Chrystelle Mavoungou is a chemist who teaches regulatory affairs and quality in pharmaceutical production at the Biberach University of Applied Sciences’ Faculty of Biotechnology. While the public might consider these issues difficult to deal with, students and early career pharmaceutical biotechnologists quickly learn that issues like these take them right to the heart of the drug discovery process.
Germans tend to prefer the English term "regulatory affairs" over German ones to describe activities relating to licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products in all phases of the drug discovery process, from preclinical to clinical phase IV. Moreover, Chrystelle Mavoungou knows that the term "regulatory affairs" has different meanings in different sectors of the healthcare industry.
Prof. Chrystelle Mavoungou, dean of pharmaceutical biotechnology at the Biberach University of Applied Sciences, is aware of the discrepancy between public perception and the actual signification of her research and teaching areas. Researchers who publish papers on active drug ingredients and target structures tend to dominate the headlines of the trade press. However, just as the research is hitting the headlines, the decisive, highly selective process begins. Feted for a time in top journals, drug candidates often fail silently far from the journalistic roar when application and pharmaceutical form are deemed unsuitable for a specific purpose.
Prof. Mayoungou works closely with her colleague Katharina Zimmermann, professor of molecular pharmacology. This cooperation brings together biomedical research with "operative" expertise such as GMP criteria (quality by design or process analytical technology). Prof. Mavoungou validates Prof. Zimmermann's research findings and assesses whether they can be translated into innovative products and methods. At present, the synergistic team of two is specifically focused on the intranasal application of drugs into the central nervous system (CNS). "We are particularly looking into second medical use (ed. note: new therapeutic uses for known active ingredients)," says Mavoungou explaining that "the intranasal approach is quite effective, because drugs are able to reach certain receptors much better than drugs applied via the systemic or invasive route. If the approach works, local administration would reduce the relatively large amount of drug that otherwise needs to be applied, and would not affect other organs, thus reducing potential adverse drug effects." The researchers are well aware that they have a lot of hard work ahead of them, but if they are successful, they will have a platform suitable for administering a broad range of drugs into the nose. Mavoungou believes that developing a suitable form of drug administration is a great challenge, especially because the size of some proteins is likely to make intranasal application rather difficult.
For Prof. Mavoungou, a chemist who earned her doctorate with a structural biology project (NMR spectroscopic examinations of actin-binding Dictyostelium discoideum proteins) from the Max Planck Institute of Biochemistry in Martinsried in 2003, the cycle closes as she is once again working with proteins. She has always wanted to work in drug discovery, but has chosen the multifaceted chemistry rather than pharmaceutical field for her work. This enabled her to stay in Munich, close to her beloved mountains.
After completing her doctorate, Mavoungou worked with the rapidly growing Merckle ratiopharm group of companies in Ulm, where she was regulatory affairs manager for nearly seven years, acquiring extensive knowledge in drug marketing authorisations and the production of drugs in compliance with GMP standards. Looking back on her time with the global company in Ulm, she says it was in what she calls the company's competence centre for regulatory affairs where she learned the craft of pharmaceutical research and everything she needed to know about drug approval.
Mavoungou was also involved in business development issues for French-speaking countries, obtained insights into licensing issues and was involved in discussions with regulatory authorities (scientific advice). She has since also learned a lot about what determines the success or failure of drug candidates.
In 2008, Mavoungou was thinking about becoming more involved in research and education. "I had the feeling that I had learned a lot. I wanted to move on and further develop this knowledge." In 2008, she started with a part-time lectureship at the Biberach University of Applied Sciences, which at that time was about to establish its pharmaceutical biotechnology programme, and in 2010, she was appointed chair of the Department of Regulatory Affairs and Quality in Pharmaceutical Manufacturing.
In addition to passing on expert knowledge, Mavoungou also wants to focus on image building. "Basically, the pharmaceutical industry is not about destroying people, but helping them and saving their lives. It is an industry where you'll find many idealists," she says explaining that this is the image she wants to communicate to her students.
She is involved in the pharmaceutical biotechnology master's course, where she covers a broad range of subjects, from GMP process development to product quality assurance and new tools (quality by design), as well as the validation of methods as quality assurance tools. She also introduces students to statistical tools used in quality assurance and risk analysis. And last but not least, she gives her students basic insights into national and international drug approval issues.
She also teaches bachelor students what quality management involves, organises company visits and teaches regulatory issues for the management of packaging inserts and medical products.
After her doctorate and many years in industry, Mavoungou is now doing what she has always wanted to do in the Institute of Applied Biotechnology at the Biberach University of Applied Sciences – drug discovery. "It is a craft that I know very well and I have knowledge that I can put to good use for many things." Mavoungou and her colleagues will transfer their know-how into the university's new innovation centre when it opens, because Mavoungou wants to do much more than just publish scientific papers.