B.Pharm.

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

In this webinar we talked about
“Understanding Pharmaceutical
industry”
We started with the Four key
building blocks of the
pharmaceutical industry which
are:
careers in pharmacy hence
gathering a basic knowledge
about the pharmaceutical
industry is very important.
Hence this session gave us the
basic knowledge which can be
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
talked about the pharmaceutical
industries history.

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 1
 B.Pharm. Industrial Training
Daily Report
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

 Pharmacy benefit
managers

 Long term care facilities.

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 2
 B.Pharm. Industrial Training
Daily Report
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
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

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 3
 B.Pharm. Industrial Training
Daily Report
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

 Availability of controls

 Controlled modification
of variables

 Accurate techniques etc.

Then we learnt about the disease

susceptibilities i.e., there are

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 4
 B.Pharm. Industrial Training
Daily Report
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:

 Normal animal models

which include healthy
normal animals.

 Spontaneous models

 Induced models. It
includes experimentally
induced models.

 Transgenic models

 Negative models. It does

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 5
 B.Pharm. Industrial Training
Daily Report
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
This session was based on discovery. like:
“PRECLINICAL RESEARCH IN
INDUSTRY.” What is the
difference between
Firstly, we learned about the PK-PD,
Process of drug development Toxicokinetics &
and need of animals testing. Toxicodynamics?

Then we discussed about the For the approval,

objective of using animals which What kind of
considerations are
included:
important?
 To improve understanding
about human biology using
an animal model.
 Helps study various
diseases.
 To test potentials

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 6
 B.Pharm. Industrial Training
Daily Report
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:
 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

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 7
 B.Pharm. Industrial Training
Daily Report

At the end we concluded by

learning about the regulatory
authorities and guidelines.

4) 4:00 – 4:45 We gathered knowledge about

In this session we learned about
the company profile of “- Sun
Pharmaceutical Industries
Limited”
this renowned firm which can
be further useful while working
in this company.

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.

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

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’s NMIMS, Mumbai 8
 B.Pharm. Industrial Training
Daily Report
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