Pharmacovigilance, a critical component of the healthcare and pharmaceutical industry, plays a pivotal role in monitoring and ensuring the safety of drugs. As personalized treatment approaches gain prominence, the responsibilities of PV companies become even more significant. This article explores the key functions of pharmacovigilance companies in the context of personalized medicine, focusing on their role in ensuring drug safety and mitigating potential risks associated with tailored therapeutic interventions.

1. WELCOME
Ensuring Drug Safety in Personalized Treatment
Approaches
Student Name: Varun G V
Qualification : 5th Pharm-D
Student ID: 004/012024
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2. CONTENTS:
• Introduction
• Definition
• Precursors of personalized treatment
• Method
• Benefits
• Challenges
• Examples of personalized treatment
• References
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3. INTRODUCTION:
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 Now widely believed that monitoring or preventing that disease must be tailored or
personalized to individual’s unique biochemical, physiological, environmental exposure
and behavioral profile.
 There have been many issues associated with the broad acceptance of personalized
medicines on the part of different health care sectors, such as Physicians, health care
executives, insurance companies and ultimately patients.
 These challenges revolve around a need to prove that personalized medicine strategies,
especially since many tailored or personalized therapies, such as autologous Chimeric
Antigen Receptor T cell (CAR-T) cell transplant therapies for certain types of Cancer and
Mutation specific medicines such as Ivacaftor to treat cystic fibrosis.
 So, in this history the motivation of personalized medicines strategies have emerged in the
last few decades.

4. Personalized Medicine:
 Personalized medicine also referred as Precision
medicine, is a medical model that separates people
into different groups with medical decisions,
practices, interventions and/or products being
tailored to the individual patient based on their
predicted response or risk of disease.
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5. The Precursors Of Personalized Medicine:
 Garrod, an English physician; he studied a phenotypic manifestations
including alkaptonuria, albinism, cystinuria and pentosuria.
 In these he focused on alkaptonuria led to some notoriety when he observed
that some members of families exhibiting alkaptonuria showed measurably
outlying values for certain basic biochemical assays (from Urine).
 This led him to conclude that alkaptonuria was due to a specific altered
course of metabolism among affected individuals, which was subsequently
proven correct.
 Then Fisher continues phenotypic variation with discrete, heritable factors
that contribute to this variation by suggesting that many factors, such as
genes, might contribute in a small way to a particular phenotype.
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History

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An individual who inherited only 1 of 25
genetic variants known to increase height
An individual who inherited only 10 or 12
genetic variants known to average height
An individual who inherited only 22 or 25
genetic variants known to shorter height
Fisher’s Examples based on Height:

7.  As a result much of the contemporary focus on personalized medicine is rooted in
the findings of genetic studies, it has been shown that individual personalized
treatment is safe and effective.
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Individual
Patient
Access to
Health
Care
Genetics
and
Genomics
Imaging
and
Radiology
Wireless
Monitoring
Environmental
Exposures
Tissue
Biomarkers

8. Method:
 In order to know that mutation is connected to a certain disease,
researchers often do a study called a “Genome-wide association
study” (GWAS).
 A GWAS study will look at one disease and then sequence the genome
of many patients with that particular disease to look for shared
mutations in the genome.
 Mutations that are determined to be related to disease by a GWAS
study then we used to diagnose that disease in future patients, by
looking at their genome sequence to find that same mutation.
 The first GWAS, conducted in 2005, studied patients with age-
related macular degeneration (ARMD).
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9. Benefits:
 Personalized treatment helps health care providers better understand the many
things – including environment, life style, and heredity- that play a role in a patient’s
health, disease or condition.
 This information gives more accurately predict which treatments will be most
effective, safe and prevent the illness in initial stage.
 Benefits are:
 Choosing the treatment for preventing the illness.
 Improve disease detection.
 Predict susceptibility to disease.
 Prescribe the more effective drugs.
 Customize disease prevention strategies.
 Avoid prescribing drugs with predictable negative side effects.
 Reduce the time, cost and failure rate of pharmaceutical Clinical Trials.
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10. Challenges:
 As personalized treatment is practiced more widely, a number of challenges arise.
 The current approaches to intellectual property rights, reimbursement policies,
Patient privacy, data biases and confidentiality as well as regulatory oversight will
have to be redefined and restructured to accommodate the changes personalized
treatment will bring to health care.
 A survey performed in the UK concluded that 63% of UK adults are not
comfortable with their personal data being used by medical field.
 Ex: Genetic data obtained from next generation sequencing requires computer
intensive data processing prior to its analysis.
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11. Examples of Personalized Medicine
 The human body deals with traditional pharmacotherapies such as,
drugs, to treat disease in two ways.
 Initially, the body must respond to a drug. The drug must distributed
throughout the body, and during this process the drug might be
biotransformed or metabolized into useful components, which would
begin to elicit effects.
 Finally, any remaining drug or drug components are excreted.
 These process are often heading of “Pharmacokinetics” and collectively
called as “ADME”.
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12. Example-1
 Warfarin is a widely used blood thinning medication, that if not dosed
properly could cause a potentially life-threatening adverse drug
reaction.
 Warfarin targets a particular gene, VK0RC1 and is metabolized in part
by the gene CYP2C9.
 Naturally- occurring genetic variation in both the VK0RC1 and CYP2C9
genes leads to variation in the pharmacodynamic and
pharmacodynamic and pharmacokinetic properties of Warfarin across
individuals, ultimately creating variation in individuals responses to
Warfarin.
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13. Example-2:
 Primaquine (PQ): PQ has been used to manage malaria with some success in
parts of the world where Malaria is endemic.
 However, military doctors working in the past observed that some of the soldiers
they treated for malaria that were provided the drug became Jaundiced and
anemic and ultimately exhibited symptoms of Acute Hemolytic Anemia (AHA).
 It was later shown that the individuals exhibiting AHA after PQ administration
carried variants in the G6PD gene.
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14. References:
 Goetz LH, Schork NJ. Personalized medicine: motivation, challenges,
and progress. Fertility and sterility. 2018 Jun 1;109(6):952-63.
 www.ncbi.nlm.nih.gov
 https://en.Wikipedia.org
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15. Thank You!
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info@clinosol.com
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