In 2006, long-time journalists Victoria English and William Ellington decided to quit their jobs and to establish their own publication, the biomedical trade journal MedNous (pronounced Med-Nows). A year later, in September 2007, the first issue appeared alongside with the website www.mednous.com.

akampion: Why did you establish MedNous?

Victoria English: Both of us thought Europe’s very innovative life science industry needed better communication. Back then, everyone was thinking in clusters and areas, and we felt by connecting the dots we could support the industry in its efforts to increase efficiency. Second, at that time the European Commission and the EMEA were very worried about the decreasing productivity of the biopharmaceutical industry, and Europe developed the Innovative Medicines Initiative, similar to the FDA’s Critical Path policy. This, too, called for better collaboration, and we wanted to capture this shift in official politics to encourage collaboration and translation of discoveries into products. Third, after working for many years in big corporations such as Reuters, DowJones, McGraw Hill and Informa, I thought it is time to start my own company.

akampion: What kind of preparations were necessary?  » Read more...

Joining the recent denunciation of personalized medicine in Süddeutsche Zeitung (SZ), Der Spiegel this week follows suit. Markus Grill and Veronika Hackenbroch cite Dr. Baerbel Huesing, Coordinator of Business Unit Biotechnology and Life Sciences of Fraunhofer ISI, as saying that the concept of personalized medicine is a “battle cry” of public relations: “Whoever invented it needs to be congratulated.” She added: “It is not a paradigm change. There is not that much in it. However, it is very well suited to justify to Jane Doe the enormous investments made in genomics – similar to the teflon-coated frying pan which was used as an excuse for manned space research.” As an example, Grill and Hackenbroch cite a study from 2009 in colon cancer patients, stating that adding Erbitux to the treatment scheme of patients selected by a concomitant Qiagen test resulted in a survival improvement of 4 months: “Is this a medical breakthrough? Is this what  progress looks like, bought by spending billions?” Instead, Grill and Hackenbroch recommend spending money on better care at home and better palliative treatment. The article ends with a quote from Wolf-Dieter Ludwig, head of the clinic for hematology, oncology and tumor immunology at Robert-Roessle-Klinik in Berlin: “Up to date, the concept of personalized medicine is an empty promise in the first place.”  » Read more...

On June 8, the Society of Investment Professionals in Germany (DVFA) and its Life Science Committee hosted its annual conference which this time focused on biosimilars. The event covered key scientific topics, regulatory pathways and commercial issues of the market.

While experts agreed that the US will soon follow the EU in establishing a regulatory pathway for filing and approval of biosimilars – with a few originator companies still taking rearguard actions – it is not yet evident whether biosimilars will conquer the markets simply because of lower prices. In many EU countries, there will be no automatic substitution as with small molecule generics so that doctors need to be convinced to prescribe a particular “branded” biosimilar.

However, while the regulatory pathway is based on comparability, this claim cannot be made for marketing as Adem Koyuncu, Partner of Mayer Brown LLP explained. He said, it will constitute a case for litigation to claim that safety and side effect profiles of a biosimilar are the same as those of the originator product as these features have not been demonstrated to the same extend during the approval procedure. So the question for marketing is to educate practitioners and patients on biosimilars as an “alternative”, not as “substitute”. In fact, as Frank Pieters of Teva Pharmaceuticals said, it may be advisable, depending on the product and the environment, to develop hybrid marketing models, mixing “generic” and “branded” approaches.  » Read more...