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François Busquet: Why Europe needs the Human Toxome Project
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François Busquet: Why Europe needs the Human Toxome Project

30.05.2012 - What is the Human Toxome Project? It’s a wide-reaching programme aimed at helping us to reconsider how hazard/risk assessment has been performed over the last 50 years on marketed substances like chemicals, cosmetic products, pharmaceuticals, pesticides, biocides and feedstuffs.

It’s necessary because most of the scientific community now accepts that animal models for testing the safety of these products have more limitations than advantages. In basic terms, the loose genetic homology to humans is no match for modern cell-culture technology, which promises to be much more apt to correctly predict toxic effects in humans. These cell cultures can additionally be used in the high-throughput screening (HTS) necessary to test growing numbers of products. In the last 15 years, cell cultures have replaced acute/short-term in vivo tests. However, chronic/long-term tests are the real bottleneck for these models, which do not accurately represent the complexity of multiple mechanisms, and for which it is very difficult if not impossible to maintain integrity (e.g. for a month of exposure). More recently, new environmental and human health challenges have appeared along with the ubiquitous mix of chemicals in the environment, among them endocrine disruptors and nanoparticles, and no test can unequivocally determine the toxicity of – or absence of – these compounds.

In the US, the Toxic Substances Control Act Reauthorization – an equivalent of the REACH programme – might address more than 80,000 chemicals. In preparation, the ToxCast programme for predicting potential toxicity for pesticides or environmental pollutants has been started by the EPA based on HTS, and it has now been extended to nanomaterials, cosmetic ingredients and drugs that failed to make it to market. How is the US dealing with these issues? 2007 was a cornerstone year for Tox-21c and the beginning of a paradigm shift in hazard/risk assessment. The NRC’s hallmark publication “Toxicity Testing in the 21st Century: A Vision and a Strategy” prompted a new, upbeat atmosphere. Its key proposal is to base regulatory toxicology on mechanisms and modes of action (preferably human-based models). The term “pathway of toxicity” (PoT) was coined to describe this concept. Then in 2010, the EPA assessed the safety of the chemical dispersants being used to treat the massive oil spill in the Gulf of Mexico by performing HTS. Analyses were concluded in about two weeks, instead of the six months it would have taken using traditional animal models.

Assuming that the mechanisms of toxicity are finite in number, the next step would be to map and annotate all of these PoT in humans to extrapolate the toxicological effects at the individual scale. To this end, it makes sense to create a public database of PoT – the Human Toxome. This could tackle animal welfare in laboratory experiments, speed up access to market for safer and better products and aid in the development of new analytical tools based on the knowledge gained. Pilot projects steered by CAAT and funded by the NIH and the FDA already exist. At the moment, they are focussed on endocrine disruptors and neurotoxicity pathways respectively. Discussions about a European branch have been initiated for the project, which is likely to be the size of the Human Genome Project – a task not for a single group, but for the international community.

François Busquet

François Busquet studied Biotechnologies at the ENSTBB in France. He graduated from the TU Dresden, completing his PhD at the MerckSerono group in Germany on the development of a new screening assay to detect proteratogenic compounds using zebrafish embryos. After his studies, he worked in ECVAM at the Joint Research Centre (European Commission) in Italy on the coordination of the OECD validation study of the zebrafish embryo toxicity test. Since 2012, Dr Busquet has been responsible for the CAAT-EU Policy Programme in Brussels.

http://www.european-biotechnology-news.com/people/editorial/2012/francois-busquet.html

15.02.2012 The extensive coverage of the worldwide financial crises has masked a looming crisis in healthcare. In addition to the financial constraints affecting every part of society, healthcare also faces an innovation crisis.

Innovation in the field is clearly advancing faster than the ability of the system to adapt to the new innovations. Most experts acknowledge that the future of healthcare will involve sophisticated diagnostic and evaluative processes to dictate precise approaches for the treatment of disease or the maintenance of individual health. The evidence in favour of personalized healthcare is accumulating rapidly in some areas – for example, the molecular diagnosis of cancer – but numerous barriers to rapid implementation remain. Because many of these new processes could save lives, we need to ask why rapidly expanding these new innovations to all patients is proving so difficult. 

