Dr Martina Schüssler-Lenz is the Deputy Head of the Advanced Therapy Medicinal Products Section at the Paul-Ehrlich Institute (PEI) in Langen, Germany, and has been vice-chair of the CAT since March 2014. She has also been the coordinator of the strategic partnership of PEI with the German Cancer Consortium (DKTK) to facilitate quick and effective implementation of scientific ideas into clinical practice. The PEI / DKTK partnership was initiated to guide scientists through the highly complex legal and regulatory framework of medical research and development.
“An ambitious CAT work plan and increased workload lies ahead of us. Therefore, my aim is to come up with adequate regulatory strategies to cope with this increasing workload, which include streamlined discussions in the Committee's meetings and even closer interaction with the committee for human medicines, the biologics and the scientific advice working parties, as well as other committees and working parties,” says Dr Martina Schüssler-Lenz.
The CAT is responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field. ATMPs are medicines for human use that are based on genes or cells. They offer ground-breaking new opportunities for the treatment of disease and injury. The Committee prepares a draft opinion on each ATMP application submitted to EMA, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorisation of the medicine concerned.