Personalized medicine aims to improve health care by integrating information about a person's genes, proteins, and other factors to tailor medical treatment. This includes using genetic or other tests to select treatments, determine dosage, and predict drug responses. Pharmacogenomics plays an important role by identifying genetic factors that influence how individuals respond to medications to optimize treatment and avoid adverse reactions. Emerging areas of personalized medicine include 3D printing of customized drug delivery systems, remote pharmacy services through telepharmacy, and bioelectronic medicines that use electrical stimulation to treat diseases.

1. PERSONALIZED
MEDICINE
Presented by:
PALLERLA NAVEEN
REDDY,
Mpharm(pharmaceutics)
Central University of South bihar

2. Contents:
Personalized medicine
Pharmacogenomics
Customized drug delivery systems
3D printing of pharmaceuticals
Telepharmacy
Bioelectronic medicines/ Device's

3. Personalized medicine:
INTRODUCTION
• Personalized medicine also referred as precision medicine 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 too
• 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.

4. Definition:
• 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.
Associated Definitions:
1.Genomics- Study of the entire set of genetic instructions found in
a cell(DNA)
2.Pharmacogenomics (PGx)– It is a branch of pharmacology
concerned with using DNA and amino acid and sequence data to
Inform drug developresponse testing.
Application of genomics to study human variability in drug
response.

5. 3. Pharmacogenetics (PGt)– The study or clinical testing of genetic va
Variation that assists in individual patient’s differentiation response to
drugs.
:Effect of genetic variation on drug response.
:PGx and PGt are expected to play important role in development of
better medicines with improved benefits/risk ratio for individuals.
Pharmacogenomics:
:The study of how genes affect a person’sresponse to drugs.
: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.

6. :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
Pharmacogenomics Goals are:
1. Optimizing proper drug therapy, dosage for patients – increasing
efficacy & safety
2. Other benefits are by monitoring biomarkers - reduces time, cost &
failure rates in clinical trials in developing new medications and
increases opportunities to develop noveltherapeutics.
Example: Genotyping variants of Cytochrome P450 involved in
metabolism of warfarin.

8. PHARAMACOGENOMICS:

9. Advantages of Pharmacogenetics:
• To predict a patient’sresponse to drugs.
• To develop “customized” prescriptions.
• To minimize or eliminate adverse events.
• To improve efficacy and patientcompliance.
• 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 improvementsin drug discovery and development.

10. PHARMACOGENETICS IN CLINICALPRACTICE:
• The development has been slowed by variousscientific,
commercial,political and educational barriers.
:3 major types of evidence thatshould accumulate in order to implicate
a polymorphism in clinical care.
1) Screens of tissues from multiple humans linking the polymorphism
to a trait;
2) Complementary preclinical functional studies indicating that the
polymorphism is linked with the phenotype;
3) Multiple supportive clinicalphenotype/genotype studies

11. CATEGORIES OF PATIENTS FOR PERSONALISED MEDICINE:
*Patients are mainly classified depending upon the genetic
polymorphism.
*Cytochrome p450 geneticpolymorphism.
*Different families of enzymespolymorphism.
Focusing on genomics, we have identified three categories:
1) 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

12. In gene-drug interactions, the focus is directed to either metabolism
genes or genes related to the immune system.
2) Gene-based drug targeting:
• Another area of individualization is thedevelopment of molecular
mechanism specific treatment, also called gene-based drug
targeting.
• Most research efforts are seen in the field of oncology (somatic
variations) 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, as in the case with the VKORC1 gene in thrombosis
patients.

