Development of Fertility Regulation Methods by Small Business (R43/R44 Clinical Trial Optional)

Purpose The purpose of this FOA is to invite SBIR applications to support and facilitate the development of new and/or improved non-hormonal contraceptive, including contraceptives with anti-infective properties, products for men and women. Background Nearly half of all pregnancies in the United States are unintended. There is a critical need for fertility regulation methods, including those that incorporate an anti-infective property, that fit the requisites of women and men throughout their reproductive lives. This FOA supports the NICHD in its mission to develop novel, safe and effective non-hormonal contraceptive products for men and women. Research Objectives and Scope Projects must be focused on the development of new and/or improved non-hormonal contraceptive products, or novel assay platforms that facilitate and support a single contraceptive, including a multipurpose prevention technology related product. Any proposed product must have characteristics consistent with the development of a safe and effective contraceptive acceptable to women or men. All applications for Phase II programs focused on contraceptive product development must include in vivo product testing. Contraception product development programs of high priority are: Pre-coital contraception Male and female contraceptives based on: Nonsteroidal mechanism of action Do not act via the hypothalamic-pituitary-gonadal (HPG) axis New and improved delivery devices for contraception Multipurpose prevention technology (MPT) products with adequate contraceptive and anti-infective properties. Proposed MPT products must have a validated contraceptive mechanism of action but may investigate potential anti-infective properties with appropriate rationale and/or supporting data Phase I applications focused on the late stage preclinical development or Phase II applications focused on the clinical development of a single contraceptive product (i.e., drug or medical device); Applications focused on the late stage preclinical development or clinical development of a single non-hormonal multipurpose prevention technology (MPT, products with both contraceptive and anti-infective properties) that does not act via the HPG; Applications for the development of a product (i.e., drug or medical device) which demonstrate current industry interest/support (e.g., advisory) Applications that include the following are not responsive to this FOA: Applications not focused on the development of a single contraceptive product, multipurpose prevention technology (contraceptive with anti-infective properties) or delivery system Applications focused on the development of an active pharmaceutical ingredient (e.g., small molecule) whereby themolecular target is not known Applications focused on the development of an active pharmaceutical ingredient (e.g., small molecules) that modulates multiple targets (e.g., a pan-antagonist or pan-agonist) Applications focused on the development of an active pharmaceutical ingredient (e.g. small molecule) that modulates its target irreversibly (eg., alkylation, Michael acceptor, conjugate addition) Applications focused of the development of multiple active pharmaceutical ingredients (e.g. small molecules) that utilize, or require, an additive or synergistic effect affording infertility Applications focused on the development of multiple inhibitors modulating a single, or multiple, contraceptive target(s) Applications for the development of molecules for male or female contraception that act via steroid receptors or by modulating the hypothalamic pituitary gonadal axis Applications for the development of contraceptive methods that require the administration of one or more exogenous steroidal molecules that act via nuclear steroid receptors Applications for the development of contraceptive methods that require the administration of selective steroid receptor modulators (SRMS), or similar chemical derivatives Applications based on mechanisms of contraceptive action that may act post-fertilization Applications that focus on the development of methods that may act via the oviduct or uterus Applications for the development of irreversible occlusion methods Applications based on intrauterine devices/intrauterine systems Applications for the development of the following molecules and/or their chemical derivatives: Gamendazole H2-Gamendazole Adjudin Gossypol alpha-chlorohydrin Applications focused on the development of type I-II kinase inhibitors Application focused on the development of molecules or devices that disrupt/perturb the blood-testis and/or blood-epididymal barriers Applications focused on molecular targets for which there is no human ortholog Validation This FOA requires that applications include data demonstrating that the mechanism proposed for development is validated. Validation, as defined in this FOA, is the demonstration in a mammalian species whereby the modulation proposed in the application to achieve a contraceptive effect, whether specific (e.g. antagonism of a single specific enzyme) or non-specific (e.g., sperm motility inhibition by exposure to a high molecular weight polymer) results in infertility. Subfertility is not sufficient to constitute validation. Subfertility, as defined in this FOA, is the generation of live animals from in vivo mating trials and/or an in vivo or in vitro fertilization rate greater than zero. Validation is not required for applications focused on the development of devices for the delivery of a non-hormonal contraceptive active pharmaceutical ingredient (including MPT); however, it must be consistent with the responsive criteria defined by this FOA. See Section VIII. Other Information for award authorities and regulations.