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'Health Ministry’s visit at the Paul-Ehrlich-Institut' – Thomas Müller, new head of the Medicinal Products Division of the German Federal Ministry of Health (BMG) visited the Paul-Ehrlich-Institut (PEI) on 2 May 2018

"We are very pleased to welcome Thomas Müller at the Paul-Ehrlich-Institut today and to introduce him to its wide range of duties in the field of biomedicine", said Klaus Cichutek, president of the Federal Institute for Vaccines and Biomedicines, which reports to the Federal Ministry of Health. The subjects on which Thomas Müller informed himself included the marketing authorisation of advanced therapy medicinal products, current research collaborations of the Paul-Ehrlich-Institut (PEI) to combat infectious tropical diseases, the collaboration with the German Centre for Infection Research (Deutsches Zentrum für Infektionsforschung) and modern vaccine test methods.

07 / 2018

Thomas Müller: "We are currently seeing impressive progress in the development of new biomedical therapies, particularly in gene therapies and tissue replacement. These novel drugs promise great improvements for the affected patients, but also bring completely new challenges. Regulatory bodies have a great responsibility to evaluate the quality and safety of these complex healthcare technologies. The Paul Ehrlich Institute has excellent competence in this area."

Thomas Müller has been the new head of the Department of Medicinal Products, Medical Devices and Biotechnology of the Federal Ministry of Health since 1 April 2018. He is physician and pharmacist and had formerly headed the Medicinal Products Division of the Joint Federal Committee (Gemeinsamer Bundesausschuss G-BA), the German HTA body, for 10 years. As a recognized drug expert, he was also involved in the evaluation of innovative medicines, such as Advanced Therapy Medicinal Products (ATMPs).

Thomas Müller informed himself on the status of approval and marketing authorisations of ATMPs and on the latest development of precision medicine where CAR-T cells (immune cells programmed for killing tumour cells) have recently won the attention of the public thanks to major successes in cancer treatment. Other areas included the Paul-Ehrlich-Institut’s research collaboration at the new LOEWE centre – DRUID (novel drug targets against poverty-related and neglected tropical infectious diseases), which is involved in neglected tropical diseases and new lab methods in product testing for proof of efficacy of vaccines against diphtheria, tetanus, and pertussis pathogens.

The conclusion jointly drawn from Thomas Müller's visit is that a continued and intensive exchange between PEI and BMG remains an important factor for the successful development and marketing authorisation of vaccines and biomedicines.

Thomas Müller, head of division Medicinal Products, Medical Devices, and Biotechnology of the BMG observing vaccine-treated cell cultures under a microscope.Thomas Müller, head of division Medicinal Products, Medical Devices, and Biotechnology of the BMG observing vaccine-treated cell cultures under a microscope. Photo, right: Dr Konstantin Keller, head of Unit Blood and Blood Products, Sera, Vaccines, and Tissues of the BMG; Back, right: Dr Michael Mühlebach, head of Section Product Testing of Immunological Medicinal Products for Veterinary Use at the PEI. Source: PEI

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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.).

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