Download Drug Discovery-New Drug Development Process

DRUG DISCOVERY – NEW DRUG DEVELOPMENT PROCESS
BY
Dr. BASAVARAJ K. NANJWADE
Department of Pharmaceutics
K L E UNIVERSITY
JN MEDICAL COLLEGE
BELGAUM – 590010
E-mail: [email protected]
09/07/2007
Dept. of Pharmaceutics
1
DRUG
• A substance used in the diagnosis, treatment, or
prevention of a disease or as a component of a medication
recognized or defined by the U.S. Food, Drug, and
Cosmetic Act.
• A drug is any chemical or biological substance, synthetic
or non-synthetic
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• A drug is anything that affects the way an
organism works.
• Drugs can be taken to enhance function, such as
a student drinking caffeine to enhance alertness.
• For now we only consider drugs which are used
to cure a disease.
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Continued
• A disease is often thought of as an infection,
where a bacteria, virus, or other living thing
invades the body.
• However, a disease is anything which affects the
proper functioning of the body.
• It can be an infection, a genetic disorder, or the
result of environmental conditions such as
malnourishment, poisoning, or stress.
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Continued
• Engineers often find it easy to see the body
as a factory.
• Individual organs can be seen as machinery.
The actual nuts, bolts, screwdrivers, and
wrenches that make up all the machinery are
the equivalent of proteins, little chunks of
organic material that move things around in
the body and attach them together.
• Most of the work in our body is done by
proteins.
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Continued
• The body contains thousands of different
kinds of proteins.
• The construction of each is determined by
the DNA in the nucleus of each cell.
• DNA may be thought of as long strings of
instructions which code for how each
protein is too be built.
• The DNA is just a long string of acids that
serves as a message about how to make
proteins.
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How Drugs are Developed
• The processes of new drug discovery and
development are long, complicated and
dependent upon the expertise of a wide variety of
scientific, technical and managerial groups.
• If you are new to the industry, it can prove a
significant challenge to understand the
significance of your contribution, even if you
belong to one of the teams directly involved; for
those on the periphery, the problem is magnified
to the point where team interactions and
efficiency are adversely threatened.
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Differences and Similarities of Drugs and
Medicinal Plants
• Today there are at least 120 distinct chemical substances
derived from plants that are considered important drug
and are currently in use in one or more countries in the
world
• Some of these drugs are simply a chemical or chemicals
extracted from plant materials and put into a capsule,
tablet or liquid.
• Eg. In Germany a Cynarin drug is manufactured and
sold to treat hypertension, liver disorders and highly
cholesterol levels.
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Differences and Similarities of Drugs
and Medicinal Plants
• The drug is simply this single chemical or an Artichoke liquid extract,
that has been concentrated and chemically manipulated to contain a
specific amount of this one chemical ; such a preparation is called a
standardized extract.
• However in the U.S artichoke extracts are available as natural products
and sold in health food stores as “dietary supplements”
• Some –U.S artichoke products are even standardized to contain a
specific amount of cynarin, yet they can still be purchased here as a
natural product without a prescription.
• There may be little to no difference between the Cynarin drug produce
in Germany and the artichoke standardized herbal supplements made
in the U.S considering that the same amount of Cynarin is being
delivered, dose for dose
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Need for consumer education about
Herbal supplements & Drugs
• Consumers find it very frustrating to sort through a lot of
ambiguous information put out by natural product
manufacturers who cannot legally label their goods with
condition-specific.
• Stop them in their tracks in the aisles at the health food
store saying “ Hey, look at me, if you have high
cholesterol.
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More is Not Always Better
• Be careful about dosage amounts
• Philosophy of excess: “ if some is good, more is better”
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Problem of One Vs Several Chemicals
• While many drugs have originated from biologically active
plant chemicals, and many plants, medicine uses can be
attributed to various active chemicals found in them, there
is a distinct difference between using a medicinal plant and
a chemical drug.
• The difference is one that scares most conventionally
trained doctors with no training in plants.
• Drugs usually consist of a single chemical, whereas
medicinal plants can contain 400 or more chemicals.
• It’s relatively easy to figure out the activity and side effects
of a single chemical.
