Personalized medicine, often referred to as precision medicine, is reshaping healthcare by tailoring treatments to the unique genetic, environmental, and lifestyle characteristics of individual patients. This approach has shown transformative potential in reproductive health, particularly in areas such as fertility treatments and developmental and reproductive toxicology (DART).
Manufacturers can leverage advanced diagnostic tools, biomarker analysis, and personalized treatment plans, to create more effective and efficient solutions for patients navigating the complexities of reproduction. Researchers are especially optimistic about its application in the DART field, where it addresses toxicological effects on reproductive health and development, paving the way for safer and more targeted interventions.
Precision medicine uses biomarker-assisted diagnostic tools to design therapies based on a patient’s biological makeup. Adequately personalizing the reproductive process requires prevention, screening, diagnosis, prognosis, and treatment. While the field is extremely exciting, it is also in its infancy.
Although the potential of personalized medicine in reproductive health is exciting, drug developers must deal with the intricacies of a rapidly-evolving landscape, and keeping up with regulation, testing and breakthroughs can be challenging. Here are three ways the personalized medicine revolution is transforming reproductive health.
1. Personalized medicine in IVF and beyond
Personalized medicine is most commonly used in reproductive health for in vitro fertilization (IVF) treatment. However, other uses are on the horizon. Applying personalized medicine in reproductive disorders and drug use during pregnancy is another rapidly evolving area of pharmaceutical research. In precision medicine, current practice involves designing drugs with companion diagnostics to target subgroups of patients.
Most drugs are approved for the targeted population with a fixed dosage regimen. However, some drugs can be approved with instructions to design therapies for individual patients through dosing, combination with other treatments, or selection among a class of medications. Therefore, personalized medicine can be designed for individuals within the context of all the metabolic and physiological changes that occur during pregnancy.
2. Integrating personalized medicine into DART
Precision medicine is an evolving and niche subset within DART. The Health and Environmental Sciences Institute has a DART committee with a working group focused on New Approach Methodologies to provide alternative assays for DART testing. These efforts are expected to clarify the context of use for these methodologies so they can be validated for use as a NAM. Three manuscripts are underway:
- A hypothesis-driven approach to DART testing
- Use of NAMs in chemical risk assessment
- Use of NAMs in pharmaceutical risk assessment
However, researchers must overcome a major challenge to implement personalized medicine in the DART field: regulatory compliance.
Because of its relatively early stage of development, regulation is still evolving. Some authorities have made progress in producing draft guidance and other documents that outline the potential pathways regarding personalized medicine and diagnostics. Still, uncertainty remains, particularly surrounding the regulatory landscape for laboratory-developed tests (LDTs). Uncertainty over regulation has discouraged industry investment in new diagnostics.
3. Embracing new technologies in personalized medicine
The level of understanding of pregnancy disorders is lagging behind other aspects of human health, and the rate of progress is slow. Early pre-term birth, pre-eclampsia, and other hypertensive pregnancy disorders continue to be the leading causes of infant mortality and a significant cause of maternal and infant mortality worldwide.
To achieve significant results in this area, work needs to expand to begin before conception, assessing pregnancy longitudinally before, during, and after pregnancy. Additionally, pathophysiology should define pregnancy disorders to design new treatments. By expanding assessments into new modalities and advanced therapies, researchers can develop new tools to treat infertility and improve women’s health during and after pregnancy.
New medical technologies will continue to transform the field of personalized medicine and reproductive health in the future. These will include increased use of machine learning and data analytics, wearable devices, and advanced diagnostic and predictive tools. Embracing these technologies will hand manufacturers an advantage in an area which is developing quickly.
A final word
The potential of personalized medicine in reproductive health brings hope to researchers, healthcare providers, and patients. Although this field is still relatively young, progress is moving quickly. For those who suffer from conditions linked to reproductive health, this advance may offer treatments that were unthinkable just ten years ago.
As with all rapidly progressing areas of medicine, developers and sponsors must ensure they use the most efficient and robust testing techniques to bring products to market. In such areas, where regulation has yet to catch up with progress in many countries, a trusted lab partner can ensure that challenges are met head-on and that no extra time or money is lost during development. With innovation, proper testing, and determination, developers can make personalized medicine another critical tool in advancing reproductive health.
