Heard in Brussels

When science makes you smile
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When science makes you smile

12.10.2012 - Hello readers! You know, when you view the biotechnology landscape from a Brussels perspective, you can very easily get stuck looking at the bad bits – meddling politicians, poor science reporting, insane funding decisions. Goodness knows I have had to solve the euro crisis already this year, and most months I have something or other to moan about.

But no more. I was recently reminded of all the joy that science can bring. In fact, I had a grin on my face afterward for the rest of the day. Certainly takes your mind off explaining to your mother that hand cream doesn’t make you go blind, and that GMOs probably won’t turn you into a zombie.

I am referring, of course, to the Ig® Nobel Awards (www.improbable.com) – a cele-bration of ridiculous but excellent science, where the prizes are handed out by bemused Nobel laureates and where, if you outstay your welcome speech, a child shouts that you are boring. 2012 was no exception, as Europe demonstrated again that it leads the world in mad science. Not all of the winners were from biotech fields, but I want to share my favourites with you anyway because they will remind you of how much you love what you do. European researchers featured in most prizes, so we can be proud of the contribution we make to science that makes you smile.

When next in Paris, remember that leaning to the left can make the Eiffel Tower seem smaller. Scientists from the Erasmus University Rotterdam delivered this stunning revelation for the Psychology Prize. And how many tourists will be at an angle next time they visit?

My second favourite was the Neuroscience Prize, which demonstrated that, using complicated instruments and simple statistics, researchers can see meaningful brain activity anywhere – even in a dead salmon. How often have I thought that in a queue for train tickets, where the person holding it up at the front is clearly dead but exhibiting signs of life?

The forces that shape and move a pony-tail was an awesome one for the Physics Prize – a joint effort from Unilever UK, the Cambridge University and the University of Warwick for that. Thanks boys!

The Anatomy Prize was also highly relevant, with research suggesting that chimpanzees can recognise each other from photos of their rear ends. Indeed, there are some distinctive backsides in Brussels, although I could not possibly comment on who they are.

Finally, French researchers played a blinder for the Medicine Prize, with work on minimising the chances of patients exploding during a colonoscopy. That was a weight off my mind – and my large intestine.

The point of the Ig Nobels is that science is fun, not boring, and everything is relevant. Europeans helped fuel technological development through scientific investigation. And if your kids ask more questions after hearing about these prizes, then we are still pursuing just the kind of research we need.

15.02.2012 Europe likes to make life hard, creating situations where an idea must struggle mightily before it can achieve success, even when there is amore straightforward route (just look at the euro). Of course, in the world of biotechnology, this maxim can be applied pretty much everywhere (as we are masochistsin this trade), but the focus of my musings today are the topics of GMOs and embryonic stem cells.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Both have received hundreds of millions of euros from the public purse, yet continue to deliver a big fat zero to the European economy due to sloth and indecision on the part of those that control their fates. 

In the case of GMOs, it has long been obvious that Europe was never going to bean economic generator for its research.The question for Europe is - why did we continue to invest public money in GMO technologies targeted at the field if wewere never going to get it back? Europe is now so far behind the rest of the world in food-crop GM technology that a euro spent is a euro wasted. We should have had the strength to either counteract anti-GMO claims immediately (too late now) or call the political bluff and say "stop the research funding for field-based GMOs." But instead, Europe did what Europealways does, creeping down the middlepath, trying to offend nobody while building a sub-optimal R&D base with no exploitation.

You might be asking yourself what has triggered this contemplation from somebody who usually supports biotech in all it's many forms. It was the closure of BASF Plant Science, at a German research base that has been open since 1914. This was no closure on an epic scale, just 140 jobs, but it tells you that the life has bled slowly from commercial research in Europe until the company finally just called it a day and went off to live in America. So Europe - spend your money on building a biotech sector that delivers a benefit you can measure, don't wait for it to die quietly while you fanny about appeasing politicians who are chasing re-election.