A recent meeting in Luxembourg entitled “Personalized Medicine in Europe: What will it take to succeed?” brought together leaders from healthcare, business and academia to discuss the various aspects of implementation of personalized care. Unique and major challenges face each sector of the system. Patients are faced with a bewildering spectrum of options; device and pharmaceutical manufacturers are faced with shrinking markets for each intervention, making it difficult to create a profitable model. Physicians and health professionals face a big challenge in filtering patient data to find the best, individualized intervention. Finally, health policy experts are expressing concern about the cost of personalized medicine and the feasibility of introducing the new innovations without bankrupting the health system. 

Most developed countries now spend from 8–12% of GDP on healthcare, and feel that if this increases substantially, it will seriously affect other essential services and compromise overall quality of life. Thus, the radical changes required in healthcare systems to accommodate innovation must occur primarily by replacing old processes with new. This approach has failed in the past, as healthcare professionals are often reluctant to give up traditional approaches for new ones without overwhelming evidence of improved outcome and efficiency. 

Health policy experts know that introducing new processes from carefully controlled clinical trials into wide-spread clinical use almost never achieves the same efficacy as that obtained in the clinical study. Many factors account for this discrepancy, and these factors lead to a reluctance to introduce expensive new processes that may not produce the expected benefits. 

A lot of healthcare researchers now recognize that we need to create a new process for introducing innovation into a healthcare system. Following confirmation in a clinical study, many new interventions should next be tested in an actual healthcare environment to determine whether or not the benefits of the new process can be easily achieved in a realistic healthcare setting. Such experiments in ‘real’ healthcare systems are difficult to organize and manage, but several countries are leading the way in testing innovations in a real-world setting before attempting to introduce the innovation in the entire system (the Maimonides Project). Such experiments in community settings – involving only a few thousand people – can provide essential information on the feasibility of implementing the innovation in the entire system. The Maimonides group of countries has already achieved some documented successes in implementing cost-effective innovations that improve health and well-being. Hopefully, more countries will adopt this intermediate method of testing innovation, and will share their experiences with others.

   

Robert Phillips

1967-2010, professor, University of Toronto: 1996-2010 Leadership positions: National Cancer Institute of Canada, Ontario Cancer Research Network, Ontario Institute for Cancer Research; 2010 CEO, Integrated Biobank of Luxembourg

   

Rudi Balling

1993-2001 Director, Institute of Mammalian Genetics, Helmholtz Centre Munich; 2001–
2009 Director, Helmholtz Centre for Infection Research, Braunschweig; 2009, Visiting Professor, Broad Institute, Boston; since 2010 Founding Director Luxembourg Centre for Systems Biomedicine, University of Luxembourg

02.04.2012 The societal and economic challenges facing Europe and the world are complex and interconnected. The Bioeconomy Strategy and Action Plan "Innovating for Sustainable Growth: a Bioeconomy for Europe", which was adopted by the European Commission on 13 February 2012, offers a unique approach to addressing these challenges in a comprehensive way.

Maive Rute, Director Biotechnology, Agriculture & Food, DG RT D, Brussels

In order to reduce heavy economic dependency on fossil resources and focus on mitigating climate change, Europe needs to move towards a post-petroleum society. The Bioeconomy Strategy will contribute to this transition by promoting research and innovation into sustainable production and exploitation of renewable raw materials, along with alternative energy and carbon sources. It will pave the way to a more innovative and low-carbon society that reconciles food security with the sustainable use of renewable biological resources for industrial purposes, while simultaneously creating new job opportunities. Biotechnology as an enabling technology will play a crucial role in enhancing sustainability and competitiveness in the EU's primary production and processing industries. It will also significantly contribute to reducing EU industry dependence on fossil resources, and improve the resource efficiency of production processes through the use of renewable raw materials (including wastes) and more environmentally- friendly bio-based processes.

The Bioeconomy Strategy is based on three complementary pillars. The first is aimed at increasing investment in research, innovation and skills. Under the European Framework "Horizon 2020" (2014-2020) Programme for Research and Innovation, €4.7bn of funding has been earmarked for bioeconomy research and innovation under the societal challenge "Food security, sustainable agriculture, marine and maritime research, and the bioeconomy" and for biotechnology as an enabling technology. It is estimated that this funding could generate about 130,000 new jobs and €45bn in value added in bioeconomy sectors by 2025, not taking into account other direct and indirect public and private investments into bioeconomy sectors. A Public Private Partnership for bio-based industries is under consideration.

