[Link].
Industrial Training
Daily Report
Date: 09-06-2021 Time: 10:15 a.m. – 5:00 p.m.
Name of Session/Topic: SELECTING ANIMAL MODELS DURING DRUG DISCOVERY and
PRECLINICAL RESEARCH IN INDUSTRY
(Use separate page for each session/Topic)
Name of Expert, Affiliation: Dr. Ramnath (Associate Research Director) Reliance Life Sciences
and Mr. Sameer Shaikh (Research Leader) Reliance Life Sciences
Sr. No. Learning Where can you apply this Question
knowledge? answer/Quiz
1) 10:15-11:15 As we have to make our
careers in pharmacy hence
In this webinar we talked about gathering a basic knowledge
“Understanding Pharmaceutical about the pharmaceutical
industry” industry is very important.
We started with the Four key
building blocks of the Hence this session gave us the
pharmaceutical industry which basic knowledge which can be
are: very useful in the future.
• Introduction to the
Industry
• Drug Discovery
• Drug Development
• Medical Affairs
Then we discussed about the
global scope and revenue. We
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 1
[Link]. Industrial Training
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talked about the pharmaceutical
industries history.
Then we discussed about
various regulations such as FDA,
Department of health and
human services, drug
enforcement administration.
Then we learned about the drug
and how it is different form
biologics. We also learned about
the API i.e., active
pharmaceutical ingredient.
Then we learned about the
prescription triangle:
• Consumers and patients
• Physicians
• Payers
Then we learned about the
managed market segments
including:
• Private health plans
• Corporate account
• Government insurance
program
And we also learned about
various smaller segments like:
• Hospitals and health
systems
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 2
[Link]. Industrial Training
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• Pharmacy benefit
managers
• Long term care facilities.
Then we talked about the
payer’s influence, consumers
influence and prescriber
influence and manufacturer
influence.
We also talked about the
demand and supply.
Then we discussed about the
importance of drug discovery.
We then learned about the
various stages of drug discovery
like:
• Exploratory discovery
• Later stage discovery
We then learned about the
various computer-based
technologies which can be used
for discovery of drug.
We also learned about the
impact of pharmacogenomics.
We then learned about the
process duration of drug
development process.
We also learned about the
various clinical and preclinical
development. We discussed
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 3
[Link]. Industrial Training
Daily Report
about the clinical testing phases
i.e., phase 1, 2, 3 etc.
At the end we discussed about
the various CROs. We also
discussed about the bridge
between research and
commercial and then we
discussed about the
organisational structure.
2) 11:30-01:00 In this session we learned There were
about “SELECTING ANIMAL questions asked
This session was based on like:
MODELS DURING DRUG
“SELECTING ANIMAL MODELS
DISCOVERY”
DURING DRUG DISCOVERY” Till what extent
This knowledge can be very alternative
In this we started with the drug method are used
useful if we want to make our
development process which as nowadays there
careers in the pharmacology
included: ongoing debate
field and hence go for R&D.
about using
• R&D animals for
• Efficacy and toxicity experiment
• Clinical research
• Market
Then we discussed about the
animal model. We learned that
the animals can be used for drug
discovery in efficacy testing or
in toxicity studies during drug
development.
We learned about the various
advantages of using animal
model which included:
• Direct information
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 4
[Link]. Industrial Training
Daily Report
• Availability of controls
• Controlled modification
of variables
• Accurate techniques etc.
Then we learnt about the disease
susceptibilities i.e., there are
various health problems
affecting both human and
animals. For e.g.:
immunological diseased like
allergies and arthritis, cancer,
asthma etc. Hence, we can use
animal models.
We also dicussed about some
disadvantages of using animal
models which included
anatomical differences,
difference in genetic regulation
etc.
Then we discussed about some
cases in which animal can react
differently than human. For e.g.:
- Penicillin is toxic to guinea
pig, aspirin causes birth defects
in most laboratory animals etc.
Then we learnt about the various
animals commonly used which
are rat, guinea pig, mouse, dog,
rabbit, primate etc.
Then we learned about the
various animal models like:
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 5
[Link]. Industrial Training
Daily Report
• Normal animal models
which include healthy
normal animals.
• Spontaneous models
• Induced models. It
includes experimentally
induced models.
• Transgenic models
• Negative models. It does
not develop in animals.
• Orphan models. It is a
model which contains
diseases not found in
humans.
Then we learned how to select
an animal model. We also talked
about how to create an animal
model and what are the factors
that should be considered. Then
we discussed about the EAE
induction.
Then through an example of
COVID-19 we were explained
the toxicology and efficacy
model.
Then at the end we discussed
about the alternative models
rather than animal model. E.g.:
computation model.
3) 2:30 – 3:45 We can use this knowledge There were
while working on new drug questions asked
discovery. like:
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 6
[Link]. Industrial Training
Daily Report
This session was based on What is the
“PRECLINICAL RESEARCH IN difference between
INDUSTRY.” PK-PD,
Toxicokinetics &
Firstly, we learned about the Toxicodynamics?
Process of drug development
For the approval,
and need of animals testing. What kind of
considerations are
Then we discussed about the
important?
objective of using animals which
included:
➢ To improve understanding
about human biology using
an animal model.
➢ Helps study various
diseases.
➢ To test potentials
treatments.
➢ To ensure safety of the
people & the environment.
Then we discussed about the
various types of animals used.
Then we gained knowledge about
the preclinical research which
included R&D and Toxicology.
In R&D we learned that:
• Done to check the efficacy of
the drug. Its steps, in brief, are:
➢ Decide product
➢ SAR
➢ Combine molecules
➢ Make various formulations
• Xenograph models are also
used.
In toxicology we learned about:
• Definitions, nature of toxicity
studies
• Types: In vitro & In vivo
• Sources: Gases, animals, drugs,
radiations, etc.
• Exposure concepts:
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 7
[Link]. Industrial Training
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➢ Routes of exposure
➢ Frequency of exposure
➢ Duration of exposure
• Activation of Toxicology
pathway: Means to expose any
chemical/drug to the test
system.
1. Exposure
2. Tissue dose
3. Biologic interaction
4. Perturbation
5. Early cellular changes-
depends on the substance
or the lethality of the
substance
6. Cell injury
7. Morbidity
At the end we concluded by
learning about the regulatory
authorities and guidelines.
4) 4:00 – 4:45 We gathered knowledge about
this renowned firm which can
In this session we learned about be further useful while working
the company profile of “- Sun in this company.
Pharmaceutical Industries
Limited”
It was founded in 1983.
It is the fourth largest specialty
generic pharmaceutical company in
the world.
It has more than 40 manufacturing
facilities.
It provides high-quality, affordable
medicines, trusted by healthcare
professionals and patients, to more
than 100 countries across the globe.
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 8
[Link]. Industrial Training
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Its vision includes:
• Reaching People and Touching
Lives Globally as A Leading
Provider of Valued Medicines.
• Mission:
• Leverage their people, expertise
and networks to address the
needs of the communities that
they serve and thereby catalyze
overall development.
• Strongly believe that business
and responsibility go hand-in-
hand.
Its products include:
• Produce a comprehensive,
diverse and highly
complementary portfolio of
generic and specialty medicines
targeting a wide spectrum of
chronic and acute treatments.
• Product portfolio includes:
➢ Generics
➢ Branded generics
➢ Specialty medications
➢ Difficult-to-make
technology intensive
products
➢ Over-the-counter (OTC)
➢ Anti-retrovirals (ARVs)
➢ Active Pharmaceutical
Ingredients (APIs)
➢ Intermediates
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 9
