Prof. Klaus Cichutek, President of the Paul-Ehrlich-Institut (PEI), and Prof. Stefan Vieths, Vice President of the PEI, explain in a recent interview how the experience of the PEI over the last two years has affected the future of drug development.
Professor Stefan Vieths (left) and Professor Klaus Cichutek (right).
Source: T. Jansen / PEI
Professor Cichutek: As a research institute and licensing agency, we are playing an active part in shaping this development! In 2017/18, many innovations were being developed and were on the way to marketing authorisation, with the PEI being involved in a large number of procedures. Two promising CAR T cell therapeutics for treating leukaemia and lymphoma have been granted marketing authorisation by the European Commission. There was an increase in procedures for other gene therapies using adeno-associated viruses as vectors, e.g. for the causal treatment of haemophilia: thanks to inserted genes, liver cells can produce missing coagulation factors themselves. A monoclonal antibody is already available that replaces a coagulation factor – and next generation recombinant coagulation factors have a significantly extended half-life. Vector vaccines are also being used more and more. A prominent example of this is the Ebola vaccine VSV-EBOV, which is currently being used in the Democratic Republic of the Congo to contain the Ebola epidemic – the centralised marketing authorisation procedure will commence in 2019.
Professor Vieths: In 2018, the first two allergen products were granted marketing authorisation in accordance with the Therapy Allergen Ordinance – an important milestone. Immunotherapies for treating food allergies are developing at a rapid pace. The European Medicines Agency assigned the first central marketing authorisation procedure for a therapy allergen against peanut allergy to the PEI.
Cichutek: Straight after the referendum we positioned ourselves for the potential scenarios. The procedures of the UK medicines agencies were distributed to other Member States. It was clear to us that the PEI, as an important European player, had to assume responsibility. The supply of biomedicines in Germany and Europe must not be endangered by Brexit. So far, we have taken over 36 European marketing authorisation procedures and a number of batch tasks.
Vieths: In meetings with the relevant associations and on our website, we have regularly informed companies at an early stage about the regulatory actions they need to initiate in good time to ensure that critical supply situations do not arise.
Cichutek: On an international level, we have very good connections with other organisations: the PEI, with its commitment to global health, can look back on a long history of fruitful cooperation with WHO. We make an important contribution through our participation in the Global Health Protection Programme – GHPP. In two projects, VaccTrain and BloodTrain, two international teams who have received regulatory training at the PEI are supporting the establishment of regulatory structures in Sub-Saharan Africa – and are doing so very successfully. The Federal Ministry of Health – the BMG – has significantly increased its funding so that we can intensify our commitment.
Vieths: Our product testing is state-of-the-art – and we are continually developing it further. Thanks to an effective quality management system which is accredited both nationally and on a European level, we can produce data that will stand up in court. This means that we not only ensure the quality of biomedicines, but we can also help detect counterfeiting and theft. The Microbiology division has succeeded in establishing a multiplex test for the serological testing of vaccines with tetanus, diphtheria and pertussis components. This means we can test batches of these important vaccines faster, more accurately and without distressing animal testing. The test has been in operation since 2018.
Cichutek: The switch to using antigens for four influenza virus strains instead of three meant that production, marketing authorisation and batch testing had to be adapted accordingly; this was accomplished without any problems and the PEI was able to release 15.8 million doses for Germany. All the vaccine doses had, however, already been pre-ordered from the manufacturers or distributed at an early stage. The PEI then enabled doctors, pharmacists and members of the public to report local shortages on its website. In November, acting upon information from the PEI, the BMG issued a notification of a supply shortage. Among other things, this allowed wholesalers and pharmacists to import flu vaccines from other EU countries; the PEI provided a service whereby, on request, it checked the European certificates of these vaccines. We were intensively involved in the smooth transition and in relieving the difficult supply situation – an outstanding effort by the Microbiology and Virology divisions.
Cichutek: We are increasingly finding that the public is interested in the relevance of our work and we are aligning our communications accordingly. We present scientific topics in a generally understandable way, offer FAQs on the most important issues and make use of the opportunities provided by digital channels. Members of the public can reach us on Twitter, YouTube and LinkedIn. We have also reinforced our personnel capacity in these areas. With our regulatory and scientific work, we make a valuable contribution to the health of the population in Germany, Europe and beyond. We need to convey this to people in a transparent manner.
Vieths: There has also been progress in digitalisation with regard to the handling of regulatory processes. Since 2018, companies have been obliged to submit all marketing authorisation procedures electronically, whether these be national procedures for Germany or European procedures. Fully electronic handling means that the processes are streamlined, standardised and transparent. The next step is the paperless handling of batch testing, from submission through to the electronic decision which can be downloaded. A precondition for digitalisation is the availability of high-performance information technologies and their continuous development.
Cichutek: In 2017/18 we appointed new staff to important management positions. Prof. Vera Mahler, a proven clinical expert, took over at the Allergology division. Since 2018, the Major Policy Issues, Coordination division has been headed by Dr Micha Nübling, who has returned to the PEI after a successful period at WHO and who is now overseeing our application to become an EU reference laboratory in accordance with the European IVD Regulation. Some highly valued colleagues have retired. In this regard, we should in particular mention Prof. Rainer Seitz, who set up the Haematology / Transfusion Medicine division.
Vieths: In the 4th European Benchmarking – BEMA – we succeeded in significantly improving our assessments in most areas. Among the issues that we still need to work on, we have identified those that are a priority for us. These include digital processes and IT support, as well as the PEI-wide implementation of a risk-based approach in the regulatory area. BEMA shows the PEI’s performance compared to other European agencies, but also acts as a quality assurance tool for our own processes.
Cichutek: The goal is to ensure the future viability of the PEI in a constantly changing environment with ever growing demands. To do this, we are promoting the action plan based on the PEI 2020 strategy. With the support of an external firm of consultants, we are carrying out an organisational review that in 2019 will result in a determination of staffing requirements. This is a prerequisite for having sufficient positions available for our ever-increasing official duties – and transforming most of the temporary positions into permanent ones. In this respect, we must also be clear that we perform scientific work that has a high value for patients – and which enables us to act independently and on an equal footing with pharmaceutical companies and internationally recognised research institutes.
Vieths: The PEI's new building is future-oriented: energy-efficient and state-of-the-art, with high-quality laboratories and space for modern working structures.
Updated: 21.06.2019
