Expert opinion

Don’t misinterpret the results of the referendum
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Don’t misinterpret the results of the referendum

27.05.2014 - During the Swiss Biotech Day in Zurich, the Swiss Biotech Report 2014 highlighted the most important innovation drivers in the country’s industry and summarised the sector’s most relevant topics.

And the report's breadth highlighted a key fact. Although most citizens remain largely unaware of the impact biotech is having on our lives outside of healthcare, the field is now central to a very wide range of sectors - from environmental protection to the food industry.

Innovation drivers and financing were of course major issues at the Swiss Biotech Day. However, the hottest topic of all was the country's recent referendum vote on mass immigration. The Swiss constitution will now have to be revised to include a statement reflecting that the country wants to control the flow of immigrants. The EU decision to suspend Switzerland from Horizon 2020 as a direct consequence of the vote certainly gave rise to plenty of discussion. Current policies, however, will remain in place for the next three years, which at least creates security in planning. Now this time period has to be used wisely to find the best possible solutions for the future. Preserving the innovative power of this research-intensive sector is vital to keeping the industry's engine running - both inside and outside the country. To achieve that, the sector needs access to the most important research networks and skilled specialists with the best possible training. The mass immigration vote creates additional hurdles that threaten to slow down the momentum of the biotech sector. However, both the Swiss federation and its cantons understand that the Life Sciences are of utmost importance, and policymakers are expected to continue to give priority to the sector.

Some commentaries suggest that Switzerland is now against a foreign work force. Nothing could be farther from the truth. For generations, Switzerland's economic success has been built on fruitful academic and industrial exchange with people from all over the world. In a recent publication, the director of the leading think-tank Avenir Suisse compared the country's immigration statistics from 2007-2012 with its neighbours. Per capita over those six years, Switzerland welcomed nearly three times as many immigrants as Austria, twice as many as Italy, and around nine times more than France or Germany. Based on its relative size, the Confederetia Helvetica therefore does very well indeed. But emotionally it is a fact: smaller countries feel that big immigration numbers dilute feelings of national identification.

Whilst direct democracy has led to many sound decisions in the past, the current situation is proving to be a challenging consensual process. Progressive forces want to find a balanced solution. The process itself is necessary and mandatory, but it doesn't have to heed the voices demanding 'immediate' decisions that are often based on personal motives and views. Because the country needs to innovate, I am confident Switzerland's liberal conditions will continue to hold true in the future. Not many industry sectors are as well connected globally as biotechnology. Relationship-building spans continents, and different cultures and the ways they mingle are certainly more fruitful than the path of isolation. It is therefore of utmost importance for Switzerland to quickly regain its status in Horizon 2020, continuing the overwhelmingly positive work begun in the EU's 7th Framework Programme.

Domenico Alexakis

is the CEO of the Swiss Biotech Association. He joined the organisation in 2003, and performs his duties in a part-time mandate. Alexakis was the co-founder of Swiss Biotech™, a brand programme that supports the positioning of biotechnology globally with changing partners. The entrepreneur holds operational mandates for other institutions, and also manages projects for clients in the fields of Innovation, Business Development and Economic Development. Before setting up his company Bridge Plus AG, Alexakis worked for Dow Chemical in various marketing departments. He holds degrees in communications and marketing.

09.12.2014 In the last few years, the regulatory landscape overseeing manufacturing process validation has faced major overhauls in two ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) regions.

Dr. Markus Goese, Roche Pharma Global Technical Operations

After publication of the US-FDA Process Validation Guideline in 2011, the EMA’s Biologics Working Party earlier this year published a draft Guideline on Process Validation for the manufacture of biotechderived active substances. The agency's Quality Working Party has also released its guideline on process validation, which focuses on finished dosage forms for new chemical entities, and stated that the principles also apply to biologic products. Finally, the EMA’s GMP/GDP Inspectors Working Group recently published its revised Annex 15 of the EU GMP Guidelines for Medicinal Products. As previously outlined in ICH Q7, Q8 and Q11, all of these guidelines contain provisions on validation activities within the context of a product's life-cycle. Activities can be pursued either in a “traditional” development setting, using an enhanced/QbD approach, or a mixture of both. Interestingly, the 2013 EMA BWP workshop on process validation revealed that the “mixed” approach appears to be current best practice for many biotech companies.

