James Breen, Chair, FOYA Judging Committee and Vice
President/Lead, Biologics Expansion, Janssen Pharmaceuticals
James Breen, FOYA Judging Committee Chair
Since 2004, a group of 10 to 15 leaders in the pharmaceutical industry, have met to judge the projects submit- ted for Facility of the Year Awards.
These are leaders in owner organizations from
all regions of the world, representing both small
and large companies within the pharmaceutical
and medical device industries. They all have extensive experience in their fields—engineering,
manufacturing, and quality; most have international responsibilities. Several have lived or
worked outside their native countries. They are
experienced, knowledgeable, and understand
the global landscape.
The judging season starts in January with a
one-day meeting to review the FOYA submissions, which are submitted to ISPE in the fourth
quarter of the preceding year. Submissions
come from all corners of the world and represent projects in the pharmaceutical, medical,
and biologic fields. Judges nominate one project for each of the FOYA awards. If they do not
identify a project that demonstrates excellence
in any one category, however, they will not
award the category that year.
Judges arrive with their individual shortlists
of projects that they have rated according to
cost, schedule, safety, and capability. While they
have a template to help them catalog their analyses, they have the freedom to use their expert
judgment in reviewing each project.
At the initial committee meeting, the judges
review each submission, discuss their individual merits within the submitted category, and
consider whether they could qualify for other
categories within the FOYA portfolio. This process allows for much dialogue, listening to each
judge’s assessment and determining whether
the project is novel. This segment provides judges with a forum to discuss new industry trends,
and how they are reflected in the submissions.
The judges’ collective expertise and experience is brought to bear during the ensuing
discussions and evaluations. Once they have
screened each submission for compliance with
the program requirements, the judges use their
broad experience to understand the project: Do
the proposed costs and schedule seem reasonable? Did the project team clearly articulate the
accomplishment and the business value for the
overall outcome outlined in the project paper?
The judges also use their internal and external
networks to benchmark the project information
and ensure outcomes as stated were achieved.
One of the areas judges focus on is safety,
and whether it was top of mind during project
execution. They carefully review the safety
portion of the submissions in terms of “days
away, restricted or transferred,” total recordable injury rate, and the general tone of the
safety culture. This reflects the judges’ experience that projects with a strong safety record
will have better performance.
Judges then select the overall winner from
among the category winners. The process involves several rounds of discussions, followed
by a series of secret ballots. Once the winners
have been selected the judges are sworn to
secrecy until ISPE announces the category winners. The overall winner is revealed at the ISPE
Annual Meeting in the fall.
While there are a limited number of category winners, judges reserve the right to recognize projects with Honorable Mentions. These
are clearly successful projects that overcame
significant challenges in planning, execution,
One myth that I know all the judges would
like to dispel is that only large complex projects
win these awards. Nothing could be farther from
the truth—the judges discuss this as they review
the submissions. Most are small projects to im-
prove quality, reduce costs, transfer in new prod-
ucts, or implement new information technology
solutions. The judges understand that these pro-
jects are critical to the success of the business at
each facility, so we focus on and award smaller
projects that demonstrate a good return.
This year we added a new category called
Facility of the Future. The category was developed in response to the changing manufacturing environment to recognize the application
and/or implementation of innovative design
concepts, new technologies, and unique solutions that exemplify the next generation of
agile, flexible, efficient, and effective new and
existing life sciences facilities.
I have led the FOYA Judging Committee for
the past five years and I have found it to be a
wonderful experience, both personally and professionally. Having a group of leaders at these
sessions allows us to share recent trends in the
industry, discuss lessons learned from these
projects, and explore how we can communicate
these best practices across the entire ISPE membership to advance the industry. I have learned a
great deal judging these projects from a technical
and project management point of view, which
allows me to perform my duties for my employer
better and more efficiently while leveraging the
latest trends in industry. I believe each ISPE FOYA
judge would claim this same benefit.
I would like to thank the FOYA judges for
volunteering their time as well as the companies that submitted projects. Selecting the final
awards gets more difficult each year as the
quality of project submissions increase.
Finally, we all enjoy working within an industry that improves the lives of our patients.
To continue this mission as an industry, we must
strive to improve our performance each day;
FOYA allows us to recognize the effort of those
that do. ‹›