Program seeks Council approval for an initiative titled “Biomarker Research to Support Fertility Regulation Development by Small Business.” The need for new, safe, non-hormonal contraceptive products accommodating to current lifestyle choices has led small business to develop innovative contraceptives: several of which are nearing clinical evaluation. It is imperative to establish validated biomarkers to support clinical research and development which is the goal of this initiative. Particular emphasis will be placed on the development and validation of pharmacokinetic and pharmacodynamic biomarkers that play a critical role in the design and evaluation in contraceptive clinical trials.
These efforts align with NICHD’s Vision for reproductive health (Theme 2) and safe and effective therapeutics (Theme 5). The development of new and improved contraceptive methods is a priority for the Contraception Research Branch. Lastly, this work may also be impactful for the development of multipurpose prevention technologies (contraceptives with anti-infective properties) should such applications be received.
Program Contact
Christopher Lindsey
Contraception Research Branch (CRB)
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