 One question that is increasingly debated, however, is when exactly a manufacturing process can be regarded as “validated” from a statutory point of view – especially in light of the recently launched “breakthrough”– and “adaptive licensing” FDA and EMA initiatives aimed at bringing life-saving new drugs to patients in an accelerated manner. In a dynamic global environment, it seems obvious that our industry should use every opportunity to discuss the current challenges facing process validation with relevant representatives from the EMA and FDA.

 We should all be striving for a convergence of regulatory guidance in this area. Even more importantly, we need frequent exchange on daily practices from industry experts, reviewers and inspectors “living” guidelines essential to our business. Open dialogue is the best way to tackle issues like the debate over “ongoing” vs. “continued process verification”, or the question of where in the regulatory dossier information can be placed solely for the purpose of transparency, yet not subjected to change control. Frankly, obstacles are often due more to terminology than a fundamental difference in approach. ICH Q12 topic on life-cycle management is more good news: the three focal areas of Q12 will be the regulatory dossier, the Pharmaceutical Quality System (PQS) and enabling tools such as post-approval change management protocols (PACMPs). Process validation is a prominent activity due to benefit significantly from a clarification of what constitutes regulatory binding and non-binding information in a submission, how exactly the PQS can act as a link to the daily GMP routine, and how PACMPs can be a support. So let's continue the constructive dialogue. The patients deserve it.

Markus Goese

currently acts as the EMA Liaison at Roche Pharma Global Technical Operations. He is also the Chair of the EBE BioManufacturing Working Group. The EBE (European Biopharmaceutical Enterprises) works to support a regulatory and financial environment that encourages the development of novel biopharmaceutical products. Within the organisation, the BioManufacturing Working group provides a forum for industry experts to develop best practices and to interact with regulators on all CMC and quality issues.

14.10.2014 “External innovation” is one of the pharmaceutical industry’s solutions for overcoming patent cliffs and gaps in innovation. It’s based on the insight that the majority of innovations in this sector do not have their origin in Big Pharma, but come from academia and small biotech companies.

Prof. Dr. Jochen Maas, General Manager of R&D at Sanofi in Germany

Big Pharma can adopt one of two approaches to this discovery. First, it can collaborate with academic institutions to address mainly the early part of the pharmaceutical value chain. Or second, it can conclude licensing deals with small or medium-sized biotech companies or even competitors.

Licensing activities are per se independent from the value chain phase. They occur during both late phase research and at other stages of development. The choice of a partner is primarily driven by scientific and strategic considerations. But even if independent of time and place around the globe – and we’re all aware that R&D is global, and doesn’t recognise frontiers – experience shows us that those collaborations and deals that are implemented on a European level happen fastest. 

One basic need for collaborations and licensing agreements is mutual trust. It’s a prerequisite for all kinds of collaborations and co-operations that can be generated by common project teams moving projects forward – by exchanging team members right from the beginning of a licensing agreement, working in the partner company, and if possible, even in common laboratories at the same bench. There is no better way to generate trust. And for simple logistical reasons, European companies find it easier to realise their goals within Europe, rather than across continents.

In any case, win/win situations have to be created if licensing activities are to be successful. In this context it has to be taken into account that business models – particularly between small biotech companies and Big Pharma – can be very different. While Big Pharma’s final objective is to hit the market with a product as rapidly as possible, a small biotech’s priority might be to sell a project to Big Pharma. The implications are obvious. Big Pharma conducts specific studies mandatory for market entry considerably earlier in the R&D process, while Small Biotech wants to postpone such studies to a later phase. Expectations for the two licensing partners can therefore be different, and have to be aligned from the beginning, as do the financial details of the licensing agreements, including exit scenarios. The era of big up-front payments appears to be over. Milestone-driven payments are the future approach. And other legal and patent conditions also have to be taken into account, even if a project is still far from market access. Potential modifications of indications should be forecast and included in contracts if licensing activities in the sector are to increase significantly. 

