Personalized Medicine

1. PERSONALIZED MEDICINE
GENOMICS – The study of genetic instructions in a cell (DNA)
PHARMACOGENOMICS (PGx) – is a branch of pharmacology concerned with DNA and
amino acid sequence data to provide drug development and testing.
PHARMACOGENETICS (PGt) – The study of genetic variation in individual patients and
assists the differentiation response to drugs.
Single nucleotide polymorphisms (SNPs) are the most common type of genetic variation in
humans. The different SNP expressions effect a drug’s therapeutic response or adverse effect
incidence
There are several well-known examples of personalized medicine applications based upon
using pharmacogenomics.
Drug Polymorphic gene
Warfarin
Phenytoin
Tolbutamide, glipizide
CYP2C9
Flouxetine
Codeine
CYP2D6
Thioridazine CYP2D6
Strattera (atomoxetine) CYP2D6
Sulfonamides
Isoniazid,
Procainamide
Hydralazine
N-acetyltransferases (NATs)
Genotyping for Warfarin Dosing
• Warfarin has a narrow therapeutic window and a wide range of inter-individual
variability in response, requiring careful clinical dose adjustment for each patient.
• In 2007, FDA approved label changes to Warfarin noting precautions for patients with
variations in two genes, CYP2C9 and Vitamin K Epoxide Reductase Complex-1
(VKORC1) which may require a lower initial dose.
• Testing for these variants can assist in dosing
• Individualized dosing can possibly increase effectiveness of therapy while decreasing
the risk of adverse events
Carbamazepine (Tegretol)
• Genetic variants have been associated with two forms of life-threatening skin
conditions (Stevens-Johnson syndrome and toxic epidermal necrolysis) experienced
by carbamazepine patients.

2. • In particular, two HLA-related variants (HLAB*1502 in Asian populations and HLA-
A* 3101 in Caucasians populations) are more likely than other patients to have
dangerous skin reactions
• Testing of this allele can reduce the frequency of these reactions
Abacavir (ziagen):
• Nucleoside analog reverse transcriptase inhibitor (NRTI) used to treat HIV and AIDS
first approved in 1998
• Subsequent studies showed that patients who carry the HLA-B*5701 allele were at
high risk for hypersensitivity to abacavir due to this allele being strongly associated
with a single-nucleotide polymorphism at the HLA-B*5701 locus
• The label was changed to recommended pre-therapy screening for the HLA-B*5701
allele and the use of alternative therapy in subjects with this allele.
• Clinicians can now safely prescribe Abacavir for the right patient and the incidence of
these reactions has diminished worldwide.
PERSONALIZED MEDICINE: as a form of medicine that uses information about a
person’s genes, proteins, and environment to prevent diagnose and treat disease.
• Natural variations (DNA polymorphisms) play a role in getting or not getting certain
diseases. External factors such as environment, diet, and exercise, along with
polymorphisms can also determine an individual’s disease
• Variations in DNA can lead to differences in pharmacodynamics and pharmacokinetics in
the individual patient. Based on the patient’s individual genetic expression, biomarkers
and DNA microarrays can help detect the best medication for the patient.
Definition: Personalized medicine also referred as Individualized medicine. It is the ability to
offer the Right Drug to the Right patient for Right Disease at Right time with the Right Dose.
Advantages:
• Increase patient adherence to treatment by targeting the right patient with the right drug
• Prescribe more effective drugs and avoid side effects
• Improve disease detection
• Improve quality of life
• Reduce the time, cost and failure rate of pharmaceutical clinical trials
• Shift the emphasis in medicine from reaction to prevention
• Customize disease-prevention strategies
• Control health care cost by avoiding unnecessary costs where drug is proven ineffective.
Limitations:
• The response to a medication may be a result of the interactions of multiple genes
• Ethical issues with genetic testing and data sharing
• Clinician are generally not educated concerning available tests, associate drugs, and
outcomes

