04 / 2017
In February this year, Dr Martina Schüssler-Lenz, clinical assessor at Division Medical Biotechnology of the Paul-Ehrlich-Institut (PEI) was elected chairperson of the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA). Dr Schüssler-Lenz is a physician trained in internal medicine, and has specific expertise in the medical and regulatory field.
Source: PEI / Reiss
Major progress in the biotechnology area has enabled the development of Advanced Therapy Medicinal Products (ATMPs). These products are generated using highly innovative techniques, and include gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineered products. Because of the complexity of this group of medicines, a specific legislation has been implemented at the European level. To assure the specific expertise for the evaluation of ATMPs at the EMA, the Committee for Advanced Therapies has been established at the EMA as a multidisciplinary committee in 2009, in accordance with Regulation (EC) No 1394/2007. One of the functions of the CAT is the scientific evaluation of the quality, efficacy, and safety of ATMPs and to prepare a draft opinion for final approval of the marketing authorisation by the Committee for Human Medicinal Products (CHMP).
Each EU member state nominates an expert as a member to the CAT. Five of these members are at the same time members of the CHMP. Iceland and Norway nominate one member each. Two additional members are representing physicians and patient organisations, respectively.
"We are very pleased to learn that Dr Schüssler-Lenz has the chance to provide the CAT with her expertise in the field of clinical assessment of medicines in connection with the expertise she gained from the Division Medical Biotechnology at the Paul-Ehrlich-Institut. The CAT supports highly innovative medicines on their way to a marketing authorisation, so that new therapy approaches for serious diseases can find their way to medical practice"
, explained Professor Klaus Cichutek, president of the Paul-Ehrlich-Institut.
Dr Martina Schüssler-Lenz has been a member of the CAT since 2009. After her clinical training she worked as a postdoctoral fellow in tumour research at the Memorial Sloan Kettering Cancer Center, New York. Later on she worked in the pharmaceutical industry and was responsible for several clinical drug development projects of anticancer agents. At the Paul-Ehrlich-Institut she is responsible for evaluating clinical data and for providing scientific advice.
"Medicine is evolving fast, and we have to make sure that new, innovative therapies reach the patient. I'm happy to contribute to this at an important interface as chair of the CAT"
, said Martina Schüssler-Lenz.
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The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.
Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.
The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).
Updated: 24.02.2017
