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A Swiss on the banks of the Spree
Life Cycle Management. These three words are enough to trigger enthusiasm in Marcel Felder, Clinical Team Leader. “To a research-based company like Bayer Schering Pharma, Life Cycle Management means that the research work is far from over when a drug product is launched or the patent expires,” says Felder. To ensure that Bayer Schering Pharma remains successful in the future, new indications have to be developed or the pharmaceutical form optimized. The aim is to improve the efficacy and tolerability of the drug product and make it easier to administer. “Both these objectives have been achieved in the case of our antibody for the treatment of leukemia,” says the 34-year old doctor.
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| Monoclonal antibodies have a particular shape: they look like the letter Y. |
The product was in-licensed by Bayer Schering Pharma in 2000. It is the first and only humanized monoclonal antibody approved for leukemia and the first drug product with proven efficacy in patients with chronic lymphocytic leukemia (CLL) who have failed to respond to either chemotherapy or fludarabine phosphate.
The antibody was developed by the U.S. company Genzyme Corporation, which is now a partner of Bayer Schering Pharma. Says Felder, “No other treatment has shown comparable efficacy in this patient group so far. The mode of action of the preparation is fundamentally different to conventional chemotherapies.”
Bayer Schering Pharma applied for an extension to the current authorization for the leukemia drug in early 2007. In future, CLL patients should be able to receive it right at the beginning of their treatment. Experts refer to cases like this as first-line therapy: “I’m now looking forward to the further clinical development of the product and to working together with the health authorities to extend the indications. It is our aim to be able to treat patients with our product when they are still at an early stage of the disease.”
Extensive documentation forms the basis for any extension to marketing authorization. Compiling this documentation is one of the Swiss doctor’s responsibilities: “I’m responsible for pulling all the threads together. I act as the interface between different departments such as Regulatory Affairs, Manufacturing and Project Management, all of which have input into the documents to be submitted to the licensing authorities in the United States and Europe.” These include the results of studies which have clearly demonstrated the benefits of the antibody as first-line therapy. Another focus of Life Cycle Management is the change of formulations. Says Felder, “At present, the antibody is administered to patients intravenously. We are now working with our partner Genzyme to develop a way of injecting it under the skin – another step towards improving tolerability and the quality of life of patients.”
The improvement of patient well-being is an important motivating factor for Marcel Felder. Before he joined Bayer Schering Pharma in 2002, he worked as a surgeon in a Swiss hospital. The move to industry was an important step for him, which he has not so far regretted. On the contrary: “A company offers so many opportunities. In the hospital, I was part of a very hierarchical system, while here I have enormous opportunities for further development.”
He has been working in Berlin since early 2006. A new city, new colleagues, and since the merger of Bayer and Schering a new company as well – over the last few months Felder’s life has changed dramatically. He does not regret opting for Berlin, however: “Cooperation with the different experts who make up a joint team and have a common objective is very attractive. It’s having a great effect on my development, not only professionally, but personally as well.”
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