The document outlines the drug development life cycle, detailing the extensive time (10-15 years) and financial investment (approximately $800 million to $1 billion) required to bring a new medicine to market. It discusses various stages, including drug discovery, the investigational new drug application process, and the new drug application, as well as the differences between branded and generic drugs. Key concepts like side effects, adverse effects, biologics, and relevant legislation such as the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act are also explored.

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Drug development life cycle Presented by: Mohammad Abuzar
Drug Development life Cycle
Presented by: Mohammad Abuzar
M. Pharm
Date:13/05/2024

2. Contents
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Contents Slide No.
Introduction 03
Drug discovery stages 04
Drug development and monitoring 06
New Drug Application 07
Side Effect & Adverse Effect 08
Branded drugs & Generic drugs 09
Biologics and Biosimilars 10
Patent and Exclusivity 13
References 14
Drug development life cycle Presented by: Mohammad Abuzar

3. Introduction
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 It takes about 10-15 years to develop one new medicine from the time of it is discovered to when it is available
for treating patients.
 The average cost to research and develop each successful drug is estimated to be $800 million to $1 billion.
This number includes the cost of the thousands of failures.
 For every 5000-10000 compounds that enter the research and development (R&D) pipeline, ultimately only
one receives approval.
 Before any potential new medicine can be discovered, scientist work to understand the disease to be treated as
well as possible, and to unravel the underlying cause of the condition.
 They try to understand how the genes are altered, how that affects the proteins they encode and how those
proteins interact with each other in living cells, how those affected cells change the specific tissue they are in
and finally hoe the disease affects the entire patient.
 This knowledge is the basis for treating the problem.
Drug development life cycle Presented by: Mohammad Abuzar

4. Drug discovery stages
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Drug development life cycle Presented by: Mohammad Abuzar
Stages
Description

5. Investigational New Drug (IND)
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Drug development life cycle Presented by: Mohammad Abuzar
Investigational New Drug (IND)Application:
Drug developers, or Sponsors, must submit an Investigational New Drug (IND) application to FDA before
beginning clinical research of a new pharmaceutical or biologic product in human subjects. Some of the
application
• Animal study data and toxicity (side effects that cause great harm) data
• Manufacturing information, Information about the investigator
• Data from any prior human research Investigational
New Drug types:
Emergency: Use of an experimental drug in an emergency that does not allow time for submission of an IND. It
is also used for patients
Fast track : An investigational drug for expedited review to facilitate development of drugs that treat a serious or
life-threatening condition and fill an unmet medical need.

6. Drug development and monitoring
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Drug development life cycle Presented by: Mohammad Abuzar

7. New Drug Application
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New Drug Application (NDA)
• It is a formal submission to a regulatory authority, such as the U.S.
Food and Drug Administration (FDA) in the United States, seeking
approval to market and sell a new pharmaceutical drug in that
country.
• The goals of the NDA are to provide enough information like
Whether the drug is safe, effective and the benefits of the drug
outweigh the risks - Whether the drug's proposed labelling is
appropriate.
Drug development life cycle Presented by: Mohammad Abuzar

8. Side Effect & Adverse Effect
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Drug development life cycle Presented by: Mohammad Abuzar
Side Effect
• An undesired effect that occurs when the
medication is administered regardless of the dose
• Side effects are generally anticipated by the
physician, and patients are informed of potential
effects during therapy
• Side effects later resolve on their own with time
after taking the medication for several weeks
Adverse Effect
• An undesired occurrence that results from taking
medication correctly
• Types of adverse events:
1. Type A reactions are predictable adverse events that
are commonly dose-dependent and can be mild,
moderate, or severe
2. Type B reactions are completely unpredictable.
• An adverse event can occur when a healthcare
provider lacks full knowledge of the drug and its
mechanism, catching both the doctor and patient by
surprise

9. Branded drugs & Generic drugs
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Drug development life cycle Presented by: Mohammad Abuzar
Branded drugs
• The first drugs created that has its specific active ingredient to receive approval
for use. It is usually the product for which efficacy, safety and quality have been
fully established
• When a new drug is created, the founding company typically holds a 20-year
patent, preventing others from making or selling the drug until the patent ends.
• At the point where a patent expires and the exclusivity period ends, other
manufacturers are allowed to apply ANDA to FDA to sell generic versions of the
drug.
Generic drugs
• Same active ingredient as that of branded drugs but their excipient may or may
not be same
• For FDA approval of a generic drug, it must match the brand in dosage form,
safety, strength, route, quality, performance, and intended use as brand-name
drug.

