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PRECISION MEDICINE -

PHARMACOGENOMICS

Ily''s Kinga

PhD student

Faculty of Pharmacy

Department of Pharmaceutical Technology and

Biopharmacy

University of Medicine and Pharmacy Iuliu Ha''ieganu,

Cluj-Napoca

Introduction

' Precision = Personalized = Individualized

' Pharmacogenomics ' Genetic medicine

' Establishing the clinical care based on the individual's genetic

information and biomarker profile

' P5 medicine

' Preventive factors measured within a population '' establish

preventive measures for at-risk individuals '' personalized and

participatory healthcare

' Survey, monitor and diagnose RISK

' Establish SPECIFIC treatment, OPTIMAL drug selection

' Treat the patient not the disease

Challenges of the

current healthcare

' Genetic polymorphism + biomarkers '' disease

variability

' Elevated risk of  low therapy effectiveness and

security

' Negative financial

implications

' Disease costs

' Clinical trial failures

(80-90%)

' Drug retrievals

Opportunities &

Applications

'' the need of therapy individualization

' Optimal drug selection based on

' Medical and familial history

' Genetics/genomics

' Exposome

' Omics '' gene mapping (HapMap), gene sequencing, identification of

SNPs'' disease diagnosis

' Preventive approach less financial implications

' Shared decision making in the therapy selection ' trust and

perception regarding the heathcare system '' indirect + effect on the

therapeutic outcomes

' Biobanks if linked to Electronic Medical Records '' translation of

genotype-phenotype data to clinical care (challenges patient

confidentiality)

' ' knowledge in drug development + better clinical trial design ' risk

of failure pre and post marketing of drug

Diagnostic tools (1)

' Biomarkers

' Biological measures of a biological state

' Microarray

' Lab-on-a-chip

Diagnostic tools (2)

' DNA chips (screenning up to

100000 SNPs in a few hours ''

diagnose phenotypic variations)

' Eg. DMET Plus (Affymetrix) ' 1936

genetic variants across 231 relevant

genes, including 100% coverage of the

PharmaADME genes (32)

 and 95% of

the PharmaADME Core Markers ''

predictory of the pharmacokinetic

variability '' improve drug

development process (effectiveness',

safety')

Pharmocogenomics in

drug development (1)

Pharmocogenomics in

drug development (2)

' SNPs in the genes of disease, drug transport, drug

metabolism, drug target '' identify genomic

markers '' predict disease response to drug

' Pharmacogenetics used for in vitro-in vivo

correlations '' better clinical trial design

' Pharmacogenomics ' drug labeling

Eg. Genomic data '' expression level of CYP3A gene '' anticipate effect of drugs

like Tacrolimus (immunosuppresiv)

idem CYP2D6 '' Tamoxifen (anticancer agent, selective estrogen modulator)

Idem CYP2C9 ''Warfarin (anticoagulant)

Idem HLA-B*5701 '' Abacvir (antiretroviral) hypersensitivity biomarker

The influence of

pharmacogenetics on plasmatic

concentrations

Old vs new approach in

drug/dose selection

Challenges in the

implementation  

Current healthcare regulations

regarding genetic testings (1)

1. Laissez-Faire

' Users have full freedom to request new tests and

disclose the results

' Heath providers can discriminate their users

according to their genetic risk

' Applied in: Australia, Canada, China, Japan, Ireland,

Korea, Russia, Portugal, Spain, South Africa

2. Disclosure Duty

' Users cannot be required to take the test

' Results can't be disclosed

' Discrimination '

' Applied in Germany, New Zealand, UK

Current healthcare regulations

regarding genetic testings (2)

3. Consent Law

' Users can keep private or disclose the results (for

lower insurance premium)

' Discrimination '

' Applied in Switzerland, Netherland

4. Under strict prohibition

' Healthcare providers cannot use the genetic

information for rating

' Discrimination '

' Applied in Austria, Belgium, France, Israel, Italy,

Norway, USA

Conclusion

' The right treatment to the right person at a right

dose

' Human genome project

''Drug Design '' individualized therapy

''Improved, early diagnosis

''Measurement of disease predisposition

''Disease course monitoring

' Under evaluation ' challenges regarding

implementation '' lack of a harmonized

healthcare regulation

References

1. Anaya, J.-M., Duarte-Rey, C., Sarmiento-Monroy, J. C., Bardey, D., Castiblanco, J., & Rojas-

Villarraga, A. (2016)

. Personalized medicine. Closing the gap between knowledge and

clinical practice. Autoimmunity Reviews, 15(8)

, 833'842.

https://doi.org/10.1016/j.autrev.2016.06.005

2. Limaye, N. (2013)

. Pharmacogenomics, Theranostics and Personalized Medicine - the

complexities of clinical trials: challenges in the developing world. Applied & Translational

Genomics, 2, 17'21. https://doi.org/10.1016/j.atg.2013.05.002

3. Gupta, S., & Jhawat, V. (2017)

. Quality by design (QbD) approach of pharmacogenomics in

drug designing and formulation development for optimization of drug delivery systems.

Journal of Controlled Release, 245, 15'26. https://doi.org/10.1016/j.jconrel.2016.11.018

4. Dickmann, L. J., & Ware, J. A. (2016)

. Pharmacogenomics in the age of personalized

medicine. https://doi.org/10.1016/j.ddtec.2016.11.003

5. Stegemann, S. (2016)

. The future of pharmaceutical manufacturing in the context of the

scientific, social, technological and economic evolution. European Journal of

Pharmaceutical Sciences, 90, 8'13. https://doi.org/10.1016/j.ejps.2015.11.003

6. Yong, W.-P., Soo, R., & Innocenti, F. (2014)

. Pharmacogenomics and Personalized Medicines

in Cancer Treatment. In Cancer Drug Design and Discovery (pp. 55'90). Elsevier.

https://doi.org/10.1016/B978-0-12-396521-9.00002-4

7. Valdes, R., & Yin, D. (Tyler). (2016)

. Fundamentals of Pharmacogenetics in Personalized,

Precision Medicine. Clinics in Laboratory Medicine, 36(3)

, 447'459.

https://doi.org/10.1016/j.cll.2016.05.006

8. Manolio, T. A. (2016)

. Implementing genomics and pharmacogenomics in the clinic: The

National Human Genome Research Institute's genomic medicine portfolio. Atherosclerosis,

253, 225'236. https://doi.org/10.1016/j.atherosclerosis.2016.08.034

Thank you!

If it were not for the great variability

among individuals, medicine might as well

be a science and not art. (Frueh, 2005)

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