| Dr David Rhodes of the Health Protection Agency analyses the importance of accelerating the development and scale-up of speciality biotechnology products
Despite the demand from shareholders for a pipeline of ‘blockbuster’ products the reality is that, in many parts of the healthcare sector, the focus is not on development of ‘blockbuster’ drugs, but on speciality and niche products. These may be manufactured on a commercial or governmental basis, and are required for a diverse range of applications as outlined in Table 1.
The development of speciality biotechnology products presents particular demands in terms of costs and timescales. Speciality products may struggle to generate a financial return, or may require a financial subsidy in order to be viable. Hard-pressed investors and funding agencies are likely to be acutely sensitive to escalating costs or project over-runs. Emergency situations, for example in countering the threat of emerging respiratory diseases such as SARS or pandemic influenza, that require every effort is made to compress development, scale-up and manufacturing timescales, and to roll out the product in the shortest possible time. Consequently, the speciality biotechnology sector is particularly receptive to approaches which can reduce cost, time, or both.
WAYS TO ACCELERATE THE PROCESS
Delays and unforeseen costs in drug development, scale-up and manufacture are caused by a multiplicity of factors, some of which are unavoidable and inherent to the technical properties of a particular drug or vaccine. However, there are a number of common features that may be addressed at the initial or preparatory stages that have the potential to save a great deal of time, money and management input. Based on the Ishikawa ‘fishbone’ analysis technique, these can be broadly categorised under the headings of people, systems, finance and equipment (see Figure 1). |