13. 3) Prediction and diagnosis:
Lastly, individualization efforts are undertake into:
1. Diagnose more accurately (detailed disease characterization or
diagnosis of hereditary diseases that are not well-understoodyet)
2. Predict risk of disease
3. These efforts provide greater insight into a patient’s constitution,
contributing to a better diagnosis.
ASTHMA:
• Inhaled β2-adrenergic (e.g.Salbutamol) and corticosteroids
• (e.g., Beclomethasone) isthe cornerstone of asthma treatment.
• One of the characteristics of asthma is resistance or reduced
responsiveness to treatment.
• Until now, pharmacogenetic studies have mainly concerned the β2-
adrenegic receptorgene. Additional research is needed in order to
evaluate the genomictesting

14. Diabetes:
• Diabetes also concerns a large patient group. While diabetes is
divided into two
• clinical categories (type I and type II), there are at least 27 single
gene mutation
• subtypes of diabetes that have been identified.
• The genetic make-up determines the clinical categorization which
has been
• shown for several genes that cause of the syndrome designated as
maturity- onset diabetes of the young(MODY).
• MODY patients with specific mutations often have high sensitivity
to sulfonylurea’s (e.g. Glipizide). Treatment of these patients could
be improved by changing the insulin regimen into a sulfonylurea’s
therapy.
•

15. CUSTOMIZED DRUG DELIVERY SYSTEMS:
*INTRODUCTION-
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.
BENEFITS:
• Better matching patientsto drugsinstead of “trial and error".
• Customized pharmaceuticals may eliminatelife- threatening
adverse
• reactions.
•

16. There are 3 types:
• 3D Printing in Pharmaceuticals
• Telepharmacy.
• Bioelectronic Medicines / Devices
Introduction:
*3D printing is layer by layer production of 3D objects from
digital design.
*It include wide variety of manufacturing technologies which
are all based on digitally controlled depositing of materials to
create free-form geometries.
* this methods extensively used in field of biomanufacturing
(specially for bone andtissue engineering ).
3D Printing in Pharmaceuticals.

17. *It became a standard tool in automotive, aerospace and
consumer goods
industries.
*More recently 3D printing has gained attraction in pharmaceutical
manufacturing illustrated by FDA approval of 3D printed drug
product in
August2015.
*It can be used for customized drug delivery system.

20. PERSONALIZED MEDICINE

22. Novel Designs made possible

23. Manufacturing steps reduced

24. Advantages & Applications is 3D Pharmacogenomics:
• High Drug loading ability when compared to conventional dosages.
• Accurate and Precise dosing of potent drugs which are administered at
small doses.
• Reduces the cost of production due to lesser material wastage
• Suitable drug delivery for difficult to formulate active ingredients with a
narrow therapeutic window.
• In the case of multidrug therapy with multiple dosing regimen, treatment
can be customized to improve patient adherence.
• As immediate and controlled release layers can be incorporated due to
the flexible design and manufacture of this dosage form.
• Avoids batch-to-batch variations seen in bulk manufacturing of
conventional dosage forms.
• 3D printers occupy minimal space and are affordable.
• Manufacture of small-batch is feasible and the process can be
completed in a single run.

25. Current 3D printing technology in pharmceutical drug
delivery systems:
1.Laser-Based Writing Systems
A) Stereolithography
B) Continuous Layer Interface Production
C) Powder Based 3D Printing
2. Nozzle-Based Deposition Systems
A) Inkjet printing
B) Fused deposition moulidng
C) Pressure-assisted Microsyringe Technology
3. Semi Solid Extrusion 3D Printing

26. 1.Laser based printing:
Powder based printing:
*This technique uses powder jetting or powder bed to spread thin layers
of powder and simultaneously applying liquid binder drops with the help
of inkjet printers.
• The ink (binders and APIs or binder solutions) is sprinkled over a
powder bed in two-dimensional fashion to make the final product in a
layer by layer fashion.
• The adaption of this technique into pharmaceutical manufacturing is
easier than other techniques as powder and binder solutions are widely
used in the pharmaceutical industry.
• This method has its own disadvantages also.
• Additional drying is required to remove solvent residues.
• Excess powder accumulates during printing leading to wastage.

27. • Also, the mechanical strength of the drug delivery system is poor due
to the
porous structure of the powder.

