Tag: EMEA

akampion Meets…. Victoria English, Co-Founder and Editor of MedNous

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?

V. E.: After quitting our jobs we spent about 12 months to set up a website and a database, before we the first issue went out. During that time, we looked at every single bio-cluster in Europe and its member companies. Our database entries are updated ever since on a regular basis.

akampion: What exactly is MedNous focusing on?

V. E.: Originally, we focused on genetic therapy and stem cell therapy as we thought these were the most innovative areas and because no one else was writing about it. But it soon became obvious that these technologies were not that advanced as we thought, so we added other areas as well. Now we report about all companies developing products that will be regulated under the centralized procedure of the EMEA, plus projects validated by either venture capital funding or pharma collaborations. In fact, some companies emerge on our radar screen only after a huge financing.

akampion: How do you work?

V. E.: We do interviews on the phone, but for bigger stories we travel to the companies to get a first-hand impression. We also visit conferences. We are very interested in data, of course, but our key interest is answering questions like “what is the management like?”, “what is their strategy?”, “what have been their failures and successes?”

akampion: What does it take to fund a publication?

V. E.: You need to have capital, an interest in marketing and the business side. Luckily, we were able to finance the start ourselves, and now the company is generating revenues from subscriptions. And of course you need to adapt your technology all the time to spread the word. As an example, RSS feeds increasingly lost their importance – now it is all about Twitter and other social networks.

akampion: You still stick to a publication printed on paper. Why is that?

V. E.: Simply because we want to have an impact by providing a product that allows for a comprehensive view, which we think is valuable to the industry. For this reason we have also chosen not to break it down to single articles that can be purchased. We do, however, provide a PDF version of each issue.

akampion: You established an editorial board for MedNous. Why?

V. E.: We want to add some depth to our editorial coverage. So we take advice from the board on topics to write about, and we also ask members of the board to review our interviews before publication. Neither William nor I are scientists. We keep to the time-honored journalistic practice of maintaining independence from our sources, e. g, the people we interview do not vet articles about themselves. Yet we recognize that we need advice on some of the technical aspects. Members of the editorial board provide this advice. They are active and very valuable contributors.

akampion: How many people are working at MedNous?

V. E.: Currently we employ six people, including a contributing editor, web and production editors, proofreaders, etc.

akampion: What is your take on the European sector right now?

V. E.: In my view, Europe has a big competitive advantage over the US: the European healthcare systems may be diverse, but all are built on some kind of reimbursement and this guarantees a much closer look at the patient benefits of new medicines. So in this respect, feedback is much better and this will lead to products better serving the need of patients.

akampion: Do you still have time to do other things?

V.E.: Running a publication is a job that needs your attention most of your days, including the weekends. But I do enjoy visiting the British Library to read and I take modern dance and tap dance classes. In addition, I also help manage a number of community organizations including our local community center where I am a trustee.

Food for Thought: Weekly Wrap-Up

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.”

Harro Albrecht and Sven Stockrahm in Die Zeit feature the suspicion expressed by medical doctors and competent authorities in the EU that the flu vaccine Pandemrix might cause narcolepsy, in particular in children and young adults. Already, EMEA issued a recommendation to use Pandemrix in children and adults under 20 in exceptional cases only. While there were only two reported cases of narcolepsy among children in the US, there were more than 300 in the EU, with 70% of those cases coming from Scandinavia. Narcolepsy is an autoimmune disease, predominantly in humans with a certain genetic modification, and the authors feature the theory that the adjuvant used in the vaccine might have induced the disease in these patients. However, the genetic variant known does not have a bigger frequency in Scandinavia.

Sven Stockrahm, also in Die Zeit, features miniature, flexible electronic devices that stick to the skin by physical means. They can be hid by a tattoo motif and are able to measure and transmit physiological data for medical purposes. One company developing these devices is mc10 Inc. in Cambridge, Mass.

Martina Lenzen-Schulte in Frankfurter Allgemeine Zeitung (FAZ) gives an overview on the arrival of maggot therapy as a means to clean wounds, stating it has become standard therapy in many German clinics already. Maggots not only remove dead tissue and eschar, they also kill bacteria. Therefore, they are increasingly being used in infections with bacteria carrying multiple resistance to antibiotics. However, maggot therapy is not yet approved in Germany (in contrast to the US).

Sebastian Matthes in Wirtschaftswoche interviews Jackie Fenn, analyst at Gartner and co-author of Gartner’s Hype Cycle Report. Fenn forecasts computers with the ability to understand spoken questions and to put out spoken answers as well as printing of organs and arteries.

Roland Fischer in Neue Zürcher Zeitung (NZZ) looks back at 50 years of the influential Science Citation Index SCI. Originally founded to make the identification of relevant scientific papers easier, it soon became a tool for sociologists of science and led to the birth of scientometry as a new discipline. However, SCI also was used to take quantity for quality, measuring quality of science as number of citations, and it is a well-known episode that in the UK funding of clinical research was cut because preclinical research generates more citations. While this controversy is still ongoing, the taking of quantity for quality is already spilling over into search engines, Fischer describes.

Alex Knapp in Forbes describes a novel approach to broad spectrum antivirals. It is based on a bi-specific drug: one arm binds to double-stranded RNA which is specific for viruses. Once bound, a second arm triggers a mechanism that leads to the destruction of the cell it is in. The experimental drug named DRACO has been successful at eliminating cells infected by 15 different viruses from the common cold to polio in vitro and in vivo (mice).

Food for Thought: The Future of Biosimilars

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.

Gertraud Unterrainer of ProBioGen explained the intricacies of developing cells lines for the production of biosimilars: the goal is to aim for the closest possible match to the originator product, not for a product that might be regarded as superior, e.g. in respect to the amount of impurities. She also stressed that activity assays are not a substitute for assessing the clinical impact of differences.

With all these details being tricky, both Falk Ehmann of the European Medicines Agency (EMEA) and Christopher Klein of Sandoz International do not expect imminent fierce competition from the many Asian and Indian companies developing biosimilars. “They can market their products in Europe,” Ehmann said, “however, they have to meet all our standards and requirements to get approval.”

Last but not least, Manfred Ruediger of LSP Life Science Partners said that as a VC, he is still refraining from investing in biosimilar companies as he still is not convinced on the investment multiples that can be reached with biosimilars within ten years time.

A link to the presentations will be available shortly here.