Chemical Screening and Optimization Facility (X01 Clinical Trial Not Allowed)

The National Institute of Child Health and Human Development (NICHD) invites applications to access services at its Chemical Screening and Optimization Facility (CSOF), aimed at developing non-hormonal contraceptive methods and therapies for reproductive health. This X01 Resource Access Award does not provide direct funding but offers preclinical services, such as high-throughput screening, protein synthesis, crystallography, structure-activity relationship analysis, and drug metabolism studies, to advance candidates toward Investigational New Drug (IND) or Investigational Device Exemption (IDE) studies. The facility aims to support the development of safe contraceptives and reproductive health therapies that target mechanisms outside the hypothalamic-pituitary-gonadal axis. Key services include protein generation and crystallization, computational chemistry, chemical optimization, and drug metabolism studies. Eligible projects may request services that support therapeutic advancements for various conditions, including infertility, polycystic ovarian syndrome, endometriosis, uterine fibroids, preeclampsia, and more. Projects that can demonstrate target validation (e.g., enzyme inhibition leading to contraception) are prioritized. Services are available for both early and late preclinical development but are limited to one-year duration unless prior approval for a longer timeframe is granted. The NICHD particularly encourages investigators with existing NIH funding to apply, though external researchers may also be considered. Eligibility is open to institutions of higher education, nonprofits, for-profit organizations, local governments, and some international institutions. Investigators should work closely with NICHD program staff to discuss service requests before applying. Additionally, each service request should focus on a single service to maintain clarity and manageability. Applications should provide well-defined deliverables, milestones, and alternative approaches should challenges arise. Services cannot overlap with those funded by other Public Health Service (PHS) efforts, and applicants should ensure that each application submitted is scientifically distinct from any concurrent submissions. Applications undergo an internal NIH review process rather than traditional peer review. Evaluation criteria include the project’s significance, investigator qualifications, innovation, and the suitability of the approach and environment for achieving the project’s objectives. Successful applications will demonstrate the potential for the requested services to advance the project toward clinical application. Milestones and timelines should be realistic and set clear success markers to guide project development. A robust data-sharing plan is required, ensuring that resources generated become available publicly after a year, allowing for any necessary IP or publication considerations. Applicants must complete mandatory registrations (SAM, NCAGE for foreign entities, eRA Commons, and Grants.gov). Submission deadlines are biannual, with application reviews occurring in May and November each year. Selected projects will not receive a Notice of Award but will be granted access to the CSOF resources, with ongoing oversight from NICHD program staff throughout the project.