PEI expert for vaccines and biomedicines elected as member of the EMA's Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) assesses new medicinal products and gives recommendations in favour of or against European marketing authorisations to the European Commission. Dr Jan Müller-Berghaus, expert for vaccines and biomedicines at the Paul-Ehrlich-Institut (PEI) renewed his candidacy for membership at the CHMP which was confirmed as per 9 November 2017 for another three years.
"The re-election is a major personal success for Dr Müller-Berghaus and highlights the vital role of the Paul-Ehrlich-Institut as a European authority in the field of vaccines and biomedicines", said Professor Klaus Cichutek, president of the PEI.
Experts of the PEI have been co-opted member of the CHMP since 2004. Such a member represents the team responsible for the assessment of quality, safety, and efficacy of medicinal products for human use at the PEI and supports the marketing authorisation of these products throughout Europe. The PEI was responsible for the assessment of medicinal products such as:
- Hexacima, a hexavalent vaccine against pertussis (whooping cough), diphtheria, tetanus, polio, haemophilus influenza B and Hepatitis B,
- Herceptin, a medicinal product the indications of which include breast cancer,
- Holoclar, for the treatment of cornea damage,
- Helixate NexGen, for the treatment of haemophilia A.
The CHMP is the central body for the assessment of medicinal products for human use. The recommendation provided by the CHMP is the basis for the decision by the European Commission in favour of or against the marketing authorisation of novel medicines for the European market. Each member state of the European Union nominates a member of the CHMP. The German member is provided by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). The committee can obtain additional expertise by electing additional members (co-opting). One of the areas considered by CHMP as requiring additional expertise is "quality, safety, and efficacy of biomedicine including advanced therapy medicinal products and vaccines". This particular expertise is provided by the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Medicinal Products at Langen near Frankfurt/Main.
Since 2012, Jan Müller-Berghaus has been the head of the Unit "Medicinal Policy Issues" at the PEI. He is a member of the "Scientific Advice Working Party" (SAWP) and the "Rheumatology / Immunology Working Party" (RIWP) of the CHMP.
His work at the PEI started in the Division Immunology in 2005, and from 2008 to 2012, he was the head of Section "Mono and Polyclonal Antibodies".
From 2002 to 2005, Dr Müller-Berghaus was a member of a translational research group at the German Cancer Research Centre (Deutsches Krebsforschungszentrum, DKFZ) which is involved in the development of immune therapies for malignant melanoma (black skin cancer).
After completing his studies of human medicine at the Ruhr University at Bochum (1984 to 1990), he qualified as specialist for paediatrics and adolescent medicine at the Paediatric University Hospital at Cologne. After that, he spent four years in the USA as a researcher, among other things, as part of a fellowship from the Dr Mildred-Scheel Foundation for Cancer Research (Dr. Mildred-Scheel-Stiftung für Krebsforschung).