Journal of Commercial Biotechnology Vol 19, Issue 1 (2013)

Journal of Commercial Biotechnology Biotechnology Entrepreneurship BootcampThe other side of innovation
Peter J. Pitts
Government sponsored comparative effectiveness research is the first step towards allowing Uncle Sam to push a restrictive formulary on more and more Americans – with step one in the process being unfettered (and unregulated) communications efforts. Unless we are aware and vigilant, such cost-think may very well lead to a single-payer system referred to in cost-think as “universal coverage” – but in reality will be nothing short of healthcare rationing…
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Fixing a broken drug development process
John Holland
It costs about $1.2 billion to bring a single new drug to market in the U.S. today. With a combination of high late-stage failure rates and the high cost of drug trials, the number of new drugs being approved by the FDA has flat-lined at historically low levels, falling from 53 in 1996 to just 19 in 2009…
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Biotechnology valuation and governance: Drug development and board of directors composition
Chad Houston, J. Edward Graham, Peter Schuhmann
This paper examines the valuation of biotechnology firms and measure firm value relative to the firms’ drug development pipelines, alliances with other firms, and the varied composition of those firms’ boards of directors.  Unsurprisingly, the advancement of drugs in the pipeline is associated with increased valuation, and the failure of drugs in testing is found to have negative impacts…
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China’s heparin revisited: What went wrong and has anything changed?
Clifford S Mintz, John Liu
China is the world’s largest producer of crude heparin. In 2007, tainted Chinese crude heparin made its way into the global finished heparin supply chain killing 149 persons in 11 different countries including 81 deaths in the US. While China never formally admitted that it was the source of the tainted heparin, US and European regulatory officials determined that adulterated crude heparin was intentionally introduced (for economic gain) into the Chinese heparin supply and subsequently shipped to other countries for final pharmaceutical formulation…
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A snapshot of the successful bio-clusters around the world: Lessons for South African biotechnology
Nirvana S. Pillay, Ramazan Uctu
Development of clusters has been one of the critical factors in the success of many countries in the field of biotechnology. Most of the literature has been focused on the biotechnology clusters in developed countries and much less attention has been paid to the development of biotechnology clusters in developing countries…
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Use of medicines for carved out indications – Time for a change in approach?
Brian Cordery
All stake-holders in the pharmaceutical industry recognise that valuable new medicines can be obtained from investing in the research and development of new uses for existing drugs.  The present system of awarding second medical use patents to originators which develop new and inventive medicines from known drugs does not provide sufficient incentive to this part of the industry…
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Improving IPO market still not an exit path
G. Steven Burrill
Recent suggestions that improving IPO activity will lead biotech venture investors to lucrative exits seems to be a bit premature and detached from the reality of these deals. The maxim oft repeated by venture investors has never been truer: IPOs are financing events, not liquidity events. Venture-backed biotechs that are going public are doing so with substantial participation from their venture investors as well as other insiders…
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NPV modelling for the selection of value-creating biosimilar development dandidates
Klaus Nickisch, Kerstin M Bode-Greuel
The purpose of this study was to apply net present value (NPV) modelling to evaluate the financial attractiveness and business risk of different categories of biosimilars. Challenges and opportunities of biosimilars are compared with those of standard small molecule generics. Minimum peak sales levels are required to create financial value were determined in order to derive recommendations for the selection of commercially rewarding biosimilar development candidates…
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EU Legal & Regulatory Update
Ewan Grist
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