With a national research strategy in place to support and nurture a “bioeconomy,” Germany’s biotech sector continues to make important scientific discoveries and an important contribution to the country’s health care industry. The principal representative for the German biotech sector is Bio Deutschland. Viola Bronsema has been the CEO of BIO Deutschland, Germany’s Biotechnology Industry Association, since 2006.

Bronsema earned her Ph.D. at the Centre for Molecular Biology (ZMBH) at the University of Heidelberg, Germany, before training to become a public relations specialist. Since then, she has held a number of different leadership positions in prestigious pharmaceutical and diagnostics corporations such as Eli Lilly and Roche Diagnostics.

As part of a WuXi AppTec Communications series on national biotech industry associations, we asked Bronsema about the strengths of the industry in Germany and the key issues fuelling the country’s biotech community.

WuXi: How would you describe the biotech industry in your country? Is it an important part of the country’s economy?

Viola Bronsema: Germany’s biotech sector has been growing steadily after the financial crisis. The numbers look good. Last year, sales increased by 8%, the number of employees by 12 percent. The majority of the companies are active in medical biotech, and the gross value added by medically relevant biotechnology is 9.7 bn Euro in 2017, which accounts for almost 3 % of the total health care industry.

WuXi: What are some of the recent major scientific advances in your country?

Viola Bronsema: Some of the front runners in the field of immunotherapy were founded in Germany. Either with cancer vaccines, e. g. BioNTech or CureVac, TCR-immunotherapy, e. g Medigene, or the development of highly cancer specific antibodies, e. g. Ganymed, which was recently acquired by Astellas. Last but not least, the most successful biopharmaceutical up until now – Humira – has been developed by a German company.

WuXi: How do biotech companies get started in Germany? Where does most of the funding come from?

Viola Bronsema: Funding comes from a variety of sources. Important support for founders and start-ups comes from government programs and investors. Germany is also home to world-class universities and research universities and research institutes such as those of the Max-Planck- and Helmholtz Society or Leibniz Association. This excellent and solid research base is key to the success of the German biotech sector. Technology transfer from the academic sector to biotech and pharma is a driving force of innovation. The current CEO of Medigene, for example, transferred with her research group from Helmholtz Centre Munich to the company. BioNTech, now Europe’s biggest private company that raised 270 Mio. Euro this year, was founded in 2008 by two professors at the University of Mainz.

WuXi: What business-related challenges do biotech start-ups face in Germany?

Viola Bronsema: The biggest challenge is probably the acquisition of sufficient capital for growth. Although pre-seed and seed funding is available, venture capital for larger investments, for example for clinical trials, is difficult to get in Germany. Therefore, we put a strong focus of our work in the improvement of conditions for venture capital investments and the mobilization of private capital as, for example, in France.

WuXi: What financial incentives does the government provide for biotech companies?

Viola Bronsema: The German government supports biotech KMUs (small and medium businesses) mostly through project funding for R&D projects. Funding programs are offered through the federal ministry for research and education and the federal ministry for economics.

WuXi: What regulatory challenges do German biotech companies face in developing new medicines?

Viola Bronsema: Approval of medicines is generally regulated through the European Medicines Agency. Pricing in Germany can be an issue. The Act on the Reform of the Market for Medical Products (AMNOG) introduced in 2010 aimed to limit the cost of pharmaceuticals.  AMNOG forces therapy developers to subject their new products to an early evaluation of their additional benefit compared to other available therapies after being launched on the market. If it is not possible to show an additional benefit to the comparative therapy the price is set in a reference price group with comparable active ingredients.

If an additional benefit can be shown, the National Association of Statutory Health Insurance Funds negotiates with the drug provider a supplement on top of the price of the suitable comparative therapy. During the first year after market access, the drug developer can set the price.

About two years ago, the government intended to set a limit to what the drug developer can earn from selling a therapeutic during the first year, a so called turnover threshold. BIO Deutschland lobbied successfully against this new threshold.

WuXi: What are some of the major ethical challenges for biotech research and drug development? Is there any public opposition?

Viola Bronsema: German society embraces the achievements of medicines from biotech. Not all might be aware that blockbuster medicines against rheumatoid arthritis, diabetes or cancer stem from biotech labs, but generally there is no ethical discussion surrounding biotechnological research for therapies. This is different, however, for plant biotech. The opposition against crop GMOs is huge and increasing. The debate here ranges from the “unnatural” argument to mistrust of big agriculture companies, the objection of patents on seeds, and the loss of plant varieties.

WuXi: What are your organization’s priorities in promoting the biotech industry in Germany and worldwide?

Viola Bronsema: At the national level, we focus our lobby work on topics such as better financing tools for biotech, technology transfer/translational medicine, and intellectual property issues. A major focus is currently the implementation of the policy agenda “From Biology to Innovation,” which was promised in the coalition agreement of our federal government. Internationally, we collaborate with other national associations, usually through our European umbrella association EuropaBio or through the International Council of Biotech Associations (ICBA). Jointly, we push global topics such as actions against the spread of antimicrobial resistance or IP issues. We also promote our industry and our members at international trade fares such as the Bio-Europe or the BIO Convention.

WuXi: If and how do you think Brexit will affect the biotech industry in the EU?

Viola Bronsema: BIO Deutschland greatly regrets the UK’s exit from the European Union. It will lead to a period of instability that will have a negative impact not only on UK biotech but also on the entire European biotech sector. Brexit will have grave consequences for business financing, for the financial markets and for the acceptance of innovation in Europe generally, and these consequences will need to be managed rigorously. The ability of British investors to provide financing to German firms will be impeded significantly by Brexit. Economic integration in research relations between German firms and research institutions and companies in the UK is deep and mutually beneficial. The conditions for the continuation of these relations need to be clarified, such as the free movement of staff as well as possible barriers to research collaborations. In addition, public-private partnerships (PPPs) could be put at a disadvantage.

The European Medicines Agency (EMA), which plays a key role in approving new drugs, is based in London and has benefited considerably from the input and assistance provided by UK government agencies. A decision has been made to relocate the EMA headquarters to Amsterdam. It is necessary, however, to ensure the proper functioning of the agency and that it has sufficient resources, including qualified personnel

WuXi:  How has Germany created a good environment to grow a biotech company?

Viola Bronsema: Germany has a very good and vibrant biotech infrastructure. Represented through the Council of the German Bioregions, several biotech clusters, hubs and innovations centers have been established throughout the country. This development started with the federal BioRegio competition back in the nineties. Clusters like the one in Munich, Heidelberg, Mainz or Berlin, to only name a few, provide laboratory space, professional networks and advice that are particularly important for newly founded companies. Also, Germany has a national research strategy for bioeconomy, which set the stage for a lot of important research activities, and the government has decided to promote biotechnology through the “For Biology to Innovation” initiative, which should be established in the next couple of years.

WuXi: What major scientific advances do you expect in 2018, and over the next five years from German biotechs?

Viola Bronsema: I think we will see major advances in the field of cell and gene therapy. Recent success stories for rare indications will find a broader application – especially the use of genome editing methods such as CRISPR/Cas will accelerate the process of finding cures for devastating diseases.