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A SPECIAL
ANNOUNCEMENT FROM: |
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Anil Kane
Executive Director and Global
Head of Formulation SciencesPatheon |
As drug developers face the ever-pressing need to get molecules to market as efficiently as
possible, firms large and small are increasingly turning to CDMOs for help. The CDMO industry
is evolving to meet this need, spurring some larger providers to offer forward-thinking services
in the form of end-to-end supply chain models for pharmaceutical and biopharmaceutical clients.
At a panel discussion held at CPhI North America 2017 in Philadelphia, four industry experts discussed
how working with a single-source CDMO partner can accelerate time to market, add cost
savings, and improve a formulation’s chances of achieving regulatory success. |
Robert Fry
Chief Economist
Robert Fry Economics, LLC |
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Paul Nelson
Vice President of
Supply Chain and R&D
Amring Pharmaceuticals |
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Doug Johnson
President
OCAM Solutions, Inc. |
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Speed and the Single-Source Model
According to Anil Kane, executive director and global head of formulation sciences at Patheon, speed
is essential in drug development. Patients need their medications, and competitors are vying to get
their products to market first. Working with even more compressed timelines are firms racing toward
commercialization with life-saving therapies that have fast-track status. Likewise, small biopharmas
deal with incredible time pressure as they function in a market-driven environment.
Unfortunately, a multi-vendor approach often adds more time and effort than many firms would
like. Drug developers need to negotiate numerous vendor contracts, complete technology transfers,
conduct revalidation, and complete other time-consuming tasks.
Compare this approach to a single-source vendor option, which has the unique ability for both drug
substance and drug product teams to collaborate from development through commercialization, representing
a major shift in the drug development world. Aligned services in end-to-end supply chains include
the development and optimization of drug substances and products; the manufacture of supplies in batch
through commercial sizes; clinical and commercial packaging; supply chain management; and more.
Because cross-team collaboration allows for real-time feedback about both the drug substance
and drug product, one can move efficiently from an API to a drug product with fewer errors. Potential
problem areas (like poor solubility, bioavailability, or process-ability) can be worked out before the
process is scaled up. If formulation problems are caught in early development phases and work is
completed to understand the molecule and its characteristics, developers will benefit from more robust
process development that avoids costly and time-consuming “re-dos” during scale-up.
Other time-savings that surface when all aspects of a project lie with the same vendor are those
associated with external technology transfers, vendor qualification, negotiations, and follow-up. All
these activities are eliminated on the client end. According to one CDMO, its trademarked single-vendor
network “eliminates 8–12 weeks of development time for small molecules and 14–20 weeks for large.”i
While the single-source CDMO option may well be a forward-thinking approach in the world of pharmaceuticals
and biopharmaceuticals, there is a strong precedent for it in other manufacturing sectors.
For instance, Robert Fry, chief economist at Robert Fry Economics, LLC, explained that Toyota’s lean
manufacturing model limited the number of suppliers it worked with so that the car maker could produce
new models much faster than its competitors. |
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Breaking Down Barriers: Communication in a Single-Source Model
A single vendor offers access to a network of experts across several disciplines who can share knowledge
about a project as a molecule moves from phase to phase, thus helping to ensure it stays on a
path toward commercial success. |
Paul Nelson, vice president of supply chain and R&D at
Amring Pharmaceuticals, offered an example of how having
such knowledge through a single vendor could have benefited
a recent R&D project he worked on. Several molecules in his
pipeline had development work completed in India while the
manufacturing activities were conducted in France. The project
came to a halt after the first pilot batches were made poorly.
An investigation was launched to determine the source of the
problem, probing the possibility of a development issue, tech
transfer problem, manufacturing issue, or something else. The
time-consuming process caused a significant delay.
If the development and initial manufacturing work had both
been done by a single vendor, the problem may not have
occurred. But if it had, the open channels of communications
that a single provider offers would have made identifying the
root cause of the issue much easier.
