One of the strengths of our program is the potential to take a novel biomarker from discovery to clinical validation. Biomarkers are biochemical substances that can be used to measure the progress of disease or the effects of treatment. In the area of vaginal product research, biomarkers could give early information about the safety and likely efficacy of both contraceptive and microbicide products, facilitating triage of less promising candidates. In addition, biomarkers of sexual behavior and study product use could help with interpretation of study results. As examples, CONRAD is developing new biomarkers of cervicovaginal inflammation, indicating safety or lack of it, new biomarkers of vaginal exposure to semen, indicating whether intercourse unprotected by condoms took place, and new biomarkers that indicate if a vaginal product has been used.
If a biomarker of HIV transmission could predict the efficacy of a candidate microbicide for HIV prevention, the need for large Phase III trials enrolling thousands of women might be obviated. This would be a large benefit to the microbicide field.
To learn more about CONRAD's preclinical and clinical biomarker activities, click here.