- Reduced Pipeline
- Blockbusters coming off patent
- Increased Regulatory Requirements
- Growth of Generics
- Cost of the drug Development Lifecycle
Large Pharma companies have taken similar approaches to addressing the shifting environment and these include strategies such as buying earnings through M&A, development of internal generic pipeline, look to developing global markets (not just the US), development of brand biologics, diversification of their product ranges, and interest in orphan drugs and biosimilars Crucially, there is a general acceptance that traditional internal development practices needed to improve to not only fill the pipelines but to accelerate the rate at which new entities are being developed. In order to achieve this there has been a dramatic increase in innovative collaboration between large Pharma, other large Pharma & Biotech companies, with innovative SME’s and with Academic groups. Each stakeholder plays a vital role in the innovation and development process. Interestingly, the challenges that these approaches bring are similar to those experienced by large EU consortium projects. The challenges are the same and the practices employed to address them, are paralleled. Some examples are as follows:
