Your API strategy: How to identify if you need additional resource
Your API fuels your drug development program, which is likely to suffer if you allow it to become depleted. It is, of course, advisable therefore to consider whether you have the resources to synthesize the quantities of the API required for your development program to move forward. Trying to produce the necessary quantities of your API while at the same time managing and running your drug discovery and/or development program can at times feel like plate spinning, and so more and more companies are opting to outsource.
Contract manufacturing of APIs is very much on the increase, the pricing of options being more competitive now there are more options available in the market. Every option comes with its a degree of risk however, as contracting often has with it the risk of late-delivery and quality issues. Researching your options is something of a theme here, as biotech companies often have their funding tied to reaching particular milestones of which these risk factors may have an impact. These things can be avoided, however, as risk associated with time delays can be minimized by using an experienced and easily accessible Contract Research Oganization (CRO) to develop and supply your API.
Researching third parties
Biotech companies that have come to this point in their drug development program will understand that careful consideration and planning is necessary to avoid failure. When you are researching the kinds of third parties you want to work with, it is worth scoping them out properly before signing any contracts. Do they actually have the ability to fill the gaps you have in your own internal resources? In short; do they complement your skill set and add value to your development program? Do they know your short and long-term goals? Communication is key; throughout the API program, there will be a degree of rapid technology development and change. The chemical route, the raw materials, the specifications, and the impurities – all of these things will change over time – but the overall milestone as well as deadlines do not tend to change. Can a third party accommodate these factors and work with you?
Your chosen CRO must be able to roll with the punches and be able to accommodate changes in an industry that is always fluctuating, to ensure the delivery of your API remains on track. Organizing meetings and visits with the team you are potentially going to work with can help alleviate any misgivings that may be had with regards to outsourcing a part of your development program. In general, it is good practice to provide all the data and information on what has been done so far in the development program when working with a third party, ensuring you do not pick and choose information from different campaigns, and you do not extrapolate on what you feel ‘should’ work.
Of course, it is always true that CROs are a viable option for outsourcing, but it may come as a surprise that there are in fact specialist CROs that can provide niche service offerings with experts in a particular form. Large specialist CROs exist that can offer truly integrated services from early drug discovery right through to a phase III clinical trial. Working with larger CROs can open the door to far more resources and larger teams of experts with a wider range of skills than a smaller one, while providing you with a dedicated project manager who oversees the integrated approach. Taking these kinds of steps in identifying who to work with and to what degree can seriously help add the right people and resources into your development program mix.