Jochen Maas

is the  General Manager of R&D at Sanofi in Germany, where he is a member of the Global R&D Management Board, the German Management Board and head of the German Hub R&D organisation. Maas has a wide range of experience in all phases of the R&D value chain, including pharmacokinetics, preclinical and clinical development. The biologist and veterinarian who holds a doctorate in veterinary medicine lectures as a professor at the Giessen-Friedberg University of Applied Sciences.

12.06.2014 Research and innovation models are changing dramatically. The emergence of platforms such as advanced therapeutics is accelerating a change from innovation within big centres and universities to smaller, decentralised and more focused units.

Roberto Gradnik, President of Europen Biopharmaceutical Enterprises, EBE

Innovation is always highest where there is freedom to be creative. An EBE member company CEO whom I know put it very succinctly: “The moment my CSO knows what’s going on in the lab, we are no longer creating new innovation.” The biopharmaceutical ecosystem has grown infinitely more diverse, with a wide variety of participants contributing to nearly every aspect of development. Networks and collaborative research establishments were originally seen as a supplement to innovation, but now they have begun generating more core innovation, and are viewed as essential. Considering the fact that most European healthcare biotech companies in the fragmented European innovation landscape are SMEs (70% of the 2,000 healthcare biotech companies in Europe have less than 50 employees), we now desperately need efficient networks of innovators from science, business and public institutions to facilitate funding and enablement. There has been a paradigm shift in attitudes towards generating innovation, and this means that all stakeholders need to begin working together much more closely – all the way from the lab to the shelves of pharmacies.

The ultimate drivers in this scenario, of course, are the return on investment and the return on health. We have seen a high return on the funding and time committed to networks that have a specific focus, with the understanding that innovation now no longer necessarily comes from our own laboratories.

A critical point is that both partners in a partnership have to benefit. Networks help to foster mutual trust, particularly where historically there has been a mutual mistrust, a situation largely born of differences in operational cultures. But the Innovative Medicines Initiative (IMI) and its successful continuation have demonstrated that these cultural gaps can also be overcome for the greater benefit of patients. Needless to say, partnerships need to demonstrate win-win, and public authorities can help encourage that. Partnerships can work to create a platform of mutual trust and benefit, just as the IMI forges programmes that foster innovation with reduced politics, creating a foundation for increased trust to flourish.

To support all of these aspects, EBE recently launched a partnership with the European Biotechnology Network (EBN) to facilitate EBE member companies’ access to diverse networks and funding opportunities across Europe. This move is aimed at helping them to build partnerships out of their comfort zone, and deliver disruptive innovation in the future. I am delighted with this collaboration, not least because it truly demonstrates the delivery power of efficient networking.

As we move forward through 2014, the two networks will bring their members together through the auspices of Horizon 2020, the IMI, and many other funding opportunities, allowing them to discover common goals around which they can combine their specialist technology platforms. From SMEs to large companies to universities – the lure of creating exciting science and business is the perfect catalyst for partnership. And as barriers between sectors and organisations fall, the results can only be positive for participants and Europe as a whole.

Roberto Gradnik

is the Chief Executive Officer of Stallergenes, and has also been the President of the European Biopharmaceuticals Enterprises (EBE) since January 2012. From 2004-2010 he served as President of the Italian biotech industry association Assobiotec. Trained as a physician, Gradnik has more than 25 years of experience in the pharmaceuticals and biotechnology sectors. Prior to his current post, he held senior positions at BASF subsidiary Knoll Group and Serono/Merck Serono.

10.04.2014 There’s no question that Europe’s biotech sector produces high-quality science. We have world-class research organisations and start-ups, as witnessed by the number of alliances with Big Pharma and the number of products being registered.

Pierre-Olivier Goineau, President, France Biotech, Paris

And let's not forget that the European biotech industry has more pipeline products than the Big Five pharma companies (Novartis, Roche, Pfizer, Sanofi and Merck ) put together! Nevertheless, the pathway from invention to innovation - from scientific and/or technological progress to a marketed product - remains stubbornly blocked in Europe.

