PERSONALIZED MEDICINES

Lecture by
Mrs. SAUMYA DAS
Assoc. Prof, Department of Pharmaceutics
Bengal School of Technology- A College of Pharmacy
Accredited by NAAC and NBA
www.bstpharmacy.in
 COURSE OUTCOME

1. To understand the concept of pharmacogenetics

2. To understand the importance and personalized medication
3. To identify the categories of patients and relate their
medication regimen
What is Personalized Medicine???
Personalized medicine also referred as precision medicine which holds great promise to
improve health care.
According to the “National Cancer Institute” personalized medicine integrates
information about person’s genes, proteins, diagnosis and treat disease.
It is the form of medicine that uses information from patient‘s genotype to; Initiate a
preventative measure against the development of disease or condition.
Select the most appropriate therapy for a disease or condition that is suited to that patient

Personalized medicine is defined as of medical treatment to the individual

characteristics of each patient that not only improves our ability to diagnose and
treat disease, but offers the potential to detect disease at an earlier stage and to
treat it effectively.

“the tailoring of medical treatment to the specific characteristics of each patient. It does
not literally mean the creation of drugs or medical devices that are unique to a patient.
Rather, it involves the ability to classify individuals into subpopulations that are
uniquely or disproportionately susceptible to a particular disease or responsive to a
specific treatment.
Understanding terminology

Genomics- Study of the entire set of genetic instructions found in a cell (DNA)

Pharmacogenomics – It is a branch of pharmacology concerned with using DNA

and amino acid and sequence data to inform drug development and testing.

Pharmacogenetics– The study or clinical testing of genetic variation that assists

in individual patient’s differentiation response to drugs.
Pharmacogenetics has been defined as the study of variability in drug response due to
heredity.

Pharmacogenetics is the study of genetic causes of individual variations in drug

response whereas pharmacogenomics deals with the simultaneous impact of
multiple mutations in the genome that may determine the patient’s response to drug
therapy
Pharmacogenetics is the study of how people
respond differently to drug therapy based upon their
genetic makeup or genes.
Pharmacogenomics can play an
important role in identifying responders and
non-responders to medications, avoiding
adverse events, and optimizing drug dose.

• Pharmacogenomics is the field of study &

examines impact of genetic variation & drug
responses via biomarkers.
• Personalized Medicine utilizes the
biomarkers, which are simply genes and
proteins that can be measured to diagnose
diseases.
• Pharmacogenomics shows how genes
determine individual variability to drug
response.
• Pharmacists would easily predict how a
patient may respond to drug, with the help of
a genetic test before prescribing a drug.
What is the difference?
Pharmacogenetics focuses on the influence of single genes on drug
response.

Pharmacogenomics takes a broader view of the influence of

an individual's entire genome on his or her response to drug therapy.
Advantages of Pharmacogenomics:

• To predict a patient’s response to drugs.

• To develop “customized” prescriptions.
• To minimize or eliminate adverse events.
• To improve efficacy and patient compliance.
• To improve rational drug development.
• Pharmacogenetic test need only be conducted once during the life time.
• To improve the accuracy of determining appropriate dosage of drugs to
screen and monitor certain diseases.
• To develop more powerful, safer vaccines.
• To allow improvements in drug discovery and development.
A genetic alteration known as a single nucleotide polymorphism
(SNP) is a change in a nucleotide sequence that alters the
pharmacokinetics and pharmacodynamic parameters of drugs.

Pharmacogenomics tests are directed to identify patients, who are

responsive or non-responsive to treatment, develop interactions, produce
side effects, and require dosing adjustment.

A breakthrough started with the identification of the specific drug-

metabolizing enzymes, Cytochrome P450 (CYP450), which are
involved in the metabolism and elimination of medicines, detoxification
of foreign chemicals, and in the production of cholesterol, steroids, and
prostacyclin.
Categorization of patients
Optimizing drug response: gene-drug interactions:
A person's genetic constitution can be determined in order to address gene-drug
interactions. The aim is to optimize drug efficacy and to minimize adverse events from drug
treatment.
Applications include genetics-based and genomics based tests that commonly target
medicines that are administered to populations with a specific gene variant.
In gene-drug interactions, the focus is directed to either metabolism genes or genes related
to the immune system.

Gene-based drug targeting

Another area of individualization is the development of molecular mechanism specific
treatment, also called gene-based drug targeting.
Most research efforts are seen in the field of oncology and increasing attention is being
paid to genetically based diseases, such as Cystic Fibrosis.
Apart from this, many research efforts are undertaken in disease areas in which there is a
significant genetic association with the disease.

Why Individualization efforts are undertaken?

