Managing Complex Pharmaceutical/Biotech Projects Across Continents
As Heather is working with clients, she often considers the question, “How can one guarantee success in projects in the Pharma/Biotech arena?” And so Heather wants to dig deeper into this question because she believes it’s an important one. With over 40 years of experience under her belt there are a few themes that make the difference between a successful project and one that fails.
A Gallup poll back in 2012 noted the following: “the higher the budget, the higher the risk of failure”. Pharmaceutical/biotech projects across all continents fit this description very well because of the very nature of the projects associated with high financial backing and very lengthy Research & Development (R&D) period.
The Project Management Institute 2010 survey noted the following:
· Only 25% of projects succeed.
· 50% of projects are delivered with cost over runs or were delivered late.
· What percentage of projects are cancelled? The other 25%.
· Cost of project failure is over $150 billion.
Before you can answer the aforementioned questioned, you have to consider all of the working parts of the project:
What makes pharma/biotech projects unique?
▪ Regulations – US FDA regulations, EU regulations, ROW regulations, ISO regulations, ICH guidelines.
▪ R&D to launch timeline is very long usually many years – market share, first to market ensure greater market share
▪ Evolution of scope & complexity
What are the characteristics of a Pharmaceutical/Biotech Project Leader/Manager?
Project leaders and managers tend to wear multiple hats:
▪ Scientist & Engineer
▪ Auditor & Engineer
▪ Scientist & Auditor
▪ SMEs of several areas such as QA and RA
▪ Adaptable – “Chameleon” – Versatile
▪ Resilient
So, lets go back to the original question, how can you guarantee success in projects in the Pharma/Biotech arena? Here are the top 3 elements to ensure success in your projects:
1. Strategy – ensure your organization is aligned in its goals and objectives from top to bottom and bottom to top.
2. Leadership – leadership teams and other senior leaders need to “who walk the talk” by sponsoring, supporting and championing projects by putting the money and leverage behind all strategic projects. Project leaders need to understand cultural nuances and act on these nuances accordingly, look for opportunities to develop your team, understand the expertise of each member of the team and utilize the strong areas of each team member as an advantage in projects.
3. Communication – a well defined communication plan supporting open communication including how and when information is shared with stakeholders of the project, transparency, upfront information released on time, no hidden agenda from anybody associated with strategic projects, co-locate if project is across continents or different side of the continent. In addition, investigate and problem solve any communication breakdown. This can make a huge difference in winning or losing on your projects.
What are your thoughts or ideas on this topic?