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Printable Handouts
Navigable Slide Index
- Introduction
- Key properties: promising experimental medicine
- Considerations: safety
- Considerations: efficacy
- Considerations: drug-ability (1)
- Considerations: drug-ability (2)
- Research & development (1)
- Research: target identification & validation
- Research: screening
- Research: counter-screening and dose-dependence
- Research: lead optimization
- Research & development (2)
- Safety pharmacology & toxicokinetics
- Bioanalytics: GLP assay development
- Product stability
- IND Aside: information included
- FDA responses to IND
- Development: phase 1 clinical trials (1)
- Development: phase 1 clinical trials (2)
- Development: phase 2 clinical trials (1)
- Development: phase 2 clinical trials (2)
- Development: phase 3 clinical trials (1)
- Development: phase 3 clinical trials (2)
- Development: other trial types
- New Drug Approval (NDA) package
- Activities after submission…
- Thank you for listening
Topics Covered
- Drug safety
- Drug efficacy
- Research and development
- Drug discovery
- Preclinical research
- Clinical trials
Talk Citation
Kinch, M. (2022, February 27). Drug development: from discovery to manufacture [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 12, 2024, from https://doi.org/10.69645/RBIX3998.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Michael Kinch has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Hello, my name is Michael Kinch,
I'm an Associate
Vice Chancellor at
Washington University
in St. Louis.
Today, I'm going to talk about
drug development from
discovery to manufacture.
0:12
The key properties of
a promising experimental
medicine can
be broadly divided
into three areas:
first and foremost to safety;
second of all, is efficacy
and third is drug ability.
By far, safety is the most
important consideration.
Any molecule you put in
the body has to be safe.
The efficacy, the ability
of the drug to affect
the intended outcome is
the second most
important consideration,
but it always falls
behind safety.
The third feature,
which is known as
druggability, we'll
discuss in a little bit,
basically reflects
the practicalities
of can you manufacture
and administer medicine in
a manner that is
sufficiently practical?
0:56
In considering safety, there
are two major questions.
The first question is what is
the impact of a single
dose of a drug?
What is the impact
of acute exposure?
In other words, once
you give a medicine,
is there any evidence of damage,
either macroscopic
or microscopic?
If so, which cells and
tissues are impacted?
It's important to
understand this
after a single administration,
but oftentimes and in general,
medicines are given chronically,
meaning that there's
a repeated exposure;
perhaps, you take
a pill every day.
In this case, it's
important to understand
whether there is an accumulation
of the drug in the
body, and if so,
whether there might be certain
safety considerations that
arise because you have
now an accumulation
of this medicine.
Or, perhaps, you are
in a sustained manner,
causing some sort of
an unsafe signal to
be given that is causing
damage over time.
In order to understand
what is going on in
the body over time after
you take a medicine,
it's important to
understand its metabolism.
It's important to
understand that the body
processes pretty
much every chemical
that is taken into the body.
This processing
generally occurs in
the liver and results in what
we refer to as metabolites.
It's important to understand
which metabolites,
which breakdown products
are created in the body,
and does this alter the safety
or the efficacy of a drug?
Looking further, consider that
the enzymes in the liver
that are responsible for
this metabolism have other
jobs in the body that they
normally do other than
metabolizing the particular drug.
As a consequence, the
drug itself might
alter those enzymes and change,
for example, the
safety or toxicity of
other molecules that we
encounter in day-to-day life.
This is important then to
understand that, for example,
diet and a well-known
example is the impact of
grapefruit juice can
sometimes change
certain enzymes in the body
and then change the ability of
a drug or a particular drug to
become toxic or to
become metabolized.
It's important to understand
what is the impact of diet.
What is the impact
of other medicines
and other features in
the environment that
we all live in that might
somehow change the
metabolism of a drug.
As important is
understanding that
there are differences
among populations.
Some populations of people,
either as a result
of genetics and
or a combination of
genetics and environment,
might mean that there is
a greater safety risk
for some populations
than others.
In understanding metabolism,
it's also important to
understand are these metabolites
safe and do they
remain effective?
Does a metabolite, does a
breakdown product of a drug,
even if the drug
itself is safe, do
the breakdown products of
these drugs have the
potential to confer damage?
Again, a question also arises
is are these breakdown
products still active?
Do they still confer
the desired efficacy?
Understanding all of
this metabolism is quite
important to understand, again,
how to administer the drug.