Professor Klaus Cichutek has been President of the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, since 2009. After a postdoctoral position in the USA, he joined at the Paul-Ehrlich-Institut as a research group leader, later becoming a division head and then Vice President. Klaus Cichutek will retire at the end of 2023. In the following interview he takes stock of the most important milestones of his presidency.
Professor Cichutek, you have a long history with the Paul-Ehrlich-Institut to reflect back on. What memories will you take with you from your time at the Institute?
Klaus Cichutek: 35 years at the Paul-Ehrlich-Institut – including 14 years as President – that is a long time in which I, together with the employees and in coordination with the Federal Ministry of Health, was able to help shape the Institute's tasks and functions and contribute to top regulatory and research achievements. It has always been a privilege for me to be able to provide regulatory and research-based support for the development of new medicinal products at the Paul-Ehrlich-Institut for the benefit of vaccinees and patients. In providing policy advice regarding regulatory frameworks and working with the World Health Organization (WHO) and the European Medicines Agency (EMA), we have also been able to contribute to the guidelines and standards that allow for a guarantee of the quality, safety and efficacy of vaccines and biomedicines. These policies allow drug developers to follow the most straightforward path when developing a new drug.
What were the highlights of your presidency?
Klaus Cichutek: The Paul-Ehrlich-Institut is the higher federal authority responsible for vaccines and other biomedicines with research tasks operating under the Federal Ministry of Health. One of my personal highlights during my tenure is the active role that the Paul-Ehrlich-Institut played nationally and internationally in combating the SARS-CoV-2 pandemic, and the very positive feedback on our work we received from politicians, scientific experts, and the public. The Paul-Ehrlich-Institut's name and activities are now widely known. We are perceived not only by scientific experts, but also by the public as a competent Federal Institute for Vaccines and Biomedicines with an important area of responsibility and as a reliable source of information. The pandemic clearly demonstrated what our experts can accomplish, even in non-pandemic times.
Our successful work during the SARS-CoV-2 pandemic was due to the conditions that we created together at the Institute in the preceding years. Our performance was exceptional thanks to the commitment of our employees, who strongly identify with the Paul-Ehrlich-Institut's mission and tasks. We are active in or chair many committees and working groups in Germany, at EMA, WHO, and the European Directorate for the Quality of Medicinal Products, EDQM for short. We network on both a European and a global level with other medicines authorities and agencies through our commitment to the HMA, the Heads of Medicines Agencies (the heads of the national European medicines authorities) and as a founding member of ICMRA, the International Coalition of Medicines Regulatory Agencies (the heads of globally active medicines authorities). Working in these networks creates the basis for providing people worldwide with vaccines and biomedicines with proven quality, safety, and efficacy in a timely manner in both pandemic and non-pandemic times. This can be achieved with measures such as innovative and flexible approaches to medicinal product testing and regulation to accelerate the issuance of necessary approvals and authorisations.
What achievements are you particularly proud of?
Klaus Cichutek: When I joined the Paul-Ehrlich-Institut 35 years ago, biomedicines, i.e. large molecules and complex medicinal products based on biological material, were considered less important in medicine than chemical medicines, the small molecules. We have since entered a worldwide era of biomedicine, and the Paul-Ehrlich-Institut has made an important contribution to that shift. The proportion of applications for clinical trials of biomedicines in Germany has risen steadily in recent years and is currently around 40 percent. Parallel to that increase, the demand for scientific and regulatory consultations with the Paul-Ehrlich-Institut – coordinated by our Innovation Office – and the number of consultations completed has also risen sharply. At the beginning of my work in the regulatory field, I was able to lay some foundations for the regulation of cell and gene therapeutics at the national and European levels. I am proud to have played an active role in this development with the Paul-Ehrlich-Institut.
The Paul-Ehrlich-Institut has been intensively committed to providing targeted regulatory support to the research and development of new vaccines and biomedicines for more than 15 years and has gained valuable experience in the process. We have already achieved processing times for submitted clinical trial approval applications that are 40 to 60 percent shorter than required by law. We provide support for many medicinal products developed for rare and common diseases – from scientific advice and approval of clinical trials to authorisation and then life cycle management and pharmacovigilance. In doing so, the Paul-Ehrlich-Institut makes indispensable contributions to the quality, safety, and efficacy of these medicinal products for both patients and vaccinees and thus for public health. We at the Paul-Ehrlich-Institut have been leaders in vaccines and biomedicine in Europe for more than a decade thanks to our expertise and are an important location for the pharmaceutical and biotech industry as well as for academic translational researchers in Germany and Europe. At the same time, we have conducted research on important aspects of medicinal product safety and efficacy. I myself have contributed research on retroviruses such as HIV and SIV, as well as on retroviral vectors.
In my view, the most important successes of the Paul-Ehrlich-Institut in the last 15 years include:
These are impressive achievements.
There were certainly many ups and downs during the years of your presidency. What were the most difficult moments or greatest challenges for you?
