Pharmaceutical Project Management
Drugs save lives. When gone wrong, wrong drugs kill beings.
Scary, isn’t it?
Getting a drug into the market is an arduous process with no guaranteed success.
There are two aspects of success.
- Successful drug launch
- Earning a decent profit from the drug
According to the US Bureau of Labour Statistics, pharmaceutical organizations fall under three broad categories.
- Mainline – have approved drugs in the market, focus on drug research and development as well as manufacturing
- Research and Development – may not have approved drugs, but focus on research and development; they may be sub-contractors for Mainline companies.
- Generics – work to bring into the market drugs that are past their patent protection.
The end-to-end cycle is unique to these types of firms, and so are the challenges.
Figure 1: New Drug Development (Representative Purpose Only)
Figure 2: Generic Drug (Representative Purpose Only)
Companies go through a complicated and time-consuming pharmaceutical project management process of drug discovery, pre-clinical research, clinical trials, and regulatory approvals before launching a new drug application to the market.
The investments could involve millions of dollars.
The effort spans multiple years of sustained effort.
With such a level of investment and effort, is success reasonably assured?
Negative!
Higher risks lead to higher rewards. It is this search for higher rewards that excites and influences pharmaceutical projects.
You may be wondering, “is there anything new?”
Well maybe not, until we review the drivers of complexity which emanate from different sources of the pharmaceutical project management cycle.
- Drug development process
- Conducting drug trials
- Managing the supply chain
- Country-specific requirements
- Environment concerns
- Regulatory compliance
- Ethics
- Others
On top of the complexity drivers highlighted above, business leaders and professionals come face-to-face with a plethora of challenges in pharmaceutical project management. A quick review would help clarify.
Let us start with project and program management governance and covers the complete cycle of building business cases, approving the project or program, detailed planning, resource and cost estimation and budgeting, robust risk and issue management, efficient progress tracking, complete documentation, and closure.
The next on the list is the time-to-market. While the teams focus on project and program management, they deal with business pressure to develop and launch the drug as quickly as possible or the time-to-market. This external focus assumes massive importance when organizations fight for market dominance.
With such complicated projects and firm deadlines, what IT systems and applications do pharmaceutical project management teams depend upon?
The above scenario can be very dicey!
In general, a majority of the pharma companies manage their business through disparate and multiple systems! Such an un-integrated set of systems brings in unwanted levels of organizational inefficiencies.
The result – project teams, struggle with data integrity and accuracy.
The impact – lack of confidence in the organizational decision-making process.
Next on the list is collaboration.
Just to refresh, pharma projects demand a very different level of collaboration – geographically dispersed project teams, cross-functional departments, vendors, government agencies, and others.
How do the project manager and the team deal with such a scenario?
Emails, phone calls, video conferences? Some of it is effective, but what we need is real-time collaboration across the stakeholder spectrum. Invariably, project teams’ energies get sapped getting this piece of the puzzle right!
In a nutshell, successful pharmaceutical project management depends on a holistic approach that covers the following dimensions.
- Configurable solutions (e.g., multiple business case templates, idea evaluation process based on drug type, diverse product life cycles, and various project management approaches and methodologies)
- Business process management that seamlessly connects all the organizational functions through specific workflows to enhance decision quality.
- Integrate multiple systems and applications (HR, Accounting, Procurement, and others) so that the project manager and team could get real-time project data to drive proactive management.
Let me try to read your mind!
Is there any software solution that accomplishes so much? Would that make my day-to-day pharmaceutical project management much better?
In a world of uncertainty, could I expect any level of predictability?
The answer is “yes!” KYTES PSA for Pharma is designed precisely with such an approach.
We welcome you to try KYTES PSA, and you will be glad that you did!
