Archive: Food for Thought

Food for Thought: Weekly Wrap-Up

Sebastian Matthes, Thomas Kuhn, Dieter Duerand and Susanne Kutter this week in Wirtschaftswoche introduce the winners of Innovationspreis 2011 (innovation award 2011). In the “Startup” category, the winner is Human Machine Intelligence, a Heidelberg-based IT company that developed the “Lingua” software able to understand and answer complete spoken sentences. “Big corporation” category winner is machine building company Freudenberg for its development of production processes that save 85% steel and do not produce waste. In the “medium-sized business” category, the winner is med tech firm Carl Zeiss Meditec which developed Intrabeam, a new cancer radiation therapy device that saves breast cancer patients week-long radiation therapy cycles and improves quality of life.

Also in Wirtschaftswoche, Andreas Menn features innovative printing technologies based on conductive ink and provides glimpses into the future of organic electronics for everyday products: flexible and printed electronic displays for ads and packages, loudspeakers from plastic foil, broadcasting metro tickets and pill containers that inform a cell phone software once a patient has withdrawn a pill. Among others, the article introduces German startup Printechnologics, based in Chemnitz, whose Aircode Touch technology can mark any type of paper with an invisible code that can be recognized and processed by smartphone touchscreens so that it can direct users to websites and/or authenticity certificates. Another German startup, Heliatek in Dresden, is developing printed solar cells that are to be sold by the meter in building supply stores.

Steven Salzberg in Forbes this week features a vitriolic comment of the decision of respected BioMedCentral (BMC), owned by Springer Science publishing house, to add a journal devoted to “Traditional Chinese Medicine”, or TCM,  to its portfolio of respected, peer-reviewed scientific journals. He introduces a “laughably bad study” and states, readers should bring “a high tolerance for quackery”, concluding: “BMC should be embarrassed to be publishing journals that promote anti-scientific theories and otherwise muddy the literature. By supporting these journals, they undermine the credibility of many excellent BMC journals. They should cut these journals loose.”

The Economist this week writes about “a serious gap in biologists’ understanding of the diversity of life”, featuring metagenomics research results that points to the existence of a new domain of life in the oceans, adding to the already known domains of archaea, bacteria, and eukaryotes. Another feature deals with back-scattering interferometry (BSI) that can be applied to studying membrane proteins unmodified and in situ using a laser in a simple, low-cost way. The technology may be used to study the interference of membrane receptors with drug candidates and to understand side effects and differences in the response of patients to already marketed drugs. Already, the inventors founded a startup, Molecular Sensing, in San Francisco, Calif.

In New Scientist this week, Helen Thomson reports that a brain electronic implant in a paralyzed women successfully passed the 1,000-day milestone. Wendy Zukerman describes that a new, non-invasive test might soon be available to diagnose the nerve damage associated with diabetes to predict the amputation risk of diabetes patients, and Peter Aldhouse writes about his first encounter with robots at Complete Genomics, a California-based startup that offers large-scale, complete human genome sequencing services as an end-to-end outsourced service to companies and research institutions.

Food for Thought: In Search of Faster Cures

Last month, The Wharton School of the University of Pennsilvania dedicated a special edition of their prestigious Knowledge@Wharton newsletter to the biopharmaceutical industry. Most importantly, the authors dealt with the pressing question how the industry may continue to develop innovative drugs – and get them approved faster.

Summarizing the current challenges, the report states that “no one doubts that the drug industry’s traditional model for developing new cures is badly broken. Fewer exciting new medicines are reaching patients these days, even as spending on research and development has risen and blockbuster drugs that have long been the backbone of pharmaceutical profits have lost their patent protection. A widening gap divides the discovery of promising new laboratory compounds from the ability to turn them into innovative therapies. A similar gap separates recent scientific gains in understanding genes from the creation of new drugs that use this knowledge to fight disease.”

The report tackles key elements of the ongoing transformation of the biopharmaceutical industry, ranging from novel drug development approaches such as personalized medicine, open-source research, pricing policies, and the latest efforts at the U.S. Food and Drug Administration (FDA) to speed up regulatory processes. One of the most conclusive observations is that partnering and strategic alliances are becoming more important than ever to meet the requirements of the changing pharma industry. However, despite identifying the crucial pieces of the puzzle, it remains to be seen how both established and new biopharmaceutical companies can cope with the challenges of a transforming industry.

Food for Thought: Future Reimbursement of Novel Cancer Drugs in Germany

Germany’s new law regulating the reimbursement of drugs, the so-called Arzneimittelmarktneuordnungsgesetz – AMNOG, requires companies planning to introduce a novel drug to the German market to provide a value dossier, if they want reimbursement of the full price for the first year of marketing (See the akampioneer, “Germany’s New Reimbursement Law“). This value dossier not only needs to demonstrate efficacy and safety, but also has to provide evidence that the drug is more advantageous to existing treatments in terms of patient-relevant endpoints such as morbidity, mortality and quality of life.

This is difficult to prove as many novel cancer drugs are approved on the basis of surrogate endpoints such as slowing or stopping cancer growth (objective response rate ORR, time to tumor progression TTP, time to treatment failure TTF or progression-free survival PFS).