The second pillar aims to improve synergies and coherence between priorities of European research and innovation policy and other policies relevant to the bioeconomy. It will provide different platforms to enhance interactions between researchers, policymakers, industries and society, as well as supporting similar initiatives in the EU Member States and Regions. The Strategy will also further develop international cooperation in the area of the bioeconomy. In its third pillar, the Strategy provides support to new markets and the expansion of existing ones; for example, by promoting the development of standards, sustainability assessments and labels for bio-based products that will help facilitate their uptake in consumer markets and by green procurement. This promotes both the establishment of networks of integrated and diversified biorefineries, and demonstration and pilot plants across Europe. Finally, the Strategy promotes the development of science-based approaches that can better inform consumers about product properties (like environmental sustainability) and aid in the promotion of a healthy and sustainable lifestyle.

Five Commissioners have demonstrated their strong commitment to the bioeconomy by cosigning the Bioeconomy Strategy. However, its success will very much depend on the commitment of member states, regions, stakeholders in the research and innovation community and citizens - like you.

     

Maive Rute

Maive Rute was nominated Director for SME policy in the European Commission in 2005. The creation of the Small Business Act for Europe and the launch of the pan-European Enterprise Europe Network are considered the two main highlights of her term. During this period, she also led the Commission's Lisbon team for Estonia. In 2009, Rute took on the responsibilities of Director for Biotechnology, Agriculture and Food research in DG RT D, which also includes fisheries and forestry research.

23.04.2012 The increase in lifestyle and ageing-associated diseases that has paralleled a rise in drug development costs – along with the financial constraints of the global economy – is putting enormous pressure on the sustainability of healthcare systems.

Prof. Dr. Kurt Zatloukal, Medical University of Graz, Austria

These challenges can only be addressed by innovations for improved prevention and treatment of diseases that are based on scientific evidence. Biobanks are a key resource for delivering such solutions, as they provide access to human biological samples linked with detailed information on diseases and lifestyle. These resources are essential for a more mechanism-based understanding of diseases as a prerequisite for the further development of personalised medicine. After all, access to high-quality human samples is vital when it comes to supporting the development of molecular diagnostics, particularly companion diagnostics. Furthermore, to aid in better understanding gene-lifestyle interactions, large population-based cohort studies that contain information on lifestyle will help deliver a scientific basis for evidence-based disease prevention.

In order to address these needs, several European countries have made major investments in favour of biobanks. However, the challenges of providing sustainable healthcare are global rather than national issues. The need for action coordinated at the global scale is therefore obvious for many reasons. First, addressing the same problem in multiple non-coordinated approaches is neither efficient nor financially justified. Second, non-coordinated actions result in unnecessary duplication and – even worse – in non-compatible solutions that would undermine competitiveness in global biotech and the pharmaceutical industry.

The planning team of the European research infrastructure for biobanking and biomolecular resources (BBMRI) has developed the concept of a global network of expert centres to achieve global harmonisation in biobanking and bio­sample analysis. One rationale for the expert centres was to improve access to biobanks for industry and to avoid scenarios of sample commercialisation, which is illegal in Europe. Expert centres could be established as public-­private-partnerships that perform the analysis of biological samples using the latest technologies, and according to internationally harmonised procedures. Pre-competitive data generated in expert centres can be used by industry for product development, and will be made available to the public following procedures developed for the Innovative Medicines Initiative. Expert centres could also be established as public entities outside Europe to transform biological samples into high-quality data and information. This would avoid the need for transnational sample shipment in international research collaboration, thereby providing a new cooperation solution with countries that have legal restrictions on sample export. In addition, sample analysis in the country of origin would exert a strong positive stimulus on generating local know-how and regional development. However, such a global network of expert centres can only work if pre-analytical and analytical procedures are thoroughly standardised, and if expert centres share common reference material and regularly participate in proficiency testing. The first voluntary activities for testing the feasibility of the concept, with a focus on genomics, metabolomics and molecular pathology technologies, are currently in development.

Kurt Zatloukal

Kurt Zatloukal is Professor of Pathology at the Medical University of Graz, Austria. From 2008-2011 he coordinated the preparatory phase of the European research infrastructure for biobanking and biomolecular resources (BBMRI). Currently he is involved in several FP7 projects that focus on standardisation of molecular biosample analysis and is Director of the Christian Doppler Laboratory for biospecimen research and biobanking technologies.

