Let’s be honest, drug development isn’t easy! Bringing a safe and effective drug to market takes a significant amount of expertise, resources and infrastructure – not to mention creativity, determination and the will to succeed. While most biotechs have the latter, when it comes to resources, many simply do not have the bandwidth to complete the process internally, so look to outsource some or all of their drug development programs.
Traditionally, the go-to solution for smaller developers was to license compounds to large pharmaceutical companies for development. However, this usually comes at the cost of giving up value and control. An alternative and increasingly popular option is the use of contract research organizations (CROs) to help build value for the drug without the burden of royalties and milestone payments.
CROs come in all shapes and sizes, from small, niche companies offering very specialist services all the way to very large organizations that can provide a comprehensive service offering, covering each stage of drug development, all under one roof.
The decision to outsource to multiple contractors or to a single full-service partner is not a straightforward decision, and will depend on a number of factors.
Some developers choose to outsource specific parts of their development programs to multiple CROs, and for larger companies working in more specialist areas, this can be an effective approach. However, a consequence of opting to use a number of different CROs to undertake projects might be that overall program timelines are longer. Opting to work with a single, full-service CRO provides access to an integrated team all under one roof, ready to meet your timelines and budget by anticipating and overcoming challenges in real-time.
Multiple providers can offer you access to the niche services that your development program may require, but does present a greater degree of management and communication than otherwise a single integrated provider would require. This offers the potential to streamline communication, manage timelines and ensure everyone agrees on strategy from the onset.
Good communication is essential to the success of any relationship. When working with several CROs and multiple project managers, the big risk is that poor communication between partners will create unnecessary delays. Instead, working with a , who has oversight of all activities, can ensure a much smoother and more efficient process through an agreed upon structure outlined at the outset of the program.
Selecting a CRO to develop your drug is an important decision, as it can greatly impact upon the potential of your lead compound. It involves the consideration and balance of many factors that will be right for taking your lead candidate from the lab to the clinic.
Learn more about selecting the right CRO for you by reading our ebook!