Biotechnology and the UK 2000-05: Globalization and innovation

This paper discusses some selected topics seen as being most important in currently affecting the development of biotechnology in the UK. The importance of demand side factors such as the role of professional experts, regulatory bodies, retailers, public opinion and political activity in stimulating or discouraging innovation in biotechnology is discussed. Supply side factors are then analysed, particularly the major changes in the organizations which generate biotechnology innovations - especially collaborative alliances and network firms, and the restructuring of the chemical, pharmaceutical and agro-food industries which use biotechnology, via merger, acquisition, demerger and divestment. Two important aspects of the infrastructure for innovation, which are rapidly changing and generating debate and concern, are then considered. These are intellectual property regimes on the one hand, and corporate governance and the sources of finance for investment on the other. The issue of globalization of innovative activity in biotechnology and in the industries which use it is addressed next, and it is concluded that collaborative alliances are the main mechanism by which overseas sourcing of technology is taking place. Finally, future trends and some policy implications are considered.     

Regulatory requirements for licensing medicinal products of biotechnology

The recent and rapidly developing application of biotechnology which leads to the discovery of new therapeutic substances has raised a new set of safety issues for consideration by industry and regulatory bodies. The experience which already exists in the assessment of the safety and quality of biological products can contribute significantly to the approaches which are evolving with this new range of products. Industry and regulatory bodies should both resist the temptation to introduce testing programmes and requirements without a sound scientific rationale. This paper reviews some of the issues which should be considered when embarking on the safety evaluation of products derived from biotechnology.     

The triad of success in personalised medicine: pharmacogenomics, biotechnology and regulatory issues from a Central European perspective

The population of the world has recently passed the 7 billion milestone and as the cost of human genome sequencing is rapidly declining, sequence data of billions of people should be accessible much sooner than anyone would have predicted 10years ago. This will form the basis of personalised medicine. However it is still not clear, even in principle, whether these data, combined with data of the expression of one's genome in various cells and tissues relevant to different diseases, could be used effectively in clinical medicine and healthcare, or in predicting responses to different therapies. Therefore this is an important issue which needs to be addressed before more resources are wasted on less than informative studies and surveys simply because technologies exist. As a typical example, we have selected and summarise here key studies from the biomedical literature that focus on gene expression profiling of the response to biologic therapies in peripheral blood and biopsy samples in autoimmune diseases such as rheumatoid arthritis, spondylarthropathy, inflammatory bowel diseases and psoriasis. We also present the state of the biotechnology market from a European perspective, discuss how spin-offs leverage the power of genomic technologies and describe how they might contribute to personalised medicine. As ethical, legal and social issues are essential in the area of genomics, we analysed these aspects and present here the European situation with a special focus on Hungary. We propose that the synergy of these three issues: pharmacogenomics, biotechnology and regulatory issues should be considered a triad necessary to succeed in personalised medicine.     

The legacy of nuclear risk and the founder effect in biotechnology organizations

In the wake of the Chernobyl nuclear accident and a decline in the public trust of science, the founders of modern biotechnology recognized the strategic importance of risk assessment and regulatory affairs. In an effort to avoid the demonization that was attached to the nuclear industry, the pioneers of modern biotechnology delegated authority for regulatory negotiation and risk management to senior positions in the firm. At the same time, the Biotechnology Industry Organization was handed great latitude and trust with making public pronouncements on issues of bioethics and public policy. The way in which founders and leaders embed norms for negotiating regulation and responding to public perceptions has proved important in the maturation and acceptance of a biotechnology sector.     

Next issue (September 2007): Talking Biotech with the Public – including a special FREE podcast!

Edited by Dr. Kristina Sinemus, Darmstadt, Germany Highlight articles: – Public perceptions of biotechnology – Future societal issues in industrial biotechnology – The co-existence debate in Europe – The Co-Extra website – Bioethics, GM crops and intellectual property – Patent scenarios for the future – Experiences in implementation of biosafety systems – Transparent communication strategy on GMOs – Options for a rational dialogue on the acceptance of biotechnology – Attitudes that predict acceptance of genetic engineering in Australia – Biotechnology: the language of multiple views in Maori communities – Science – or not? The scientific status of biotechnology ... and much more: Read the next issue of BTJ!     