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Acetyldigoxin
Cardiotonic
Digitalis lanata
Adoniside
Cardiotonic
Adonis vernalis
Aescin
Anti-inflammatory
Aesculus hippocastanum
Aesculetin
Anti-dysentery
Frazinus rhychophylla
Agrimophol
Anthelmintic
Agrimonia supatoria
Ajmalicine
Circulatory Disorders
Rauvolfia sepentina
Allantoin
Vulnerary
Several plants
Allyl isothiocyanate
Rubefacient
Brassica nigra
Anabesine
Skeletal muscle relaxant
Anabasis sphylla
Andrographolide
Baccillary dysentery
Andrographis paniculata
Anisodamine
Anticholinergic
Anisodus tanguticus
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Anisodine
Anticholinergic
Anisodus tanguticus
Arecoline
Anthelmintic
Areca catechu
Asiaticoside
Vulnerary
Centella asiatica
Atropine
Anticholinergic
Atropa belladonna
Benzyl benzoate
Scabicide
Several plants
Berberine
Bacillary dysentery
Berberis vulgaris
Bergenin
Antitussive
Ardisia japonica
Betulinic acid
Anticancerous
Betula alba
Borneol
Antipyretic, analgesic,
antiinflammatory
Several plants
Bromelain
Anti-inflammatory,
proteolytic
Ananas comosus
Caffeine
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CNS Dept.
stimulant
of Pharmaceutics
Camellia sinensis
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Camphor
Rubefacient
Cinnamomum camphora
Camptothecin
Anticancerous
Camptotheca
acuminata
(+)-Catechin
Haemostatic
Potentilla fragarioides
Chymopapain
Proteolytic, mucolytic
Carica papaya
Cissampeline
Skeletal muscle relaxant
Cissampelos pareira
Cocaine
Local anaesthetic
Erythroxylum coca
Codeine
Analgesic, antitussive
Papaver somniferum
Colchiceine amide
Antitumor agent
Colchicum autumnale
Colchicine
Antitumor agent, antigout
Colchicum autumnale
Convallatoxin
Cardiotonic
Convallaria majalis
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Curcumin
Dept. of Pharmaceutics
Choleretic
Curcuma longa
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Cynarin
Choleretic
Cynara scolymus
Danthron
Laxative
Cassia species
Demecolcine
Antitumor agent
Colchicum autumnale
Deserpidine
Antihypertensive,
tranquillizer
Rauvolfia canescens
Deslanoside
Cardiotonic
Digitalis lanata
L-Dopa
Anti-parkinsonism
Mucuna sp
Digitalin
Cardiotonic
Digitalis purpurea
Digitoxin
Cardiotonic
Digitalis purpurea
Digoxin
Cardiotonic
Digitalis purpurea
Emetine
Amoebicide, emetic
Cephaelis ipecacuanha
Ephedrine
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Etoposide
Antitumor agent
Podophyllum peltatum
Galanthamine
Cholinesterase inhibitor
Lycoris squamigera
Gitalin
Cardiotonic
Digitalis purpurea
Glaucarubin
Amoebicide
Simarouba glauca
Glaucine
Antitussive
Glaucium flavum
Glasiovine
Antidepressant
Octea glaziovii
Glycyrrhizin
Sweetener, Addison's
disease
Glycyrrhiza glabra
Gossypol
Male contraceptive
Gossypium species
Hemsleyadin
Bacillary dysentery
Hemsleya amabilis
Hesperidin
Capillary fragility
Citrus species
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Hyoscyamine
Anticholinergic
Hyoscyamus niger
Irinotecan
Anticancer, antitumor
agent
Camptotheca
acuminata
Kaibic acud
Ascaricide
Digenea simplex
Kawain
Tranquillizer
Piper methysticum
Kheltin
Bronchodilator
Ammi visaga
Lanatosides A, B, C
Cardiotonic
Digitalis lanata
Lapachol
Anticancer, antitumor
Tabebuia sp.
