Negotiating performance clauses in licensing contracts
Roger Davies, Pharmaceutical Licensing Group (UK)
Trusting a prized technology asset to another company will always require a number of guarantees, particularly if the licence granted is going to be an exclusive one. Of course actually agreeing the performance measure is only the first step – there are then the penalties or possibly incentives for adhering to the agreed performance measures.
Global pricing strategies for pharmaceutical goods
Eckhard Kucher, Simon-Kucher & Partners
In the context of national price controls in many pharmaceutical markets and strong interdependencies between these markets as a result of parallel trade and international price referencing, a global pricing strategy is essential. A global approach is necessary to maximise the long-term revenue and profit for new pharmaceutical drugs.
Drug delivery
Steve Ellul, Eurand, and Jill Ogden, independent consultant
The drug delivery industry is a relatively young sector within the pharmaceutical industry; starting out in the 1960’s the number of companies and technologies under development boomed throughout the 1980’s and 1990’s. Early pioneer companies include Eurand, Elan and Alza, all founded in the late 1960’s as companies focused on applying their technologies to add value to existing drugs.
Product life-cycle management through second indications – a case study
Mariana Brea-Krueger, IMI Consulting GmbH
This article explores the use of ‘second indications’ as a strategy and means of prolonging a product’s life cycle while increasing a company’s return on investment (ROI), using buprenorphine as a working example. Buprenorphine has been used as an analgesic for many years but is now assuming a critical role in the management of opioid dependence following its approval for this indication.
Data protection for pharmaceuticals in the European Union
Ulrich Granzer, Granzer Regulatory Consulting & Services
The first pharmaceutical legislation in the European Union (EU) came into force in 1965 (Directive 65/65). It required all member states to implement an assessment and approvals system for new pharmaceuticals within a time frame of 15 years. This article examines the development of EU pharmaceutical legislation since then.
‘Mind the gap’: how to negotiate with innovators and scientists
Andrew Gottschalk, Group AG
Business development executives often describe, and frequently complain about in vivid terms, the difficulties they have encountered when negotiating with innovators and scientists. From these conversations, two sets of linked concerns emerge: those about planning for negotiations and those about the management of the negotiating process itself.
Patent pools – a practical guide
William Kerr and Mark Palim, LECG
The pharmaceutical industry has seen a continuous increase in the number of patents being issued in Europe and the USA. In simple terms, the industry is continuing its transition from a world where the patent is the compound and the compound is the product, to gene-based diagnostics and therapies that require a licence to patent rights from multiple patent holders in order to bring new products to market.
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