Austria is a rich resource for biotech and medtech, enabling technologies and special service providers backed by world-class engineering and science. In recent years, the Austrian scene has been a hive of business development activity. Sonja Polan, International Marketing Manager at Life Science Austria, takes us on a tour of Austria’s wealth of innovative potential and the bright future ahead for the Austrian life science industry.
Steve Poile, the founder and chief executive officer of Wildwood Ventures Ltd explains in this article that personalised medicine has recently grown in importance as drug companies and regulators alike come to terms with optimising resources on the right interventions for responsive patients, as well as improving early diagnosis of those patients susceptible to certain diseases before they become manifest.
The change to e-publishing has brought about many challenges for regulatory affairs professionals. Conventionally, the end result was the focus of consideration – the electronic submission, and therefore the capability of a company to submit electronically. But e-publishing is much more. As an end-to-end process, it defines the critical capability a company needs to create and fine-tune.
The move towards e-publishing has come in waves, and went hand in hand with the advancements in technology and the evolution of standards. Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group, expands further in this article.
Dr William C. Maier and Dr Carl de Moor of Registrat-Mapi explain that the last decade has witnessed an increase in the power of national regulatory authorities to require explicit programmes to control and mitigate risks related to the use of new and existing drugs. The impact on the pharmaceutical industry is substantial, because these new laws and regulatory powers will require a significant change in the way drugs are developed and supporting research is done prior to the filing of new drugs. This detailed article concludes that this new era of risk control and accountability requires that companies obtain evidence of the likely effectiveness of their proposed risk control programmes prior to the submission of an application for drug marketing.
Innovation is the key word for the life sciences and biotechnology sector. Flanders has a long and successful tradition of discovery and innovation. Some of the major scientific breakthroughs achieved there include the first unravelling of the DNA sequence of a gene, the discovery of tPA, a major treatment for heart failure, and the discovery of treatments for schizophrenia, pain management, gastro-intestinal disorders and parasitic infections.
Clinical trials have gone global. According to the National Institutes of Health, a division of the US Department of Health and Human Services, there are currently more than 58,000 trials taking place in more than 150 countries. In addition, clinical trials have been moving from Europe and the United States to emerging markets such as India, China, Vietnam, and South America.
In order to obtain a patent it is necessary to show that your invention is novel and inventive. One aspect of this is that the invention should make a contribution to the relevant field of research. As a result, when a patent application is filed it ought to contain data, usually in the form of experimental results, to convince the patent office that this is the case.
Where to start? The recession of course! In 2009 the pharmaceutical industry was affected just the same as everyone else by the economic downturn. Biotechnology companies found their funding being withdrawn or just not being there in the first place, large pharma suffered from drug pipelines drying up, and the related services industries found it difficult to win work, with their margins being squeezed hard by clients who found themselves in a very strong bargaining position.
Although intellectual property (IP) is regarded by many as an intangible asset for some companies, especially those in the life science arena, it can be the company’s sole or primary asset. Intellectual property includes patents, trademarks, service marks, copyrights, and trade secrets. Like any other asset, IP can be bought and sold as a part of everyday commerce. Even though IP is frequently traded, the valuation of IP does attract some scepticism due to doubt as to whether the value can be measured reliably.
14 March 2012 Recipharm and ViroPharma today signed a commercial contract to initiate supply of Plenadren® for named patient use.…