03.05.2012 In the last 30 years, biotechnology has become a major source of innovation in combating untreated diseases and improving current treatments. A better understanding of the human genome rests at the heart of this incredible technological progress. With the dawn of personal medicine, we are also witnessing the dawn of a new era in medicine.

Marc de Garidel, President European Biopharmaceutical Enterprises, Brussels

The aim of personalised medicine is to improve prevention, diagnosis and treatment of diseases by using patients’ individual characteristics to identify the most appropriate care. The industry is using this knowledge to create medicines with more clearly defined molecular targets, and to profile these medicines more effectively during development and after market introduction using biomarker science. Personalised medicine promises to improve individual health. At the same time, it enables healthcare systems – especially here in Europe – to better allocate constrained healthcare budgets, thereby achieving savings in the delivery of medicines.

In the field of personalised medicine, diagnostic supporting technologies and devices are brought together with the disciplines underpinning medicinal product development. Implementing personalised medicine will therefore require a high degree of collaboration amongst the many stakeholders in the life science and medical sectors, to a point that has not been the norm in the past. These stakeholders include the research community, medicines and diagnostics manufacturers, regulators, health technology assessors, doctors and other health professionals (including health experts), and of course patient organisations and patients as a whole.

In this research area, sequencing the human genome has resulted in an avalanche of knowledge about the molecular biology of human health and diseases, leading to the many new ‘omics’ disciplines: genomics, proteomics, epigenomics, transcriptomics, metabolomics and metagenomics, to name just a few. Translating ‘omics’ from basic to clinical research can yield more innovative approaches for the prediction, prevention, treatment and cure of diseases. 

As new technologies emerge, there is a corresponding need for standardisation. The key challenge for the EU regulatory framework will be to allow as much flexibility as possible in order to ensure the rapid uptake of novel approaches and innovations, whilst at the same time ensuring the health and safety of the patient.

The introduction of personalised medicine to the point-of-care will affect the way healthcare is organised. One positive example: since its launch in May 2005, the French National Cancer Institute has been developing an increasing network of regional centres linked to healthcare institutions. These allow cancer patients to be rapidly diagnosed and identified for suitability to drug treatment, which has in turn lead to an overall reduction of costs of treatment.

Personalised medicine can bring significant benefits for patients, healthcare providers and healthcare authorities at the national level, but challenges across the innovation cycle – from basic research through to the uptake in the healthcare setting – still need to be overcome. Because of their nature, these challenges will need to be addressed at European, national, regional and local levels.

Personalised medicine is a promising challenge for Europe’s biotechnology industry, and EBE is proud to contribute to this new medical era.

Marc de Garidel

Marc de Garidel is the President of European Biopharmaceutical Enterprises, as well as Group Chairman and CEO at Ipsen and a member of its strategic committee. In the course of his career, he has also worked at Eli Lilly and Amgen, where he advanced to the post of VP for Southern Europe, MEA and Latin America. Marc de Garidel has also held teaching positions at the École Centrale de Paris and the ESSEC Business School since 2008, and has been named a «Chevalier de la Légion d’Honneur».

26.06.2012 Twenty-eight percent of the products given marketing authorisation between November 2010 and October 2011 in the US and one-third of all the new drugs in the EU have biotechnological origins. And experts unanimously agree that the market share of biotechnology products will continue to grow in the future. While the small-molecule drug market is predicted to expand by 3.9% annually between now and 2015, the market for biopharma products is expected to grow by more than 10% a year.

Erik Bogsch, Managing Director of Gedeon Richter and Chairman of the Hungarian Pharmaceutical Manufacturers Association Board

The trend is further bolstered by the fact that approximately one-third of current clinical development projects are of biotechnological origin. According to expert estimates, seven of the world’s top ten drugs will be of biotechnological origin by 2016. Based on the above, it can be firmly stated that biotech medicines are making a substantial contribution to the world’s healthcare system, including that of Eastern Europe.

The most appropriate way to ensure affordable biological medicines is the use of biosimilar versions of new biological entities after patent protection has run out. These products have a very similar biological profile – including efficacy, safety and tolerability – and they are, of course, cheaper. The EU was the first to introduce this type of regulatory pathway, but now several other countries, including the US and Japan, apply a regulatory approach that differs in only minor ways.