Why? The answer is simply that following an initial idea and proof-of-concept, developing and marketing an invention (whether biotechnological or anything else) requires significant financial resources. European innovation in general is hamstrung by one fundamental problem: a lack of access to adequate funding. The recent financial crisis broke an upward trend in European equity investment in high-tech, and the continent's capital risk sector now needs rebuilding. In addition, the stock markets have broken down (with the notable exception of France, which has become the European leader in terms of IPOs). In some countries, the ecosystem of analysts/brokers/lawyers/auditors has simply disappeared.

Some efforts, on the other hand, are beginning to pay off, as witnessed by the emergence of a whole ecosystem of maturing life science companies. France Biotech is continuing to help its recently incorporated members to improve their practices and benefit from their elders’ experience. We are also intensifying efforts to bring members into contact with Big Pharma companies in Europe and worldwide, and promote sustainable funding in our sector.

But a lack of funding is our Achilles’ heel. Unlike otherwise similar North American companies in this field, that makes us easy prey. Unless a European biotech company tries to gain a foothold in North America to raise funds, it soon becomes vulnerable. Its know-how and intellectual property can be bought by third parties, who go on to develop the latter in-house.

Asia has also entered the game, but Europe does not always play by the same rules there. Japan and South Korea use their regulatory agencies as tools for business competitiveness (in the field of cell therapy, for example). The same can hardly be said of the European Medicines Agency. China is investing massively in infrastructure and know-how, but we still have very few links with our Chinese counterparts. Even countries like Singapore and Taiwan are showing themselves to be very dynamic. And there are plenty of other examples.

The European Union has (at last!) become aware of this situation. However, its initiatives are not scaled to meet the challenges we face! Our innovative, value-added industry deserves much better. Access to European Union funding programmes is still laborious, and restricts inter-company collaborations. The key success factor in our industry is speed. So are we moving fast enough?

As entrepreneurs and representatives of industry bodies, it is up to us to put these arguments on the table and gear up for June’s European elections. I call on you all to send out the same, shared message: “Wake up, Europe!”

Piere-Olivier Goineau

is the co-founder, Vice President and CEO of Erytech Pharma. Before setting up the company, he was a Senior Consultant in Strategy and Development at KPMG in Lyon (France) where he was in charge of the Health Division. Goineau was chosen as the new President of the biotechnology association France Biotech in February. He has a DEA (post-graduate degree) in Management Science and a Master's degree in Pharmaceutical Industry Management from the IAE (School of Business Management) in Lyon.

18.03.2014 In October 2012, the European Commission issued a communication on its new Industrial policy identifying biotechnology as one of six Key Enabling Technologies. Biotech will be an important tool in helping Europe deliver on its Europe 2020 strategy of creating an innovative, resource-efficient, smart, sustainable and inclusive economy.

Beat Spaeth, Director Green Biotechnology, EuropaBio, Brussels

Due to the many challenges facing Europe and the world today - among them the threat of climate change, a decreasing amount of arable land and a growing population worldwide - we will need to use every available tool to optimise the use of land and resources and enable those in developing countries to improve their quality of life. Innovation in plant breeding is essential to feed the world's growing numbers and help reduce poverty by improving food security. Global demand for food is expected to increase by 70% by 2050. To meet this demand, we will need to produce the same amount of food in the next 40 years as we did in the past 8,000.

However, land is the limiting factor in producing sufficient food, feed and fuel to meet global demands. Biomass should therefore always be produced with land and resource efficiency in mind, and should ultimately be used in a smart and sustainable way. To make this possible, farmers need the right to choose what they plant and grow. That will allow them to make the best use of the available resources and enable them to preserve other land for biodiversity purposes. In biobased industries, there should be a level playing field when it comes to biomass used for energy purposes and that used for high value chemicals and biobased plastics production. The production of the latter two provides greater economic benefits in terms of economic growth and jobs, and uses far smaller amounts of biomass. In addition, helping to create new markets for biobased products through incentives and public procurement would help increase the value of agricultural residues, thereby bringing greater benefits to farmers.

