Course

Unit I: Introduction to Pharmacogenomics (5 hours)

• Definition and Scope of Pharmacogenomics 1
  • Understanding pharmacogenomics: Concept and significance
  • Historical perspective and major milestones
  • Relevance in personalized medicine
•   Basic Genetics and Genomics       2 hr.
• Overview of human genetics: Genes, alleles, and polymorphisms
• DNA structure and function
• Gene expression and regulation
• Key Terminologies in Pharmacogenomics     2 hr.
• Pharmacogenetics vs Pharmacogenomics
• Genomic variants: SNPs, INDELs, CNVs, and HLA types

Unit II: Pharmacogenomic Mechanisms (8 hours)

• Pharmacokinetics and Pharmacodynamics: The Genetic Basis 4
  • Enzyme polymorphisms: Cytochrome P450 (CYP2C19, CYP2C9, CYP3A4/5, CYP2D6,CYP1A2,CYP2E1), UGTs, NAT2, TPMT

• Transporter polymorphisms: ABCB1, SLCO1B1
• Receptors: ADRB2, VKORC1, ACE
• Gene-Drug Interactions       2 hr.
• The impact of genetic variation on drug absorption, distribution, metabolism, and excretion (ADME)
• Case studies: Warfarin, Clopidogrel, and Thiopurines
• Genetic Testing Methods     2 hr.
• Genotyping technique: NGS (Demonstration)
• Pharmacogenomic biomarkers

Unit III: Clinical Applications of Pharmacogenomics (8 hours)

• Pharmacogenomic Testing in Clinical Practice 4
  • Examples of pharmacogenetic testing: Warfarin, Carbamazepine, and statins
  • Clinical guidelines: CPIC, FDA recommendations

·         Pharmacogenomics and Drug Safety    2 hr.

• Adverse drug reactions and pharmacogenomics
• Case study: Stevens-Johnson syndrome (Carbamazepine) and HLA-B*1502

·         Personalized Medicine in Oncology      2 hr.

• Targeted therapies: HER2, EGFR, ALK inhibitors
• Pharmacogenomic approaches in cancer treatment

Unit IV: Ethical, Legal, and Social Implications of Pharmacogenomics (5 hours)

• Ethical Issues 2
  • Privacy and consent in genetic testing
  • Genetic discrimination and equity in healthcare

·         Legal Aspects     2 hr.

• Regulatory frameworks: FDA, EMA guidelines
• Implications of pharmacogenomic data in clinical trials and drug approval

·         Social and Economic Impact      1 hr.

• Pharmacogenomics in developing countries
• Cost-effectiveness of pharmacogenomic testing

Unit V: Emerging Trends and Technologies in Pharmacogenomics (8 hours)

• Next-Generation Sequencing and Pharmacogenomics 3
  • The role of whole-genome sequencing (WGS) in personalized medicine

• CRISPR and gene editing technologies

·         Pharmacogenomics and Artificial Intelligence         3 hr.

• Machine learning in drug discovery and genetic data analysis
• Integration of pharmacogenomic data into electronic health records (EHRs)

·         Future Directions                                  2 hr.

• Pharmacogenomics in rare diseases
• The role of pharmacogenomics in vaccine development

Unit VI: Case Studies and Real-World Applications (8 hours)

• Case Study 1: Warfarin and Genetic Testing 3
  • Understanding VKORC1 and CYP2C9 gene polymorphisms
  • Case-based analysis of therapeutic drug monitoring and dosing

·         Case Study 2: Pharmacogenomics in Psychiatry          3 hr.

• Antidepressants and genetic testing: CYP450 polymorphisms
• The impact of genetic testing on treatment outcomes

·         Case Study 3: Adverse Drug Reactions (ADRs) and Pharmacogenomics 2 hr.

• Identifying patients at risk for ADRs
• Pharmacogenomic guidance in clinical decision-making

Unit VII: Therapeutic Drug monitoring (8hours)

• Introduction – 1hr
• Individualization of drug dosage regimen (Variability – Genetic, Age and Weight, disease, Inter- acting drugs). – 1hr
• Indications for 1hr
• Protocol for 1hr
• Pharmacokinetic/Pharmacodynamic Correlation in drug therapy 1hr
• TDM of drugs used in the following disease conditions: cardiovascular disease, seizure disorders, Psychiatric conditions and organ transplantations 1 hr
• Design TDM protocol for Digoxin, Phenytoin, Carbamazepine , Gentamycin, Colistin, vancomycin, voriconazole,Lithium, Everolimus, Tacrolimus, 2 hrs