a-Lobeline
Smoking deterrant,
respiratory stimulant
Lobelia inflata
Menthol
Rubefacient
Mentha species
Methyl salicylate
Rubefacient
Gaultheria procumbens
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Monocrotaline
Antitumor agent
(topical)
Crotalaria sessiliflora
Morphine
Analgesic
Papaver somniferum
Neoandrographolide
Dysentery
Andrographis paniculata
Nicotine
Insecticide
Nicotiana tabacum
Nordihydroguaiaretic
acid
Antioxidant
Larrea divaricata
Noscapine
Antitussive
Papaver somniferum
Ouabain
Cardiotonic
Strophanthus gratus
Pachycarpine
Oxytocic
Sophora pschycarpa
Palmatine
Antipyretic, detoxicant
Coptis japonica
Papain
Proteolytic, mucolytic
Carica papaya
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Phyllodulcin
Sweetner
Hydrangea macrophylla
Physostigmine
Cholinesterase Inhibitor
Physostigma venenosum
Picrotoxin
Analeptic
Anamirta cocculus
Pilocarpine
Parasympathomimetic
Pilocarpus jaborandi
Pinitol
Expectorant
Several plants
Podophyllotoxin
Antitumor anticancer
agent
Podophyllum peltatum
Protoveratrines A, B
Antihypertensives
Veratrum album
Pseudoephredrine*
Sympathomimetic
Ephedra sinica
Pseudoephedrine, nor-
Sympathomimetic
Ephedra sinica
Quinidine
Antiarrhythmic
Cinchona ledgeriana
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Qulsqualic acid
Anthelmintic
Quisqualis indica
Rescinnamine
Antihypertensive,
tranquillizer
Rauvolfia serpentina
Reserpine
Antihypertensive,
tranquillizer
Rauvolfia serpentina
Rhomitoxin
Antihypertensive,
tranquillizer
Rhododendron molle
Rorifone
Antitussive
Rorippa indica
Rotenone
Piscicide, Insecticide
Lonchocarpus nicou
Rotundine
Analagesic, sedative,
traquillizer
Stephania sinica
Rutin
Capillary fragility
Citrus species
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Salicin
Analgesic
Salix alba
Sanguinarine
Dental plaque inhibitor
Sanguinaria canadensis
Santonin
Ascaricide
Artemisia maritma
Scillarin A
Cardiotonic
Urginea maritima
Scopolamine
Sedative
Datura species
Sennosides A, B
Laxative
Cassia species
Silymarin
Antihepatotoxic
Silybum marianum
Sparteine
Oxytocic
Cytisus scoparius
Stevioside
Sweetner
Stevia rebaudiana
Strychnine
CNS stimulant
Strychnos nux-vomica
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Plant Source
Taxol
Antitumor agent
Taxus brevifolia
Teniposide
Antitumor agent
Podophyllum peltatum
a-
Antiemetic, decrease
Tetrahydrocannabinol(
occular tension
THC)
Cannabis sativa
Tetrahydropalmatine
Analgesic, sedative,
traquillizer
Corydalis ambigua
Tetrandrine
Antihypertensive
Stephania tetrandra
Theobromine
Diuretic, vasodilator
Theobroma cacao
Theophylline
Diuretic, brochodilator
Theobroma cacao and
others
Thymol
Antifungal (topical)
Thymus vulgaris
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Plant Based Drugs and Medicines
Drug/Chemical
Action/Clinical Use
Topotecan
Antitumor, anticancer agent Camptotheca acuminata
Trichosanthin
Abortifacient
Trichosanthes kirilowii
Tubocurarine
Skeletal muscle relaxant
Chondodendron
tomentosum
Valapotriates
Sedative
Valeriana officinalis
Vasicine
Cerebral stimulant
Vinca minor
Vinblastine
Antitumor, Antileukemic
agent
Catharanthus roseus
Vincristine
Antitumor, Antileukemic
agent
Catharanthus roseus
Yohimbine
Aphrodisiac
Pausinystalia yohimbe
Yuanhuacine
Abortifacient
Daphne genkwa
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Abortifacient
Yuanhuadine
Dept. of Pharmaceutics
Plant Source
Daphne genkwa
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The New Drug Development Process
(Steps from Test Tube to New Drug Application Review)
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Non-clinical Drug Development
• Non-clinical drug development is a complex,
regulatory-driven process designed primarily to
assess the safety and viability of new molecular
entities.
• Non-clinical, or preclinical, services encompass
toxicology, pharmacology, metabolism,
bioanalysis, pharmaceutical analysis and
biosafety testing in support of non-clinical drug
development.
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Non-clinical Drug Development
• A sponsor must first submit data showing that the drug is reasonably
safe for use in initial, small-scale clinical studies.
• Depending on whether the compound has been studied or marketed
previously, the sponsor may have several options for fulfilling this
requirement.
1. Compiling existing non-clinical data from past in vitro
laboratory or animal studies on the compound
2. Compiling data from previous clinical testing or marketing of the
drug in the U.S or another country whose population is relevant to
the U.S population
3. Undertaking new preclinical studies designed to provide the
evidence necessary to support the safety of administering the
compound to humans.
