Michelson Prize Criteria
The winning entry for the Michelson Prize in Reproductive Biology will have, at minimum, the following characteristics, as defined below.
- Single-dose, permanent, nonsurgical sterilant
- Administered in a single patient encounter
- Must not require general anesthesia
- May require sedation or local anesthesia
- Injectable administration is preferred to oral administration
- Subcutaneous implant is considered nonsurgical for the purpose of the Michelson Prize
- Must induce permanent sterility for the reproductive lifetime of the species, defined as at least 10 years after administration
- Will generally require 3 years of data with a trend line with no expectation of recovery of fertility, may require that study extends for additional time
- Safe and effective in male and female cats and dogs
- Must be one product for both species and genders, pre- and post-pubertal
- Must be no more dangerous than surgical gonadectomy
- Must be safe for the treated animal, environment (including predators), and the person administering the product
- Efficacy must be ≥ surgical spay/neuter. For the purposes of experimental design, a lower standard of proof may be acceptable.
- Must not induce clinical abnormalities or pathological lesions at 1X dose in safety studies
- Must not be carcinogenic, mutagenic, or clastogenic
- Must not be a “bait” formulation (i.e. administered without handling of treated animals)
- Ablates sex steroids and/or their effects
- Must prevent testicular secretion of testosterone in males, or ablate androgen receptors
- Must prevent ovarian secretion of estradiol and progesterone in females, or ablate their receptors
- Suitable for administration in a field setting
- May require refrigeration/cold chain but no frozen storage, water source, or other electricity than refrigeration
- Must have shelf life of at least two years
- Must not require sterile environment/surgical theater
- Viable pathway to regulatory approval
- As defined by the Food & Drug Administration's Center for Veterinary Medicine (FDA CVM) as a prescription product in dogs & cats
- Regulatory approval, including requisite clinical trials, will be sought by Found Animals
- Reasonable manufacturing process and cost
- Target is a low cost product to deliver to shelters
- Must be no greater than $50 cost per dose to deliver labeled, packaged product to Found Animals or other distributor, with <$25/dose preferred when manufactured at commercial scale
