Posted at 16:27h
In 2023, Matthieu de Kalbermatten, CEO of CellProthera, looks forward to presenting the final safety and efficacy results of the company’s Phase II clinical trial, and for moving into Phase III. He says "Significantly, there is a new scheme set up in France whereby innovative biotherapies that address unmet medical needs can enter the market following a successful Phase II clinical, while running a Phase III in parallel. This will give us the opportunity to open dialogues with the regulatory body and gain invaluable experience in the marketing of our CGT product."
For the industry, especially in Europe, initiatives and government regulatory reforms represent a great opportunity for companies such as CellProthera to bring their therapies to patients more easily. De Kalbermatten says the accelerated regulatory pathways will be key to getting more CGTs to market, however, in order to make it to approval pathways, many start-ups and smaller biotechs need to secure investments. He says: “The investment landscape has been tough this year and that looks to be carrying over into 2023. However, there is solid hope that the situation should come back to normal by the end of 2023 according to the usual 'up and down' cycle in the industry.”