Also known as precision medicine, this kind of individualized treatment is designed specifically for the patient and has revolutionized cancer therapies in recent years.
These treatments also have massive potential for reproductive health and, by extension, the developmental and reproductive toxicology (DART) field, which studies the toxicological effects on reproductive health and development.
The most common use of personalized medicine in reproductive health is in IVF treatment, but there are many other uses on the horizon. Each advancement will bring with it significant challenges considering the complexities of anything related to reproduction and development in the human body.
Kevin Denny, executive technical director and toxicologist at WuXi AppTec, gives his thoughts on personalized medicine in the field of reproductive medicine to Liza Laws, senior editor of Outsourcing Pharma (OSP), including its challenges, potential for future use, and integration into the DART field.
LL: What is personalized medicine, and how does it differ from traditional approaches to treatment?
KD: Personalized medicine uses marker-assisted diagnosis tools to tailor specific targeted therapies constructed from a patient’s biological makeup. This essentially designs drugs specifically for an individual.
LL: How is personalized medicine integrated into the DART (Developmental and Reproductive Toxicology) field?
KD: This is a new and evolving specialty subset within DART. There is a new working group within HESI DART NAMs/Alternatives which aims to create a New Approach Methodology (NAMs) toolbox that will provide for and clarify the context of use for alternative assays. These will comply with various regulatory guidelines so that they can be validated for use as a NAM. Three manuscripts are underway: (1) A hypothesis-driven approach to DART testing; (2) Use of NAMs in chemical risk assessment; and (3) Use of NAMS in pharmaceutical risk assessment.
LL: What are the key considerations when applying personalized medicine in reproductive disorders and drug use during pregnancy?
KD: This is another rapidly evolving area of pharmaceutical research. Current practice in precision medicine often involves designing drugs with companion diagnostics to target subgroups of patients. Most drugs are approved with a fixed dosage regimen for the targeted population. However, some drugs and biologics are approved with instructions to tailor therapies for individual patients, whether it be dosing, combination with other therapies, or selection among a class of medications. Personalized medicine can be designed for individual patients within the context of all the metabolic and physiologic changes during pregnancy.
LL: What advancements have been made in personalized medicine to improve outcomes in reproductive health and pregnancy?
KD: Personalized medicine in reproductive health and pregnancy is still in the very early stages—we’re still uncovering and validating biomarkers. In Vitro Fertility (IVF) treatment is currently the most mature field. Reproductive medicine is extremely complex and requires identification and verification of multiple biomarkers that are needed to tailor specific treatments. To adequately personalize the reproductive process, developing a targeted therapy is complicated and includes prevention, screening, diagnosis, prognosis, and treatment.
LL: How do personalized medicine approaches contribute to safer drug use during pregnancy?
KD: Personalized medicine is about tailoring a treatment, so it’s as individualized as the disease. This relies on first identifying biological and clinical information that allows for the design of new drugs based on understanding how someone’s physiology makes them vulnerable to certain diseases.
LL: What are the challenges and limitations associated with implementing personalized medicine in the DART field?
KD: Regulations are still evolving for personalized medicine because it’s still in its infancy. Despite regulators’ progress in producing draft guidance and other documents that outline potential pathways regarding personalized medicine and diagnostics, uncertainty remains about the regulatory landscape for laboratory-developed tests (LDTs).
This uncertainty has also discouraged industry investment in new diagnostics. Regulatory considerations are currently the largest challenge and limitation to implementing personalized medicine in DART.
LL: What future directions or research priorities exist for advancing personalized medicine in reproductive health and pregnancy?
KD: Early pre-term births, pre-eclampsia and other hypertensive pregnancy disorders continue to be the leading causes of infant mortality and remain a major cause of maternal and infant mortality worldwide.
The rate of progress toward understanding pregnancy disorders is behind other aspects of human health.
Work in this area needs to be expanded to begin before conception, assessing pregnancy longitudinally, before, during, and after pregnancy. Pregnancy disorders should be defined by pathophysiology to design new treatments. Expanding assessments into new modalities and advanced therapies will be necessary to develop new tools for treating infertility and improving womens’ health during and after pregnancy.
A Final Word
Personalized medicine has the potential to revolutionize healthcare and bring treatments to many people who otherwise may have lost hope. In the context of reproductive health, precision medicine is still in its infancy, but the future holds great promise for researchers and clinicians working in this area.
Scientific progress always encounters challenges—especially regulatory hurdles—but a trusted lab partner can help drug developers and sponsors tackle them head on and make personalized medicine another tool in advancing reproductive health.