That brings me to the 2011 embryonic stem cell ruling - you must have heard me rolling my eyes from the other side of Brussels when that was announced. Welldone Europe! Once again we have taken a technology where the EU had a leg upand killed its commercial potential. This time it wasn't even due to a public outcry. European citizens generally like the idea of stem cells - they can see the possible benefits and understand in general what they do. But if the ruling isn't overturned, you might as well cancel the funding. If Europe cannot benefit economically, then there is no point in funding the science.There isn't enough money to fund biotech where the door is closed to a return. The sector has spent decades persuading people to part with large sums of cash for high-risk technology, and it cannot justify its existence if the gate to clinic and market has been shut.

12.03.2012 In February, I heard of a slightly mad and very worrying trend in decisions handed down by the Court of Justice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification. IP is not very exciting to start with, but the more you understand about the situation developing, the more you see Europe backing itself into a corner about something that could have major ramifications for commercialisation of technologies.

Claire Skentelbery, Secretary General of the European Biotechnology Network

It all started with IP for antibodies. As everyone in the industry knows, antibodies are incredibly complicated items in terms of IP - with a product that cannot be pinned to the wall accurately, and with post-translation modification and environmental factors influencing structure, activity and effect. This leads to long development times in groundbreaking regulatory and IP arenas. The supplementary protection certificate (SPC) in theory gives 5.5 years of extension beyond the original patent duration, and this has been used by a number of organisations to enable effective biological products to be protected to market. Of course, this is a very challenging area of IP, which was not designed to include biological entities, and which refers strongly to the regulations of the original patent. Increasingly, national patent offices are referring tricky cases to the CJEU for clarification, and this is where the wheels are coming off - with very serious consequences for the European commercial environment. Instead of casting light into the darkness, aside from a few notable decisions, the CJEU has instead returned slow, lengthy and impenetrable decisions that make it nearly impossible to make a national decision to grant an SPC. Clarification has been requested but actively avoided by the court, a great example being reference to 'non-European rules governing patents' but without actually saying which ones, even when asked a straight question on the matter.

National authorities are unable to interpret the legal way forward. "I am bound to say that I find this reasoning difficult to follow," says Lord Justice Arnold, and "not only has the Court not answered the question referred, but also the guidance it has provided is not sufficiently clear to enable future disputes to be resolved". Translation: it would seem that Europe has knitted itself a time-bomb for extending protection of biological products. The CJEU, through either a profound lack of understanding of the issues or through wilful incompetence, is preventing the successful exploitation of next-generation therapeutics, and can't be touched. The price will be paid by European companies trying to develop products, by researchers who have dedicated years to the innovation behind biologicals and of course by the patients, who may wait much longer for a groundbreaking therapy. Those products will one day be developed elsewhere and imported into Europe - exactly the opposite of the EC's drive to create a knowledge-driven economy ... and a mess of Europe's own making.

17.04.2012 If Jane Austen was writing in the early 21st century in Europe, she could well have begun one of her novels with: “It is a truth universally acknowledged, that a country in possession of a biotech sector, must be in want of a pharma company.“

Claire Skentelbery, Secretary General of the European Biotechnology Network

Europe is experiencing a contraction in overall pharma presence as the sector on the whole continues to downsize. Entire industrial sites, all shiny and lovely, are emptying, with experienced pharma scientists and managers returned to the wild to forage for nuts and twigs.

This is the horrible new reality for countries such as Sweden, which prides itself on a national environment of scientific innovation and big business. Site closures have been regularly making headlines across Europe, and every time they raise questions about the suitability of the countries concerned to retain such business.

But wait a minute…we’ve been here before, haven’t we? From my dim and distant youth in the Cambridge cluster, we watched large biotechs and pharma close doors as the first major funding crunch came. Biotech has taken quite a zigzag, crazy route to maturity, and the industry rarely repeats itself, but this is familiar and we should be learning from the past.

The notable outcome for the cluster as a whole was that scientists and managers turned to their own business enterprises, with IP and skills from big business being turned into new small business. That was really the making of the Cambridge cluster. Through this flux of new enterprises, it managed to reach critical mass before the finances really got chilly and start-ups got harder.