Late last month, Germany‘s Institute for Quality and Efficiency in Health Care (IQWiG) has published details on how it is going to evaluate the patient benefit in these cases. IQWiG usually is evaluating drugs on behalf of the so-called Gemeinsamer Bundesausschuss G-BA (Federal Committee), a decision body within Germany´s statutory healthcare system.

In cancer, IQWiG plans to primarily address „the question as to whether a therapy can prolong the life of affected patients. In addition, a new therapy should alleviate symptoms, prevent complications, and improve quality of life.“ If surrogate endpoints have been used for approval, IQWiG will only accept them as evidence for patient benefit, if the validity of these endpoints for demonstrating patient benefit can be proven by correlation-based approaches based on randomized controlled trials.

In a 160 page „rapid report“ (available in German only) IQWiG details its approach to search available literature for studies on the correlation between surrogate and patient-relevant endpoints. In addition, it describes how it is performing a meta-analysis of these studies for assessing the strength of the correlation (three levels) and the reliability of the validation studies (four levels) to reach an overall conclusion about the validity of the surrogate endpoint for a decision whether the new drug is providing patient benefit.

While the institute so far has only differentiated between „proof“ of surrogate endpoint validity and „indication“ of validity (meaning medium reliability), it proposes to introduce a third category called „hint“ for the fulfillment of certain minimal requirements for the available studies. This category will be applied in cases where the validity of a surrogate endpoint is unclear – a situation IQWiG expects to be quite common. In these cases, IQWiG states, „it can also be taken into account how strong the effect of a treatment turns out to be“. IQWiG would then seek to find a threshold value for the surrogate marker and evaluate whether the new treatment exceeds this value, e.g. whether it decelerates tumor growth for longer than a specified period of time.

Last not least, IQWiG appeals to drug makers and study groups to make accessible their analyses on the validity of surrogate endpoints and the specification of threshold values, e.g. in special registries.

A short English summary of IQWiG‘s basic assumptions on how to recognize at an early stage whether a new cancer therapy prolongs life can be found here. IQWiGs proposals for the early benefit assessment of cancer drugs can be read, also in English, here.

Food for Thought: Weekly Wrap-Up

In Germany, science pages were dominated by Japan’s nuclear disaster. Apart from topics such as radioactivity as a threat to human health and the environment, Christiane Hucklenbroich in Frankfurter Allgemeine Zeitung (FAZ) deals with an upcoming new definition of autism. Instead of seeing autism as a defined disease category, physicians have come to the conclusion that one should rather use the term “autism spectrum”, comprising several aspects of autism. The medical community also has started focusing on co-morbidity aspects as well as autism-like symptoms in other psychiatric diseases.

Susanne Kutter in Wirtschaftswoche summarizes latest advances in stem cell medicine. Among others, she features a clinical trial conducted at the University of Rostock in which the heart muscle of patients suffering from an infarction is injected with adult stem cells to initiate regeneration of muscle. The trial includes more than 150 patients and will be finished end of 2012. A method already successful has been established in India, where more than 700 people with blindness caused by Vitamin A deficiency regained eyesight after injection of stem cells into the cornea.

Roni Caryn Rabin in The New York Times reports on a Lancet study that pooled data from 58 studies involving more than 220,000 people with a mean age of 58 to find out whether the idea that obese people with an apple shape (carrying the overweight predominantly in the belly) are more at risk for heart disease than overweight people with a pear shape. The answer is: they are not. Overweight matters, but shape does not.

Ferris Jabr in New Scientist introduces a small implantable device developed by researchers from the  Massachusetts Institute of Technology (MIT) that can track tumor growth in the body of cancer patients. The device contains magnetic nanoparticles covered with monoclonal antibodies able to bind cancer-related molecules, e.g. human chorionic gonadotrophin (hCG), a hormone released by testicular and ovarian cancers. The first generation had read-out by MRI scans that detect formation of clusters within the device due to binding of the molecules. However, the researchers now improved detection so that readout can now be done by a hand-held device. The principle can also be adapted to monitor other changes in the body, e.g. silent heart attacks.

For blood transfusion, medical doctors need to carefully choose the right blood group from 29 possible combinations of the AB0, Rhesus, the MNS and other systems. This challenge sometimes needs to complications and logistic problems. The Economist reports on a successful approach by researchers from the University of Montreal to disguise the antigenic proteins from red blood cells. The trick is done by first dressing the fatty surface membrane of the cells and then attaching another cover so that the immune system does not pay attention to the cells. The cover is fully permeable by oxygen and carbon dioxide.

David Whelan in Forbes calls for a psychological study of people investing in biotech stocks, in particular those writing rude comments on articles featuring the ups and downs of stocks. He claims the phenomenon is only seen with articles on biotech stocks.

And finally, David M. Ewalt in Forbes reports about errors in Craig Venter’s first synthetic life form in which Venter inserted DNA composed on a computer. The DNA included quotes from James Joyce and Richard Feynman, however Craig used the Joyce quote without written permission from Joyce’s estate and misquoted Feynman by obtaining the quote from the internet. Craig said he was now going back to the organism to correct the error.

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