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.
CLOSING THE GAPS
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.
Table 2. The following companies participated in FutureBio 2016.
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.
HOW THE CONSORTIUM WILL HELP
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
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, email@example.com