Manufacturing: BioPharmaceutical Operations Roadmap 2007

FutureBio 2016 is developing a roadmap to help the biopharm industry achieve operational excellence.
Apr 01, 2007
Volume 20, Issue 4

On September 14, 2006, 22 senior executives from the world's leading biopharmaceutical companies assembled in Boston to attend FutureBio 2016. This forum was established to provide an opportunity for executives to develop an operational roadmap for the biopharmaceutical industry. The roadmap will define the key challenges that need to be addressed to achieve breakthrough operational performance in the future.

Marc Puich
This article summarizes the key themes discussed during the session.


In many ways, biopharmaceutical organizations have shown increasing maturity in their approach to operations over the past several years. Newer facilities are using automation to better manage process performance. In many companies, plant leaders have been recruited from outside the industry, and offer a more mature manufacturing perspective. The tools of Lean and Six Sigma are prevalent, and are driving improvements in the business. Pharmaceutical company acquisitions have resulted in a more cost-focused mindset, and senior leadership is making cost and delivery a priority in response to market and regulatory pressures.

Despite these achievements, biopharmaceutical organizations fall short in their operational practices, compared with those of more mature and cost competitive industries. Supply chain practices, R&D processes, and the use of automation are areas with much opportunity for improvement, and require visionary leadership, at the very top of the organization, to maximize their potential.

However, the industry is still relatively young, and has the opportunity to learn from other manufacturing industries and make significant improvements in a relatively short time.

Future operational challenges are cross functional, requiring collaboration from different parts of the organizations, and a culture and leadership style that fosters change.


The goal of FutureBio 2016 is to develop an industry roadmap that will

  • identify the desired future state for biopharmaceutical operations 10 years from now
  • specify the gaps that need to be bridged to meet that desired state
  • communicate this roadmap to industry stakeholders.

Quick Recap
Another way to think about the roadmap is to ask, "If I were to build a biopharmaceutical operation in 2016, how would it function, how would it be designed, and what are the current gaps to achieving those objectives?"

The forum included two main parts: a series of introductory presentations that set the stage and opened the minds of the attendees. Marc Puich, a partner with Tefen, Ltd., presented his perspective on the current state of operations improvement outside of biopharmaceuticals. Jim Vaughan, general manager of 3M Healthcare, described how the company has adapted operational best practices from its highly competitive consumer businesses to the life science arena. And finally, Dr. Jean Novak, founder of CBR International, discussed the future of regulatory policy and its impact on managing operations.

Roadmap development sessions were the most important part of the meeting. Participants were divided into four groups, each of which discussed an operational area—manufacturing, quality, supply chain, or R&D. Each group was instructed to identify the goals within its area and define the path to achieving them. Several key themes emerged.

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