Ask CATO: Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to lag behind and often do not recognize that project management is not too complex or does not cost too much to fit into their smaller culture. Project Management should not be considered as only a box of tools but a mindset on how to approach management of a project. A small company can get huge payback just by incorporating basic project management into their processes. Simple processes such as developing a project scope, identifying risks, and setting common goals for the project team performance can lead to benefits by shortening timelines, eliminating costly mistakes, and ensuring project success. A cooperative alliance between a biotech company and a contract research organization (CRO), such as Cato Research, can help bridge any gap that may exist in the company’s experience level and ensure clear communication among all the team members through experienced project management. Understanding the differences in the team’s work environments will lead to better communication and improve the overall performance.

Drug Development and Project Management: Who are the team members and what do they do?

Project teams are multidisciplinary and the ability of the CRO to fit into the company’s corporate culture and fill in the areas where additional expertise is needed are vital in drug development. In my experience, most biotechs stay “lean and mean” to avoid carrying excessive overhead costs which often means that not all disciplines are sufficiently covered inhouse. Disciplines involved in most drug delivery programs usually include R&D, CMC (synthesis/manufacture), nonclinical, clinical, CMC (final formulation), and regulatory. Each biotech is unique in the set of inhouse skills available, and by collaborating with the CRO, they can draw upon its multiple assets to fill in wherever additional help is needed for the particular drug and the regulatory pathway. There are complex team dynamics that exist in any multidisciplinary project team. Sources of conflict can develop due to the different work environments, the different priorities, or misunderstandings, and inadequate communication among the various team members. Additionally, environmental diversity among the various team members may arise from the different motives, the distinct rewards/recognition, and the unique regulatory constraints that each team member faces in their specific area.

To find more information please click here: Ask CATO: Project Management for Biotech Companies