Seqens eBook - 7

The CMO/Sponsor Relationship:
How to Strike the Perfect Balance
Ed Price, CEO, Seqens CDMO North America
The roles of Contract Manufacturing Organizations (CMOs) and Contract
Research Organizations (CROs) are growing at light speed as pharma, life
sciences and biotech firms of all shapes and sizes discover the benefit of
outsourcing key functions in the race to get products to commercialization
faster and more efficiently. But unlike the traditional model, in which a
company conducts R&D, as well as manufacturing and commercialization
in-house, this new services-based model requires a new way of thinking.
So what does it take to ensure a good working relationship between a
sponsoring organization and the CMO/CRO?
Perhaps the utmost requirement is trust. Both the sponsor and CMO/CRO
must trust each other, while ensuring that the lines of communication
remain open to ensure that there are no surprises - in terms of timetables,
cost overages or in expectations. When a problem arises - whether the
information is positive or negative, most people are grateful to know the
true story in a timely fashion; yet it's the delivery that also counts. When
hearing of a problem, no one likes to feel like it's being dumped in his
or her lap. Rather, it's important for the deliverer to explain it, while also
providing some solutions - and there are always solutions.
to disclose events/activities that can seem unrelated to the product

Below are other prerequisites for an effective partnership:

delivery timetable.

Transparency. Pharmaceutical development is a messy thing and it's not
easy. Historically, there's a hierarchy with the sponsors, of course, wielding
the most power. But even the best intentioned sponsor can have internal
problems and difficulty with communication and collaboration. For this
reason, transparency is key, and when you don't have it, things can start to
spiral unnecessarily. The CMO has to appreciate that it doesn't understand
what's going on behind-the-scenes at the sponsor organization. It's not
uncommon to work several months with a sponsor, only to learn that the
sponsor has to shut down the project - despite having already invested $1
million; we've seen sponsors who, due to budget restraints that may have
nothing to do with the project we're working on, temporarily shut down
a project until the next fiscal year's budget came through - even though
shutting down and starting back up added significant delays and costs to
the project. By being transparent and letting the CMO/CRO know about
possible concerns early in the game, both sponsor and CMO can avoid
unnecessary costs to restart the program. It's important to act like true
partners, which can be a challenge internally, externally and financially.

Addressing Mistakes. There are many people involved in a project -
from the sponsor's staff to its consultant and its CROs/CMOs - who can
be helpful or detrimental to a project. And because of the people role,
human mistakes can happen. Many sponsors, who work closely with
their consultants can be quick to blame the CRO/CMO, but it can always
be many factors involved in a situation, and no one side always holds
the blame. The CMO should be your main consultant. And all parties
must understand that mistakes happen, but they need to be looked at
realistically. Some mistakes can be minor without affecting the outcome,
yet, because of them everything else is often called into question by
the sponsor, which delays the entire project. Sponsors must remember
that the CMO/CRO will get the work done, at one-third to one-quarter
of the time and cost it would take to develop it in-house, building the
infrastructure and hiring the staff.
Let's face it, the market for CMO and CRO service providers is only getting
bigger and more competitive. There are many highly qualified firms, filled

Technology Transfer. Sponsors consistently work with many service
providers on different phases of the development lifecycle, so it's
imperative that critical information be shared each step of the way.
Aside from legally required disclosures, it's important that each provider
understands the challenges of the others and how they can impact the
eventual product. While technology transfer is critical, it's also important
Pharmaceutical Outsourcing |

with expert scientists, chemists and other professionals, but what can be
a clear differentiator is the ability to work together with mutual respect
and understanding. In an ironic twist, in light of all the scientific advances
available today, the most important factor in a successful outcome is the
human relationship.
7

| pharmoutsourcing.com



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Seqens eBook

Table of Contents for the Digital Edition of Seqens eBook

Contents
Seqens eBook - 1
Seqens eBook - Contents
Seqens eBook - 3
Seqens eBook - 4
Seqens eBook - 5
Seqens eBook - 6
Seqens eBook - 7
Seqens eBook - 8
Seqens eBook - 9
Seqens eBook - 10
Seqens eBook - 11
Seqens eBook - 12
Seqens eBook - 13
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