1. Diagnose more accurately (detailed disease characterization or diagnosis of hereditary
diseases that are not well-understood yet)
2. Predict risk of disease
3. These efforts provide greater insight into a patient’s constitution, contributing to a better
diagnosis.
CUSTOMIZED DRUG DELIVERY SYSTEMS:
Customized drug delivery, also termed personalized medicine, is a medical procedure that
separates patients into different groups—with medical decisions, practices,
interventions and/or products to the individual patient based on their predicted
response or risk of disease.

The Person:
Their DNA
Exposure to environmental factors
Types and amount of stress they experiences
What they eat

Advantages:
• Better matching patients to drugs instead of “trial and error”.
• Customized pharmaceuticals may eliminate life threatening adverse reactions.
• Reduce costs of clinical trials by quickly identifying total failures.
• Favorable responses for particular backgrounds.
• Improved efficacy of drugs.
DNA POLYMORPHISMS: It is the natural variations in our genes that plays a role in risk of
getting or not getting certain diseases. The combination of these variations across several
genes affects each individual’s risk.

SNPs – a major source of variation

Single Nucleotide Polymorphisms (SNPs)
Single base change in DNA
SNPs arise as a consequence of mistakes during normal DNA replication
Other sources of variation are Insertions, deletions, translocation, duplications
3D Printing of Pharmaceuticals

In this technology a concept is transformed into prototype by taking help from

3D computer-aided design (CAD) files, hence digitally controlled and
customized product can be fabricated. This technology utilizes a bottom-up
approach in which layers of materials like living cells, wood, alloy,
thermoplastic, metals etc. are placed on top of each other in order to make the
required 3D object. Therefore, 3D printing is also known by other
terminologies such as layered manufacturing, additive manufacturing,
computer automated manufacturing, rapid prototyping, or solid
freeform technology (SFF).
Advantages:
Enhanced productivity: 3D printing works more quickly in contrast to traditional
methods especially when it comes to fabrication of items like prosthetics and
implants with an additional benefit of better resolution, repeatability, more
accuracy, and reliability
Customization and personalization: One of the pioneer benefits of this
technology is the liberty of fabrication of customized medical equipment and
products. Customized implants, prosthetics, surgical tools, fixtures can be a great
boon to patients as well as physicians.
Increased cost efficiency: Objects produced by 3D printing are of low cost. It is
an advantage for small-scale production units or for companies that produce highly
complex products or parts because almost all ingredients are inexpensive
3DP allows controlled size of droplets, complex drug release profiles, strength of
dosage and multi-dosing
Bioelectronic medicine

They are the devices that use electricity to regulate biological processes, treat
diseases, or restore lost functionality. BEMS can interact with excitable tissue in
3 distinct manners: they can induce, block & sense electrical activity.
Specifically, the peripheral nervous system will be at the center of this advance, as
the function it controls in chronic disease is extensive.
Components of Bioelectronic: In bioelectronic medicine, interfaces are
required to access the peripheral nerves.
Electrode: Silicone based penetrating electrode, polymer based, life & cuff
electrode arrays, Complementary metal oxide semiconductor.

Material: Noble metal, Alloys, Platinum, Platinum- iridium, Gold, Laser

patterned
Gold or Platinum iridium foil (12 micrometer), lithographically patterned gold
or Platinumthin (300 nm), Films on polyamide or polylene, thermally
evaporated Ultra Thin (35 nm)

Polymer: Polyimide, Parylene, polydimethyl siloxane (PDMS), liquid Crystal

polymer, SU-8 photoresist, polyurethane, Sheet or film (polyimide).

Light: Emitting diodes for optogenetic stimulation, receiving elements for

wireless Power transfer, such as inductors, antenas and ultrasonic transducer.
Mechanism of Bioelectronic Medicine: All body organ functions are regulated through
neural circuits communicating by electrical impulses; it should theoretically be possible to
interpret the electrical language of diseases. By extension, it could be possible to stimulate
or inhibit the malfunctioning pathways with tiny electrodes in order to correct the defect.
This micro-manipulation of the nervous system targeting impulses(action potentials) to
specific cells within neural circuits could conceivably be exploited to manipulate abroad
range of bodily functions, such as controlling appetite or blood pressure or stimulating the
release of insulin in response to rising blood sugar, Strategy to isolate the nerve bundles
sending efferent signals involved in specific diseases from the peripheral nervous system to
the brain, and blocking them.
BEMs help includes:
1) Understanding molecule/cell-electronic Interfaces
2) Understanding cellular responses and the variabilities to stimulation (electrical,
mechanical, chemical, thermal, and the like)
3) Ability to collect and analyze essential data on the state of bimolecular and cells
(chemical, physical, structural, functional)
4) Ability to monitor, in real-time, the biochemistry of a single cell or a population of cells,
which requires comprehension of interaction between molecules.