ferent expertise sets at different stages. Obviously, compliance
records, costs and expertise are important but most companies
will look competitive in these areas, so it is important to think
In the CDMO world, when a pharmaceutical company is considering an outsource partner they should have considered what
their success looks like long term and be planning for achieving
that best chance of success. Starting with the finish in mind, enables the foundational concepts around a target product profile
to be produced, which acts as an excellent guide to the enormity
or simplicity of the task at hand. The consideration should then
be around whether a generalist outsourcing partner will suffice or
whether specific areas of expertise are critical to product development success.
Based on this type of approach it is possible to then be specific
in the analysis of which CDMOs or even multiple CDMOs best fit
the need. That is, if you have a challenging molecule with a high
risk of failing to achieve relevant bioavailability, it would make no
sense to focus on a great CMO, if they lack innovative expertise
in early formulation development phases. Likewise, if you have a
challenging timeline you would want to consider which company
can be most nimble to respond whilst still providing expertise in
development of a robust validated product.
However, where the product development follows a more
conventional path, then a generalist CDMO offering cost effective development will clearly suffice. This type of risk-based approach would hopefully avoid costly mistakes of either under or
over estimating the criticality of each development step.
Mackay: Regulatory compliance, technical capability and operational flexibility are core client service expectations that we believe
need to be demonstrated in today’s competitive environment.
As mentioned, we believe that cultural fit is also fundamentally important. We ideally partner with dynamic, fast-growing
companies, who are pragmatic yet focused on achieving the core
project objectives. Smaller drug developers are more likely to
want to partner with smaller CMOs that will value their business and offer real experience to help them navigate the drug
development landscape. We’ve heard time and time again from
smaller drug developers that they don’t like to feel like a little fish
in a very large pond, which is often the case when using a larger,
one-stop-shop style CDMO.
Sheehan: As a result of the supply chain efficiencies, such as reduced lead times and cost savings, that can be gained from using
a single supplier, it’s becoming increasingly common for pharmaceutical companies to seek a turnkey service from CDMOs to
support taking their products through the entire product lifecycle.
The broader the scope of services your CDMO can offer the better, particularly if you’re looking to develop a long-term partnership. A wider service offering could meet the requirements
of future products too and mitigate the task of finding a new,
reputable CDMO for each project. In addition to a breadth of services and technologies, your contract partner should also have
a responsive and experienced team that can help to overcome
development, manufacturing and distribution challenges as well
as adding genuine value to your operations.
Quick: Firstly, due to the nature of our industry, quality standards and compliance culture are key. Pharmaceutical companies
should also consider the range and breadth of services offered by
a contract partner and its geographic reach, as ultimately, this will
help to simplify and streamline their supply chain. At present, the
greatest challenge faced by CMOs is the upcoming deadlines for
pharmaceutical serialization in the U.S. and Europe. When choosing an outsourced partner, it’s important to assess its serialization
program and how prepared it is to meet the 2017 and 2019 compliance requirements. There is a likelihood that many CMOs will not
be ready to supply serialized drug products and this will have a
serious impact on product supply into key markets.
Leal: Besides the required technical capabilities, it’s important
pharmaceutical companies choose a partner that is client-orien-tated—having the customer as the ‘end goal’ and not just as a
means to other objectives. It also takes long-term focus, a clear
and well-defined business model and the avoidance of conflicts
of interest, which inevitably appear if the CDMO has its own
product portfolio, for instance.
Alignment and integration with the customer as well as reliability, responsiveness and flexibility remain very important factors for long-term success.
CP: IN WHICH AREAS OF DRUG DEVELOPMENT AND
MANUFACTURING ARE YOU SEEING THE GREATEST
DEMAND FOR OUTSOURCING?
Madden-Smith: In general, the CDMO sector across the board
has seen considerable annual growth over the past five years.
Specifically, at Juniper we have seen an increased outsourcing
tendency for preclinical and early Phase I and II development
activities where there are challenges around small molecule APIs,
for example poorly water-soluble drugs. Clients are increasingly
coming to CDMOs that can bring a breadth and depth of expertise to the development and manufacture of dosage forms, to deal
with significant technical challenges.
Mackay: We have experienced significant growth in the U.S. market in recent years, with the North American market now accounting for over a third of our revenues. We expect that to continue
as demand from U.S.-based biotechnology firms looking for small
scale aseptic manufacturing capabilities to support clinical trials increases in line with their collective financial good health.
However, with a shift towards the development of personalized medicines among emerging biotech and pharma companies
and a greater need for cytotoxic products, there will be a greater
need than ever before for specialist CMOs that can rapidly manufacture small (and potentially complicated) batches for small
Sheehan: There is growing demand for controlled release technologies that can optimize the performance of novel and existing
drugs by reducing the potency of a product or the risk of dose
dumping and adverse side effects. Given the level of skill and
technical expertise required to develop and manufacture controlled release dosage forms, pharmaceutical companies are increasingly asking their CDMOs for these services. CDMOs with