NEW DRUG DEVELOPMEN

(OR)
DRUG DISCOVERY

BY

Dr. SAMINATHAN KAYAROHANAM

M.PHARM, M.B.A, PhD

1
 TABLE OF CONTENT
S.N TITLE PAGE
O
1 OVERVIEW OF NEW DRUG 4-11
DEVELOPMENT

2 OVERVIEW OF CLINICAL TRAIL 12,13

3 DIFFERENT TYPES OF CLINICAL TRIALS 14

4 DIFFERENT PHASE OF CLINICAL 15

TRIALS

5 PROCESS OF CLINICAL TRIAL 16

Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 2

 LEARNING OUTCOMES
• Able to explain drug discovery process
• Able to determine the preclinical study
• Able to demonstrate the clinical study.
• Able to explain the distribution.

Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 3

 1. OVERVIEW OF NEW DRUG DEVELOPMENT
 In the fields of medicine, biotechnology and pharmacology, drug discovery is
the process by which new candidate medications are discovered.

 Historically, drugs were discovered through identifying the active ingredient from
traditional remedies.

 Modern drug discovery involves the identification of drug affinity, selectivity,

efficacy/potency, metabolic stability, and oral bioavailability.

 Once a compound that fulfills all of these requirements has been identified, it will
begin the process of drug development prior to clinical trials.

 Drug discovery is done by pharmaceutical companies, with research assistance

from universities.

 The drug discovery requires expensive Phase I, II and III clinical trials, and most
of them fail. Small companies have a critical resources to run the clinical trials.
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 4
 DRUG DEVELOPMENT
Pre-Clinical
Process R&D
Pharmacology Chem Eng. R&D
Safety Assessment Manufacturing
Toxicology
Drug Metabolism
(ADME)

Pharmaceutical R&D
Formulation Bio Process R&D

Clinical Investigator
& patient
Regulatory Affairs
Clinical Pharmacology Project Planning & Management
Clinical Research Marketing

Statistics & Epidemiology

Data Coordination
Research Information Systems
Information Services
Clinical
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 5
 THE NEW DRUG DEVELOPMENT
1 2 3 4 5 6 7 8 9 10
Gene or Genome Target Target Lead Pre- Clinical Clinical Clinical Clinical
Sequencing Discovery Validation Discovery Clinical Phase I Phase II Phase III Phase IV Distribution

Drug Discovery Animal Clinical Tests Commercialization

Studies

Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D)

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 1) GENE OR GENOME SEQUENCING
1 2 3 4 5 6 7 8 9 10

Gene or Target Target Lead Pre- Clinical Clinical Clinical Clinical

Genome Discovery Validation Discovery Clinical Phase I Phase II Phase III Phase IV Distribution
Sequencing

Drug Discovery Animal Clinical Tests Commercialization

Studies

 Building a library of gene/protein (genome/proteome)

sequences to mine for information
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 7
 2) TARGET DISCOVERY
1 2 3 4 5 6 7 8 9 10

Gene or Target Target Lead Pre- Clinical Clinical Clinical Clinical

Genome Discovery Validation Discovery Clinical Phase I Phase II Phase III Phase IV Distribution
Sequencing

Drug Discovery Animal Clinical Tests Commercialization

Studies

 Look for proteins or protein modifications associated with

a disease.
 Find regulatory pathways required for disease process.
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 8
 3) TARGET VALIDATION
1 2 3 4 5 6 7 8 9 10

Gene or Target Target Lead Pre- Clinical Clinical Clinical Clinical

Genome Discovery Validation Discovery Clinical Phase I Phase II Phase III Phase IV Distribution
Sequencing

Drug Discovery Animal Clinical Tests Commercialization

Studies

 Molecular level
 Cellular Level
 Organismal level
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 9
 4) LEAD DISCOVERY
1 2 3 4 5 6 7 8 9 10

Gene or Target Target Lead Pre- Clinical Clinical Clinical Clinical

Genome Discovery Validation Discovery Clinical Phase I Phase II Phase III Phase IV Distribution
Sequencing

Drug Discovery Animal Clinical Tests Commercialization

Studies

 Discover leads that affect the target gene, protein

or pathway
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 10
 5) PRE CLINICAL
1 2 3 4 5 6 7 8 9 10
Gene or Target Target Lead Pre- Clinical Clinical Clinical Clinical
Genome Discovery Validation Discovery Clinical Phase I Phase II Phase III Phase IV Distribution
Sequencing

Drug Discovery Animal Clinical Tests Commercialization

Studies
• Animal tests of toxicity and efficacy of therapy
• Rodents (mice and rats)
• Mammals (pigs)
• Primates (monkeys and chimpanzees)
• Mouse Lemurs (Microcebus)
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D)
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 2) OVERVIEW OF CLINICAL TRAIL
1. What is a clinical trial and why is it conducted?

Clinical trials are health or medical related research conducted in

humans, which are conducted to find out the risks and how well a
particular experimental treatment, drug, procedure of medical device it
may or may not work.

2. How is clinical trial conducted ?

1.A pharmaceutical, biotechnology or medical devices company, any

other medical research organization or the government.

2.The investigators and the sponsoring party then prepare the study
protocol (study plan) and other relevant documents for submission to an
Institutional Review Board (IRB) for approval.

ALL CLINICAL TRIALS IN MALAYSIA MUST BE APPROVED AND

MONITORED BYDr.K.Saminathan.M.Pharm(Ph.D)
THE IRB (institutional , M.B.A (Ph.D)
review board ). 12
3. Who conducts a clinical trial?

A pharmaceutical, biotechnology or medical devices company, any other

medical research organization or the NIH appoints physicians to conduct
these trials. The investigators can be attached to either public or private
institutions and these institutions can be hospitals or universities with
access to patients.

4. What are participant’s rights, roles and responsibilities?

Before agreeing, participants should ask as much questions as possible, so

that they are clear on the trial procedure, their role, as well as their rights as
participants.

5. Are there any risks involved?

These events can be minor, serious or life-threatening.

Adverse reaction or side effects include
headache, nausea, hair loss, skin irritation, rash or other physical
problems.
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 13
 3. DIFFERENT TYPES OF CLINICAL TRIALS
1. Treatment trials
Tests experimental treatments, drugs, surgery technique or
radiation therapy

2. Prevention trials
Tests for better ways to prevent a disease

3. Diagnostic trials
To find better tests to identify a disease

4. Screening trials
To find better ways to detect a disease or health condition

5.Quality of Life trials

To find better ways to improve the quality of life of patients
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 14
4. (6,7,8,9) DIFFERENT PHASE OF CLINICAL TRIALS

Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 15

 5. PROCESS OF CLINICAL TRIAL

1 2 3

6 5

8
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 16
EXAMPLE OF CLINICAL TRIAL CONDUCTION

Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D)

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Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 18
6. (10) DRUG DISTRIBUTION MODEL

Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 19

THANK YOU FOR YOUR ATTENTION
AND ANY QUESTION?

Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 20