28. 2.Nozzle based deposition system:Nozzle-based deposition
systems comprise of the blending of drugs and polymers and other
solid components before 3D printing.
• The blend is gone through a nozzle that certainly begins, layer by
layer, the three-dimensional item.
Pressure assisted microsyringe technology
• This technology uses syringe extruder, which deposits a viscous
material using pressurized air piston.
• It deposits in layer-by-layer fashion in the predetermined geometry.
• The important parameters that decide the robustness of the technology
are the viscosity, viscoelasticity, and the apparent elastic limit.
• Advantage: flows continuously and works at room temperature.
• Disadvantage: use of solvents could pose a health hazard and can
degrade the active pharmaceutical ingredient as well.

30. 3. SEMI-SOLID EXTRUSION 3D
PRINTING:
• Extruding semi-solids (e.g.
homogeneous paste) over the
moveable stage in a layer by
layer fashion into a product.
• This method uses a syringe-like
tool head to deposit semi-solid
material layer by layer.
• The semi-solid can be gel or
paste is a combination of polymer
and solvent in a ratio that makes
the consistency of the semi-solid
suitable for printing.

32. Telepharmacy:
*Delivers pharmaceutical care via telecommunication to patients in
location where they may not have direct contact with a pharmacy.
*Telepharmacy services include drug monitoring therapy, patient
counselling, Authorize for prescription drug.
*Also used for video conferensing in pharmacy education, training to
pharmacy staff.
Disadvantages:
*The main disadvantage is decreased human interaction with medical
technician and patient.
*There might be also increased risk of errors in drug delivery to patient.
*PharMacy laws
*Operational difficulties.
*Increased effort and time
*Reluctance to use technology.

33. Advantages:
*Access to healthcare benifits.
*Economic benefits to patients.
*Patient satisfaction.
*Minimal scarcity of pharmacist.
Conclusion:
*Rural communities and residents lack easy access to healthcare
services and benefits Often due to gerographical and
demographical factors.
*Telepharmacy holds a significant promise as a technology to
improve access to pharmaceutical care for people living in both
urban and rural areas.

34. Bioelectronic medicines/Device's:
DEFINITION:
*The national institute of standard and technology(NIST)an agency of
U.S.,department of commerence.,defined bioelectronics in
2009.,reported as "the discipline resulting from convergence of biology
and electronics".
*A branch of science that deals with the role of electron transfer in
biological processes. Also called as electroceuticals
*Aimed at interfacing electronics with nerves to specifically target the
biological processes underlying disease. It emerging medicine that
utilizes electrical impulses to control the body's neural circuits as a
substitute to drug-based interventions.lt also focuses on physical
interfacing electronic devices with biological systems. Eg.,brain-machine.
*Application of electronic devices to living organisms for clinical
testing,diagnosis and therapy.

35. MECHANISM:

37. ADVANTAGES:
*The introduction of various revolutionary technique in medicine
field makes less pain in approach to cure diseases.
*These implants provide targeted treatment;by controlling the
neural signals going to specific organ.
*Device would minimal or even zero side effects.
*It will avoid or overcome the problems faced by conventional
dosage forms.
*With merging with nanotechnology, aimed at increasing selectivity
and specificity of cellular control.
*It could be customerized for each patient to account for severity of
a disease for better patient compliance.
*These better results lead people more faith in modern medical
sciences.

38. DISADVANTAGES:
*Costly process;if a single part of chip is damaged the total
technique wil be meaningless. Eg., bionic eye.
*High compact state of nerve and cardiac
systems,indiscrimate stimulator can lead to undesirable
effects.
*Chances to get electrical shock.
Installation of an implant may cause harm to our body.

39. CONCLUSION:
*Bioelectronic medicine is a growing field where major advancements
in treatment and diagnosing are being achieved. Therapies based on
neural stimulation and application of electric fields are currently used
to improve patients quality of life.
*However, these therapies still require a multidisciplinary approach to
produce less invasive techniques. In order to achieve this,
development of nanotechnology, materials and new methodologies
will greatly contribute to this field offering new therapeutic tools that
create great impact over the future medicine and pharmacology.

40. Thank
you