ASSIGNMENT:

1. Write an essay on the historical evolution of pharmacogenomics, focusing on key milestones and their relevance to the development of personalized medicine.
2. Compare and contrast pharmacogenetics and Provide examples of how each approach is used in clinical practice.
3. Analyze the role of genetic polymorphisms (SNPs, INDELs, CNVs, and HLA types) in determining drug Use relevant examples from literature to support your analysis.
4. Prepare a detailed report on how cytochrome P450 polymorphisms affect drug metabolism and provide case studies illustrating these effects (e.g., Warfarin).
5. Conduct a critical review of genetic testing methods used in pharmacogenomics (PCR, SNP arrays, NGS). Discuss their advantages and limitations.
6. Create a table or infographic that summarizes the key pharmacogenomic biomarkers for common drugs (e.g., Warfarin, Clopidogrel, and Thiopurines).
7. Discuss the application of pharmacogenomic testing in the clinical management of Warfarin therapy, emphasizing VKORC1 and CYP2C9 polymorphisms.
8. Analyze a case study of an adverse drug reaction (ADR) caused by a pharmacogenomic interaction (e.g., Stevens-Johnson syndrome from Carbamazepine). Suggest clinical strategies for managing such cases.
9. Write a paper discussing the ethical implications of pharmacogenomic testing, focusing on privacy concerns, consent, and genetic discrimination.
10. Evaluate the social and economic impacts of implementing pharmacogenomic testing in developing countries. Discuss the cost-effectiveness and accessibility of pharmacogenomics technologies.
11. Identify and discuss the challenges faced in implementing TDM, including issues related to sample collection, timing, and interpretation.
12. Examine how pharmacokinetic (PK) and pharmacodynamic (PD) data are integrated to individualize drug therapy.with case studies where PK/PD correlation has led to improved therapeutic outcomes.

The scope of the subject of Precision Medicine covers a broad range of concepts that explore the relationship between genetic variations and drug response, ultimately leading to personalized medicine. The course addresses the fundamental genetic mechanisms that influence drug metabolism, highlighting key Precision Medicine concepts such as enzyme polymorphisms, gene-drug interactions, and the genetic basis of pharmacokinetics and pharmacodynamics. Additionally, it emphasizes the practical application of genetic testing in clinical practice, focusing on the use of Precision Medicine in optimizing drug safety, efficacy, and individualized treatment, particularly in oncology, psychiatry, and for adverse drug reactions. Ethical, legal, and social implications are integral to the field, addressing privacy concerns, genetic discrimination, and regulatory frameworks for Precision Medicine. Emerging technologies such as Next-Generation Sequencing (NGS), CRISPR, and artificial intelligence are discussed in relation to their potential in advancing pharmacogenomics and personalized medicine. The course ultimately aims to equip students with the knowledge, skills, and ethical awareness required to implement Precision Medicine practices effectively in clinical settings.

 K1: Identify the impact of genetic variation on drug metabolism.

K2: Discuss the ethical implications of pharmacogenomic testing.

K3: Illustrate clinical guidelines for pharmacogenomic testing in specific drug therapies.

K4: Apply genetic factors involved in adverse drug reactions.

K5: Employ the role of pharmacogenomics in personalized oncology treatments.

K6: Evaluate the potential of next-generation sequencing and CRISPR technology in advancing pharmacogenomics.

S1: Apply pharmacogenomic principles to optimize drug dosing.

S2: Perform genetic testing using PCR, SNP arrays, or NGS to identify polymorphisms relevant to drug responses.

S3: Interpret genetic test results in clinical contexts to guide treatment decisions.

S4: Analyse emerging technologies like machine learning or AI into pharmacogenomic practice.

S5: Design case-based analyses to assess pharmacogenomic interactions with drugs. S6: Evaluate the cost-effectiveness of pharmacogenomic testing in clinical settings.

A1: Recognize the importance of ethical considerations in pharmacogenomic testing.

A2: Demonstrate an openness to the integration of pharmacogenomic data into clinical practice.

A3: Exhibit sensitivity toward patients’ cultural and socioeconomic contexts in the application of pharmacogenomics.

A5: Commit to continuous learning about the advancements in pharmacogenomic technologies.

A5: Value personalized medicine approaches to improve drug safety and efficacy.

A6: Exhibit ethical responsibility in considering the social impact of pharmacogenomics.