APR Sept/Oct 2023 - 100

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BIOPHARMACEUTICAL
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In life sciences hotspots, real estate investors and developers have
found success converting single company campuses into dynamic
multi-tenant parks. For example, several years ago, GlaxoSmithKline
sold its campus in Research Triangle Park to Karlin Asset Management,
which assembled the parcel with the DowDuPont and Ellis DNC
campuses to create the 638-acre Research Triangle Park. Karlin
invested $80 million in building upgrades and amenities to eventually
attract tenants such as Duke Health and Lab Corp.
In another creative development, a life sciences company sold the bulk
of its campus to a multifamily developer while continuing to occupy an
office building on the site. To eliminate an overly branded, corporate
campus atmosphere, the company transformed the first floor of the
office building into a welcoming public facility that includes a library,
food services and group exercise space for the larger community.
These examples illustrate how companies have found creative uses
for underutilized space. The pace of change in the world today
opens many possibilities for legacy campuses, such as repurposing
older buildings for biomanufacturing, e-commerce logistics
facilities, multifamily neighborhoods, warehouse development and
more. No matter what route a company takes, giving new life to an
old campus presents a tremendous opportunity to enhance culture
and reinforce quality.
How Enlivening a Campus Enhances
Quality Culture
Whether
an
organization
enlivens
attitudes and behaviors that promote a dedication to excellence and
continuous improvement.
Uniting Quality Expectations on a
Shared Campus
its campus through social
events, wellness amenities or more transformative initiatives such
as developing a multi-tenant innovation park or live-work-play
community, its effort can have an unexpected indirect benefit:
enhancing its campus quality culture.
Quality assurance ranks among the top priorities for every company
in the highly regulated life sciences industry. Maintaining consistent
quality requires something that goes beyond the act of checking
boxes for compliance. It requires adapting quality as a core value to
support a culture where everyone - from scientists to custodial staff
- prioritizes quality in everything they do.
Nothing enhances quality culture quite like a beautiful, dynamic
facility where people enjoy spending time. Employees tend to
produce their best work when they enjoy coming to the campus and
thrive in their environment. That's because when people don't want to
lose something they love, they outperform to keep it. Having pride in
one's workplace can deepen commitment to the company's purpose
and reinforce each individual's role in maintaining quality.
Working in a multi-tenant environment, where employees can
network with others in the industry, has the potential to enhance
quality culture even further. People can meet face-to-face to discuss
best practices and industry trends, sparking new ideas and fresh
ways of approaching old problems. Organizations can also plan
community events and friendly competitions focused on qualityrelated
themes. This collaborative spirit
strengthens the values,
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| September/October 2023
Overall, I believe the benefits of a dynamic, multi-tenant environment
have great potential to enhance quality culture, outweighing any
challenges that may emerge. However, bringing outside organizations
or other community members onto a legacy company campus
introduces a few compliance-related complexities.
The issues arise around shared regulated spaces, utilities and support
services, such as utility plants, shared warehouses, pest control
and security services. A proactive approach helps ensure that these
utilities, services and spaces are managed appropriately to address
each organization's unique compliance requirements. The first step is
to identify an owner that is ultimately responsible for the operations,
performance, maintenance and quality. The responsible party is
typically the landlord who owns the facility, but sometimes a space
such as a shared warehouse or a central utility building may be
managed by a tenant.
To ensure that everyone has the same understanding of quality
expectations of regulated systems, the owner and all tenants should
establish an agreement that lays out all expectations for how the
space or service must be managed to provide compliance.
The agreement must also set forth the involved parties' mutual
understandings regarding certain responsibilities, specifying how
each duty will be managed, supported, and maintained against the
highest quality standards. This agreement should also specify relevant
regulatory bodies because each company occupying a shared campus
may face different compliance obligations based on their products
and where they sell them. For example, a company that exports its
products to the UK, Latin America or other geographies faces different
regulations than one that sells only in the US.
Additionally, the agreement should lay out the requirements for how
the space, system or service must be managed. No issue is too small
- the more specific the requirements are, the better. The following
examples illustrate some sample issues that might be covered by a
quality agreement in a shared campus:
* Central utility plant: Depending on the type of companies
operating on campus, a plant may provide a variety of utility
services, such as chilled water, steam, compressed air, purified
water and more. Many of those utilities may be classified as
FDA-regulated services by some companies but not others,
making it imperative that the quality agreement establish which
utilities are considered regulated. Then the agreement can
outline the roles and responsibilities to comply with regulatory
expectations, such as operational parameter monitoring,
sampling of the utilities and a well-documented preventative
maintenance plan.
APR Sept/Oct 2023

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