According to the latest global biotech crop acreage report published by the International Service for the Acquisition of Agri-biotech Applications (ISAAA), more than 18 million farmers are currently planting biotech crops on 175 million hectares. Of those farmers, more than 90% - or 16.5 million of them - are small-scale and resource-poor. The benefits of agricultural biotechnology are clear in countries that have adopted it. A recent study has shown that the adoption of Bt maize allowed Spain to reduce its imports of the crop by over 853,000 tonnes between 1998 and 2013, with consequent savings of €156m. It is time that we begin to view agricultural biotechnology as what it is: a technique that is an integrated part of the European transition to a lower-carbon, more resource-efficient bioeconomy.

Beat Spaeth

studied European affairs and languages in the UK, France and Belgium. He began
his career in 2001 at the European Parliament, where he worked as an assistant to a German MEP, before moving on to join the Brussels office of the German Retail Federation as an advisor with a focus on the environment, social affairs and corporate social responsibility. At EuropaBio, Späth currently manages the political aspects of agricultural biotechnology at the EU level. He interacts with representatives from member companies to facilitate industry positions on political developments, and communicates with EU decisionmakers on behalf of the association.

04.03.2014 When penicillin was discovered by Dr. Alexander Fleming in 1928, people around the world believed it was one of the greatest medical and scientific advances in the history of mankind – and they were right. Before penicillin, a bacterial infection in a minor cut or injury could easily become fatal. Diseases like scarlet fever, pneumonia, meningitis and diphtheria were essentially untreatable.

Janet Hammond, Roche Pharmaceutical Research and Early Development, Basel

In the following decades, more antibiotics appeared on the scene, among them tetracyclines, isoniazid, macrolides, glycopeptides and cephalosporins. 

Doctors began to routinely prescribe anti-biotics – even when they weren’t sure that patients actually had bacterial infections – and it seemed that this miracle of modern medicine had the potential to eradicate one of mankind’s tiniest but deadliest enemies. 

Ominous data began to appear, however, suggesting that the miracle wouldn’t last forever. In the early 1980s, Staphylococcus aureus infections appeared that were resistant to mul-tiple antibiotics. At the same time, mul-tiple drug resistant Streptococcus pneuomoniae infections also surfaced. 

Each passing year carried more troubling findings and an expanding list of bacteria that challenged even the most powerful antibiotics. Methicillin-resistant Staphylococcus aureus (MRSA) outbreaks in hospitals became headline news. More than 1.5 million people around the world are now dying each year from bacterial infections. 

What happened to change bacterial infections from a health problem once considered by many to be nearly “solved” into an implacable foe described by a leading scientist as a “catastrophe” equal to bioterrorism?

Although pharmaceutical research into anti-biotics continues, a “discovery void” has emerged. Since 1987, the number of new antibiotics reaching the market has stalled. Meanwhile, new resistance mechanisms in bacteria have emerged, making even the most advanced antibiotics virtually ineffective. 

Fearing that widespread resistance to anti-biotics could bring “the end of modern medicine as we know it,” the World Health Organization has made finding new, effective antibiotics one of its top three priorities, and regulatory authorities now offer incentives related to the research and development of new anti-bacterials.

In November 2013, Roche pRED (Pharma Research and Early Development) entered a partnering deal to develop novel anti-biotic POL7080, a Phase II compound targeting Pseudomonas aeruginosa (PA), a Gram--negative bacterial species causing severe infections. PA is responsible for a significant percentage of multi-drug resistant pneumonias in the hospital setting. 

Encouraged by changes in the regulatory landscape and a better understanding of the under-lying biology, Roche is one of just a few companies that have so far returned to the development of antibiotics, determined to take on this threat to global health. Roche was an industry leader with Bactrim and Rocephin, two groundbreaking antibiotics credited with saving billions of lives, and the new focus on pathogen-specific drugs for multi-drug resistant bacteria plays on our legacy and our strengths.

For patients who are under siege by a microscopic enemy that seems to ward off all weapons, there is hope on the horizon. 

Janet Hammond

is Head of Infectious Diseases at Roche Pharma Research and Early Development. She received her medical training at the University of Cape Town before specialising in internal medicine and pulmonary/critical care medicine. She then moved to the US, where she completed her fellowship in Infectious Disease at Duke University and Infectious Disease and Clinical Pharmacology at Johns Hopkins University. Prior to joining Roche in 2011, Dr. Hammond was Chief Medical Officer at Valeant Pharmaceuticals.  