These forecasts and data unequivocally support Richter’s strategic decision to set up a biotechnology portfolio. Our aim is to create a complex and competitive biopharma line that will help expand the company’s portfolio with high added-value products, and we are making great progress in establishing the infrastructure supporting the development of biosimilar products. In 2007, Richter and Helm AG established a joint venture for the development and manufacture of microbial proteins. A biotechnology pilot plant with the capability to develop biosimilar versions of monoclonal antibodies went operational at our Budapest site in 2009. Most importantly, Richter’s new biotechnology plant in the Hungarian city of Debrecen was completed and officially inaugurated in April. The state-of-the-art €84m  facility will initially produce samples for clinical tests with the use of mammalian cells, and will begin to manufacture drugs for treating human diseases in 2014. The plant will later produce proteins and antibodies for fighting cancer and chronic inflammatory diseases.

The governments of nearly all CEE countries have recognised the high priority and important role of biotechnology among innovative technologies,  and some of them (including Hungary) have made it a vital part of economic development plans. In this respect, Richter’s strategic move was definitely in harmony with the intention of CEE countries and, in a wider context, the world itself. 

Exploring new areas is always a risky proposition. Still, I am confident that Richter’s forward-looking innovative spirit will help us achieve our goal: a biosimilar-enforced product portfolio that can help to improve quality  of life for even more patients, whether they live in Eastern Europe or anywhere else on the planet.

Erik Bogsch

Erik Bogsch is the Managing Director of Gedeon Richter Plc., a leading European specialty pharma company, as well as Chairman of the Board at the Hungarian Pharmaceutical Manufacturers Association. He holds a degree in chemical engineering and economic engineering. Bogsch began his career at Richter in 1970 in R&D managerial positions, and became CEO in 1992. He was fundamental in turning the firm into a major multinational company. His achievements and efforts to promote Hungarian innovation have been recognised with a number of awards. 

13.09.2012 During the last thirty years, healthcare expenditure has been growing much more rapidly than GDP in OECD countries, causing increasing concerns about the long-term sustainability of current trends. As we have seen with the global impact of the financial crisis, economic realities are moving faster than political ones.

Andrea Rappagliosi, Co-Chair EFPIA HTA Task Force, Sanofi Pasteur MSD, Lyon

The standards of healthcare that European citizens are provided with today risk becoming economically unsustainable, if the efficiency of healthcare systems is not factored in when assessing the value of prevention and treatment of diseases. Against this background, we need to look in more detail at the determinants of healthcare expenditure in the countries of Europe, explicitly taking into account aspects like the role of income, the effects of an ageing population, life habits, technological progress, and institutional and budgetary variables. 

When developing products and solutions for European patients today, the research-based pharmaceutical industry is responding to evi-dence--based requirements put in place by regulatory agencies – which request proof of efficacy, quality and safety – and 30+ Health Technology Assessment (HTA) agencies across Europe, which want proof of relative effectiveness. In the area of prevention, the vaccine industry has to provide dedicated evidence to public authorities, which in turn make recommendations prior to any public prevention programme. There is a potential for unnecessary duplication between these different requirements, as they are actually sourced from the same sets of data.

The need to secure timely, equitable and sustainable patient/citizen access to healthcare services has led to a growth in collaboration between HTA agencies recently, and this has been strongly supported by the European Commission. Industry believes there is room for this initiative, whilst simultaneously keeping regulatory and HTA processes separated and keeping pricing and reimbursement decisions fully at the national level. 

Of particular note is the collaboration between HTA agencies, which is supported by the European Commission and will be formalised in a permanent network as of next year. The current network (EUnetHTA) is working on developing methodological guidance for relative effectiveness assessment. Industry is supporting this approach, and is contributing to this discussion in order to feed in experience and know-how. Moving forward, industry would certainly favour increased collaboration between the regulatory world and the European collaboration on HTA, as this would ensure that evidence-based requirements receive the best scientific attention and are aligned across the range of decisionmakers, allowing for an ongoing dialogue between the parties. What is crucial is that consultation with stakeholders, including those in industry, is warranted. 

Today, the key challenge for governments is designing pluralistic systems of healthcare delivery and financing. In this area, a well-balanced mix of public and private financing would put market forces to work promoting investment and innovation, without imposing unsustainable burdens on public budgets or denying prevention and care to the disadvantaged population.


