Seqens eBook - 12

Successful API Development:
Lessons from a CMO
Ed Price, CEO, Seqens CDMO North America
Ingredients (APIs) is a costly and time-consuming process, there currently
is enormous market demand for APIs to address the challenges of an
aging population, and an increasing amount of chronic diseases such
as cancer, cardiovascular diseases, diabetes and many others. According
to a new market report published by Persistence Market Research,
"Active Pharmaceutical Ingredient (API) Market," the global API market is
estimated to reach $186 billion by 2020, up from $127 billion in 2014.
And it's not just market demand that's driving new projects. There are
also investors eager to turn a profit or merely survive - as the growth or
demise of an entire company can ride on this one project that must be
considered. One of the ways you can not only ensure successful outcomes,
but also keep costs in check is to make sure the Contract Manufacturing
Organization (CMO) you are working with is the right one for your project.
Yet, the biggest thing in the API development business is the unknown.
There's uncertainty about whether your drug will ever receive FDA

the problem and works to remedy it. Because so many details and aspects

approval and become commercialized - despite all of your best efforts.

of API development need to be managed very closely, things can fall

But before you get to clinical trials and approvals, you need to find a

through the cracks, so getting to the core of the problem is crucial.

CMO you can trust. Finding the right CMO for the project is an important
decision, and you need to reduce any uncertainty when evaluating (and

Insist on transparency: When problems arise, the need to have

then working with) a CMO you have never worked with before. Even when

transparency is critical. Sometimes the problems are no fault of anyone,

you do all your homework, you can have doubts that it was the right

for example, you might not be able to get decent yield, or the right level

decision, yet choosing the right CMO is something within your control.

of purity. Yet the sooner problems are raised, the faster everyone can

To help drug sponsors navigate this process, below are four best practices
to consider when selecting a CMO to help with API development initiatives:
Understand that bigger isn't always better: When looking for a CMO
partner, it's not always the largest one that is the best fit. Sometimes
sponsors think their safest bet is to go with a large CMO, which may have
more resources and staff. But it's also possible to get lost, particularly if

work on a resolution. And the level of transparency can vary from region
to region. Many countries think it's a sign of weakness to disclose any
problems in API development and manufacture, and they don't want to
burden the sponsor with the problems that are occurring, hoping they can
resolve them on their own. But what is often the case, is that the problems
become insurmountable and costlier, and without time to plan ahead and

your project has a small budget compared to their other clients. Instead,

perhaps notify investors, things can spiral out of control. Because of this,

ask the prospective CMO about how it ensures that smaller projects don't

ensure nothing less than complete transparency from your CMO.

get orphaned as resources are allocated to bigger-budgeted projects.

It's never too soon to start looking for a CMO: Before you think you

Make sure to get commitments regarding resources, specialized expertise
and timelines, as well as proof that the team will be collaborative, and
transparent. Smaller CMOs are always more eager to please because they
never take their customers for granted.
Ensure good communication: Nothing can substitute for good
communication each step of the way. To ensure good communication,

need a partner to help develop your API, start doing your homework and
leave enough time to explore your options. Additionally, lots of upfront
documentation and relationship building has to take place before the
project can commence, so don't let the CMO selection delay what is
usually a very long process anyway.

both the sponsor and the CMO should have good systems in place to

API commercialization is a costly and time-consuming process and the

make sure everyone is well aware of project timelines, budget and goals.

companies you choose to partner with along this journey should be

They also need to immediately communicate problems that arise to

carefully considered. Regardless of your choice, it all should come down

ensure a collaborative discussion takes place that gets to the root cause of

to openness, honesty and trust.

Pharmaceutical Outsourcing |

12

| pharmoutsourcing.com



http://www.pharmoutsourcing.com

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
Seqens eBook - 14
Seqens eBook - 15
Seqens eBook - 16
Seqens eBook - 17
Seqens eBook - 18
Seqens eBook - 19
Seqens eBook - 20
Seqens eBook - 21
Seqens eBook - 22
Seqens eBook - 23
Seqens eBook - 24
Seqens eBook - 25
Seqens eBook - 26
Seqens eBook - 27
Seqens eBook - 28
Seqens eBook - 29
Seqens eBook - 30
Seqens eBook - 31
Seqens eBook - 32
Seqens eBook - 33
Seqens eBook - 34
Seqens eBook - 35
Seqens eBook - 36
https://www.nxtbookmedia.com