PharmaceuticalOutsourcingQ42020 - 10

INSIDER INSIGHT

API Manufacturing Can Be
Riskier Than You Think

Six Best Practices to Minimize Risk and Avoid
Time and Cost Over-Runs
Ed Price

The API manufacturing business can be a risky one - especially when
dealing with chemical substances that will be consumed by humans.
But it's not only potent drugs that create risk for API manufacturers. Risk
also can come from project delays or problems in the lab or plant that
can derail projects and their timelines and result in cost over-runs.

Founder
Seqens North America CDMO

According to the consultant firm, Booz Allen, it often takes more than
a decade and an estimated $2.6 billion to bring a new drug to market.
And, all too often pharmaceutical companies fail to reach success. In
fact, nearly 14% of all drugs in clinical trials eventually win approval from
the FDA.
While the costs are high and the success rate low, it's important for drug
sponsors to do all they can to minimize risk to ensure a successful (and
the least costly) outcome. Yet, many factors can impact risk, especially
when it comes to drug substance manufacturing: the experience of the
team producing your API; the quality or availability of raw materials; the
method development prescribed; or the changing regulatory mandates
that must be met. Any one of these issues can put your project at risk
of going over-budget or failing, and resulting in the loss of millions of
dollars with nothing to show for it. It's quite the gamble, but on the
other hand, for those drug candidates that succeed, most often the
rewards far outweigh the challenges.
To minimize risk and set the project up for the greatest chance for
success, below are six best practices to consider.
1.	
Ed Price is founder of Seqens North America CDMO (formerly PCI
Synthesis), an integrated global provider of pharmaceutical synthesis
and specialty ingredients. From the company's Newburyport, Mass.
operations, Seqens N.A. CDMO provides emerging and mid-sized
pharmaceutical companies access to the expertise needed to develop
and manufacture complex small molecules. Seqens is part of Seqens
CDMO, an integrated global leader in pharmaceutical synthesis and
specialty ingredients, delivering custom-made products and solutions
to its customers that operates 24 industrial plants and 3 R&D centers in
Europe, North America and Asia.

Pharmaceutical Outsourcing |

10

Developing regulatory strategy. It's important to understand
the regulatory landscape before initiating API development.
This includes the guidelines, key stakeholders and regulatory
requirements. Developing a clear strategy in these areas
creates a framework for the project and helps you determine
the fastest route to successful completion. One way to
accomplish this is to hire an experienced consultant. You can
also request a meeting with the FDA for guidance. Once you
have your regulatory strategy in place, the key is to share
it with your CDMO in order to accurately execute chemical
development processes.

| October/November/December 2020



PharmaceuticalOutsourcingQ42020

Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Roundtable
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4
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