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DR.G.K SHARMA
PHARMD, C.P.P.M, R.C.PH, C.G.C.P
D.C.M.S, M.PHA, B.PHA
APPROACHES OF DRUG DISCOVERY
5/21/20191 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
INTRODUCTION
 The various approaches to drug discovery include
1. Pharmacological
2. Toxicological
3. IND application
4. Drug characterization
5. Dosage form
STEPS 1 and 2 constitute the PRECLINICAL STUDIES
5/21/20192 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
Pharmacological Approach
1. To identify a molecular target: is associated with a particular disease is The first step in the process of drug
discovery.
2. To establish that modulation or intervention: associated with a reversal of the disease process is next step.
3. Therapeutic intervention: novel molecular targets to consider for therapeutic intervention.
4. Biological activity: use of small molecules or protein biological such as monoclonal antibodies.
5. Yale West Campus screening facilities: High Throughput Cell Biology (HTCB) that offers screening with
RNAi and Small Molecule Discovery Center that provides access to libraries of unique small molecules.
6. Lead optimization: to obtain candidate compounds that are suitable for further investigation.
7. Preclinical studies and the most pro missing compounds: examined in clinical trials in humans.
8. Drug discovery process: works from the identification of molecular targets and therapeutic candidates to the
design of clinical trials in humans.
9. Pharmacological testing: including testing for effects on liver enzymes, specific cardiac channels, and a
large number of unrelated targets where interactions might be problematic.
5/21/20193 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
Toxicological Approach
1. Development phase: Although basic toxicology parameters will have been assessed in lead optimization
series of in vitro and in vivo studies will be performed in the development phase.
2. Safe administration: fully determine the toxicity profile and therapeutic index, maximum doses for safe
administration etc.
3. Species: These will usually be performed in at least two species and should determine both specific
(mechanism related) and non-specific (chemical) side effects which could limit the safe dose which can be
used in man.
4. Ex-vivo human studies: being implemented to assess the mechanism related effects. The duration and
number of dose levels used in these studies will be determined by the drug exposure, length and protocols of
the proposed initial (Phase I/II) clinical studies in man.
5. Safety effects: such as behavioral and physiological effects in vivo.
6. Clinical signs or pathological changes: that are indicative of a disease state.
7. As noted by MacDonald and Robertson: The approaches that have been taken to assess human risk of
adverse effects from chemical exposure have changed very little over the last several decades.
8. Most of the toxicology tools: used for regulatory assessment rely on high-dose animal studies.
5/21/20194 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
5/21/2019DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)5
9. In vitro screens: evaluated to identify efficacy using in vivo models.
10. To identify a lead compound: (Phase I studies).
11. Drug discovery and development is a dynamic process.
12. Discovery pharmacology and medicinal chemistry: early identification of a lead drug candidate
that might satisfy efficacy and safety hurdles to become a successful pharmaceutical agent.
13. Toxicity studies: began in the 1920’s but it wasn’t until the ‘thalidomide disaster’ in the 1960’s
14. Toxicology in vitro: two-dimensional cellular assays is already routinely used throughout the drug
discovery pipeline, however these do come with limitations.
15. Toxicology in silico: computational techniques to analyze, simulate, or predict the toxicity and
ADME of a compound, in silico methods are primarily based on quantitative structure–activity
relationships (QSARs); the association between a compound’s chemical structure, and its biological
activity.
16. Toxicogenomics: Toxicogenomics combines both toxicology and ‘omics’ technologies, spanning
genomics, transcriptomics, proteomics, and metabolomics. These strategies can be used to determine
the molecular mechanisms that control responses to toxic compounds
17. Genomics: DNA sequencing technologies have advanced significantly, resulting in the construction
of many organisms’ genomes, including humans.
18. Transcriptomics: RNA transcripts is defined as it’s transcriptome. Two key techniques for the
analysis of the transcriptome include microarrays and RNA-Seq.
19. Proteomics and Metabolomics: determining toxicology
20. Metabolites can be affected by both environmental and genetic factors. proteome allows you
together cellular insights that are unattainable through genomics studies.
5/21/20196 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
Investigational New Drug Application (IND)
 An IND is a submission to the FDA requesting permission to initiate a clinical study of a new drug
product.
 It allows a company to initiate and conduct clinical studies for their new drug products.
 It provides the FDA with the data necessary to decide whether the new drug and the proposed clinical
trial pose a reasonable risk to the human subjects participating in the study.
