Seqens eBook - 4

What's On the Minds of Biotech and
Generic Drug Manufacturers in 2019?
Ed Price, CEO, Seqens CDMO North America
While rising prescription drug prices hogged the headlines last year,

The U.S. and China will continue to rely on each other. Despite a trade

pharma firms and Contract Development & Manufacturing Organizations

war and tariffs between the U.S. and China, the two countries will continue

(CDMOs) were busy working behind the scenes, developing Active

to work together for their self-interests. China is a major low-cost supplier

Pharmaceutical Ingredients (APIs), New Chemical Entities (NCEs) and

of raw materials used in drug manufacturing in the U.S., and manufacturers

medical devices that are driving a new level of innovation in 2019.

will continue to rely heavily on these suppliers to help them provide

From medical-grade polymers that provide new ways to deliver medicine

generics and small-batches of specialty drugs. Since the U.S. is a source of

to patients, to pharma foods to treat chronic diseases, this new year will

new lifesaving drugs that aren't otherwise available in China, the Chinese

completely transform how we develop and deliver new treatments that

will continue to approve record numbers of U.S.- based products.

focus on personalized patient experiences and better outcomes.

Faster FDA approvals may lead to shortages of raw materials. GDUFA

In addition to working toward better outcomes, the race to deliver

(Generic Drug User Fee Amendments) and GDUFA II, which extended

new innovation is driven by patent expirations on brand-name drugs,

FDA inspections of international manufacturers while also speeding up

which are opening up new opportunities for generics to provide the

the approval process, may lead to a shortage of raw materials, which

same effectiveness in different forms and create a new market of

could hinder the availability of generics. As more and more generics are

healthy competition.

in demand, there may be a scarcity of raw materials required to produce

So being the first to commercialize new offerings in these areas will be

them, which could lead to drug shortages and higher prices for raw

of top concern for drug manufacturers in this new year; and their efforts

materials and final products. Even if the FDA opens barriers to entry for

just may be realized a little faster, as the FDA continues to speed up the

generics, industry consolidation among big pharma, with deeper pockets

approval process in the wake of high priced drug monopolies.

and significant buying power, could make it tougher and more expensive
for small generic manufacturers to acquire the necessary raw materials.

While easing FDA regulations, drug discovery and a robust economy are
opening up new opportunities and optimism in the industry, in 2019

The shortage of qualified chemists will affect the industry. Two out of

drug makers are increasingly becoming concerned with the ability to

five Americans say the STEM worker shortage is at a crisis level in the U.S.

hire qualified scientists and source quality raw materials to keep pace

The shortage of qualified scientists to fill all areas of chemical research,

with demand.

development and manufacturing will be one constraint on growth

Below are five trends that will impact the industry in this new year:

and productivity this year. When it comes to encouraging students to
pursue STEM education, many look to computer coding but what the

Strong growth for CDMOs. There are a number of factors driving growth,

industry must do is find ways to work with educators and policymakers

including a robust economy; private and foundation money flowing into

to encourage careers in physical sciences in order to maintain continued

the sector; big pharma's continued move to shut plants down; a shift to

growth, innovation and manpower to ensure our biotech sector remains

a more cost-effective outsourcing model; and the FDA speeding its drug

world-class.

approval process. That said, risk factors for the sector include: a fluctuating
economy; a stock market that has seen wild drops; and increased

As we dive full steam ahead in this new year, we can expect to see

consolidation among CDMOs.

breakthroughs in drug delivery, as well as greater options through an

Practical innovation becomes the watch word. Big data and artificial

expanding generics marketplace. But, companies recognize that they

intelligence will help in drug discovery, but, along with continuous

can't do it alone, the FDA needs to remain committed to faster approvals,

manufacturing, they're all still in the early phases. Yet, batch manufacturing

CDMOs need to continue to work with China and elsewhere on mutually

will continue to represent 99 percent of all pharma manufacturing.

beneficial sourcing partnerships and academia has to work to help us

Advanced techniques like cryogenics, micronization, lyophilization and

educate the next generation of scientists to fill critical positions. It's an

polymer-based drug delivery systems will see an uptick in demand as

exciting time to be a part of the industry and working together, we can

providers and patients look for more readily available, affordable and

ensure an industry where everyone profits - patients, government and

effective drug delivery and treatment options.

pharma firms.
Pharmaceutical Outsourcing |

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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
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Seqens eBook - 23
Seqens eBook - 24
Seqens eBook - 25
Seqens eBook - 26
Seqens eBook - 27
Seqens eBook - 28
Seqens eBook - 29
Seqens eBook - 30
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