Author name: Yali Friedman

Five years ago I built a biotechnology innovation index and I have been using it since tracking global biotechnology innovation […]

The 1980 Supreme Court decision in Diamond v. Chakrabarty established the patentability of human modifications to bacteria, and arguably laid

The importance of the business development and licensing (BD&L) function in the global biopharmaceutical industry has grown significantly over the past 20 years as pharmaceutical companies have sought to supplement their internal R&D with innovative products and technologies sourced from biotechnology and drug delivery companies. This has required companies to employ BD&L executives to search, evaluate, negotiate and alliance manage deals ranging from small biotechnology companies to the largest of the Big Pharma companies. Nowadays all the large companies have BD&L teams, sometimes in excess of 100 people. To inform new BD&L entrants and to improve the professionalism of the experienced BD&L executives, various training courses are offered by not-for-profit associations and commercial organisations. The leading not-for-profit association in Europe for biopharmaceutical executives is the Pharmaceutical Licensing Group and in the US it is the Licensing Executive Society. Both organisations offer basic training courses but as far as is known, the only university accredited Master’s degree qualification in BD&L is the distance learning MSc offered by the University of Manchester. The dissemination of specialist knowledge and best practice is through the journals and conferences of the professional associations. The need for well-qualified BD&L executives in the biopharmaceutical industry is demonstrated by the fact that 25% or more of Big Pharma sales come from third party products and the cost of licensing deals alone is over $200m on average.

This paper examines the roles of culture in the principles of biomedical ethics.  Drawing on examples from African, Navajo and Western cultures, the paper maintains that various elements of culture are indispensable to the application of the principles of biomedical ethics.

This article looks at the findings of Marks & Clerk’s 2013 Life Sciences Report, launched in April 2013. Of interest to both R&D/IP experts and professionals in strategic positions within biotechnology companies, it explores many of the issues facing the biotechnology industry and is informed by an industry survey of over 330 international life sciences professionals. Topics explored include the financial climate, growing markets in Asia, IP reforms in the US and Europe, biosimilars and personalised medicine.

The PhD is becoming more and more prevalent as a degree. However, PhD students are not adequately prepared for careers outside academia and most of them have trouble translating their skills to the job market. The biotech sector is a science-driven industry that is now mature and flourishing and requires business leaders that are technically trained. But technical skills are only a partial requirement, with in-depth industry education and knowledge being equally important. There is an inherent advantage to pursuing a PhD alongside education in management in the form of an advanced/professional master’s degree. This will allow PhDs to explore alternative careers outside academia.

On April 1, 2013, the Supreme Court in India handed down its decision to dismiss Swiss drug maker Novartis AG’s attempt to win patent protection for its cancer drug Glivec. In doing so, the Supreme Court held that incremental improvements or modifications to an existing drug are not patentable under India’s patent laws. While the ruling may have allowed India to maintain its ability to manufacture generic drugs, the ruling has increased the challenges that pharmaceutical and biotechnology companies face in obtaining patent protection in India. In the long term, these challenges may prove to have far greater implications for the biotechnology industry that go beyond merely the patentability of one drug product. In view of this recent decision, pharmaceutical and biotechnology companies are undoubtedly re-evaluating their foreign patent strategies.