>> Based on the thesis that 2020 was the year of an incredible research achievement, in which researchers around the world developed vaccines against a previously unknown virus in less than 12 months, the discussants should answer the question of whether the speed of vaccine development can be transferred to other fields and what new things await us in medicine in this decade. In addition to the clear commitment to a patient-centered view and approach, Pfizer boss Albiez sees not only the “problem of the complex administrative requirements that have to be met,” but also the challenge of integrating important data from different sources. He expects politicians to provide suitable framework conditions to promote the translation of knowledge into application; Here Germany is “simply significantly behind other regions of the world”. Germany would have the substance in terms of both university and non-university research output. Albiez: “We are actually still world leaders in many areas, but a lot still has to happen to translate that and put it into practice.”
Could it then be that the rolling review system could also become the standard in the pharmaceutical sector? One of the issues to be explained here is the rolling review procedures widely used by the EMA in the area of vaccine approvals. While Prof. Dr. med. Wolf-Dieter Ludwig, the chairman of the Drug Commission of the German Medical Association (AkdÄ) in the cover interview of “Monitor Healthcare Research” (MVF 02/21), explains that, outside of the approval of vaccines in crisis situations, he would rather not “be concerned with an increased use of the “rolling system”. “Review” process in the next few years” is exactly what Pfizer expects. This requirement is not that new. On September 17, 2019, the FDA started the “Orbis” pilot test, which is intended to accelerate the approval process of new cancer drugs worldwide. The goal: Patients should have faster access to innovative therapy options by allowing applications for approval to be submitted and reviewed simultaneously in the countries involved in the project. The Oncology Center of Excellence (OCE) is responsible for this initiative. So far, the Australian Therapeutic Goods Agency (TGA), Health Canada (HC), the Health Sciences Authority (HSA) and Swissmedic are involved. As part of this project, two applications for indication extensions for already approved oncologic drugs have so far been assessed across countries by the FDA, TGA and HC. In addition to indication expansions, applications for approval of “New Active Substances” (NAS) are also planned for future applications.
Kosch also gave positive examples from his own company. An immuno-oncological bladder cancer drug has just been introduced with this type of rolling review process. This also happens with a new lung cancer drug. Kosch: “I could imagine and very much hope that this will become the standard, the norm.” This approach can save time, but without neglecting quality. During the pandemic, it was seen that months to half a year of approval review times and bureaucracy could be saved, which translated directly into patient benefits. However, this also comes at the expense of the pharmaceutical companies. In addition to the flexibility required, these accelerated procedures are complex real-time processes that require more resources. “You really have to organize closely coordinated processes hand in hand. It’s time-consuming, but possible. And I hope that this becomes standard,” concluded Kosch. <<
by: MVF editor-in-chief Peter Stegmaier

1: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis