The interface between the pharmaceutical industry and academia in the UK
Tim Sparey, Merck Sharpe & Dohme and Francesca Gliubich, King’s College London
At the interface between the pharmaceutical industry and academia, the role of the academic technology transfer manager (ATTM) is difficult. Firstly, they have to ensure patent protection for new academic discoveries, second, transfer the more commercially relevant discoveries to an industry partner, and third and possibly most difficult, ensure that the interface between the industry and the academic is trouble-free. These functions are not necessarily complementary which, taken alongside anecdotal evidence for how successful ATTMs are in this role, offers an excellent starting point to examine the relationship between the industry and academia in the UK. A better understanding of the issues should be beneficial to both sectors. With this in mind, opinions were solicited from representatives of pharma, biotech and academic institutions in the UK to establish some common ground.1 The aim was to find suggestions for making the interface work more effectively. This is not a quantitative study but more a commentary based on the views and experiences of the authors and interviewees. The key issues identified included the people factor, different mindsets, financial problems and finding the right contact point; all issues facing both ATTMs and industry academic liaisons (IALs).
Cultural aspects in managing development and marketing alliances
Anthony A. Hoerning Novartis Pharma AG
One of the most fundamental aspects of any successful international business is anticipating and understanding cultural differences. In today’s collaborative Pharmaceutical environment the huge impact that “culture” (social background, behavior, language etc.) can have on the results of negotiations and alliances with business partners, is still under-estimated. Raising the awareness of cultural gaps will allow collaborations to run smoothly and successfully.
The Pharma Negotiator: a style profile
Andrew Gottschalk
The data in this article draws heavily on my work with PLG members who completed the Woodstock Negotiating Style Profile, or the Negotiating Style Inventory, as it was previously known, over a period of about ten years. In addition I will be using data obtained during my negotiating, consulting and training work with a number of global pharmaceutical companies in the same time frame. These companies vary in size from the industry “top twenty to the top one hundred”. The population whose results I am presenting are predominantly European, in terms of nationality, but who during their work have to negotiate on both sides of the Atlantic and now increasingly in South Asia and Japan. Two hundred plus may not be a significant sample on which to make sweeping statements but I hope that the fact that these profiles were completed by professionals working exclusively in Business Development may enhance the reader’s curiosity and recognition of some of the conclusions that the data suggests. In order to provoke further discussion and, I hope insight, I am also making use of comparable data from the oil and gas industry. Both industrial sectors share certain key features including: the length and complexity of the returns on investment, operating in complex partially administered markets with governments and state agencies pursuing political agendas and the continuing requirement for highly qualified manpower to drive innovation and manage operational complexity in global markets. Over many years both sectors have developed a similar network of relationships through strategic alliances and joint ventures that seek to maximise the opportunities for collaboration and mitigate their sector’s structural risks.
Negotiating boomerang deals
Dr. Ulrich S. Koch, Bayer Schering Pharma
Over the past years I had the pleasure of negotiating a number of out-licensing deals which included options to take back the projects concerned after specific clinical development criteria were met. Some of these collaborations were significantly re-negotiated after the initial signing. In this article I will summarise the concept of these out-licensing deals as well as the lessons I learned prior, during and after the deal making process.
Opportunities and barriers in the biosimilar market: Evolution or revolution for generics companies?
Jo Pisani and Yann Bonduelle, PricewaterhouseCoopers LLP
Biopharmaceutical drugs (or biologics) have outperformed the pharmaceutical market as a whole largely due to two factors: they address areas of clinical need that are unmanageable with conventional therapeutics (including many cancers and genetic diseases) and they are able to command a premium price. At some point the patents protecting the successful biologic will expire and the potential of a sizeable market will attract generic companies. However the process to develop a biosimilar – essentially generic version of biopharmaceuticals – is more complex than that of developing a generic copy of a chemical-based compound. The regulatory pathway is not completely finalised, whilst the EMEA approved the first biosimilar (Sandoz’s Omnitrope (somatropin; somatrophin) in April 2006), the FDA has not yet approved any. Nevertheless, the biosimilars markets in Europe and the USA have the potential to generate sales of $16.4 billion by 2011 (Frost & Sullivan).
This article considers the commercial implications and the market entry requirements for biosimilars by reviewing:
- the commercial factors driving the biosimilar market.
- the most likely therapeutic and geographical targets for generic manufacturers.
- ways in which conventional generics companies will have to reconfigure their business models if they are to become competitive in the biosimilars market.
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