Therapy Areas (TAs)
The bulk of the organization in Bio/pharmaceutical R&D tends to be organized under Therapy Areas. Therapy Areas are clusters of diseases for which the company is pursuing therapies, e.g. Allergy & Respiratory; Cardiovascular and Metabolic Diseases; Inflammation; Infectious Diseases; Gastrointestinal; Neuroscience (and pain); Oncology; and Ophthalmology. Each Therapy Area has budgetary and resource control over the majority of resources within each Area.
The resource within each Therapy Area is typically organized into line departments based on areas of expertise, e.g. Medicinal Chemistry, Biology, Analytical Chemistry, Computational Chemistry, DMPK, Formulations, Toxicology, Clinical, etc. This website is concerned with the management of projects that involve a matrix of line departments. A useful reference on line management is the recently revised book by Bamfield. 1
Most R&D organizations establish a 3-5 year business plan for each TA, containing the long term goals of the TA. 2 At the end of that period the organization may make organizational adjustments that could include re-clustering of diseases in the TAs, and initiating or eliminating work on certain diseases. At least once a year each TA reviews its progress towards its annual goals and towards the completion of its business plan. This review is often referred to as the portfolio review. In that review the budget for the next year is typically established. Each TA business plan establishes a set of disease area strategies, which includes a set of desired product profiles, which specify what kinds of indications the TA is seeking to meet with the therapeutic agents it will be pursuing. Each Disease Area (DA) Strategy 3 also provides a technical assessment of the risks and opportunities, resource requirements and what unique technologies need to be brought to bear in the area, as well as a commercial and competitive evaluation. The DA Strategy also specifies whether the corporation should pursue the work in-house, or consider working with external partners.
- Peter Bamfield, “Research and Development in the Chemical and Pharmaceutical Industry”, Wiley-VCH, 2006. ↩
- Section 126.96.36.199, The Standard for Portfolio Management, 2nd Ed. p. 51, Project Management Institute, 2008 ↩
- A nice discussion of therapy areas and disease area strategies – Jean Lee, Pfizer, “Integrating Value into the Portfolio Decision-Making Framework”, Strategic Resource & Portfolio Management Conference, Nov. 17-19, 2008 ↩