Andrea Rappagliosi

Andrea Rappagliosi is Vice President Market Access, Vaccine Advocacy & Medical Affairs at Sanofi Pasteur MSD, the only company in Europe totally dedicated to vaccines. During his career in both the public and the private sectors, he has focused on access issues that impact patients and healthcare systems in Europe. Rappagliosi is also VP of the European Vaccine Manufacturers Group and co-chair of the EFPIA HTA Task Force.

17.10.2012 Since the beginning of the year, there have been numerous government initiatives in the most advanced countries to implement and strengthen policies to support biotechnology.

Emilio Munoz, Chair of the ASEBIO Scientific Committee, and Regina Revilla, Chair of ASEBIO

The UK launched a strategy early this year to promote the life sciences through a framework agreement between the pharmaceutical and biomedical industries, universities and the NHS that is aimed at making research more efficient. Sweden also implemented a national strategy to produce an economy based on biotechnology and sustainable development. The US unveiled the ‘Fostering a Biobased Economy’ programme, while Europe is working on the ‘Innovating for Sustainable Growth: a Bioeconomy for Europe’, which focuses on applying innovation and biotechnology in such areas as agriculture and energy.

ASEBIO thinks that the Spanish Government should follow this lead. Biotechnology is a field of scientific endeavour in which Spain is already successful. That success is attributable to many factors: a long-established scientific community that has attained a very high standard in qualitative and quantitative terms; strategies and policies to foster biotechnology, promoting an appropriate linkage between science and business, which has made good – though insufficient – progress; appropriate cooperation between the public and private sectors (e.g. ASEBIO, SEBIOT, SEBBM); a successful move to internationalisation and competitiveness (e.g. BioSpain, Zeltia, Grifols, Oryzon, Progenika); and intelligent use of the diversity of niches that biotech offers.

Those factors make Spain a country to be reckoned with in working towards a sustainable bioeconomy, but the industry here needs regular funding, continuous support for links between the public and private sectors, and clear strategies towards internationalisation and competitiveness. There are a number of success stories among Spanish companies, firms with a wholehearted commitment to R&D and innovation. They want biotechnology to play a more prominent role in the transformation of society and the economic model, with a tax policy that fosters the development of biotech, more uniformity in autonomous region policies, and determined support from public and private funding. This will  not only facilitate the creation of technology start-ups, but also finance proofs-of-concept to enable companies to bring products to market.

The BioSpain 2012 event showcased our potential. It saw over 1,800 attendees (+20%), 762 companies (+9%), 217 exhibitors (+29%), an international presence amounting to 28% of the total, and a partnering section that hosted nearly 3,000 business development meetings (+29%).

The time has come for us to help Spain rise from the ashes of its beleaguered economy and expand, buoyed up by innovation. We have the flame, and the proposals to achieve it: promotion of public procurement of innovative technology, enhancing Spain’s presence in European projects, establishment of a stable framework and favourable tax treatment, determined support for entrepreneurs and innovative products, and encouragement for large industrial groups to get involved in this sector. We have the potential here and now to catalyse a recovery from the crisis. To that end, we offer our full support at any time to politicians and businessmen who are willing to listen, and who are receptive to a common project that can effectively produce growth.


Regina Revilla Pedreira

Regina Revilla Pedreira is the President of Asebio since July 2011. During her career, the Director of Policy and Communication at Merck, Sharp & Dohme (España) has been Pharmacy General Director in the Ministry of Health.

Emilio Munoz

Emilio Munoz is a member of the National Research Council of Spain (CSIC) and the President of ASEBIO’s Scientific Committee. He also has been the General Director for Science Policy in Spain and the General Secretary of the Spanish National Plan on R&D. He has been elected to the French Legion of Honour for his achievements. 

20.11.2012 Partnering and even open innovation is becoming increasingly important for our industry in a world where health systems are undergoing profound transformations.

Nigel Sheail, Head of Global Business Development & Licensing, Bayer HealthCare, Leverkusen

As the global population has grown above seven billion, emerging markets have become major markets. Mature markets around the world are aging. These factors and others are giving rise to greater medical need at a time when many health systems are reaching their financial limits. One key to addressing these challenges is innovation – both internal and external. 