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Non-clinical Drug Development
• During preclinical drug development, a sponsor
evaluates the drug’s toxic and pharmacologic effects
through in vitro and in vivo laboratory animal testing.
• Genotoxicity screening is performed, as well as
investigations on drug absorption and metabolism, the
toxicity of the drug’s metabolites and the speed with
which the drug and its metabolites are excreted from the
body.
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FDA will generally ask
1. Develop a pharmacological profile of the drug
2. Determine the acute toxicity of the drug in at
least two species of animals
3. Conduct short-term toxicity studies ranging
from 2 weeks to 3 months, depending on the
proposed duration of use of the substance in
the proposed clinical studies.
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Subpart E
• CFR (Code of Federal Regulations)
establishes procedure to expedite the
development, evaluation and marketing of
new therapies intended to treat people
with life-threatening and severelydebilitating illnesses, especially where no
satisfactory alternatives exist.
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Sponsor/FDA Meetings ( Pre-IND)
• Prior to clinical studies, the sponsor needs evidence that the
compound is biologically active, and both sponsor and the
FDA need data showing that the drug is reasonably safe for
initial administration to humans.
• Meeting at such an early stage in the process are useful
opportunities for open discussion about testing phases, data,
requirements, and any scientific issues that may need to be
resolved prior to IND submission
• At these meeting, the sponsor and FDA discuss and agree
upon the design of the animal studies needed to initiate
human testing
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Synthesis and Purification
• The research process is complicated, time-consuming, and
costly and the end result is never guaranteed.
• Literally hundreds and sometimes thousands of chemical
compounds must be made and tested in an effort to find
one that can achieve a desirable result.
• FDA estimates that it takes approximately eight and half
years to study and test a new drug before it can be
approved for the general public.
• Computers can be used to simulate a chemical compound
and design chemical structures that might work against it.
• Enzymes attach to the correct site on a cell’s membrane,
which causes the disease.
• A computer can show scientists what the receptor site looks
like and how one might tailor a compound to block an
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enzyme from attachingDept.
there.
Animal Testing
• Drug companies make every effort to use as few animals
as possible and to ensure their humane and proper care.
• Generally two or more species ( one rodent, one nonrodent).
• Animal testing is used to measure how much of a drug is
absorbed into the blood, how it is broken down
chemically in the body, the toxicity of the drug and its
breakdown products metabolites, and how quickly the
drug and its metabolites are excreted from the body
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Short and Long Term Animal Testing
• Short-term testing in animals ranges in duration from 2
weeks to 3 months, depending on the proposed use of
the substance.
• Long-term testing in animals ranges in duration from a
few weeks to several years.
- Some animal testing continues after human tests begin
to learn whether long-term use of a drug may cause
cancer or birth defects.
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Institutional Review Board
• Institutional review boards (IRB) are used to ensure the rights
and welfare of people participating in clinical trials both
before and during their trial participation.
• An IRBs at hospitals and research institutions throughout the
country make sure that participants are fully informed and
have given their written consent before studies ever begin.
• An IRBs are monitored by the FDA to protect and ensure the
safety of participants in medical research.
• An IRBs must be composed of no less than five experts and
lay people with varying background to ensure a complete and
adequate review of activities commonly conducted by
research institutions.
• An IRBs must be composed of people whose concerns are in
relevant areas.
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IND Submitted
I.
Introduction
II.
Current requirements and practices
III. Clarifications of present IND regulation
A.
Cover Sheet (FDA Form – 1571)
B.
Table of contents
C.
Introductory statement and general investigational plan
D.
Investigator's brochure
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Protocols
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IND Submitted
F. Chemistry, Manufacturing, and Control information
1. Chemistry and manufacturing introduction
2. Drug substance
a. A description of the drug substance, including its physical,
b.
c.
d.
e.
chemical, or biological characteristics
The name and address of its manufacturer
The general method of preparation of the drug substance
The acceptable limits and analytical methods used to assure
the identity, strength, quality, and purity of the drug
substance.
Information to support the stability of the drug substance
during the toxicology studies and the proposed clinical study
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IND Submitted
3. Drug product
a. A list of all components, which may include reasonable
alternatives for inactive compounds, used in the
manufacture of the investigational drug product,
including both those components intended to appear
in the drug product and those which may not appear,
but which are used in the manufacturing process.
b. Where applicable, the quantitative composition of the
investigational new drug product, including any
reasonable variations that may be expected during the
investigational stage.
c. The name and address of the drug product
manufacturer
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IND Submitted
d. A brief, general description of the method of
manufacturing and packaging procedures as appropriate
for the product.
e. The acceptable limits and analytical methods used to
assure the identity, strength, quality, and purity of the
drug product.
f. Information to support the stability of the drug substance
during the toxicologic studies and the proposed clinical
study(ies)
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IND Submitted
4. A brief general description of the composition,
manufacture, and control of any placebo to be used in
the proposed clinical trial.
