After a brief introduction by dr. Caroline Riley, Phase1 Unit, professor and research director at Rigshospitalet, Malene Fischer delivered an inspiring talk on how hope, faith and knowledge is merged in early clinical trials. Professor Ulrik Lassen, Rigshospitalet took the audience back in time to the early 2000's where the Phase 1 Unit was founded and the journey from a local initiative to being one of the leading Phase 1 Units in Europe.
Jan van de Winkel, CEO of Genmab, a long-time collaborator and sponsor on clinical trials gave the audience a hugely inspirational talk on the development of antibodies and antibody drug conjugates over the years.
Lone Melchior, Roche Denmark, Martin Hutchings, Professor and Head of Phase 1 Unit Haematology RH, Kristoffer Rohrberg, Head of Phase 1 Unit Oncology, RH
Equally instrumental for the success of phase one oncology and hematology trials in Denmark was the close collaboration with Roche Denmark, here represented by Dorthe Klokker and Lone Melchior depicting the industry's perspective on early clinical trials.
Clinical trials are highly dependent on regulatory authority interaction with both investigators and sponsors. Denmark is a leading country for providing rapid and competent processing of early clinical trials applications, also under the EU CTR (European Union Clinical Trials Regulation). This was underlined by Mikkel Sachs (Danish Ethics Committee) and Frederik Nørgaard's (Danish Medicines Agency) speech that also concluded the morning session.
Frederik Grell Nørgaard, DKMA
In the afternoon session, Dr. Kristoffer Rohrberg, head of the Phase 1 Unit at Rigshospitalet, spoke about the advantages of an integrated hematology and oncology phase one unit. He also provided insights into their large-scale genomic and proteomic profiling program. Subsequently, dr. Simon Husby from Dept. of Hematology, Rigshospitalet, shared results from the translational research in lymphoma and myeloid biology.
Pablo Umaña, Roche Innovation Center rounded off the scientific sessions with a breathtaking journey through immuno-oncology concluding with insights of some of the most recent compounds dosed at the Phase 1 Unit, e.g., FAP-LTBR agonists.
Pablo Umaña, Roche Glykart AG and Simon Husby, Phase 1 Haematology, RH
Professor Martin Hutchings, head of Phase 1 Unit Hematology, Rigshospitalet concluded the symposium with both highlights from the past 10 years of hematology trials at Rigshospitalet and setting the stage for another ten years with more highlights to come.
Thank you to all who participated and our amazing collaborators
It was a distinct pleasure for the organizing committee to host the symposium which not only gave everybody the opportunity to take some inspiration from the leading beacons of science in the field of developmental therapeutics but hopefully also to network with new and old acquaintances.
We also sought to give a unique understanding of the framework required to operate a clinical trials facility at an international level, a framework of both regulatory authorities, pharmaceutical industry, dedicated and skilled personnel at Rigshospitalet and elsewhere in Danish healthcare and not least patients and their caregivers.
We are looking forward to the next ten years of groundbreaking Phase 1 hematology trials in Denmark.