Future clinical trials – from tomorrow to 2030 – Why choose the Nordics?

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 European Federation for Pharmaceutical Industries and Associations (Efpia) and the Nordic Pharma Industry Associations (PIF, LIF, LIF, LMI) act as supporters.

The event will take place in Team Finland House (Porkkalankatu 1, Helsinki). It is also possible to follow the event via live stream.

Attendance is free of charge, but requires a pre-registration via the link below. The deadline for registration is no later than May 25th.

Program and registration

Program

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 CET)

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
• Academic example (TBC) 
• Pragmatic clinical trials in vaccine evaluation
  Arto Palmu, Chief Research Officer, Vaccine Research Center Finvac Ltd

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. 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

• 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

6. Closing words