Klaus Cichutek: I experienced a whole series of infectious health crises in these 35 years: from the AIDS pandemic and the blood scandal at the Federal Health Office, in which the Paul-Ehrlich-Institut did not play a part; to the BSE crisis, the so-called swine flu; the MERS coronavirus; Ebola; and the SARS-CoV-2 pandemic. Other crises included the first difficult results in gene therapy trials for hereditary monogenic diseases. The Paul-Ehrlich-Institut has always been able to make an important, universally recognised contribution to overcoming such crises.
The SARS-CoV-2 pandemic is just the latest example. The Institute's employees outdid themselves in every aspect of their work after the outbreak of the pandemic: we supported the development of the COVID-19 mRNA vaccines in Germany and evaluated the first COVID-19 vaccine in its authorisation process one year after the occurrence of SARS-CoV-2. One day after the first COVID-19 vaccine was authorised by the European Commission, the Paul-Ehrlich-Institut released the first vaccine doses after batch testing for Germany and certified them for Europe. In the midst of the pandemic, our experts went to inspect production facilities outside Europe. The Paul-Ehrlich-Institut approved SARS-CoV-2 neutralising antibodies in Germany and made them available. In addition, our experts comparatively evaluated SARS-CoV-2 antigen tests so that tests available in Germany were particularly sensitive. Side effects of the COVID-19 vaccines were closely monitored, analysed and the findings quickly published in safety reports. The Paul-Ehrlich-Institut discovered the very rare side effect of thrombosis with thrombocytopenia syndrome (TTS) after administration of the COVID adenovector vaccines in Germany and coordinated safety-enhancing measures. Through important research results, the Institute has also contributed to a better understanding of SARS-coronavirus-2, the immune reactions it triggers, and side-effect mechanisms.
How well is the Paul-Ehrlich-Institut positioned for the future?
Klaus Cichutek: The Paul-Ehrlich-Institut focuses its expertise on biological medicinal products – vaccines and biomedicine – through the combination of medicinal product evaluation and experimental batch testing as well as through the combination of regulatory tasks with its own experimental and pharmacoepidemiological research. These combinations make the Institute an immensely important location for the production and development of biomedicines in Germany and Europe and also for pioneering the medicines regulation of the future. In this way we are similar to the Center for Biologics Evaluation and Research at the US FDA. We have shown that we can look to the future, constantly evolve and quickly take on new tasks.
What challenges do you see for the Paul-Ehrlich-Institut in the future?
Klaus Cichutek: At the Paul-Ehrlich-Institut, we have a valuable resource – our numerous experts with comprehensive and complex expertise in biology, medicine, pharmacology, and veterinary medicine. They are also experienced in regulation. This combination has a positive effect on medicinal product development. We must continue to promote the development of this expertise so that we are as prepared as possible for situations such as future pandemics. But the focus should not only be on pandemics. We need this expertise, this knowledge in the areas of research and regulation, in order to be able to counteract our society's health challenges with effective medicines. Cancer, cardiovascular diseases, and autoimmune diseases limit people's capability to work and live with vitality. Scientific progress can make improvements here. To assist in those improvements, it is important that the Paul-Ehrlich-Institut continues to use its ability to adapt and change in the future in order to best fulfil its federal tasks such as medicinal product evaluation, approval of clinical trials, batch testing, and research.
Do you have any advice you would like to share with your successor?
Klaus Cichutek: Professor Vieths has been Vice President of the Paul-Ehrlich-Institut since 2010 and, like me, has internalised the Paul-Ehrlich-Institut's DNA. He doesn't need any advice, just the friendly offer that I am always available for advice if needed. Mr Vieths has been successfully active in medicines regulation nationally and at the European level for decades and has known the Paul-Ehrlich-Institut for decades. He is an award-winning researcher and an efficient manager. Most recently, he has headed the internal reorganisation project, the new building planning, and the administration division. He will take over as acting head of the Institute from January 2024, which we are very pleased about. He will start this position with momentum due to his many years of expertise and management experience and will continue to develop the Institute.
How do you, as a scientist, plan to spend your retirement after all these years of service?
Klaus Cichutek: For me, retirement means above all that I am no longer responsible for the Paul-Ehrlich-Institut and for the medicinal products within the Institute's remit. I will certainly miss the work and the many friendly colleagues in the Institute and in the research community. But I will of course stay connected to the Institute and its forward-looking approach. I will continue to be involved in medicines innovation in some function. I am grateful to have been able to experience the discovery of oncogenes, the successful development of HIV therapies, CAR T-cell therapies, and the use of gene editing with CRISPR/Cas very closely in the research community, even in personal acquaintances, and to have contributed to discoveries in retrovirology itself. However, I am also looking forward to having more time for the family in the future: my wife and I already have a whole series of plans. I will also continue to pursue my hobbies, such as football, fitness training, sailing, and, in the future, perhaps also golf.
Updated: 20.12.2023
