Manufacturing: BioPharmaceutical Operations Roadmap 2007 - FutureBio 2016 is developing a roadmap to help the biopharm industry achieve operational excellence. - BioPharm International


Manufacturing: BioPharmaceutical Operations Roadmap 2007
FutureBio 2016 is developing a roadmap to help the biopharm industry achieve operational excellence.

BioPharm International
Volume 20, Issue 4

Likely Owner: the groups inside and outside of biopharmaceutical organizations that should spearhead the effort to close the gap.

Relevant Desired States: an indication of which desired state the gap impacts most.


Table 2. The following companies participated in FutureBio 2016.
Based on the desired operational states the group identified, it is clear that it is necessary to leverage the skills and capabilities of those outside of operations.

Much work has been done (and still needs to be done) within operations to reduce cycle times, improve maintenance reliability, and improve operational efficiencies. Currently, the required skills needed to improve these operational metrics reside within the traditional operational groups. However, when looking towards the future, where step change improvements are required, other groups like regulatory and R&D become vital participants. Historically, these groups have not had to play a significant roll in driving operations excellence.

Keeping this in mind, there are several things that need to happen to help close the identified gaps:

1) Engage company leadership in operations issues. The organizations most likely to succeed in closing the gaps will have a leadership team that will drive the appropriate behaviors across the organization. Some companies are more ready for this than others.

2) Build the capabilities to close the gaps. Many of the identified challenges have been addressed in other industries. Consultants, forums, and new employees can all provide the tools and expertise required to help improve systems and processes without needing to reinvent the solutions.

3) Work together. Some of the gaps will require the industry, in the form of consortia or existing industry groups, to drive policy at the regulatory level. The Biopharmaceutical Operations Excellence Consortium, a group that has already been working together for the past four years, is one arena in which the identified gaps will be addressed.

4) Leverage vendors. For many aspects of the business, vendors are the keepers of the most current and cutting-edge knowledge of facility design, automation, and process techniques. Companies need to be sure they are leveraging those capabilities and, in some cases, incorporating key vendors into their own organizations during process and product development.


For four years, through 25 meetings, the Biopharmaceutical Operations Excellence Consortium has been a place for industry leaders to meet and discuss operational challenges. This year, the consortium meetings will focus on the gaps described in this article. The meetings will leverage knowledge from inside and outside biopharmaceuticals and ideally include representatives from the industry who are tasked with helping close the identified gaps.

Executives (Table 2) who contributed to the roadmap will reconvene and review their progress. Updates will be provided on the outputs of the consortium meetings, and individual companies can discuss their internal projects that have been successful. Roadmap priorities may change, new priorities may appear, but the commitment to maintaining a consensus on what is important for the industry will not waver.


Implementing the roadmap will be a long and challenging process. Some companies, with the appropriate support and focus from senior leadership, will achieve early wins and success in closing the gaps. Others will see the challenges of operations take a back seat until market or regulatory conditions force them to significantly improve their organizations to remain competitive.

The identified industry collaboration opportunities are challenging because they require cooperation between firms, as well as regulatory support. However, the rewards will be dramatic for patients and for the industry. Therefore, the consortium will serve as the clearinghouse for vetting these opportunities and we will continue the dialogue to identify a concrete path forward.

At the end of the day, the roadmap is simply a construct of the minds of industry leaders. Turning strategy into something real is where the hard work begins.

Marc Puich is a partner at Tefen, Ltd., Foster City, CA, 650.357.1120 x117,

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