Dr Björn Carlsson

Björn joined the NDA in October 2020, he is an expert in non-clinical development for all types of pharmaceuticals and all types of indications.  As a highly experienced non- clinical assessor his strategic & scientific expertise is essential for the successful development of new medicinal products.

He is also an associate professor in industrial experimental clinical immunology at Uppsala University.

Key Areas Of Expertise

• Extensive expertise in the inner workings of the EU regulatory systems
• Advanced Therapies (cell, gene therapies and tissue engineering)
• Non-clinical development for all types of pharmaceuticals in all types of indications.
  • Preformed 100+ scientific advices (national and centralized)
  • Non-clinical assessor for 20+ MAAs (SE acting as Rapporteur)
  • Principal non-clinical assessor for multiple CAT ATMP certifications
  • Horizon 2020 application evaluator 2016-2019

• Professional presentation skills and extensive teaching experience
  • Associate professor in industrial experimental clinical immunology at Uppsala University

Before NDA

Björn spent 12 years at the Swedish Medicines Agency (MPA) primarily as a non-clinical assessor. He was also the Swedish alternate delegate to the committee for advanced therapy (CAT) at the European Medicines Agency (EMA).
Between 2016-2019 Björn was an Horizon 2020 evaluator for the European Commission.

Recent Publications

Berglund D., Karlsson M., Biglarnia A-R., Lorant T., Tufveson G., Korsgren O. and Carlsson B. Obtaining regulatory T cells from uremic patients awaiting kidney transplantation - for the use in clinical trials. Clin Exp Immunol. 2013 Aug;173(2):310-22.

Rashkova V., Nilsson B., Carlsson B., Eriksson F. and Essand M. T cells engineered with a T cell receptor against the prostate antigen TARP specifically kill HLAA2+ prostate and breast cancer cells. Proc Natl Acad Sci U S A., 25;109(39):15877-81, 2012.

Ulenhag GJ., Sadeghi AM., Carlsson B., Ahlström H., Mosavi F., Wagenius G. and Tötterman TH. Adoptive T cell therapy for malignant melanoma patients with TILs obtained by ultrasoundguided needle biopsy. Cancer immunology Immunotherapy, 61(5):725-32, 2012

Carlsson B., Cheng WS., Tötterman TH. and Essand M. Ex vivo stimulation of cytomegalovirus (CMV)-specific T cells using CMV pp65-modified dendritic cells as stimulators. Br. J. Haematology, 121: 428-438, 2003

Related reading

• Welcome Interview
• Get to know Dr Björn Carlsson
• Addressing the challenges of GTMPs

• Why is a potency assay important for cell and gene therapy products?

• The outlook for gene editing in treating disease