So the current round of closures needs to be channelling as quickly as possible to support more innovation and make use of the skills becoming available, before people retrain as lorry drivers or move to a commune in Peru. This time around, the big difference is that there is little or no start-up funding available privately, and this leads straight to the door of national governments.

So governments, it’s time to put aside the handwringing and the vague statements about creating a leading scientific environment, and put your money where your mouth is. Seize the day for your healthcare sectors and invest for a political and financial return! If pharma moving out is inevitable, make good use of what it leaves behind in the next phase of biotech industry development. They have already made it cheap for you by building world-class sites and training top-notch scientists – what more do you want, the moon on a stick?

15.05.2012 I co-chaired a session at the Commission’s ‘Innovation in Healthcare’ conference recently, and learned a very interesting lesson there that is overwhelmingly obvious, yet overlooked in our continuing mission to become one Europe.

Claire Skentelbery, Secretary General of the European Biotechnology Network

The session looked at how business skills are developed in the EU – what we have, what we need and how we get it. I expected specific skills to be targeted as missing and needing to be developed. Wrong. The overwhelming conclusion from our panel of EC, pharma, university and SME geniuses was that Europe pretty much has all the skills that it needs, but each expert is kept in his or her own little world, creating exceptional skills within a very narrow space.

The researcher pushed to publish, the SME that must meet the next milestone, the clinician locked into the healthcare system, the pharma guy stuck in an antique drug-discovery process … the list is long. For the last 25 years, training has been poured into a multitude of areas to ensure that the researcher becomes an entrepreneur, an SME CEO knows everything about FDA approval, and TTOs are gurus of industry development. It hasn’t really worked. Applying a thin layer of knowledge does not guarantee absorption. Why should a researcher, measured by publication success, also become an expert on commercial implications and plan research now for exploitation in 10 years time? 

The blindingly obvious conclusion from the panel was not to train people a bit harder, but physically to get them into other worlds and bring other worlds to them. Entrepreneurs in residence at universities, academic researchers placed in SMEs and pharma, clinicians on the boards of companies, pharma people in universities and SMEs. It’s not going to happen on its own, and it hasn’t yet – so we need to make it happen. Horizon 2020 should make staff exchanges bet-
ween partners in collaborative projects compulsory, up numbers of industry-academia research fellowships, increase pharma staff working in small company partners – there is loads we could do.

It’s not going to cost more money. The price is instead in the mindset. Europe talks the talk, but does it really walk the walk on direct integration of different worlds in the healthcare chain? People are so insulated in their own worlds, and the disruptive technology/attitudes of people from other worlds are not welcome. However, the evidence from the panel and audience confirmed direct integration as the most effective way to bring new skills and knowledge into each step of the chain. 

So Europe – are you listening? Stop fretting about growing new skills through the age-old training and ‘have an MBA’ culture to create your vision of the perfect business mind, and start moving existing skills about between different bits of the healthcare sector. They don't bite, and it might prove the only effective way to help them integrate.

12.06.2012 Good news! After some thinking, I’ve solved the eurocrisis and saved national investment in biotechnology! As with most people who champion a single Europe, what is going to happen in the eurozone weighs heavily on my mind. Not just because of the surreal and seemingly uncontrollable debt crisis, but also because investment in growth in most European countries has stalled.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Governments are only going to invest again when there’s a market for the products that such investment will deliver. 

And governments aren’t investing in biotech, as it doesn’t produce large-scale employment or big shiny things, and it usually doesn’t deliver within an electoral cycle. A nagging voice at the back of my mind has been saying: ‘and why would they?’ If I were a regional government looking to rescue the economy, biotech wouldn’t be high on my list unless there was already significant commercial presence. 

You have no idea how guilty writing that just made me feel. But fear not, dear reader, that was just a dark turn of the soul, and now the relentless optimism that drives all people who love biotech has already returned. Here’s the deal. People aren’t buying things from shops, so governments aren’t investing in growth there. But what DO they always need to buy? Easy – medicine, food and energy. 