03.01.2014 In the past year, the debate surrounding increased transparency of clinical trials has seen a great deal of progress. From an industry perspective, we have engaged more openly with a greater diversity of stake­holders on the topic - a positive development, as an intelligent exchange of ideas is needed to determine the best path forward.

Richard Bergstroem, Director General EFPIA, Brussels

Opinions on how to best increase openness around clinical trials data are varied, but as the conversation has progressed, one thing has become clear: It will be necessary to strike a certain balance if we are to develop data-sharing measures that will best serve public health interests. Greater transparency around clinical trials data is needed - but it must be a responsible transparency. This means protecting not only patients by ensuring their private data is appropriately protected, but also protecting the information contained in clinical trials data that is potentially commercially sensitive. This is a must if we are to safeguard innovation, the tool that the pharmaceutical industry relies on to develop treatments for improved patient outcomes. Publishing Clinical Study Reports (CSRs) in their entirety, as they are written now, does not strike this balance. Making patient-level data available to all does not strike this balance. Allowing indeterminate access to full data sets - again, does not strike this balance. A responsible transparency is one that safeguards patients and their privacy, respects regulatory systems at all levels and protects research incentives. These are the premises underlying the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing, which EFPIA and PhRMA member companies have agreed to implement from January 1, 2014. These commitments enhance patient and public access to clinical study information by providing synopses of clinical study reports, which give the public information it needs while protecting sensitive patient information. More detailed patient-level and study-level data can be made available on request to those who can do good with it, including qualified researchers who will further science.

In a recent NEJM article (doi: 10.1056/ NEJMp1310771), the EMA's Hans-Georg Eichler, Guido Rasi and other authors argue that access to patient-level trial data could help drug developers in how they conduct clinical trials - something that could potentially improve healthcare outcomes. Drugmakers have already recognised the value of sharing data with qualified researchers. We are increasingly seeing cases of open innovation and companies that were once competitors joining forces to tackle areas of unmet need. The Innovative Medicines Initiative, the public-private partnership between EFPIA and the European Commission, is fostering open innovation and encouraging collaboration, with companies sharing data and pooling resources. There are undeniable benefits to increasing openness around clinical trials data - but only if it is shared in the right way, with the right people.

Knowledge is power, and this is especially true when it comes to healthcare. The science of medicine has allowed for amazing progress in improving treatment for a variety of illnesses, from HIV to cancer. Medical and scientific innovation is one of the most powerful tools we have for improving patients' lives. Responsible data-sharing is about recognising this and striking the right balance - one that protects both patients and innovation.

Richard Bergstroem

was appointed Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) in April 2011. Over the past 20 years, he has worked for Roche, Novartis and with the Swedish pharmaceutical industry association (LIF). A pharmacist by training, he received his MScPharm degree from the University of Uppsala (Sweden) in 1988. Since 2006, Bergström has been an advisor to the WHO on Good Governance in Medicine.

03.12.2013 Put simply, biotechnology is the use of living organisms to develop useful products. Its basic principles have been employed to alter plants and livestock for domestication for thousands of years.

Nathalie Moll, Secretary General EuropaBio, Brussels

In Europe today, however, biotech is either perceived at best as a dream, or at worse as a nightmare. Most consumers remain only vaguely aware of the biotech products that are helping Europeans live healthier, longer and greener lives. The short list alone includes vaccines, insulin, rare disease therapies, improved crops, detergents for washing at lower temperatures, bio-plastics, cosmetics and biofuels.

So what can be done to help make this invisible revolution more visible? We‘re living longer and healthier lives thanks to advances in medicine. More than 350 million patients globally are already benefiting from healthcare biotech that is helping to treat and prevent common ailments like heart disease and diabetes. And it is also developing therapies for rare diseases – often debilitating and life-threatening – that affect up to 30 million Europeans. 20% of all medications are made using its methods, and by 2015, 50% of our medicines will come from biotech.

