The auto industry was one of the first large industries to apply project management (PM) principles. Historically, drug development programs in pharma/biotech industries were focused around R&D and the management style depended heavily on the expertise of the scientist/manager in-charge of the product development.
As the biotech industry grows to encompass layers of technical, geographical, and regulatory compliance - based complexity, relying on a more sophisticated project management style has become necessary. However, this does not necessarily mean the pharma industry can blindly mirror processes of the auto industry or the IT industry.
The biotech industry, inclusive of start ups to large multinational entities, often find themselves handling manufacturing, clinical trials and regulatory applications covering the entire globe that often requires multiple vendor management, academia collaboration, and CRO/s partnership.
A single project in the biotech company is highly cross-functional often with moving parts across several departments requiring a manager to lead and facilitate the different phases represented by different colors in Infographic A. Each phase further contributes to drug development stages of a company, shown in Infographic B. To keep ahead of the timeline woes, more often than not several stages are running in parallel, with activities from one feeding into the critical path of the entire project. As a result, seamless project management requires an intimate knowledge of complex manufacturing processes; non-clinical activities; regulatory affairs; and in-depth mastery of targeted therapeutic area.
(A) Role and Areas1 of Project Management during Drug Development Stages
(B) Drug2 Development Stages
1R&D: Research & Development; POC: Proof of Concept; IND: Investigational New Drug Application; CTA: Clinical Trial Application; NDA: New Drug Application; BLA: Biologics License Application; LOE: Loss of Exclusivity; CMC: Chemistry, Manufacturing, and Controls.
2 "Drug" refers to small molecules and biologic.
Since in its very essence project management is utilized to perform work that is not part of the company's routine, it is a form of management that is built around completion of a specific project. Therefore, many companies have now started bringing in task-oriented PM consultants instead of expanding an in-house Project Management Office (PMO). Such a shift in organizational strategy provides several advantages:
Consistent application of PM tool kits
Added industry - wide functional expertise
Project-specific deployment of managers
Custom-built team dependent on the project deliverables
A successful project manager is knowledgeable of individual functional areas and capable of deploying PM tools to prioritize tasks, assess resources and timelines, identify critical path, mitigate risks, allocate adequate resources, and manage goals. Our company boasts of a team of unique project managers who have the strategic, technical and operational know-how - contact us to understand how we can provide much needed PM support your precious biotech asset.
References:
1. Pharmaceutical and Biomedical Project Management In a Changing Global Environment, Babler, S.D.; Wiley Series on Technologies for the Pharmaceutical Industry Book 8.
2. Development, Design, and Implementation of Manufacturing Processes; First Edition; Jagschies, G., Lindskog, E., Lacki, K., Galliher, P.