Watershed Therapeutics — Multi-Country LATAM Trial-Conduct Approvals for a Novel Intravesical Platform

Watershed Therapeutics (Bellevue, WA; founded 2019) is developing a novel intravesical drug-delivery platform designed to maintain sustained local therapeutic concentrations in the bladder for conditions including recurrent urinary tract infections (rUTIs), overactive bladder, and bladder cancer. bioaccess® secured the in-country regulatory and ethics-committee approvals required to conduct Watershed's clinical studies in El Salvador and Panama, and earlier supported a study in Colombia. The platform is investigational; nothing here implies FDA clearance, approval, or product commercialization.

Study facts

• Sponsor / company: Watershed Therapeutics
• Indication / area: Urology / Drug Delivery
• Country: El Salvador, Panama, Colombia
• Study type: First-in-Human (FIH)

Key metrics

• Countries Authorized: El Salvador, Panama
• Prior Program Support: Colombia
• Indications: rUTIs, OAB, bladder cancer
• Status: Investigational

The challenge

Watershed needed to move a novel intravesical drug-delivery platform into human clinical experience across multiple Latin American jurisdictions — anchored to a U.S. FDA strategy — while preserving startup capital and coordinating regulatory and ethics-committee approvals in each country before study conduct could begin.

bioaccess® solution

bioaccess® managed the country-by-country regulatory and ethics-committee submissions required to authorize study conduct in El Salvador and Panama, building on earlier work supporting a study in Colombia. Clinical operations were structured under ISO 14155 / ICH E6 good clinical practice and anchored to the sponsor's U.S. FDA strategy, consistent with bioaccess®'s standard first-in-human execution model.

Results

• Regulatory and ethics-committee approvals to conduct clinical studies secured in El Salvador
• Regulatory and ethics-committee approvals to conduct clinical studies secured in Panama
• Earlier study conduct supported in Colombia
• Clinical operations delivered under ISO 14155 / ICH E6 good clinical practice
• Program anchored to the sponsor's U.S. FDA strategy

Frequently asked

What did bioaccess® do for Watershed Therapeutics?

bioaccess® managed the country-by-country regulatory and ethics-committee submissions required to authorize study conduct in El Salvador and Panama, building on earlier work supporting a study in Colombia.

Where was the Watershed Therapeutics First-in-Human (FIH) study run?

The Watershed Therapeutics First-in-Human (FIH) study was executed in El Salvador, Panama, Colombia by bioaccess® in the urology / drug delivery area.

What was the outcome of the Watershed Therapeutics study?

Reported outcomes for Watershed Therapeutics's device: Regulatory and ethics-committee approvals to conduct clinical studies secured in El Salvador; Regulatory and ethics-committee approvals to conduct clinical studies secured in Panama; Earlier study conduct supported in Colombia.

Run a similar trial: Clinical trials in El Salvador · Clinical trials in Panama · Clinical trials in Colombia

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