In other aspects of our lives, industrial biotech is helping to minimise environmental impact while boosting manufacturing output and creating more jobs. Europe is a world leader in white biotech, producing about 75% of the world‘s enzymes. In production processes, industrial biotech reduces the need for crude oil by using renewable raw materials, leading to significant reductions in greenhouse gas emissions. In fact, the WWF estimates industrial biotech will help reduce up to 2.5 billion tonnes of CO2 equivalent per year by 2030.

With agricultural biotech, Europe’s farmers have been able to increase yields by up to 30% on the same amount of land, helping protect biodiversity and wildlife. These crops also reduce fuel consumption and CO2 emissions by requiring less tillage. In 2011, this was like removing 23.1 billion kg of CO2 from the atmosphere – the equivalent of taking over 10 million cars off the road for a year.

Great things of course often come in small packages, and the 2000+ biotech SMEs in Europe are crucial to delivering innovative solutions for our most pressing societal needs. Europe will suffer competitively if we don‘t give the right financial backing to these firms. We hope that the annual EuropaBio Most Innovative Biotech SME Award will go some way towards providing a voice for the sector, and highlight the importance of a supportive regulatory framework to help it flourish.

We cannot afford to let biotech‘s many positive aspects pass consumers by or – even worse – be misunderstood. It is up to our industry to better communicate the benefits of biotech to Europeans. This year we celebrate the first ever European Biotech Week – showcasing this innovative and vibrant sector. Over 60 events took place across the EU during the first week of October, underlining the importance its various fields now play in our lives.

The European Biotech Week will be an annual occurrence in October from now on to emphasise that biotechnology has grown more important than ever to job creation, improving health and creating a more sustainable environment. Anyone with a curious mind, an interest in how we can achieve better health as we grow older, and a cleaner environment is invited to celebrate and learn more about the incredible world of biotechnology and how it evolves each year. Let‘s make the invisible revolution visible!

Nathalie Moll

has spent almost a decade representing the European biotechnology industry through EuropaBio in the posts of External Relations Manager, Director for Strategic Policy, Director of the Healthcare Biotech sector, Director of the Agricultural Biotech sector and most recently as Secretary General - a post she took over in 2010. Prior to her career at EuropaBio, the trained biochemist worked in the biotechnology and food policy area for the European Crop Protection Association, as well as for the Italian National Biotech Association (Assobiotec) and Dompé Farmaceutici S.p. A dealing with the implementation of EU biotech legislation at the national level.

Photo: EuopaBio

04.11.2013 The start of Europe's new financial framework and the framework research programme Horizon 2020 seems a good moment to take a step back and look into some recent and not so recent - but even more substantial - changes in (bio-)technology policy paradigms.

Peter Schintlmeister, Austrian Federal Ministry of Economics, Family and Youth

From technology-orientation towards justification: In 2002, the European Commission (EC) published its first overarching strategy for Life Sciences and Biotechnology. The focus then was clearly on new technologies and their promise. Meanwhile policy mainstream has changed and all technological efforts are superseded by the need for justifying the possible contribution to society's 'Grand Challenges'. In practice, even technologies that have been politically identified as 'key technologies' fall under this regimen, which in turn narrows horizons for possibilities outside this scope. The good news for cutting-edge science and technology, however, is that new and more precise instruments (e.g. the ERC) are easily countermanding the loss of focus on technology.

The loss of the knowledge-base: the term 'knowledge-based bio-economy' first appeared on the radar of technology policy in 2005. At that time, it was totally in line with the (Lisbon) goals of making Europe competitive through enhancing its knowledge-base. When the 2012 strategy 'Innovation for sustainable growth: A Bio-economy for Europe' was published, the term 'knowledge-base' had interestingly disappeared from the title (although it still appears in places on the website). While this move widens the base of stakeholders significantly by embracing entire traditional industries like agriculture and forestry, it still has to be shown whether Europe can maintain a focus on innovation. This trend can also be seen in the composition of the new Bio- economy Panel, which is aimed at providing the European Commission with feedback from the community.

