Introduction. Definition. Eg. of Personalized medicine. Advantages of Personalized Medicine. Scientific challenges for PM, The success of personalized therapy depends. Future aspects of PM. The FDA's Role in Advancing Precision Medicine. Next-Generation Sequencing (NGS) tests. Future of Personalized Medicine.

1. FUTURE ASPECTS OF
PERSONALIZED MEDICINE (PM)
Presented by:
Naman Ruhela
M.Pharm (Drug Regulatory Affairs)
Centre of Drug Regulatory Affairs, Amity Institute of
Pharmacy, Amity University, Sector-125, Noida (UP), INDIA
E-Mail: naman.ruhela@gmail.com

2. Index
 Introduction
 Definition
 Eg. of Personalized medicine
 Advantages of Personalized medicine
 Scientific challenges for PM:
 Success of personalized therapy depends
 Future aspects of PM
 The FDA's Role in Advancing Precision Medicine
 Next Generation Sequencing (NGS) tests
 Future of Personalized medicine
 References

3. Introduction
“Everyone knows that different people
don’t respond the same way to
medications”.

4. One Size Doesn’t Fit All
And harmful to some….

5. Definition
Personalized medicine (PM) is a type of
medical care in which treatment is
customized for an individual patient on the
basis of specific characteristics, including
age, gender, height/weight, diet,
environment, etc.
Reference. 1

6. Eg. of Personalized medicine
Reference. 1

7. Advantages of Personalized
medicine :
Direct the selection of optimal therapy
Reduce trial-and-error prescribing.
Help avoid adverse drug reactions.
Increase patient adherence to treatment.
Improve quality of life.
Help to control the overall cost of health
care.

8. Scientific challenges for PM:
 Determine biomarker that have the most
clinical significance.
 Limiting the off target effects of gene
based therapies
 Conduct clinical studies to identify
genetic variants that can correlate with a
drug response.

9. Success of personalized therapy
depends :
Accurate diagnostic tests.
 Identify patients.
who can be benefited from target
therapies….

10. Future aspects of PM :
Reference. 2

11. The FDA's Role in Advancing
Precision Medicine
These days FDA is working to ensure the
accuracy of NGS tests, so that clinicians
and patients can receive accurate and
meaningful test results.
The massive amount of information
generated through NGS poses novel
regulatory issues for the USFDA.
Reference. 3

12. Next Generation Sequencing
(NGS) tests:
Reference. 3

13. Next Generation Sequencing
(NGS) tests:
These tests are capable of rapidly
identifying or 'sequencing' large sections of
a person's genome and are important
advances in the clinical applications of
precision medicine.
Reference. 3

14. Future of Personalized medicine
In today's world, only 30-60% of drugs work effectively.
However, in future the success rate of drugs will increase
to100%, curing all patients.

15. References
[1] FDA Continues to Lead in Precision Medicine
(2015, March 23) by FDA Voice retrieved from URL
https://blogs.fda.gov/fdavoice/index.php/2015/03/fd
a-continues-to-lead-in-precision-medicine .last
accessed on 2017, December 05.
[2]The Age of Personalized Medicine (2011,May 12)
retrieved from URL
http://www.personalizedmedicinecoalition.org/Userf
iles/PMC-
Corporate/file/pmc_age_of_pmc_factsheet.pdf
. last accessed on 2017, December 05.
[3] U.s. FOOD & DRUG ADMINISTRATION
,Precision medicine retrieved from URL
https://www.fda.gov/ScienceResearch/SpecialTopics/
PrecisionMedicine/default.htm last accessed on
2017, last accessed on 2017, December 05