Personalized reproductive medicine: regulatory considerations.

Area of Science:

• Biomedical Sciences
• Pharmacology
• Medical Ethics

Background:

• Personalized medicine is often conflated with precision medicine, leading to definitional ambiguity.
• Precision medicine classifies patients into subpopulations based on biomarkers or genomics for targeted treatments.
• Personalized medicine encompasses a broader approach, considering individual patient context and preferences.

Purpose of the Study:

• To clarify the distinct definitions and applications of personalized and precision medicine.
• To examine the role of regulatory approval in drug development for personalized and precision approaches.
• To differentiate between regulatory actions and clinical practice in achieving personalized medicine.

Main Methods:

• Literature review and conceptual analysis of existing definitions and regulatory frameworks.
• Comparative analysis of drug development pathways for precision medicine (companion diagnostics) versus personalized medicine.
• Examination of regulatory approval processes and their implications for tailored therapies.

Main Results:

• Precision medicine relies on classifying patients into subgroups, often with companion diagnostics.
• Personalized medicine can extend beyond predefined phenotypes to include individual patient context and preferences.
• Most personalized medicine, especially for individual patients, is realized through clinical practice rather than explicit regulatory approval.

Conclusions:

• Distinguishing between personalized and precision medicine is crucial for understanding therapeutic strategies.
• Regulatory approval primarily supports subgroup targeting (precision medicine), while individual tailoring (personalized medicine) often occurs in practice.
• The practice of medicine plays a key role in delivering personalized therapies beyond regulatory mandates.