Pharma companies have long embraced the concept of outsourcing research activities using a range of models including full-facility, manpower supply, specific project overflow and capital transfer. Their strategy is based on the idea that it is more efficient to contract-out routine/standard R&D activities whilst maintaining more creative, discovery, and critical decision-making stages in-house.
Biopharma companies in particular have a strong focus on partnering with academia, SMEs and CROs during early stage development, transferring technologies where appropriate. In a world where the economic environment is unstable and the technologies required to develop a biopharmaceutical increasingly sophisticated, this approach to improve early stage discovery whilst decrease R&D costs is growing, despite some perceived and actual drawbacks (see below). It is important that these issues be factored into the decision-making process at the start to ensure “buy-in” for the strategy.
Undoubtedly, cutting costs has become a major drive for companies. Development campaigns will have peaks and troughs of requirements. To decrease R&D costs whilst increasing the success rate of the discovery programs, new areas of science are being exploited to develop better in vitro, in vivo and in silico models. The challenge at the development stage, particularly in analytical areas, is that a range of high-end, expensive instrumentation is required. It may not be economically feasible to establish in-house labs for techniques which may see little use outside of specific stage-dependent needs.
Flexibility of externalised R&D is probably the key consideration- it can be turned on or off thus basically transforming a fixed internal resource cost to a variable one. Other potential benefits are given below.
Arguably the most critical aspect to consider prior to outsourcing is choice of the correct partner – and “partnership” is the optimal description for the relationship as it should be mutually beneficial and not just transactional. Minimum requirements to look for would be a sustainable business model, successful track-record of providing services, measurable in-house performance and state of the art technical capacity together with appropriate expertise.
Listed below are some other points that should be considered. Ideally this should not be just a tick-box exercise; a more holistic approach should be adopted to judge if individual company styles of working will be compatible. In a good partnership the CRO should be willing and able to engage in discussion and contextualising of results post analysis to ensure understanding of the data. Even better if they are able to identify what other experiments may be needed to fill in knowledge gaps, bolster conclusions or target investigative studies on key structural features etc.
One outsourcing trend that has been apparent in recent years is in Biosimilar development. This often involves a variety of partners collaborating together, perhaps with one group providing manufacturing expertise and another responsible for clinical, regulatory and marketing. In some instances the developers are “virtual” companies, using the services of consultants, contract manufacturers and contract testing laboratories. We have seen an increasing demand for structural characterization services from these clients, particularly for the initial characterization of the innovator product and comparability assessment of the biosimilar candidates. Read our Case Study on comparability of Simponi innovator and Golimumab biosimilars.
Most companies looking to outsource R&D will have dedicated procedures and Project Managers for this task, however, from my experience there are some additional pieces of information which can be gleaned to evaluate whether the “match” will be a good one. Ask the lab if it can give examples where they have been able to rapidly adapt to a client’s requirements, deliver vital results within a short time frame when in-house capabilities were full, work in tandem with an in-house team and specifically turn on a sixpence/dime/rupee! This demonstrates their nimbleness and flexibility, together with willingness to communicate and cooperate.
BioPharmaSpec had a recent example where a client’s own physicochemical instrument broke down. Samples were already in-house for another routine test, and so the required technique was performed at the same time. Within an hour of being told the instrument had broken down, BioPharmaSpec scientists were able to confirm their ability to add the analysis to the current project and started testing the next day. Adaptability to individual client’s requirements is an essential CRO attribute, rather than just offering “cookie-cutter” analyses or one-size-fits-all services.
Even with the same molecule approaches can be different, as experienced by BioPharmaSpec when recently working on PEG-GCSF. For one client they were required to develop and run custom methods but for another they worked with the client’s own methods, since they had down-sized their internal capabilities. This “bespoke” approach again demonstrates flexibility.
A final word: as in any relationship, communication is critical so it’s vital to ensure each party understands the other. In a “perfect partnership” the contract lab will function not just as an extension of the team, but an enhancement!