Economic issues for the UK biotechnology sector

This paper examines the economic prospects for the biotechnology industry, focusing on the UK position. I discuss some economic issues relating to the structure of the biotechnology industry and examine whether these factors can account for the relative success of the biotechnology sector in the UK compared to other European countries. I emphasize the importance of the science base, pharmaceutical companies and capital markets in giving the UK an advantage. Looking ahead I argue that prospects are good for the global growth of the industry due to supply and demand side factors. The UK is in a leading position in Europe but faces significant dangers, especially from the public towards biotechnology.     

European attitudes on the regulation of modern biotechnology and their consequences

Modern biotechnology has gradually attracted ever greater interest over the past four decades, from ever-widening communities across the world--from academic scientists, of course, and then from industrialists, journalists, medical specialists, agricultural practitioners, environmental "experts," economists, trading companies--and, so far as it concerns regulation, above all from political interests whose product is indeed legislation. As the interests widened, conflicts developed: between departments, between sectors, between countries and between international agencies. The European Community made choices, bitterly contested; the battles on conducting and regulating the field release of GMOs (genetically modified organisms) were usually won--at least in Europe--by the environment ministries, often in conflict with agriculture and/or the research and science ministries. The result has been the construction over the past 30 y of an ever heavier regulatory burden on those who seek to develop and launch products based on the use of modern biotechnology. The pretense is labeled "the precautionary principle." No lives have been saved, but many jobs have been created in bureaucracies large and small around the world. So far as academia was concerned, their experiments and field trials were repeatedly wrecked by NGOs (non-governmental organizations) claiming thus to have saved mankind and the environment. This is a story of grave political failure in Europe with globally adverse consequences.     

Environmental protection: applying the precautionary principle and proactive regulation to biotechnology

Biotechnology is a broad field encompassing diverse disciplines from agriculture to zoology. Advances in research are occurring at a rapid pace, and applications that have broad implications socially, economically, ecologically and politically are emerging. Along with notable benefits, environmental consequences that affect core quality-of-life issues for present and future generations are materializing. The precautionary principle should be applied to biotechnology research, activities and products, and a strengthened, enforceable and proactive regulatory framework is needed. The environmental impacts of agriculture, aquaculture, genetically modified organisms (GMOs) and even pharmaceuticals are raising public concerns and demonstrate the need for guidance from a variety of social, economic and scientific disciplines to insure the benefits of biotechnology are enjoyed without unacceptable and irreversible environmental costs.     

Improving the politics of biotechnological innovations in food security and other sustainable development goals

The unwarranted interference of some environmental non-governmental organisations (ENGOs) in decision-making over genetically modified (GM) crops has prompted calls for politics to be removed from the regulatory governance of these products. However, regulatory systems are inevitably political because their purpose is to decide whether the use of particular products will help or hinder the delivery of public policy objectives. ENGOs are most able to interfere in regulatory decision-making when policy objectives and decision-making criteria are vague, making the process vulnerable to disruption by organisations that have a distinct agenda. Making regulatory decision-making about GM crops and other green biotechnology more resistant to interference therefore requires better politics not the removal of politics. Better politics begins with political leadership making a case for green biotechnology in achieving food security and other sustainable development goals. Such a policy must involve making political choices and cannot be outsourced to science. Other aspects of better politics include regulatory reform to set policy aims and decision-making criteria that encourage innovation as well as control risk, and engagement with civil society that discusses the values behind attitudes to the application of green biotechnology. In short, green biotechnology for sustainable development needs better politics to counter well-organised opposition, to encourage innovation, and to build the trust of civil society for these policies. Removing politics from regulatory governance would be a gift to ENGOs that are opposed to the use of biotechnology.

     

Preclinical development of monoclonal antibodies

The development of mAbs remains high on the therapeutic agenda for the majority of pharmaceutical and biotechnology companies. Often, the only relevant species for preclinical safety assessment of mAbs are non-human primates (NHPs), and this raises important scientific, ethical and economic issues. To investigate evidence-based opportunities to minimize the use of NHPs, an expert working group with representatives from leading pharmaceutical and biotechnology companies, contract research organizations and institutes from Europe and the USA, has shared and analyzed data on mAbs for a range of therapeutic areas. This information has been applied to hypothetical examples to recommend scientifically appropriate development pathways and study designs for a variety of potential mAbs. The addendum of ICHS6 provides a timely opportunity for the scientific and regulatory community to embrace strategies which minimize primate use and increase efficiency of mAb development.     

