Drug development is no easy task. With the enormous resources the process consumes, and the risk inherent in every drug program, it’s no wonder biopharma companies are always striving for an edge when it comes to managing their portfolios. Today’s big problems in managing these programs are nothing new:
- Costs – The cost to develop a drug for full regulatory registration and marketing is immense. Usually, it is in the hundreds of millions of dollars (if not more) over the course of 5 – 7 years.
- Data Collection – It takes an enormous amount of time to gather, calculate, and report the data to many levels of management.
- Traditional Project Management Processes – These can be elaborate and time-consuming to manage for day-to-day operations. MS Project, Excel, SharePoint and other systems design, forecast, store data, and report the progress of the project. However, they are only as transparent as the systems allow. Traditional drug development paradigms are slow when the time arises for teams needing data for decision making.
The goal of the company, of course, is to be either first to market or be best in class with each drug developed. Being first to market can mean a huge revenue advantage. Being best in class enjoys the same benefit. But it also allows the company to set the industry standard for that class of drug. This means realizing even greater revenue and earning potential while dominating market share.
It is the number one goal of the development team to meet one of these criteria in the most cost and time efficient manner. To have both goals met is the ultimate prize. But teams usually must compromise just to be sure at least one is possible.
Most companies have been managing their portfolio the same way for decades. Not much has changed despite the advent of many technological solutions. So the question is, can the combination of a new technology and an old theory help redefine how to undertake complex drug development project management?
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Can Agile Methodology
Improve Clinical Management
Traditional Use of Agile Methodology
Agile methodology is traditionally used by IT teams to roll-out and test new software on the fly. It enables an IT team to discover bugs early on and allows teams to fix them during development. As a result, they speed up the time from development to market.
Experience shows that most companies struggle to use their current management practices in the face of solving different or complex project challenges.
APM theory requires the use of certain practices and tools, such as the concepts of product vision and iterative development. It also utilizes visual artifacts such as boards, panels, sticky-notes, and so forth (Highsmith, 2004; Chin, 2004; Augustine, 2005, Boehm & Turner, 2004). But can Agile Project Management (APM) practices enhance the clinical management of a drug?
Experience shows that most companies struggle to use their current management practices in the face of solving different or complex project challenges. Additionally, the presence of some APM enablers indicates opportunities to adapt the APM theory for different sciences or companies other than those in traditional software development.
In most cases, you’ll see that APM enablers exist in every project regardless of the industry. So in that context, clinical project management, and manufacturing or CMC functions lend themselves well to Agile Methodology management practices. Multidisciplinary teams, project manager experience, project team experience, suppliers, and partners are just a few enablers that can have an impact on the project.
So, can an old theory and a new technology help redefine a new way for pharmaceutical companies to undertake complex drug development project management? In my next blog, you’ll see how this potent combination can provide a more efficient manner to provide oversight of issues with manufacturing formulations and drugs, not to mention opportunities to realize areas for acceleration in all phases of clinical development.