In this context, partnering plays an important role. At Bayer HealthCare, we are committed to research & development in areas with high medical needs like oncology, cardiology, gynecological therapies, hematology and ophthalmology. Our partnering activities are also addressing both regional and local business needs, and we are constantly looking for new collaborations with academia, pharma and companies in the biotechnology field across all phases of the value chain to combine the innovative science of our partners with our drug discovery activities, our development experience and our marketing expertise worldwide. 

Today, we are well-positioned, with a strong portfolio of innovative products and an outstanding pipeline of new developments. However, to add more value for physicians and patients, our company is seeking to think beyond the scope of individual products and increasingly develop healthcare solutions. In the cardiovascular area, for example, such solutions could start with prevention, encompass diagnosis and treatment where disease does occur, and also protect against recurrence – a truly comprehensive approach to heart health. Following the idea of developing innovative solutions, as well as individual products, our business deve-
lopment organisation brings together colleagues from Pharmaceuticals, Consumer Care, Medical Care, and Animal Health divisions. 

One of the unexpected benefits of the tight financing environment over the last few years is that companies are forced to collaborate early on in the drug-discovery and development process. This may allow the next generation of molecules to benefit from ‘collaborative advantages’ – bringing together the science and experience of organizations for mutual benefit, and ultimately increasing the chance of developing new therapies that will have an impact. These days, more than 80% of Bayer HealthCare meetings at partnering conferences deal with pre-clinical opportunities. 

Our company is open to all types of collaborations, but prefers structures that allow both partners a seat at the table and real input to ensure the best decisions are made for the programs. We want to work with strong partners that thrive independently, and ideally will bring multiple opportunities to the table. We also recognize the need to meet the needs of investors who will need successful exits if they are to have confidence to reinvest in healthcare innovation

The growing importance of collaborations in our industry is also nicely reflected by the demand for, and increasing number of, partnering events worldwide. Events like the upcoming Bio-Europe offer excellent opportunities, both to catch up with companies we already know and to meet new companies or academic institutions at an early stage of their development. 

Nigel Sheail

Nigel Sheail, has been a member of the Bayer HealthCare Executive Committee and Head of Global Business Development & Licensing since November of 2011. The biologist (BSc, University of Edinburgh) began his professional career in the pharmaceuticals industry in 1990 at GlaxoSmithKline, before transferring to F.Hoffmann-La Roche Ltd. in 1993. There he held a variety of positions with increasing responsibility in both the firm’s finance and research organisations. Prior to joining Bayer HealthCare, Sheail was Head of Corporate Mergers & Acquisitions and Head of Global Pharma Licensing at F.Hoffmann-La Roche Ltd. in Basel.

21.12.2012 The revision of the EU Medical Devices Directives (MDD) could not have come at a more critical moment. The recent PIP breast implant incident has made it crystal clear that healthcare actors must pull together to ensure similar cases of fraud never happen again.

Serge Bernasconi, Chief Executive Officer, Eucomed, Brussels

We believe Europe needs a clear, predictable and effective regulatory system that deserves patient trust – a system that provides them with safe and timely access to the latest innovative technologies. The European Commission has tabled a proposal, and we welcome the majority of their recommended measures. They improve patient safety, do not unnecessarily delay patient access to life-saving medical technologies and do not hamper innovation. The proposal is on the right track in several key areas, and we applaud the Commission’s calls for improving notified bodies, increasing EU Member State coordination on vigilance and establishing a central registration database that can be accessed by governments and patients alike.

But as we work together towards an improved system, we must remember that the current decentralised notified body system has provided a high level of safety, and consistently granted people in Europe the very fastest access to life-saving medical technologies.

We are convinced that, with the support of a regulatory framework that successfully marries safety and the availability of new technologies, we can remain in this privileged situation in Europe. The Commission’s proposed “scrutiny procedure”, however, represents a step in the wrong direction. When considering changes to the EU regulatory framework, we must strive to answer three questions:

1. Will the changes improve safety for patients?

2. Will they allow life-saving medical technologies to be made available to people in Europe just as fast as they do today?

