Investment in start-up biotech. companies outside the USA has essentially disappeared. VC investment in biotechnology and healthcare as a whole has nearly returned to pre-2008 levels, but almost all is in later stage opportunities. But companies continue to be founded, and continue to flourish. We examine the VC investment patterns for the past 7 years, and show that a start-up today can expect little VC support. We show from companies’ financial records that companies are adopting financial models based on angel investment, grants and revenue, and moving away from business models that need substantial investment. There is a time lag, but government and research council policy is beginning to recognize and align with the new investment realities. We believe this trend will accelerate as internet-mediated angel investing, such as crowd-funding schemes seen in other sectors, become a developing force in the next decade.

According to the World Intellectual Property Organization, nearly 100,000 pharmaceutical and biotechnology patent applications are filed each year around the world, and the trend is increasing. These companies have very little room for error in the work they conduct each day. As a result, the translations of these patent applications need to be completely accurate, which requires a translation service provider who follows best practices. These best practices include centralized processes, highly specialized teams, quality control, terminology management and advanced technologies.

By following them, they will ultimately reduce office actions and litigation risks, as well as decrease time to grant. 

This case study will highlight how a large biotechnology company worked with their translation service provider to develop a series of best practices for the translations of their intellectual property, focused primarily on their patent applications. Readers will come away with an understanding of how their multinational enterprises can leverage these best practices to get improved quality, reduced time to grant and more filings for the budget.

 

This paper offers some insights on the European regulatory situation with respect to raw materials used in production of gene, cell and tissue therapy products, including advanced therapy medicinal products. By focusing on the existing EU and French rules, the purpose of this paper is to review the content and scope of the measures restricting their placing on the market and/or use, the legal implications and hence key challenges ahead. Also known under the specific term ‘ancillary products’ in France, raw materials are subject to a fragmented regulatory environment that could indirectly hinder innovation in this rapidly evolving area. Taking account of contamination risk that could originate from such materials, the question as to whether it is necessary to assure their quality and safety by means of one or various regulatory instrument(s) does not arise. Nevertheless, it is vital that, in a sector as innovative as this one, an appropriate and more predictable regulatory regime applies in Europe, which requires undertaking a constructive work aimed at harmonising the rules in relation to production of and trade in raw materials intended to be used for advanced therapies while ensuring the EU objective of public health protection: a work already in progress.