Issues arising from the TGN1412 clinical trial
Paul Ranson, Stringer Saul
The disastrous TGN1412 clinical trial at Northwick Park in March 2006 provoked a near-fatal reaction in six previously healthy volunteers. As a result, the pharmaceutical industry’s drug testing procedures came under intense scrutiny from both regulatory bodies and the national media. This article provides an important update on recent events, addresses the legal and regulatory position and highlights lessons that can be learned for the future.
IP valuation in pharmaceuticals and biotech
By Jo Pisani, PricewaterhouseCoopers LLP
Intellectual property (IP) is particularly important for early stage companies. This article aims to explain the various valuation techniques and how they can be applied to the pharmaceuticals and biotech industries. In addition, it addresses the use of expected net present value (eNPV) in project valuation, in the support of licensing negotiations.
Legal Implications of different licensing structures
Jo Pisani, PricewaterhouseCoopers LLP
Technology licensing structures can take many forms. Although they all involve, at their root, the granting of, or access to, technology, the manner in which that is done varies enormously. They may depend upon the parties involved, the technology in question, the market to which that technology is directed, the stage of development of any product, and so on. This article reviews some different licensing deal structures and considers some of the key issues in current negotiations, such as performance, liability and the consequences of termination.
Negotiating with the tribes
Andrew Gottschalk, Group AG
The purpose of this article is to raise a few eyebrows – and perhaps a wistful smile- while at the same time drawing some illuminating parallels between tribal and professional cultures. The word ‘tribe’ brings a number of different connotations, from childhood memories through to a more complex anthropological meaning that contains words such as language, structure, organisation, values, customs and dress. In linking the concept of tribes to professional cultures in organisations, we can enhance our ability to navigate business deals through what is essentially a complex ‘latter-day organisational jungle’.
Licensing opportunities in China’s emerging bio-pharma industry
Ben Nichols and Ben Walker, Walker-Nichols
China’s bio-pharma sector has grown rapidly in the last five years, and according to a new study by Walker-Nichols there are now over 30 companies focused on innovation, with a combined pipeline of over 100 drugs and therapies in pre-clinical or clinical development. This article provides an update on the technologies that are emerging from China and considers the new growth of business development within local companies. It also assesses the evidence for innovation and the factors driving the growth in bio-pharma, and highlights the opportunities for Western pharmaceutical companies.
Building ethical and generic partnering deals in Poland
Mieczyslaw Starkowicz, Polpharma S.A.
The pharmaceutical industry has demonstrated a burgeoning will for co-operation between both branded and generic companies. The trend is emerging in markets where the national budget is not capable of financing growth expenses via reimbursement. This article reviews the factors that have contributed to the growth of the generics business in Poland and gives an insight into the benefits of ethical and generic company partnering deals.
The great leap for small and medium-sized pharma companies
Sergi Trilla, Grupo Trifermed
Small and medium-sized enterprises (SMEs) will only be able to capture prolific international growth once they have embedded strong business development capabilities. This article explores the vital importance of business development in marketing-based companies and uncovers experiences which will strike a common note for those members working in SMEs across Europe.
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