Digitisation and innovation in drug testing

Dr. Thomas Gebhart and Prof. Klaus Cichutek Source: H. Stoll / PEI

The importance of vaccines and other biomedical medicines is steadily increasing. Special innovations are provided by certain advanced therapy medicinal products (ATMPs) based on cells or genes. The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines accompanies and supports the development of these complex medicines through regulatory life-cycle management. This includes the early scientific advice of potential applicants, the speedy authorisation of clinical trials as well as the benefit-risk assessment in the authorisation process and in the standardised therapy afterwards. The Institute's regulatory research in the fields of immunology and haematology, infectiology, allergology and cell and gene therapy is indispensable for the high quality of the PEI's work. Dr Thomas Gebhart, Parliamentary State Secretary to the Federal Minister of Health, informed himself yesterday about the contributions of the PEI to the safety, tolerability and effectiveness, but also the availability of biomedicines and the research work of the PEI.

"The PEI combines drug regulation and task-oriented research, embedded in an international environment - this is our competence and strength," said Professor Klaus Cichutek, President of the PEI. Thus the PEI can also take charge of the new immuno-therapeutics against cancer from the first discovery via the authorisation up to the patient’s therapy. In addition, the PEI is helping shape the regulatory framework in Germany and Europe. In research and regulation, the PEI will increasingly focus on the use of big data and the digitisation of work processes.

Gebhart continued: "Even in the post authorisation phase, the possibilities and limits of innovative medicines in particular must be continually evaluated. We must seize all opportunities so that patients have fast access to efficient and safe drug innovations. For this, close cooperation between BMG and PEI is a great advantage."

Since March 2018 Dr Thomas Gebhart is Parliamentary State Secretary in the German Federal Ministry of Health (Bundesgesundheitsministerium, BMG). In this function and as a member of the Bundestag, he supports the Federal Minister of Health in fulfilling political tasks.