Archive: Food for Thought

Food for Thought: Moving Into the Clinic Without Animal Toxicity Tests

This month, MedNous provides an in-depth case study on an immune therapy developed by Immunocore Ltd. that won approval from the British and US regulators MHRA and FDA to start clinical trials on the basis of in-vitro safety studies only – without conducting any toxicity tests in animals.

The product in question, IMCgp100, is a monoclonal T cell receptor fused to an anti-CD3 single chain antibody fragment. The molecule is tricky in that both binding sites bind to human proteins and cells only. As a result, animal studies would have been without any predictive value. The company therefore had to design a reliable preclinical test for predicting the behavior of the drug in humans.

This has been a particular challenge as regulators still were digesting the shock from the TeGenero disaster in 2006, when six healthy volunteers almost died from cytokine storm in a Phase I clinical study of an immune therapy. Back then, the drug had been tested in animals and the volunteers received only a fraction of the dose that had been safely administered to monkeys.

After intense consultations with the regulators, Immunocore conducted a battery of tests on human cells to find out about potential cytokine release, cross-reactivity, etc. The company, too, tested whether hormones were able to shut done activity of the drug in case something would go wrong during the trials.

Trials are on the way already at three UK and two US sites in patients with metastatic melanoma and Immunocore hopes to have preliminary data, including some efficacy results, by 2012.

Food for Thought: Weekly Wrap-Up

Can bioplastics, which is derived from renewable resources and biodegradable, become an alternative to conventional plastics made from mineral oil? Not yet, writes Nina Weber in Der SPIEGEL. Cultivation of raw material needs pesticides and fertilizers and the predominant bioplastics used to date is made from polylactic acid (PLA), which is biodegradable only at high temperatures. The prospects may become better – but only if PLA can be derived from plant remains and if enough PLA is on the market so that recycling is profitable.

Gardiner Harris in The New York Times reports on flaws in a widely cited lung cancer study involving more than 50,000 patients. The study’s conclusion that  80% of lung cancer deaths could be prevented through wide use of CT scans made the headlines in 2006. Now it seems that the researchers are unable to locate 90% of the consent forms so that  a confidential report evaluating the study on behalf of the lead study center recommend that the trial be stopped already in 2008. The study is still ongoing.

The New Scientist reports on findings that the malaria parasite Plasmodium falciparum can be killed by kinase inhibitors, common anti-cancer drugs. In in-vitro experiments at Lausanne Federal Polytechnic in Switzerland researchers exposed malaria-infected liver and blood cells to kinase inhibitors and observed that some of these compounds selectively killed the parasite, but not the cells.

Also in New Scientist, Ahmed Zewail, who won the Nobel prize in chemistry in 1999, claims that the Middle East is ripe for a scientific revolution.  At present, he states, Arab, Persian, and Turkish scientists as a group are underperforming as compared to colleagues in the West or Far East. Zewail thinks that the recent revolutions will open the door to improve on literacy, women’s participation and education and bear the chance to remove red tape and allow freedom of thought. He calls on partnering with Muslim countries to establish centers of excellence in science and technology.

Finally, Alex Knapp in Forbes introduces Justin, an impressive humanoid robot made in Germany by DLR, the German aerospace agency. So far, this incredible piece of German hard- and software engineering is used to catch two balls at once while making coffee. the akampioneer very much hopes he will learn better tricks to avoid the “invented in Germany, marketed elsewhere” pitfall.

Food for Thought: Weekly Wrap-Up

Andreas Menn in Wirtschaftswoche introduces the latest medical applications of smartphones for monitoring physical functions, ranging from the heartbeats of unborn children to blood sugar, blood pressure and pulse rates of elderly people to even pacers and other implants. According to Menn, the Mobile Health sector has a 19% market growth. In the US, patients are joining movements like The Quantified Self to collect health data for research purposes (and, as an example, to determine the ideal moment for wake-up). Contact lenses measure and report blood sugar levels, while tests strips or clothes with in-built wearable electronics control breathrate, wound swelling and urine for dangerous deviations. The field is still littered with startups, but big players like Siemens, Philips, sanofi aventis and Deutsche Telekom also have stepped in already.

Joachim Müller-Jung in Frankfurter Allgemeine Zeitung (FAZ) reports from the recent meeting of the Stem Cell Network North Rhine Westphalia. The debates focused on quality control of induced stem cells and the ability to derive motor neurons from such stem cells.

In The New York Times, Nicholas Wade reports on a recently discovered bundle of genes regulating the growth of heart muscles cells. The study published in Science will be of great interest for the development of novel therapeutics. It is known today that heart muscle cells are replaced in humans – however, the growth rate is too slow to replace the loss of many cells, e.g. in a heart attack. By modulating these genes, it might one day be possible to regenerate heart muscle in a targeted manner.

In Wired, Brandon Keim features a proposal by theoretical physicists that bacteria might transmit electromagnetic signals by using their DNA chromosomes as an antenna. The proposal is likely to trigger controversy as many biologists doubt that bacteria emit electric signals. French nobelist Luc Montagnier had already claimed in 2009 that bacteria do transmit radio signals in the 1 kHz range.

In the New Scientist, Ferris Jabr introduces a super twisty beam of laser light that is able to tell left-hand molecules from right-hand ones, with potential applications in drug development. Rowan Hooper reports on successful attempts to cure certain forms of blindness by introducing genes from algae into the eyes. The genes are encoding for channelrhodopsin-2 (ChR2), a photosensitive protein used by unicellular algae to orient towards light. The mice carrying a hereditary form of blindness were treated with subretinal injections of viruses carrying the algal gene and subsequently were able to use light beams for orientation in a maze. Trials in humans, the article states, might begin in two years. Finally, Andy Coghlan features findings that humans can be grouped by one of three gut ecosystems. These three “enterotypes” – dominated by three different species each – have been found all over the world and have a bias towards degradation of certain nutrients and production of certain vitamins.

And finally, for those of you who loved the Get a Mac ads by Apple (“I’m a Mac, I’m a PC”), please have a look at the ad campaign of Ion Torrent comparing its PGM sequencer to competitors such as MiSeq.

Food for Thought: Navigating A Changing Investor Relations Landscape in the Healthcare Sector

Even though professional principles in investor relations do apply to all industries, IR executives face important sector-specific developments and challenges. A recent whitepaper by Bloomberg and IR Magazine summarizes a roundtable held with IR professionals, buy-side and sell-side analysts in the healthcare sector.

Characterized by inherent long-term business strategies and goals, the healthcare industry faces increasing pressure from short-term oriented imvestors. At the same time, shortened investment horizons and the risk of high volatility requires IR professionals to have access to the same high-standard data analysis and monitoring tools as their buy- and sell-side counterparts. How to manage the conundrum of short-term trading and long-term business goals (and long-term oriented investors)? The challenge is to provide strong arguments and perspectives without over-selling the stock or ignoring rumors on the market. “Framing the issues and providing the necessary positioning to educate analysts and investors about the stock”, as the authors put it, remains the key to successful IR in the healthcare sector. Sounds a little bit too vague? Read further details in the whitepaper “A Healthy Debate: Navigating A Changing Investor Relations Landscape in the Healthcare Sector”!

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