To Outsource or to Insource?
The decision whether to hire a Pharmacokineticist or outsource clinical pharmacology work to a consultant is difficult. When do pharmaceutical companies have enough work to support an in-house, full-time Pharmacokineticist? Where is the inflection point for building an in-house team versus outsourcing clinical pharmacology work? The answers may surprise.
Typically, in-house Pharmacokineticists are the last hire within an R&D group. This is due to the sparse nature of clinical pharmacology and pharmacokinetic work within a drug development program. Companies with one or two drugs in their pipeline have a strong need for expert clinical pharmacology/PK/PD support, but find it difficult to justify hiring a team to support the work.
When companies determine that there is a need for in-house clinical pharmacology support, typically the hire is a high-level position. However, there are sub-specialties within the field of clinical pharmacology that make hiring a robust clinical pharmacology group out of reach for many but the largest pharmaceutical companies. Typically, a full team consists of a:
- Clinical Pharmacologist,
- Pharmacometrician, and
- Programming Support
It can be difficult to build a robust team with the expertise to conduct all clinical pharmacology/PK/PD activities needed in a program. Often, when companies do build an in-house clinical pharmacology/PK group, the amount of work outpaces their capacity and the company ends up outsourcing the work anyway.
In most cases, it is best to consider partnering with a consulting firm that works on an as needed basis, has the bandwidth and expertise to address any clinical pharmacology question, can stand toe-to-toe with the regulatory agencies in terms of experience and knowledge of the field, and is able to conduct complex PK/PD analyses.
What gaps or needs do you have in your program right now?