 The United States Food and Drug Administration's Investigational New Drug (IND) program is the
means by which a pharmaceutical company obtains permission to start human clinical trials and to ship
an experimental drug across state lines (usually to clinical investigators) before a marketing application
for the drug has been approved. Regulations are primarily at 21 C.F.R. 312. Similar procedures are
followed in the European Union, Japan, and Canada.
5/21/20197 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
5/21/2019DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)8
 The IND application may be divided into the following categories:
1. Preclinical Testing: consists of animal pharmacology and toxicology studies to assess whether the drug is
safe for testing in humans. Also included are any previous experience with the drug in humans (often foreign
use).
2. Manufacturing Information: includes composition, manufacturer, and stability of, and the controls used for,
manufacturing the drug. Used to ensure that the company can adequately produce and supply consistent
batches of the drug.
3. Investigator Information: on the qualifications of clinical investigators, that is, the professionals (generally
physicians) who oversee the administration of the experimental drug to the study subjects. Used to assess
whether the investigators are qualified to fulfill their clinical trial duties.
4. Clinical Trial Protocols: are the centerpiece of the IND. Detailed protocols for proposed clinical studies to
assess whether the initial-phase trials will expose the subjects to unnecessary risks.
5. Other Commitments: are commitments to obtain informed consent from the research subjects, to obtain
review of the study by an institutional review board (IRB), and to adhere to the investigational new drug
regulations.
5/21/2019DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)9
 Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes
effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the
IND, prohibiting the start of the clinical studies until the problem is resolved.
 Experimental drugs under an IND must be labeled "Caution: New Drug – Limited by Federal (or United
States) law to investigational use."
 Investigator's Brochure: An IND must also include an Investigator's Brochure intended to educate the
trial investigators of the significant facts about the trial drug they need to know to conduct their clinical
trial with the least hazard to the subjects or patients.
CATEGORIES OF IND
1. Commercial IND: goal is to obtain marketing approval for a new product.
2. Non-commercial IND: It includes
A. Investigator IND: In this case ,the physician is both the sponsor and investigator.
B. Emergency IND: FDA authorize immediate dispensing of a non-approved drug in a life threatening
situation when no standard acceptable therapy is available.
C. Treatment IND: FDA will permit investigational drug to be used to treat a serious or life threatening
disease or if there is no comparable alternative drug available.
5/21/201910 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
INVESTIGATIONAL PLAN
 Description of clinical studies planned for the experimental drug
1. Purpose of the study
2. Indication to be studied
3. Types of trials to be initiated
4. Number of study subjects
5. Risks involved
5/21/201911 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
5/21/201912 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)

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Approaches of drug discovery

  • 1. DR.G.K SHARMA PHARMD, C.P.P.M, R.C.PH, C.G.C.P D.C.M.S, M.PHA, B.PHA APPROACHES OF DRUG DISCOVERY 5/21/20191 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
  • 2. INTRODUCTION  The various approaches to drug discovery include 1. Pharmacological 2. Toxicological 3. IND application 4. Drug characterization 5. Dosage form STEPS 1 and 2 constitute the PRECLINICAL STUDIES 5/21/20192 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
  • 3. Pharmacological Approach 1. To identify a molecular target: is associated with a particular disease is The first step in the process of drug discovery. 2. To establish that modulation or intervention: associated with a reversal of the disease process is next step. 3. Therapeutic intervention: novel molecular targets to consider for therapeutic intervention. 4. Biological activity: use of small molecules or protein biological such as monoclonal antibodies. 5. Yale West Campus screening facilities: High Throughput Cell Biology (HTCB) that offers screening with RNAi and Small Molecule Discovery Center that provides access to libraries of unique small molecules. 6. Lead optimization: to obtain candidate compounds that are suitable for further investigation. 7. Preclinical studies and the most pro missing compounds: examined in clinical trials in humans. 8. Drug discovery process: works from the identification of molecular targets and therapeutic candidates to the design of clinical trials in humans. 9. Pharmacological testing: including testing for effects on liver enzymes, specific cardiac channels, and a large number of unrelated targets where interactions might be problematic. 5/21/20193 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
