Recent US patent legislation: what's new for biotech?

New reforms bring US law closer in line with those of other major countries.     

Can biotech deliver new antibiotics?

The evolution of support for the discovery and development of antibacterial (or antibiotic) agents from the larger pharmaceutical companies to the entrepreneur-like small biotechnology companies has been an experiment in the making for the past 15 years. The word 'experiment' is precisely chosen as the outcome is not certain. Many of the antibiotic biotech organizations that were most likely to undertake the task of picking up where large pharmaceutical companies left off have failed to survive, despite their use of outstanding science and their novel approaches to the development of discovery platforms. So this leaves one with the question of 'can biotech deliver the new antibiotics?'.     

Implementing quality by design for biotech products: Are regulators on track?

Quality by design (QbD) is an innovative approach to drug development that has started to be implemented into the regulatory framework, but currently mainly for chemical drugs. The recent marketing authorization of the first monoclonal antibody developed using extensive QbD concepts in the European Union paves the way for future further regulatory approvals of complex products employing this cutting-edge technological concept. In this paper, we report and comment on insights and lessons learnt from the non-public discussions in the European Medicines Agency''s Biologicals Working Party and Committee for Medicinal Products for Human Use on the key issues during evaluation related to the implementation of an extensive QbD approach for biotechnology-derived medicinal products. Sharing these insights could prove useful for future developments in QbD for biotech products in general and monoclonal antibodies in particular.     

Will genomics guide a greener forest biotech?

Forest biotechnology has been increasingly associated with wood production using plantation forestry, and has stressed applications that use pedigreed material and transgenic trees. Reasons for this emphasis include limitations of available technologies to conform to underlying genetic features of undomesticated forest tree populations. More recently, genomic technologies have rapidly begun to expand the scope of forest biotechnology. Genomic technologies are well suited to describe and make use of the abundant genetic variation present in undomesticated forest tree populations. Genomics thus enables new research and applications for conservation and management of natural forests, and is a primary technological driver for new research addressing the use of forests trees for carbon sequestration, biofuels feedstocks, and other 'green' applications.     

The biotech equipment and supplies sector in Europe-is it European?

Socio-economic research on biotechnology is dealing mainly with the sectors of biopharmaceuticals, agro-food or environmental technologies. In contrast, the equipment and supplies sector seems to be largely ignored. This is surprising because this sector provides important input in terms of technology and material for the development of biotechnology in general. Our comparative analysis of the sector in eight countries indicates that there exists no specific science base for the sector and that it is largely neglected by public research funding. Commercial activities are concentrated in countries with a large general science base in biotechnology and strong multinational pharmaceutical or chemical companies. There is a rather broad diversity in the way the sector has developed in the eight countries. Our data support the notion that national peculiarities seem dominant for explaining this picture. We anticipate growing business opportunities for European firms to step into large markets of equipment and supplies for functional genomics and protein analyses where Europe maintains a strong science base.