GermanyGermany

The new age of tailored medicine

11.07.2010

Personalised medicine is all about treating an individual based on the specifics of his or her disease. However, both current EMA or FDA regulations and present clinical practice are stochastic, and thereby fundamentally in opposition. If we wish to truly usher in the era of personalised medicine, we need to change this environment. The TREAT1000 project is a good way to begin.

Imagine that you’ve taken your Ferrari to the mechanic because of a breakdown, and the mechanic consults a chart that tells him that a Ferrari with this problem needs a new fuel filter 30% of the time. So he changes your fuel filter. But the problem persists, so he replaces the the next item on the chart – the fuel injectors. This is how he continues until the problem is fixed. Wouldn’t you prefer to go to a mechanic who actually understands how the different parts of your car work together?
Unfortunately, this is still the current “state-of-the-art” in cancer medicine. Your doctor knows what type of cancer you have, and may also know a few additional things about it. Even so, physicians treat cancer patients based primarily on the stage and tissue of origin of their cancer, with no real understanding of what has gone wrong in their tumour cells. For a long time, this has been the only possible treatment, because establishing a cellular blueprint of an individual’s cancer was impossible, both in practical and economic terms.
However, as we approach the 10th anniversary of the UC Santa Cruz publication of the first working draft of the human genome, rapidly dropping sequencing costs will soon make full genome sequencing of all cancer patients a routine diagnostic.Along with the other dividends of the genome project – like the accumulated body of knowledge on the general molecular mechanisms of cancer – this will allow doctors to build a detailed blueprint of the workings an individual’s cancer cells. This very personalised information will allow physicians to identify the right therapy, greatly increasing the chance of successful treatment and reducing side-effects.
Substantial changes in regulatory and medical practice must take place for that to happen, and both the EMA and the FDA are well aware of the challenges. In a recent speech, former FDA Commissioner Andrew von Eschenbach touched on them, saying that “the transformation is not a linear extrapolation of the past. It’s a metamorphosis. The future will look no more like the past than a butterfly looks like a caterpillar.”
A good example for the next step in the development of true individualised medicine for cancer patients is a transatlantic EU-US pilot project called TREAT1000 (www.treat1000.org). Its goal is to identify the somatic changes in the genomes and transcriptomes of 1,000 cancer patients and to put their diagnoses, therapy recommendations, and clinical data into the public domain. This will allow us to begin a fact-based dialogue with regulatory agencies and medical professionals about the best way to ensure that von Eschenbach’s caterpillar turns into a butterfly.

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21.12.2011

Martinsried/Paris - Sanofi has done some Christmas shopping in Munich and has licensed Scil Technology’s programme for the regenerative treatment of osteoarthritis and cartilage disorders. Under the agreement, Scil could reap up...

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20.12.2011

Monheim - It's nearly Christmas, and Bayer Crop Science gives out some presents. As the company announced, a $750 million settlement with U.S. rice farmers is now binding and can move forward. In summer the German firm had agreed...

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16.12.2011

Bonn – Germany’s federal government is prolonging one of its most successful measures to date for stimulating the establishment of high-tech companies – the High-Tech-Gründerfonds (HTGF). The HTGF was launched in 2005 with €272m...

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15.12.2011

Leverkusen – One short statement from the European Medicines Agency (EMA) means one giant step for German biotech company Biofrontera. The agency issued a favourable opinion on the firm’s marketing approval application for its...

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15.12.2011

While the European sovereign debt crisis keeps capital markets in a choke-hold, with potential negative effects on the financing situation in many industries – including biotech – there was encouraging news for drug-developing...

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08.12.2011

Heidelberg – There is still life in the European life science finance. EMBL Ventures has closed a €40m fund. The early stage investor and the venture capital arm of the European Molecular Biology Laboratory(EMBL) announced the...

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03.11.2011

Düsseldorf – BIO-Europe 2011 in Düsseldorf has again broken all previous records in terms of participants and company numbers. More than 3,000 representatives from 1,800 companies registered for Europe‘s largest partnering event....

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02.11.2011

Brussels/San Francisco – As the biggest biotech partnering event on the continent, BioEurope, draws to a close, the venture capital community sent ambivalent messages for life sciences. Dow Jones VentureSource, an analyst,...

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