Project Management

Can Big Pharma Benefit From Agile?

Amir Nasiri is a Project Management Professional (PMP)® certification holder and a proud PMI member. He is also a Certified Scrum Master from Scrum Alliance and is a proud Scrum Alliance Member. Mr. Nasiri has been practicing project management for the past 15 years. He has created a PMO, coached and trained other project managers, established governance and best practices, and has been the author of several articles promoting the project management and scrum communities.

The title of this paper is a two-part question, both of which complement each other. The first question: What areas of the pharmaceutical industry related to clinical trials can benefit the most from adopting an agile approach, which is based on lean, no-waste process management? The second question: After you have figured out where you want to apply agile, how can we roll it out and make sure it gets adopted across the organization? This part is the most important and challenging issue, and involves change management.

A pharmaceutical company’s main challenge is getting the next best drug to the market as quickly as possible. The pharmaceutical industry faces many hurdles, including regulations, pricing pressures, ever-changing infrastructure needs, and most importantly, the visibility and management of studies. As people depend on and await the next new drug, pharmaceutical companies are still trying to figure out how to become more efficient in getting these life-saving drugs into the hands of those who need them most. Traditional project management, outdated tools, and red tape, combined with bureaucracy, have basically paralyzed the release of some important drugs to the market. Plus, the culture for change and the adoption of new technologies and methodologies has also been very challenging.

In this article, I will focus on how pharmaceutical …

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