3. Will they encourage the innovation that European healthcare systems urgently need to become more efficient?

In the case of the scrutiny procedure, we believe the answer to all three of these questions is “no”, and therefore strongly oppose the proposed measure. The procedure will fundamentally change the current system, but will not lead to the desired outcome: increased safety for patients. It would address some calls to move towards a centralised, pharmaceuticals-like system, but will ultimately harm European patients and negatively impact European small and medium sized enterprises (SMEs). Recent independent research has shown that systems like these (similar to that at the US FDA) delay patient access to new technologies by 3 to 5 years without delivering additional safety.

Europe needs a decentralised system that is specific to medical devices if it is to maintain safe and timely patient access to technologies, and keep Europe’s medical technology “innovation engine” running.

We are committed to providing medical technologies that improve people’s lives and that are at the same time cost-effective. Europe has become a leader in healthcare innovation, and now more than ever it needs to cope with increased pressure on national healthcare budgets. The current regulatory framework has provided a high level of safety for patients in Europe without delaying access to life-saving medical technologies. Let’s not unnecessarily drive Europe’s strong innovation and research capabilities to other continents at a time when they are urgently needed here.  

Serge Bernasconi

Serge Bernasconi, currently the Chief Executive Officer of Eucomed – the European Medical Technology Industry Association – has more than 30 years of experience in the worlds of pharmaceuticals and medical devices at companies such as Johnson & Johnson, Schering Plough in the US and Europe, and more recently Medtronic. In his capacity as President & International Regional Vice President of Medtronic France, Bernasconi was elected President of APIDIM (The French Association for the Promotion of Innovation in Medical Devices), and Vice President and Treasurer of SNITEM (French Medical Technology Industry Association).

21.02.2013 In an era when Member States are doing their utmost to limit national exposure in the EU budget, making the right choices has become more crucial than ever before to shaping Europe’s future.

Derrick Williams, European Biotechnology Network, Brussels

The problem with the current tenuous economic situation is that research-driven sectors like biotechnology need reliable support. Without it, they will be unable to deliver jobs and growth in the global markets of the future – among them biological production, personalized medicine and health-enhancing nutrition. To remain at the forefront of these fields and employ funds effectively, Europe has to foster even more collaboration, while at the same time putting frameworks in place to prevent research projects from being being carried out more than once.  Both Big Pharma and global agribiotech players have to fully implement biotechnological platform technologies in product development. To improve their products, global industry leaders – like BASF in chemistry, for example, or Nestlé in nutrition – increasingly rely on biotechnologies invented by academic groups and perfected by life sciences SMEs. While this biologisation of industry is moving forward at a global scale, continuous support for collaboration is essential to ensure that innovations continue to flow steadily in both directions. In the past, Europe has supported R&D collaboration with significant amounts of funding (Framework Programmes) as well as through the creation of European research infrastructures provided by the the European Strategy Forum on Research Infrastructures (ESFRI). One example is the EU biobanking resource BBMRI, which is aimed at pooling data from local biobanks in Europe and harnessing it for drug target and biomarker discovery. This lays the foundation for personalised medicine and therapies that target diseases where they need to be battled – at their roots. Better collaboration and data standardization are key to squeezing the greatest possible gain from pooled resources. That rule of thumb is also true for other collaborative EU projects that generate huge datasets for the research community. To ensure that public funds are invested well, one fairly simple step would be to make collaboration and standardization of research outcomes – i.e. by means of ring tests – a prerequisite for EU funding. This would help improve comparability in research results, and prevent duplication in research projects. The only way to guarantee the high-quality results that future markets will demand is through collaboration and networking in the 27 Member States of the European Union, Switzerland and Norway. Only through collaboration among all the stakeholders in the value chain can we set the common standards necessary to take full advantage of vast projects, like searching cancer patient genomes for new targets and diagnostic biomarkers. Realizing European synergies can only happen, however, if potential partners are aware of one another. EU science, research and industry has yet to make really good use of the advantages provided by a common market, when these could be helping to drive even faster technology transfer and even more flexible labour. And at the end of the day, establishing a truly sustainable future through biologisation will never be achieved without even more political commitment.

 

Derrick Williams

Derrick Williams is the head of communications at the European Biotechnology Network in Brussels. A biologist, the US native is a science correspondent and media professional who has worked in Europe since 1996. Williams is a journalist and PR professional in a variety of different formats, including both broadcast media and print. His productions, TV reports and articles generally focus on helping the wider public better understand biotech and life sciences topics. 

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No liability assumed, Date: 21.09.2014


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