Speciality Chemicals Magazine October_November 2018

Does fear of QbD slow
breakthrough therapy
drugs’ speed to market?
As pharma continues to evolve, the drive to pursue new cuttingedge
drugs will become even greater. Piramal Pharma Solutions
discusses how, for those companies competing to push the
boundaries of innovation, a fear of implementing Quality by Design
(QbD) might end up being the biggest threat in its race to the finish.
The pharmaceutical industry’s
evolution from one that relies on the
high revenue of blockbuster drugs
to one that focuses on the unmet
needs of smaller patient populations
has changed the paradigm of drug
development. It has also driven
a rise in innovation over the past
several years, due to the advances
in technology that have generated
new opportunities in the laboratory
and in the body. Scientists learn
more and more each day about
how to produce products that can
transform patient care.
The breakthrough therapy drug
designation (BTD) made possible by
the Food and Drug Administration’s
(FDA) Safety and Innovation Act in
2012 creates even more potential
for the treatment of many diseases.
Its ‘fast-track’ status paves the
way for novel drugs to make it to
market more quickly. However,
while the review process is expedited
for a BTD, the expectation of the
FDA remains unchanged when it
comes to safety and efficacy. Proof
of a drug’s “profound clinical
effect” must be accompanied by a
development and manufacturing
strategy that can deliver a consistent
level of quality in the face of any
market demand.
An approach well known for its
emphasis on process understanding,
process control and risk mitigation
is Quality by Design (QbD). While
there are many benefits to QbD,
there is longstanding scepticism
about applying its tools and
principles to drug development.
This is due not only to the time and
financial commitment required
for successful implementation
but also because of an industry
that is well known for being risk
averse. Nonetheless, as pharma
continues to evolve, the drive to
pursue new cutting-edge drugs will
become even greater. For those
companies competing to push the
boundaries of innovation, a fear of
implementing QbD might end up
being the biggest threat in its race to
the finish.
The rocky road of a
breakthrough therapy
designation
As pharma navigates this new
era, a company developing one
of these niche drugs may find
exciting early promise in the
preliminary clinical evidence.
If these results demonstrate a
dramatic impact on patients with
serious or life-threatening disease,
a company may submit evidence
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