  • 4. Toxicological Approach 1. Development phase: Although basic toxicology parameters will have been assessed in lead optimization series of in vitro and in vivo studies will be performed in the development phase. 2. Safe administration: fully determine the toxicity profile and therapeutic index, maximum doses for safe administration etc. 3. Species: These will usually be performed in at least two species and should determine both specific (mechanism related) and non-specific (chemical) side effects which could limit the safe dose which can be used in man. 4. Ex-vivo human studies: being implemented to assess the mechanism related effects. The duration and number of dose levels used in these studies will be determined by the drug exposure, length and protocols of the proposed initial (Phase I/II) clinical studies in man. 5. Safety effects: such as behavioral and physiological effects in vivo. 6. Clinical signs or pathological changes: that are indicative of a disease state. 7. As noted by MacDonald and Robertson: The approaches that have been taken to assess human risk of adverse effects from chemical exposure have changed very little over the last several decades. 8. Most of the toxicology tools: used for regulatory assessment rely on high-dose animal studies. 5/21/20194 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
  • 5. 5/21/2019DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)5 9. In vitro screens: evaluated to identify efficacy using in vivo models. 10. To identify a lead compound: (Phase I studies). 11. Drug discovery and development is a dynamic process. 12. Discovery pharmacology and medicinal chemistry: early identification of a lead drug candidate that might satisfy efficacy and safety hurdles to become a successful pharmaceutical agent. 13. Toxicity studies: began in the 1920’s but it wasn’t until the ‘thalidomide disaster’ in the 1960’s 14. Toxicology in vitro: two-dimensional cellular assays is already routinely used throughout the drug discovery pipeline, however these do come with limitations. 15. Toxicology in silico: computational techniques to analyze, simulate, or predict the toxicity and ADME of a compound, in silico methods are primarily based on quantitative structure–activity relationships (QSARs); the association between a compound’s chemical structure, and its biological activity. 16. Toxicogenomics: Toxicogenomics combines both toxicology and ‘omics’ technologies, spanning genomics, transcriptomics, proteomics, and metabolomics. These strategies can be used to determine the molecular mechanisms that control responses to toxic compounds
  • 6. 17. Genomics: DNA sequencing technologies have advanced significantly, resulting in the construction of many organisms’ genomes, including humans. 18. Transcriptomics: RNA transcripts is defined as it’s transcriptome. Two key techniques for the analysis of the transcriptome include microarrays and RNA-Seq. 19. Proteomics and Metabolomics: determining toxicology 20. Metabolites can be affected by both environmental and genetic factors. proteome allows you together cellular insights that are unattainable through genomics studies. 5/21/20196 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
  • 7. Investigational New Drug Application (IND)  An IND is a submission to the FDA requesting permission to initiate a clinical study of a new drug product.  It allows a company to initiate and conduct clinical studies for their new drug products.  It provides the FDA with the data necessary to decide whether the new drug and the proposed clinical trial pose a reasonable risk to the human subjects participating in the study.  The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at 21 C.F.R. 312. Similar procedures are followed in the European Union, Japan, and Canada. 5/21/20197 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
  • 8. 5/21/2019DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)8  The IND application may be divided into the following categories: 1. Preclinical Testing: consists of animal pharmacology and toxicology studies to assess whether the drug is safe for testing in humans. Also included are any previous experience with the drug in humans (often foreign use). 2. Manufacturing Information: includes composition, manufacturer, and stability of, and the controls used for, manufacturing the drug. Used to ensure that the company can adequately produce and supply consistent batches of the drug. 3. Investigator Information: on the qualifications of clinical investigators, that is, the professionals (generally physicians) who oversee the administration of the experimental drug to the study subjects. Used to assess whether the investigators are qualified to fulfill their clinical trial duties. 4. Clinical Trial Protocols: are the centerpiece of the IND. Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks. 5. Other Commitments: are commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
  • 9. 5/21/2019DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)9  Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved.  Experimental drugs under an IND must be labeled "Caution: New Drug – Limited by Federal (or United States) law to investigational use."  Investigator's Brochure: An IND must also include an Investigator's Brochure intended to educate the trial investigators of the significant facts about the trial drug they need to know to conduct their clinical trial with the least hazard to the subjects or patients.
  • 10. CATEGORIES OF IND 1. Commercial IND: goal is to obtain marketing approval for a new product. 2. Non-commercial IND: It includes A. Investigator IND: In this case ,the physician is both the sponsor and investigator. B. Emergency IND: FDA authorize immediate dispensing of a non-approved drug in a life threatening situation when no standard acceptable therapy is available. C. Treatment IND: FDA will permit investigational drug to be used to treat a serious or life threatening disease or if there is no comparable alternative drug available. 5/21/201910 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
  • 11. INVESTIGATIONAL PLAN  Description of clinical studies planned for the experimental drug 1. Purpose of the study 2. Indication to be studied 3. Types of trials to be initiated 4. Number of study subjects 5. Risks involved 5/21/201911 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)
  • 12. 5/21/201912 DR.GAURAV KUMAR (PHARMD, CPPM, CGCPh)