5. A copy of all labels and labeling to be provided to each
investigator.
6. A claim for categorical exclusion from or submission of
an environmental assessment.
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IND Submitted
G. Pharmacology and Toxicology information
1. Pharmacology and drug distribution.
2. Toxicology: Integrated summary.
3. Toxicology- Full data tabulation.
H. Previous human experience with the investigational drug
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Phase 1 Clinical Studies
• Phase 1 includes the initial introduction of an
investigational new drug into human.
• Phase 1 studies usually conducted in healthy volunteer.
• Phase 1 studies are designed to determine the metabolic
and pharmacologic actions of the drug in humans, the side
effects associated with increasing doses, and if possible to
gain early evidence on effectiveness.
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Phase 1 Clinical Studies
• Phase 1 studies also evaluate drug metabolism,
structure-activity relationships, and the
mechanism of action in humans.
• The total number of subjects included in Phase I
studies varies with the drug, but is generally in
the range of 20 to 80
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Phase 2 Clinical Studies
• Phase 2 includes the early controlled clinical studies
conducted to obtain some preliminary data on the
effectiveness of the drug for a particular indication or
indications in patients with the disease or condition.
• This phase of testing also helps determine the common
short-term side effects and risks associated with the
drug.
• Phase 2 studies are typically well-controlled, closely
monitored, and conducted in a relatively small number of
patients usually involving several hundred people.
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Sponsor/FDA Meeting (End of Phase 2)
• One month prior to the “end of the Phase 2”, the sponsor
should submit the background information and protocols
for phase 3 studies.
• This information should include data supporting the claim
of the new drug product, chemistry data, animal data and
proposed additional animal data, results of Phase 1 and 2
studies, statistical methods being used, specific protocols
for phase 3 studies, as well as a copy of the proposed
labeling for a drug, if available.
• This summary provides the review team with information
needed to prepare for a productive meeting.
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Phase 3 Clinical Studies
• Phase 3 studies are expanded controlled and
uncontrolled trials.
• They are performed after preliminary evidence
suggesting effectiveness of the drug has been obtained
in Phase 2 and are intended to gather the additional
information about effectiveness and safety that is needed
to evaluate the overall benefit-risk relationship of the
drug.
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Phase 3 Clinical Studies
• Phase 3 studies also provide an adequate basis for
extrapolating the results to the general population and
transmitting that information in the physician labeling.
• Phase 3 studies usually include several hundred to
several thousand people.
• Great care is taken to ensure that this determination is
not made in isolation, but reflects current scientific
knowledge, agency experience with the design of clinical
trials, and experience with the class of drugs under
investigation
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Accelerated Development/ Review
• Accelerated development/review is a highly specialized
mechanism for speeding the development of drugs that
promise significant benefit over existing therapy for
serious or life-threatening illnesses for which no therapy
exists.
• The fundamental element of this process is that
manufacturers must continue testing after approval to
demonstrate that the drug indeed provides therapeutic
benefit to the patient.
• If not, the FDA can withdraw the product from the
market more easily than usual.
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Treatment IND
• Treatment investigational new drug are used to make promising
new drugs available to desperately ill patients as early in the
drug development process as possible.
• An immediately life-threatening disease means a stage of a
disease in which there is a reasonable likelihood that death will
occur within a matter of months or in which premature death is
likely without early treatment.
• Treatment INDs are made available to patients before general
marketing begins, typically during Phase 3 studies.
• Treatment INDs also allow FDA to obtain additional data on the
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drug’s
safety and effectiveness.
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Long – Term Testing
• Long-term testing in animals ranges in duration from a
few weeks to several years.
• Some animal testing continues after human tests begin
to learn whether long-term use of a drug may cause
cancer or birth defects.
• Much of this information is submitted to FDA when a
sponsor requests to process with human clinical trials.
• The FDA reviews the preclinical research data and then
makes a decision as to whether to allow the clinical trials
to proceed
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IND Review Process
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NDA Review Process
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Generic Drug (ANDA) Review Process
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OTC Drug Monograph Review Process
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