And this is why governments should be investing in biotech – it delivers all of these things and there will always be a market for it, even if people are not buying anything else. 

 – In medicine, the rush to manage diseases more effectively has huge market pull, and companies literally cannot get products through the pipeline fast enough. 

– In energy, Europe has the capacity to lead the world in sustainable, intelligent power generation at local and national levels. Any country leading on this has a global market at their fingertips.

 – In food, the easiest sell of all, there are demonstrable returns within an electoral cycle. The role of biotechnology in all steps of the food production chain is a winner, and oddly enough, the global demand for things to eat has not been damaged by the crisis.

So this is the message for national and regional investors in biotechnology: you should be investing each year at a local level to deliver products to a constant global market that gets hungrier as the cost of medicine, food and energy increases. By doing so, you will also establish your country as an intellectual driver behind these key sectors. Healthcare is already well-advanced, but in energy and food technologies, the leads are there for the taking.  Significant money advancing biotech delivery – translational centres of excellence, global partnerships with big business and placement of the sectors on the national policy agenda. It can’t fail. Phew – glad we got that sorted. The eurozone will be saved by
biotechnology, and I’ll have something to write about next time. See you then!

09.07.2012  Bioeconomy is the new health, and that is official. You only have to look at all the planning for Horizon 2020 and all the big words coming out of politicians at national and European levels to see that. But is Europe really ready or willing to embrace what it will take to replace existing technologies with new, bio-driven ones?

Claire Skentelbery, Secretary General of the European Biotechnology Network

Let’s look at one example: biofuels. We’re talking about a sector where the global players in fuel production and oil supply are not bit players. They dominate the global economy, and sit at the right hand of presidents and prime ministers. None of these organisations have made a significant shift into biofuels. A fraction of the money spent on discovery programmes transferred into bio-fuel production would revolutionise global production and supply. But do you think that they are going to make it easy for other organisations to change policy and start eroding market share?

There is also no escaping the fact that new technologies will need significant public funds to create a platform from which to grow. They are not going to make it on a purely commercial basis. Opponents already harp on this, forgetting the massive subsidies – disguised or otherwise – that other energy industries have soaked up over the years. Solar panels are the perfect example here. Look what happened to the sector when subsidies were cut by cash-strapped governments.

Are European governments going to create this funding? It will have to be big, sustained and commit to a new energy platform over others. Interestingly, biofuel production from crops will have to take place close to the source of the crops. The economics don’t add up to ship carbon sources long distance, so you are producing locally for local consumption. That changes the game for energy production, turning it from a global market into a national one, which makes for interesting prospects in Europe. Will we invest in national production infrastructure and realign our agricultural production to supply facilities? This goes far beyond nice words about reducing dependence on fossil fuels. It requires wholesale commitment.

It works in economies with massive crop waste supplies and little or no domestic oil/gas industry. This could point to regions other than Europe as the future for biofuel production. And the irony is that these countries will embrace GM crops that improve fuel production from crop waste, where Europe is still having hissy fits about potatoes for starch production.

This could be a revolution in Europe, but we will need to seize it with both hands and make major changes to the agricultural production system across all countries, expanding farm to fork to include farm to fuel-tank. Think we can handle that?

13.09.2012 Well ladies and gentlemen of the biotechnology community, welcome back after the silly season. I hope you had a nice one, whether it was in the sunny bit, the rainy bit or the bits that were on fire. As usual, summer in Europe was quiet. I see we still have a Eurozone, which is nice, and shows that the revolutionary, biotech-driven solution I came up with earlier in the year is still working.

Claire Skentelbery, Secretary General of the European Biotechnology Network

But to business – what startling insights and wisdom can I provide from Brussels this month? Very little based on activity over the summer, so I shall instead turn once again to my crystal ball, and present a list of predictions based on my incurable optimism. 

European public funding: after a year of wrestling with the Framework pro-gramme and Innovative Medicines Initiative, my gut tells me that the agencies will at last start planning their funding together, finally allowing partners to plan an annual calendar of collaborative project applications without having to worry about deadlines all landing in the space of a single month.