The shift from supply- to demand-side of technology policy: A couple of recent studies concur on the necessity of keeping current austerity measures in place in most EU Member States, and have concluded that investing taxpayer money in technology-based areas might only solve the technological side of the problem. Bringing innovation to the market - an area where Europe has a notoriously bad track record - is a wholly different affair. The Commission's Lead Market Initiative has sought to balance out issues by emphasising the importance of (low-cost) political measures, such as streamlining the regulatory framework, labeling and certificate schemes (both admittedly tasks worthy of Sisyphus) and enhancing the efficiency of standardisation. The technologypolicy community has recognised that the measures are bringing results, and they have acquired prominent positions in current high-level strategies like Europe 2020 and the Innovation Union. This will enable them to make a positive difference in the years to come.

European policies are about the larger and broader vision, but most of the impact they have still derives from the national implementation that takes place farther down the road. The Greek philosopher Heraclitus is attributed to have said that the only constant in life is change - and that aphorism applies to policies as well!

Peter Schintlmeister

joined Austria's Federal Ministry of Economics, Family and Youth in 2003 as an expert for life sciences and biotechnology. He has enjoyed chairmanships at a number of different entities, including the OECD Task Force on Industrial Biotechnology, the ERA-NET EuroTransBio and the European Commission's Advisory Group on bio-based products for the Lead Market Initiative. Schintlmeister is a member of the European Bioeconomy Panel and the Commission's expert group for bio-based products. He has spent the better part of 2013 in China, where he has been contributing to the establishment of Austria's Office of Science and Technology in Beijing.

26.09.2013 Biosimilar products are not generic medicines, nor are they identical to their reference product or each other. Instead, they are similar versions of well-established recombinant proteins with well-characterised structures and pharmacology. All biologics (biosimilars and reference products) have complicated safety and immunogenicity profiles.

So far only three classes of biosimilar have been approved for use in the EU (somatropins, epoetins and GCSFs), but a second generation of biosimilars is on the way that focuses on more complicated molecules – such as monoclonal antibodies and fusion proteins – to help patients fight diseases like RA and cancer. This has been made possible by the EU’s science-led regulatory framework, which has established confidence in the quality of existing biosimilars. Various biosimilars are currently in different stages of clinical development and regulatory approval in the EU, and biosimilar regulatory pathways are also in place in countries like Canada, the US and Australia. 

Biosimilars have been providing alternative therapeutic choices for European patients and physicians since 2006. The European Commission recently completed an exhaustive study on the introduction of biosimilars into European medical practice, and determined that their availability is helping increase market competition.

Although the available commercial data says otherwise, some claim biosimilars have had a disappointing introduction, and that regulators and politicians need to do ‘more’ to spur their uptake. As a representative for a company developing several biosimilar medicines, I tend to disagree. It’s important to let the market decide, and ensuring patient safety should be the foremost concern for both governments and the biosimilars industry. 

There have been significant advances in our ability to use analytics to better understand the biology of both reference product and biosimilar. However, we haven’t yet (and may never) reach a stage where biosimilars should not be absolutely required to exhibit fidelity to their reference products and be rigorously evaluated in analytical, non-clinical and clinical comparisons. 

The industry has an obligation to take proactive steps to be accountable to providers and patients for product quality. For example, all stakeholders, manufacturers, regulators and healthcare professionals should embrace pharmacovigilance and naming systems that allow all biologics to be properly identified and traced in cases of adverse events. The EU’s pharmacovigilance legislation addresses this, and will help instill further confidence in the field.

It’s evident that high-quality, reliably supplied biosimilars can offer additional choices to patients and other key stakeholders, although development and supply of these complex medicines is scientifically challenging and capital-intensive. We now know manufacturers need significant expertise, infrastructure and capital to successfully develop these molecules. 

The healthcare community, industry and regulators have a key opportunity – to work as partners to ensure appropriate standards for these products are maintained. As we at Amgen move forward with developing our own portfolio, we know our experience is critical in a field where patient safety and reliability of supply are paramount concerns.

Carsten Thiel

is the Vice President and Regional General Manager of Amgen Europe. He joined the European oncology franchise in 2002, and held the post of General Manager for Amgen’s Central and Eastern European operations from 2006-2007 before taking up duties as General Manager in Germany from 2007-2010. He moved to his current post in 2011.

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