Pharmaceutical companies encounter enormous challenges during the long product-development process. The identification of risks at the right stage and an effective mitigation plan are key factors for success, both financially and technically.
The complex drug-development process from lab to launch includes management of several business processes, such as technical development using quality by design, regulatory strategy, clinical studies, and supply chain.
These processes are affected not only by many circumstantial factors but also by each other. The inherent uncertainties during the evolution of any of these processes require constant change in plans.
In general, it takes 10 to 15 years and researching approximately 10,000 molecules to launch one new product to the market. The activities during this period need to be focused on speed of delivery (time costs money) and reduction of risk.
In 2014, the Tufts Centre for the Study of Drug Development examined 10 pharmaceutical companies and 106 randomly selected drugs that were first tested in human clinical trials. Experts at the centre concluded that the true cost of bringing a new drug to market was $2.56 billion (in 2013 dollars). Given the enormous investment required it’s vitally important that project plans structure development activity to identify “early kill” opportunities for molecules that aren’t going to make the grade.
The move to outsourcing has also intensified the need for project management. Contract development and manufacturing organisations are becoming a strategic part of any drug company’s projects and operations.
Pharma Project Managers must address the following:
Scope management of individual projects and overall programs
Project planning, execution, and monitoring
Identification of “early kill” priority opportunities, and planning appropriately
Establishing measures of success for each project
Standardising routine tasks, especially those that are centred around regulatory compliance issues
Managing budgets and timelines
Managing change
Managing the value chain management
Incorporating best practices for quality (for product and process)
Optimising availability and use of resources
Managing stakeholder expectations and communication
Managing regulatory and compliance strategies
Ensuring environmental health and safety compliance
Managing risk
Given the above complexities and level of cost, the return on investment in professional project management is higher in pharma than in any other industry, please don’t underestimate the importance.
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