'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

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

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.

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