3. • Integration of pharmacogenomics, personalized medicine, and the payer and regulatory
environment is still ongoing
• Reimbursement pathway of testing not established
CUSTOMIZED DRUG DELIVERY SYSTEMS:
1. BIOELECTRONIC MEDICINES:
The nervous system uses electrical signals to communicate information throughout the body.
Virtually every cell and organ of the body is directly or indirectly controlled by these neural
signals. The researchers are learning the language of these neural signals so that we can listen
for signals of disease or injury. The bio electronic medicine technologies to record, stimulate,
and block neural signals which will change the way of treat diseases, injuries and conditions
such as rheumatoid arthritis, diabetes, paralysis, bleeding, and even cancer.
Definition: Bio electronic medicines are a tiny implanted device treating disease by changing
the electric pulses in nerves to and from specific organs.
Implantable devices can be attached to individual peripheral nerves to decipher and modulate
neural signalling patterns and achieving therapeutic effects of specific organs.
Bioelectronic Devices:
1. Heart Pace Maker:- Small device placed in the chest to control abnormal heart rhythms
,it is used to treat Arrhythmias
2. Brain Pacemakers:- A small device inserted in the affected area of brain, and is used to
treat Parkinson's disease, Epilepticsand people who have Tremor's.
Working of bioelectronic Device:
Example of Diseases
Arthritis: The nervous system triggers production of proteins that cause an immune response
and lead to inflammation of the joints. That a small device could be attached to a nerve to
potentially stop that chain reaction.
Asthma: The device attached to the pulmonary nerve to block the signals that causes lungs to
contrict.

4. Hypertension: The device attached to the heart nerve to modulate signals travels to brain and
give the response signals travels to heart and blood vessels to reducing pressure.
2. 3D PRINTING:
The process of making three Dimensional solid object from a Digital file by layer to layer
fabrication. More recently, 3D printing has gained traction in pharmaceutical manufacturing,
by FDA’s approval of a 3D-printed drug product in August 2015.
Advantages:
1. High production rate due to fast Operating system.
2. Reduction of material wastage which can save the cost of production.
3. Ability to achieve accuracy especially for potent drug.
4. Most popular in Solid dosage form because of pain avoidance and accurate dosing.
Types of 3D Printing Technology
1. Inkjet printing
2. Fused Deposition modelling
3. Direct write
4. Extrusion
Inkjet Printing: different combination of active ingridients and excipients are precisely
sprayed in small droplets which then solidifies into solid dosage form.
Direct Write: It is a computer aided program that moves in a pattern to achieve layer by
layer 3D micro transformation.
Fused Deposition Modelling: multiple dosage form is produced by applying polymer as
apart of framework in this process polymer is melted and pass through a movable heated
nozzle.
Extrusion: Extrusion is the most widely used 3D printing technology. In an extrusion
process, material is extruded from robotically-actuated nozzles.
Example of 3D Printed drugs:
3D Technology Dosage form Active Ingredient
Inkjet 3DP Implant Levofloxacine
Inkjet 3DP Nanosuspension Folic aid
3DP Technology Tablet Acetaminophen
3DP extrusion printing Tablet Niedipine and Glipizide
Thermal Jet printing Solution Salbutamol sulphate
3. TELEPHARMACY
Deliver pharmaceutical care via telecommunication to patient in location where they may not
have direct contact with a pharmacist. Telepharmacy service includes Drug monitoring

5. therapy, patient counseling, authorize for prescription drug. Also used for videoconferencing
in pharmacy for providing education, training to pharmacy staff.
Disadvantage are decreased human interaction between medical professional and patients.
An increased Risk of error when medical services deliver in the absence of registered
professional.
Types of Telepharmacy:
1. Inpatient
2. Remote dispensing
3. Remote counseling
Inpatient: Pharmacist refers to a remote area where they receive medication order before
hospital staff administers the drug to patient, real time medication review and verification is
done by pharmacist.
Remote Dispensing: Pharmacist supervise technician, review prescription and perform their
duty from a remote location via technology.
Remote Counseling: Pharmacist provide counseling to the patient via live and interactive
video session