10. Biologics and Biosimilars
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Drug development life cycle Presented by: Mohammad Abuzar
Biologics :
A class of drugs that are produced using a living system, such as a
microorganism, plant cell, or animal cell.
They are different from "small molecule" drugs, in that they are
generally larger, more complex molecules. Biologics are usually
administered via injection or infusion
Biosimilars :
• A biosimilar is a biologic product developed to be highly similar to
a previously FDA-approved biologic, known as the reference
product. A biosimilar must have no clinically meaningful
differences from the reference product
• Patients respond similarly to biosimilars as they would to the
reference product.
Manufacturers demonstrate this through comparisons of factors like
immunogenicity, pharmacokinetics, and pharmacodynamics.

11. Hatch-Waxman Act
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 The Drug Price Competition and Patent Term Restoration Act informally known as the Hatch-Waxman
Act, is a US federal law which encourages the manufacture of generic drugs by the pharmaceutical industry
and established the generic drug regulation
 Drug innovators were provided protections in two ways:
• First, during that period the FDA cannot approve a generic version of the drug
• Second, the Act allowed the life of patents covering a drug to be extended by a portion of the time the drug is
under regulatory review by the FDA, ensuring innovator companies that regulatory review will not unduly
consume patent life
 The Act also provided generic companies with safe harbour from patent infringement lawsuits when they are
preparing ANDA
• during this, the manufacturer needs to learn how to manufacture the drug, manufacture a test batch, and run
bioequivalence studies with it, which are all activities that it could be sued for infringement
Drug development life cycle Presented by: Mohammad Abuzar

12. Biologics Price Competition and Innovation(BPCI) Act
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 The BPCI act aims to create an abbreviated approval pathway for biosimilars that are demonstrated to be
"highly similar" with an FDA-approved biological product
 It aligns with the FDA's policy of permitting appropriate reliance on what is already known about a
biologic, thereby saving time and avoiding unnecessary human or animal testing
 To meet the standard of interchangeability, a manufacturer must demonstrate that the biosimilar product can
be expected to produce the same clinical result as the reference (biological product in any given patient
Drug development life cycle Presented by: Mohammad Abuzar

13. Patent and Exclusivity
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Drug development life cycle Presented by: Mohammad Abuzar
Patent
• A patent is a property right issued to an inventor
"to exclude others from making, using, offering
for sale, or selling the invention throughout the
Us or importing the invention into the US" for a
limited time, in exchange for public disclosure of
the invention when the patent is granted.
• Generally, the term of a new patent is 20 years
from the date on which the application for the
patent was filed in the US and more than one
patent can apply to a drug
Exclusivity
• Exclusivity is exclusive marketing rights granted by
the FDA upon approval of a drug and can run
concurrently with a patent or not
• It prevents the submission or effective approval of
ANDAs and was designed to promote a balance
between new drug innovation and generic drug
competition
• Exclusivity is not added to the patent life

14. References
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1. Process of new drug development published by seikagaku corporation.
2. Bree Iskandar, What to expect when running the gauntlet of drug development, The Pippettepen March 18,2020.
3. Frazier KC. Biopharmaceutical research & development: The process behind new medicines. PhRMA:
Washington, DC, USA. 2015.
4. Cui W, Aouidate A, Wang S, Yu Q, Li Y, Yuan S. Discovering anti-cancer drugs via computational methods.
Frontiers in pharmacology. 2020 May 20;11:733.
5. Gupta R, Srivastava D, Sahu M, Tiwari S, Ambasta RK, Kumar P. Artificial intelligence to deep learning: machine
intelligence approach for drug discovery. Molecular diversity. 2021 Aug;25:1315-60.
6. Stanzione F, Giangreco I, Cole JC. Use of molecular docking computational tools in drug discovery. Progress in
Medicinal Chemistry. 2021 Jan 1;60:273-343.
7. Sabe VT, Ntombela T, Jhamba LA, Maguire GE, Govender T, Naicker T, Kruger HG. Current trends in computer
aided drug design and a highlight of drugs discovered via computational techniques: A review. European Journal of
Medicinal Chemistry. 2021 Nov 15;224:113705.
Drug development life cycle Presented by: Mohammad Abuzar

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Drug development life cycle Presented by: Mohammad Abuzar