Guest Blog: “Analytical R&D: Thoughts on Outsourcing vs In-house” – Dr. Fiona Greer

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 Partnering

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.

Perceived/potential barriers/hurdles to outsourcing

  • Internal resistance- prefer to expand in-house, keep positions secure, expand departments etc. Risk of losing in-house knowledge base.
  • Fear of loss of control- particularly over turn-around-time.
  • Confidentiality issues.
  • Analytical/regulatory standards not compatible.
  • Time input & complexity of sourcing, researching and selecting suitable CRO partners, together with ongoing management overhead costs.

Outsourcing- not just cost-cutting

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.

Accessing specialized knowledge and technologies

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.

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Benefits of Pharma R&D Outsourcing

  • Efficiency: can be switched on and off as time/stage appropriate.
  • No need to invest in sophisticated equipment, maintenance and updating of instrumentation, orthogonal techniques, development of emerging technical methods, specialized training of staff.
  • Independent assessment of the product (well-regarded by regulatory bodies).
  • Access to knowledge-base in niche areas, particularly where sophisticated instrumentation involved.
  • Access to knowledge-base of specific product classes, including regulatory requirements.
  • Small CROs in particular can be flexible, nimble, adaptable.
  • Extension of in-house team if managed correctly.

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.

CRO Laboratory Selection: some questions to consider

  • Experience with specific product type – extensive knowledge-base, understanding of molecule.
  • Experience with specific analytical instruments - range of instruments, orthogonal techniques available, range of methods, duplication of instruments, non-routine techniques, high-end instruments, etc.
  • Experience with developing methods – including method transfer and non-routine.
  • Experience with regulatory requirements – knowledge of what is needed, at what particular stage.
  • Experience and expertise to be able to perform problem solving and deal with unknowns when needed.
  • Back-up of capabilities- not all eggs in one basket.
  • Solid expertise in many different areas, with understanding how these all fit together. (Internationally renowned scientists/experts).

Multi-laboratory collaboration

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.

Being strategic about picking your partner

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!

Dr. Fiona Greer is an independent consultant with extensive technical experience and industry knowledge built up over 40 years of supporting drug development and, in particular, biosimilar projects.