NTA), Business Finland and Åbo Akademi University with the Support of The European Federation of Pharmaceutical Industries and Associations (EFPIA).
The Nordic Trial Alliance (NTA) is a project with the aim to facilitate clinical research co-operation in the Nordic region. NTA is funded by the Nordic Council of Ministers and NordForsk. NTA has funded several conferences related to clinical trials and RWD with the aim to increase the collaboration between Pharma, Academia and all stakeholders relevant for Clinical Trials.
Join this event in June to hear about the Future Clinical Trials and why choose the Nordics! You are welcome to contribute and network with all the relevant stakeholders in this event.
Preliminary event program
Day 1 (7.6. at 13.00-17.45 EEST / 12.00-16.45 CEST)
1. Welcome words
Mia Bengtström, Associate Professor, Åbo Akademi University
2. Looking into the Future – use of data in medicines development
- What have we learned from two decades of digitizing clinical development and where are we headed next?
Kai Langel, Senior Director, Strategy and Innovation, Janssen Global Regulatory Policy and Intelligence - Next generation of clinical trials
Sam Hariry, Global Head Clinical Innovation, Novartis (Virtual) - Drug Development: the future is today!
Solange Corriol-Rohou, Senior Director Regulatory Affairs & Policy, Europe, AstraZeneca, EFPIA Clinical Research Expert Group
3. Decentralized Clinical Trials – potential benefit and value for stakeholders
- The promise of decentralised trials: What does industry need to consider
Nick Sykes, Senior Director, Global Regulatory Policy & Intelligence at Pfizer, EFPIA Clinical Research Expert Group - Designing Decentralized Clinical Trials with a Patient-Centric Approach
Henna Alanko, Global CPA Oncology, Crown CRO and Bayer
Coffee break and Networking
4. Investigators view of DCT (TBC)
5. Examples of virtual elements in clinical trials conducted by different sponsors in the Nordic countries. Why is the Nordics a good choice for these kind of studies? Johanna Hemdahl, Boehringer-Ingelheim, Chair for the Clinical Trial Expert Group, Pharma Industry Finland in collaboration with Nordic colleagues.
Comments from the Nordic country representatives:
- DCT activities in Sweden Gunilla Andrew-Nielsen, Head of Clinical Trials, MPA
- DCT in Finland, Pirjo Inki, Head of section Clinical Trials, Fimea
- DCT in Norway, Hege Edvardsen, Senior Manager Research, Development & Innovation, LMI
- DCT in Denmark, presented by Marianne Pilgaard, Trial Nation on Day 2
6. Panel discussion (moderated by Sini Eskola, Director, Team Leader, Regulatory Strategy, EFPIA)
- Patients, CA, EC, Pharma, Investigators view
The official program ends at 17.45 and it is continued by a Networking Event.
Day 2 (8.6. at 09.00-16.00 EEST / 08.00-15.00 CEST)
1. Complex Clinical Trials
- Innovation in Clinical Trials: What has been achieved with CCTs and key challenges that need addressing
Chrissie Fletcher, VP Biostatistics GSK and Lead for Innovation in Clinical Trials Pillar, Clinical Research Expert Group, EFPIA - Regulators view on complex clinical trials
Elina Asikanius, Biostatistician Fimea, Member of EMA methodology working party - Presentation (TBC)
2. Pragmatic clinical trials
- Pharma perspective on pragmatic trials
Ola Vedin, Scouting & Innovation Lead, Clinical Development & Operations, Boehringer-Ingelheim - Pragmatic clinical trials in vaccine evaluation
Arto Palmu, Chief Research Officer, Vaccine Research Center Finvac Ltd
Why choose the Nordic Region for research and trials? Examples of activities in the Nordic countries – ecosystems making the country competitive and role model for the other countries
Feasibility and recruiting tools
- Recruiting subjects to clinical studies fast with modern digital tools
Petteri Kolehmainen, Managing Director. Healthware International
Lunch
3. The effective use of data and digitalization
- Utilizing Finnish nationwide RWD to create an external control arm to a clinical trial
Jussi Leinonen, Expert Clinical Data Scientist, Bayer - Leveraging technology for better clinical endpoints
Jelena Curcic, Senior Expert in Data Science, Novartis (Virtual)
4. Example of activities in the Nordic countries – ecosystems making the country competitive and role model for the other countries
- Trial Nation – A Part Of the Danish Clinical Research Ecosystem
Marianne Pilgaard, CEO, Trial Nation - Other examples to be confirmed
Coffee
5. Company examples
- Beyond the Secure Processing Environment: The future of clinical trials and real-world studies
Erkki Soini, CEO, ESiOR Oy - Virtual control arms – why and how?
Johanna Vikkula, Data Scientist, Medaffcon Oy - Advanced approaches for generating virtual control arms in oncology
Tero Ylisaukko-oja, CEO, MedEngine Oy - Turning RWD into RWE: External Control Arm for Label Expansion
Kate Prior, BC Platforms (Virtual)
Transcelerate
Transcelerate
Joachim Lövin, eTrials Senior System Supporter, NovoNordisk
Inflames flagship – Collaboration opportunities for Pharma with Åbo Akademi University/Turku University researchers
Timo Veromaa, Professor of Practice (Drug Development),
University of Turku, Finland
6. Closing words
ORGANIZERS
SUPPORTERS
