Panion in ITF-meeting at EMA
Development of new and unique medicines for animals (and humans) requires a close cooperation with the authorities that in the end will decide on the approval and allow marketing of the product.
In Europe, genetically based novel medicines are authorised by application to the European Medicines Agency (EMA), currently located in London. To facilitate the understanding of new ideas and approaches to treatment of diseases, the EMA has established an Innovation Task Force (ITF) which consists of experienced scientific reviewers and persons involved in the assessment and processing of new medicinal inventions, who will meet with a small number of selected companies each year.
Panion’s epilepsy product, which is based on CombiGene’s scientific development over many years, was accepted for an ITF meeting in 2018. A briefing package of background information and research results was send to EMA before the ITF meeting with the experts in London in June 2018. Associate professor at the University of Copenhagen, David Woldbye, led the scientific questions on the project. Chief Research and Development Officer from CombiGene, Karin Agerman,
led the discussion on manufacture and product development.
CEO and veterinarian from Panion, Anja Holm, led the presentation and the clinical discussion on the development of the product for animals.
“The meeting was very successful, and our expectations were fully met. We got some new things to think about and new angles that we can use for the benefit of the product development. It was clear that they understand our approach very well. Importantly, we also got a feeling for where the authorities see potential short-cuts that we will explore, and where we need to investigate and explain more thoroughly”, says Anja Holm, CEO of Panion Animal Health AB.
Anja E. H. Holm, CEO
+ 45-22 94 66 00
Panion will develop and commercialize a gene therapy treatment for dogs with drug refractory epilepsy, and other new animal health products and treatments that improve the quality of life for animals suffering from chronic diseases.