Cover Picture: Biotechnology Journal 3/2014

This “regular” issue of Biotechnology Journal gathers the state‐of‐the‐art in biotechnology, including articles on CHO cells, plant biotechnology and tissue engineering. The cover image shows immunohistochemical staining of tissue sections using antibodies recognizing different target proteins (www.proteinatlas.org) and is provided by Sophia Hober et al., authors of “Antibody performance in western blot applications is context‐dependent” (http://dx.doi.org/10.1002/biot.201300341)     

Genomics: shifts in metaphorical landscape between 2000 and 2003

Modern biotechnology has been characterized by being surrounded by scientific and public debate and by interest conflicts. An early Danish debate and regulation has been criticized for inhibiting or retarding development and thus growth. Though much regulation and debate have been transferred to the European arena, their role and extension are still an issue. In this paper, the often anticipated innovation-inhibiting effects of regulation are questioned by giving an account of regulations and debates in Denmark. An account which includes the shifting positions of industry, the research community, environmental groups, regulators and other interest groups. The paper indicates that the regulatory measures, introduced as a response to public and interest group critique, have generally reduced industrial uncertainty and promoted industrial Danish biotechnology development. It is further found that regulation and debate changed the rate and direction of new biotechnology development, contributing to technology acceptance, without however ensuring it. The paper thus questions the caricatured assumptions in economics and industrial policy that regulation restrict techno-economic growth. The paper further states regulation and controversies to have contributed actively to the specific technology development, but also states the difficulties in setting radically different technology development agendas.     

A bias-ed assessment of the use of SNPs in human complex traits

Although many biotechnological advancements have been made in the past decade, there has been very limited success in unraveling the genetic component of complex traits. Heavily invested research has been initiated based on etiological models of unrealistic simplicity and conducted under poor experimental designs, on data sets of insufficient size, leading to an overestimation of the effect sizes of genetic variants and the quantity and quality of linkage disequilibrium (LD). Arguments about whether families or unrelated individuals provide more power for gene mapping have been erroneously debated as issues of whether linkage or LD are more detectable sorts of correlation. Although the latter issue may be subject to debate, there is no doubt that family-based analysis is more powerful for detecting linkage and/or LD. If the recent advances in biotechnology are to be exploited effectively, vastly improved study designs will be imperative, as the reasons for the lack of success to date have much more to do with biology than technology, an issue that has become increasingly clear with the findings of the past years.     

Preclinical development of monoclonal antibodies: Considerations for the use of non-human primates

The development of mAbs remains high on the therapeutic agenda for the majority of pharmaceutical and biotechnology companies. Often, the only relevant species for preclinical safety assessment of mAbs are non-human primates (NHPs), and this raises important scientific, ethical and economic issues. To investigate evidence-based opportunities to minimize the use of NHPs, an expert working group with representatives from leading pharmaceutical and biotechnology companies, contract research organizations and institutes from Europe and the USA, has shared and analyzed data on mAbs for a range of therapeutic areas. This information has been applied to hypothetical examples to recommend scientifically appropriate development pathways and study designs for a variety of potential mAbs. The addendum of ICHS6 provides a timely opportunity for the scientific and regulatory community to embrace strategies which minimize primate use and increase efficiency of mAb development.Key words: mAb, non-human primate, species selection, ICHS6, homologous protein, preclinical, toxicology studies, potency, relevance     

