Please wait while the transcript is being prepared...
0:00
This overview addresses
pharmaceutical life cycle
with particular emphasis
on the journey of
a pharmaceutical product
from drug discovery and
pre clinical development through
clinical trials and
the complex regulatory
approval process.
We will explore how
intellectual property and
regulatory exclusivity
are managed
to balance innovation
with affordable access.
The presentation will also
discuss commercialization,
market expansion,
and the strategies
required for effective
lifecycle management.
Finally, we will
examine the impact
of generic competition after
patent exploration
and the importance of
planning for sustained
innovation and access.
The journey of a modern medicine
begins long before it
reaches a pharmacy shelf.
Drug discovery starts
with screening
thousands of compounds to
find promising candidates.
Pre clinical development
then tests these
for safety and efficacy
in labs and animals.
Clinical trials from
phase one to phase three,
establish safe dosing
and prove effectiveness.
This process, taking over a
decade and costing billions,
highlights the challenges and
complexity of
pharmaceutical innovation.
After clinical development,
a critical chapter in
the pharmaceutical life cycle
is the regulatory
approval process.
A dossier is submitted
to authorities like
the Food and Drug Administration
or European Medicines Agency,
containing evidence
from research,
manufacturing controls,
and clinical trials.
Regulators scrutinize
this to ensure
safety, efficacy, and quality.
