All indicators seem to point towards an increased use of CROs in the future. I believe that a major change will occur in the industry as we see a greater shift towards more risk-sharing agreements between pharma and CROs.
The volume of outsourcing is unlikely to change substantially, but more likely the type and complexity of bioanalytical work will increase. As external providers invest in novel platforms and pharmaceutical companies look to externalize more complex pieces of work with different endpoints (e.g. PK and biomarkers for a single study), the time and resource necessary will rise. With more sophisticated automation in areas like liquid handling, it may be possible in the future to increase output further, which if coupled to reduced cost per sample, would make an attractive proposition for increased volume of externally supported work.
Yes, as the overall research and development pipeline is continuously increasing.
Currently pharma outsource a lot to CROs. Using my own department as an example: 10 years ago, we used to support most of the GLP and clinical bioanalytical work internally. Now with only one third of the original staff, we have doubled the responsibility from development work to supporting both discovery and development portfolios. It is always important to maintain sufficient internal expertise within the office and laboratory, as when there is insufficient internal expertise and thus insufficient study monitoring, one can start to see the quality suffers slippery and cost jumps higher.
We will continue see increased outsourcing activities, especially for small molecules, to a certain threshold. We will see a rapid increase of outsourcing LC–MS bioanalysis for large molecules for either intact or signature peptide approaches. CROs with unique capabilities in this area will have the inside track.
The challenges that have become apparent are that the nature of clinical trials are changing as they reflect the disease types and the manner and subject populations that that are being researched. One significantly increasing area is the number of therapies directed towards orphan and rare disease states. From an operational perspective this has an impact on the number of subjects, the progress of recruitment and the geographical areas where the trial centers are located. Whilst there can still can significant amount of consolidation of sample logistics, there is an increasing trend that the size of particular analytical batches available to be matched against the data feedback that sponsors are requesting is diminishing. From an operational bioanalysis perspective this is going to present challenges to both costing models and allocation of bioanalytical resources.
An additional factor is in the nature of trial designs, such that it is now relativity commonplace for multiple bioanalytical endpoints to be required to be measured. Here the challenge can be one of a limited amount of biological sample available for these measurements from each subject. Furthermore, if the technologies required to be used to make the measurements are not available in a particular location or at a particular provider, the need for co-ordination and collaboration across and between vendors is an area of potential growth and transformation.
Yes I believe it – right now I think a lot of pharmaceutical companies are starting to contract out and outsource their product development and even discovery projects, so they reduce internal resources and head counts, so they will contract more in the future.
This remains likely, as outsourcing has become an essential part of our drug development process. Much like small companies who drive discovery of new targets and therapeutic areas, bioanalytical outsourcing is a key way small companies can expand their capabilities and focus on core competencies internally, while large companies can increase their capacity.