摘要：

A cornerstone of any molecule's long-term success is its early phase development.Having the needs of the finished product in mind from the outset of a project,including how the molecule will be manufactured and ultimately formulated,can help to avoid potentially significant additional costs and delays at a later stage.There are many reasons why small molecule drugs fail in clinical trials;by contrast,there are some measures that can be taken during early phase development to minimise future setbacks.Six factors that organisations should carefully consider are funding,analytical capabilities,solid state science,regulation,hazard evaluation and a full-lifecycle perspective.Funding and effective spending Current estimates typically put the time that a molecule takes in preclinical discovery and development at 3-6 years...and the cost of progressing a project from discovery to commercialisation at up to $2.8 billion.Annual global pharmaceutical R&D spending is now upwards of $186 billion,partly because of the rise in therapeutic complexity and increased costs of biologic and advanced medicines(such as cell and gene therapies).3 One study showed that 22% of failed Phase III candidates resulted from insufficient funding;securing adequate finance for a new project can be challenging,particularly for smaller or relatively unknown biotech companies focusing on a single molecule.4 Early phase development is often about speed of progression and there could be limited data or results to show investors that may be keen to see a potential return on investment.A credible and experienced outsourcing partner can offer guidance and advice to innovators regarding how to be resourceful and prioritise the allocation and most effective use of capital during multiple fundraising rounds.The early development phase often involves intensive research and analytical work;and,for companies with limited resources or expertise in these areas,outsourcing can offer the best method of meeting these needs.Satisfying stringent regulatory requirements,characterising the product's properties and affirming its safety and efficacy require a comprehensive analytical approach and experienced scientists using specialised equipment.

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