National funding: countries in Europe will suddenly remember, in the midst of reducing funding for innovation, that it is innovation that drives economic growth. If all your scientists are fired, particularly those in SMEs, you throttle economic progress, making earlystage research pointless and large company growth in your country impossible.

Policymakers: these will return from their holidays miraculously alive to the fact that some things are not worth arguing about any more – I refer of course to GM technology in food crops (just say yes or no), the EU patent law (just get it finished for crying out loud) and consumer genetic testing legisla-tion (don’t let quacks and charlatans sell tests).

Big companies: my inner eye is particular focussed here, foreseeing that the pipeline crisis and continued shrinkage of R&D capacity will revolutionise the way that large companies work with others. There will be less of a ‘business on our terms’ approach to partnership and more quick movement, shared skills and earlier-stage partnerships.

Small companies: those rascals, they're taking up a lot of space in my crystal ball.  Biotech SMEs will certainly start working more closely together, rather than trying to nurse a single technology through to blockbuster status. And they will start to understand the strength brought about by partnership with other SMEs – that they are stronger together than alone.

That's it for my post-summer predictions  – and given my astounding success at curing the Eurozone crisis earlier this year, I'm sure they will all have come to pass by Christmas. See you next edition – by which time that holiday tan will have faded and the silly season will be a distant memory.

12.11.2012 We all read with dismay – but not a huge amount of surprise – the October paper from French researchers led by Gilles-Eric Séralini on the two-year rat-feeding study looking at the effects of glyphosate-treated GM maize.

Claire Skentelbery, Secretary General of the European Biotechnology Network

It‘s almost boring these days when new headlines emerge saying we're all going to DIE HORRIBLY from eating GM food. This is despite a conspicuous lack of people DYING HORRIBLY from anything other than the usual human-inspired causes, which are not worthy of comment or action because they are 100% ‘natural’.

In the bad old days, scientists, companies and politicians would have been looking the other way when the report was published, and before long the headline would have been accepted as fact. Any response would have been far too late and far too weak to look like anything other than an evil corporate cover-up.

This time, however, I was pleasantly surprised. As they raced to hit deadlines, I heard journalists adding that an awful lot of people disagreed with the results, and that the science was actually a bit suspect – not enough animals, dodgy design, cancer-prone rats and less maths than my budget planning for shoes. They also added, in pensive tones, that the researcher was a long-time opponent of GM crops, and this might mean he isn‘t exactly unbiased.

Even more refreshing was the rapid response from researchers and politicians. The latter got it badly wrong when the GM farce first hit the headlines. But then the French research community itself bit back quickly. The country‘s national academies of agriculture, medicine, pharmacy, sciences, technology and veterinary studies signed a statement that not only are the conclusions unsupported by the presented data, but that the paper spreads fear in the public. 

This was rapidly backed up by the European Food Safety Authority, which published a statement pointing out that the author had been invited to supply the evidence missing from the paper, but had obviously ”forgotten” to post it before their deadline. The full review from the EFSA contained the damning phrase “the study has unclear objectives and is inadequately reported in the publication, with many key details of the design, conduct and analysis being omitted. Without such details it is impossible to give weight to the results.” Dark words for any scientist to hear, and I’ll bet the peer review process in Food and Chemical Toxicology is now undergoing an overhaul.

Bravo, I say. The scientific community needs to manage its scientists better. It has been too easy for too long to grab headlines with poor but sensationalist science, and the price is paid by everybody.

When science is bad, it should be the scientists who point it out and remind their own community and the rest of the world that to be science, it has to be scientific – you don’t start from the result, and you always show the maths. Obviously, that doesn’t apply to shoes.

11.12.2012 It’s getting a little boring listening to conversations about the 2014-2020 budget. As citizens, we’re subjected to endless national bickering and point-scoring as national leaders look to secure their own positions through sounding ‘tough on Europe’, as if the EU was a strange alien beast designed to steal their money and straighten all their bananas.

Claire Skentelbery, Secretary General of the European Biotechnology Network

As a fugitive from the UK, I am particularly embarrassed, and can’t wait for them to have a referendum on in/out. At least the Brits will finally shut up afterwards.

But I digress. What people overlook is the impact of a big European freeze on national development. Europe has enabled the massive development of regions that would have been unlikely to see many benefits under purely national direction. This has created the infrastructure through which science is being delivered, and a consequence of reducing this now will be to throw away much of the progress and investment we’ve made to date.

Support on the Horizon

When not talking about biotech, I talk about cluster development (that’s right – I’m such a blast at parties) and right now we are witnessing a battle for survival. These precious structures are nurseries for economic returns on research. After 25 years of investment, they are creating SMEs that are coming through on promises, making the transition from discovery to clinical phases for new drugs – exactly what investment was intended to deliver.

However the market is moving further away from SMEs. The gap where they need support gets wider every year. So if investors won’t come unless you have a Phase III product, how do you get there? This is where the critical support from Horizon 2020 comes in. It must expand its reach beyond FP7, with cluster support, PPPs, later-stage trial funding, infrastructure creation, skills development and a relentless drive to support the commercialisation of great science. 

Savouring the fruits of innovation

If the funding falls away from Horizon 2020 as national governments reduce their input to Europe, then the countries themselves will pay the price. As national austerity reduces innovation support, Europe has in many places become the only source of assistance – both financially and strategically – when creating long-term plans as part of an international map. Kill it, and those clusters and regions that are at the cusp of economic delivery from biotechnology will shrivel, and the billions of euros invested thus far will be wasted.

Right now, Europe has an opportunity to seize the market. It would be a crime if short-term national political games prevented the strengths of 27 countries from finally delivering substantial economic returns in biotech.

14.02.2013 All the hard work I invested in 2012 to rescue the Eurozone with biotechnology has reaped a new reward in 2013, as the European Parliament and Council finally approved the European patent in December.

Claire Skentelbery, Secretary General of the European Biotechnology Network

All the hard work I invested in 2012 to rescue the Eurozone with biotechnology has reaped a new reward in 2013, as the European Parliament and Council finally approved the European patent in December. We can now look forward to a revolution in the commercialisation of innovation, as a unified Europe opens the doors to lower cost and wider impact patents. Many accuse the EU of over-caution, like an old lady wrapped up warm on a summer’s day, but this is a glorious example of Europe going a bit mad and dancing naked in the street. Metaphorically, of course. It’s far too cold for that in reality right now.

My friend Steven Zeman  can give you the formal overview of what the unified patent means for Europe (as he actually knows what he is talking about) so I will just relax and enjoy the feeling of freedom that the patent gives to technology in Europe.

I am intrigued to know how Europe will score on innovation rankings worldwide now, as universities can afford to protect more great science and SMEs don’t have to sell their grandmothers to bring their precious technology to an investable stage. We can expect to see far more patented innovations from collaborative research and people bold enough to take risks, as you have to do in biotechnology. We can also expect to see many technologies hitting the market at an earlier stage. Now you don’t have to hide it in your pocket for 10 years until you can finally afford that patent, or know for sure that it will do something.

Will this help to liberate Europe from its traditionally cautious approach to early-stage businesses? Let’s hope so. I would love to see European entrepreneurs seize the day and investors take early-stage opportunities more seriously. We yearn for the bold investments seen on the other side of the Atlantic. But money talks very quietly on this side of the pond, often because it is still muffled in the pockets of VCs who, in the face of early-stage companies, increasingly resemble me when my children describe the latest ‘must-have’ game or gadget, without which they will surely die.

This is not just about the point of purchasing patents. It’s also about the fact that it changes the whole value chain of innovation, and makes a serious statement from Europe as a whole. And that statement is that there might be a defragmentation of finance through the unfortunate situation of there being no money out there, but there has now also been a defragmentation of innovation because that is the right and glorious thing to do. Europe should be very proud of itself. Vive la revolution! 

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