Doug Johnson, president of OCAM Solutions, Inc., adds that
communication in a single-vendor network helped fix a major
problem his client had with an API. Had the client used multiple
vendors, resolving the issue would have required breaking a
commitment with one manufacturer and starting a new contract
with another vendor. Rather, the single-source vendor was
responsible for figuring out how to remedy the problem with
the API because it was their work to begin with.
A single vendor with involvement in a project from soup to
nuts has a unique opportunity to help their client by integrating
information that is generated from all points along the project
continuum. “A single vendor can leverage expertise typically
stashed in silos across different stages of the process, from API
development to formulation and the supply chain,” noted Kane.
For example, in the Patheon OneSource™ model, a single
program manager oversees all activities, and bridges various
teams and sites performing the work. Having a program manager
so close to the client and the operations brings efficiency
and speed to the process.
Nelson agreed that this type of program management
strategy can be key to a project’s success. Decisions on
sourcing of API development and subsequent manufacturing
are usually made before an application for regulatory approval
is filed. Many companies do not have the coordination needed
to determine where final commercialization will be done at the
time they are getting ready to file. A program manager can
facilitate good coordination and look at the value stream that
cuts across all business units and functions.
Due Diligence: Selecting the Right Partner
When helping pharma clients evaluate single-source vendors,
Johnson said he looks for four must-have characteristics:
capability, flexibility, stability, and caring.
- A variety of capabilities are essential for helping to improve
a process and elevate a compound from early-stage
work through commercialization. When trying to make a
good match between what a client is looking for in an
outsourcing partner and the CDMO’s capabilities, Nelson
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- added that the process is as much an art as it is a science.
Several CDMOs may all have similar equipment, but what
really differentiates them are the dedication and knowledge
of the individuals working on the projects. Is that know-how
and capability embedded in the organization? In some
cases, clients have been burned by the claim that an
outsourcing partner had competencies in areas it did not.
- Without fail, unexpected twists and turns will surface
during drug development. A CDMO’s flexibility is critical,
especially in early phases. Firms should have the dexterity
to address unanticipated problems quickly and adjust.
- The vendor cannot simply provide a service; they must
have a track record of providing services well. CDMOs ted
to acquire other companies with expertise in a specific
area. A single-source vendor must also be reliable and
stable—fiscally and in terms of longevity, all while putting
out high-quality work.
- Larger CDMOs may be working on hundreds of projects
simultaneously, but a good partner also ensures every
client receives the attention it deserves.
If a client pays more to have these four elements in a single
provider, Johnson said it is money well spent in exchange for
time saved and a better end-product.
Streamlining from the Start: One Vendor, One Contract
A key advantage of the single-vendor network is that clients will
only have one contract. Having to negotiate contracts and legal
agreements with multiple vendors requires a lot of time and
energy—even if just two suppliers are involved. Nelson said he
has seen contract negotiations between two vendors working
on the same project take as long as 18 months to finalize. This,
of course, takes time away from doing more valuable tasks, thus
the single-source provider is far more efficient in this respect.
When negotiating a contract with a single supplier, it is critical
to get the language right. From the stance of an economist,
Fry said incentives must be balanced such that both parties
benefit from doing the right thing. It is crucial to consider all
contingencies and to cover all the bases. For example, is the
client protected if the price of raw material sharply increased?
Nelson noted that risk management is also important when
looking at an end-to-end supply chain. There is economic risk,
the change of a supply interruption, and even location risk, for
instance, if the vendor is in a hurricane zone. All types of risk
must be examined to build the best risk-management strategy.
Summary
Like any new technology, some pharmaceutical companies
are still hesitant to adopt the single-vendor sourcing model,
especially small, emerging firms. While some companies are
taking a watch-and-wait approach to see how the singlevendor
concept pans out, those that are already embracing
it are reaping the benefits of efficiency and expertise.
i Patheon OneSource™, www.patheon.com/onesource/index.html, accessed June 1, 2017.
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