JCB, Volume 11, Number 1, 2004 Editorial Vol.11 No. 1 (2004) Editorial: Are clinical trial authorisations truly being harmonised? Linda R Horton   Article Vol.11 No. 1 (2004) Bioentrepreneurship in Japan: Institutional transformation and the growth of bioventures Michael J Lynskey Until recently, Japan had relatively few biotechnology start-up firms and they did not play a significant role in the commercialisation of university research results. Article Vol.11 No. 1 (2004) Changes to the European Union pharmaceutical legislation: Implications of the 'Pharma Review' for biotechnology companies Erkki Liikanen A global revision of the European regulatory framework for medicinal products, the 'Pharma Review', has recently been adopted by the European Institutions. This is an i Article Vol.11 No. 1 (2004) A brave new Europe with the introduction of the EU Clinical Trials Directive: Impact upon the pharma industry and academic research with special emphasis on pharmacovigilance Graeme Ladds 1st May, 2004, saw the national implementation of the EU Clinical Trials Directive (2001/20 EEC). Additionally, Europe changed from 15 to 25 member states, all implemen Article Vol.11 No. 1 (2004) Interference basics Thomas J Kowalski A US patent is a prized form of intellectual property, and the first to invent the claimed subject matter is awarded the patent right. When two or more parties, however Article Vol.11 No. 1 (2004) Where will industry go to for its high-calibre staff? Faiz Kermani The presence of individuals who can effectively and intelligently communicate ideas and results will help to influence the overall performance and success of a company. Article Vol.11 No. 1 (2004) Cross-border transactions: A roadmap for commercial arrangements between North American and European companies Raymond S Fersko Major advances and breakthroughs in the biotechnology industry are increasingly reached through cross-Atlantic strategic alliances and collaborations. This paper explor Article Vol.11 No. 1 (2004) Biotech blockbuster forecasts to 2008 Alex K Pavlou Datamonitor analysis recognises 18 biological brands that are expected to drive sales within the biopharma sector. The group includes 12 recombinant DNA proteins and si Legal and Regulatory Updates Vol.11 No. 1 (2004) Regulatory data protection for medicines John Wilkinson Pending the coming into force in November 2005 of the changes to the regulatory data protection regime under European Medicines Legislation to be effected under the 'Fu Legal and Regulatory Updates Vol.11 No. 1 (2004) Financial accounts reports Colin Aaronson Cambridge Antibody Technology plc (CAT) has established itself as a leader in the development of human monoclonal antibodies as new treatments for disease, based upon i