World Antibody-Drug Conjugate Summit,October 15–16, 2013, San Francisco,CA

The World Antibody-Drug Conjugate (WADC) Summits organized by Hanson Wade are currently the largest meetings fully dedicated to ADCs. The first global ADC Summit was organized in Boston in October 2010. Since 2011, two WADC are held every year in Frankfurt and San Francisco, respectively. The 2013 WADC San Francisco event was structured around plenary sessions with keynote speakers from AbbVie, Agensys, ImmunoGen, Immunomedics, Genentech, Pfizer and Seattle Genetics. Parallel tracks were also organized addressing ADC discovery, development and optimization of chemistry, manufacturing and control (CMC) issues. Discovery and process scientists, regulatory experts (US Food and Drug Administration), academics and clinicians were present, including representatives from biotechnology firms (Concortis, CytomX Therapeutics, Glykos, Evonik, Igenica, Innate Pharma, Mersana Therapeutics, Polytherics, Quanta Biodesign, Redwood Bioscience, Sutro Biopharma, SynAffix), pharmaceutical companies (Amgen, Genmab, Johnson and Johnson, MedImmune, Novartis, Progenics, Takeda) and contract research or manufacturing organizations (Baxter, Bayer, BSP Pharmaceuticals, Fujifilm/Diosynth, Lonza, Pierre Fabre Contract Manufacturing, Piramal, SAFC, SafeBridge).     

World Antibody-Drug Conjugate Summit,October 15–16, 2013, San Francisco,CA

The World Antibody-Drug Conjugate (WADC) Summits organized by Hanson Wade are currently the largest meetings fully dedicated to ADCs. The first global ADC Summit was organized in Boston in October 2010. Since 2011, two WADC are held every year in Frankfurt and San Francisco, respectively. The 2013 WADC San Francisco event was structured around plenary sessions with keynote speakers from AbbVie, Agensys, ImmunoGen, Immunomedics, Genentech, Pfizer and Seattle Genetics. Parallel tracks were also organized addressing ADC discovery, development and optimization of chemistry, manufacturing and control (CMC) issues. Discovery and process scientists, regulatory experts (US Food and Drug Administration), academics and clinicians were present, including representatives from biotechnology firms (Concortis, CytomX Therapeutics, Glykos, Evonik, Igenica, Innate Pharma, Mersana Therapeutics, Polytherics, Quanta Biodesign, Redwood Bioscience, Sutro Biopharma, SynAffix), pharmaceutical companies (Amgen, Genmab, Johnson and Johnson, MedImmune, Novartis, Progenics, Takeda) and contract research or manufacturing organizations (Baxter, Bayer, BSP Pharmaceuticals, Fujifilm/Diosynth, Lonza, Pierre Fabre Contract Manufacturing, Piramal, SAFC, SafeBridge).     

Assessment of Field Reentry Exposure to Pesticides: Limitations,Uncertainties, and Alternatives

There are many complex scientific as well as regulatory issues associated with the assessment of field reentry exposure to pesticides. These issues largely come from the limitations and uncertainties inherent in the simplified algorithm that many regulatory agencies use to estimate the reentry exposure. The main objective of this Perspective Article is to bring out these issues systematically in an open forum for further consideration by the exposure assessment community. Accordingly, in this Perspective Article, the simplified algorithm is elaborated first to provide a basic understanding for the complex issues involved. Both the limitations and the uncertainties revolving around this algorithm's real-time application are then discussed extensively, including those specific to monitoring dermal residues in a study trial, measuring dislodgeable foliar residues, and dealing with dislodgeability as well as transferability of foliar residues. The discussion ends by proposing a more practical alternative to the current assessment approach.     

Asian Federation of Biotechnology (AFOB)

Cover illustration: This issue is the first official special issue of Biotechnology Journal with the Asian Federation of Biotechnology (AFOB). In the cover, we use the grain as a symbol and analogy for biotechnology, as both the grain and biotechnology are common and uniting factors that link the member countries of the AFOB. Gran image credit: © Myimagine– Fotolia.com.     

Cover Picture: Biotechnology Journal 5/2016

This regular issue of BTJ includes articles on biocatalysis, biomaterials, and industrial biotechnology. The cover picture shows several aspects of bacteriophage therapy, including phages adsorbing to bacterial cell surfaces, commercial preparations Pyo‐ and Intesi‐phages that are currently produced and used in Georgia, and administration of phages by medical staff to a patient. Image is provided by Aleksandre Ujmajuridze, Jon Caplin, Nino Chanishvili, and Aidan Coffey authors of ”Silk route to the acceptance and re‐implementation of bacteriophage therapy“ ( http://dx.doi.org/10.1002/biot.201600023 ).