Seqens eBook - 27

CMOs

While there continues to be great opportunity for CMOs, they
continue to be confronted with key challenges that require they
continuously reinvent themselves. These challenges include:

Inequitable policies that inhibit competition: The high cost of new

Recruitment and Training: One of the most pressing challenges
for CMOs is recruiting and training the next generation of technical
employees. Salaries aren't always as high in CMOs, as in biotech/
pharma sponsor sectors, yet opportunities abound for young
scientists, through more intense, hands-on-learning within a variety
of projects. CMOs are challenged with finding the right candidates
with the expert credentials, who also have the flexibility and agility
to adapt to different projects, cycles and phases within such as
outsourced environment.

And because companies can charge more for the same medicines

Funding: With so many companies increasing their outsourcing, one
of the challenges virtual pharma companies face is that they need
drug substance for toxicological studies, yet investors may be holding
back funding until certain successful milestones are achieved.
Investment decisions need to keep pace with the realities of the clinic.
Additionally, as regulations continue to constantly change, more work
needs to be done to keep pace, which requires additional investment.
As the market intensifies, CMOs must learn to better collaborate with
sponsors, consultants and other partners to ensure proper funding of
each step of the way during early stage development.

counterpart agencies like the European Medicines Agency to address

Pharmaceutical Outsourcing |

drugs is a bigger issue in the U.S. than the rest of the world because
the U.S. lacks the same price controls that Europe and Japan offer.
than they can elsewhere, the industry relies on American patients
to subsidize the necessary investments to go from discovery to FDA
approval. Further, under current FDA policies, closed distribution
loopholes provide a virtual monopoly even after the patent has
expired for drugs like Daraprim, which enabled its U.S. manufacturer,
Turing Pharmaceutical, to raise the per-pill cost of the drug. The FDA
needs to look into the closed distribution loophole and to talk with its
the unfair financial burden placed on U.S. consumers who subsidize
the drug costs for patients in other countries.
As the opportunity for pharma and biopharma firms to seize
market share and bring much-needed drugs to market continues to
accelerate, CMOs are sharing in the excitement and rewards. Those
that can adapt to changing product developments and regulations,
bringing innovative technologies and wide-ranging expertise to bear
on critical projects will come out on top.
27

| 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
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