RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS
ULTRA RARE DISEASE DEVELOPMENT:
Facet helps growing start-up design a development plan for a pediatric ultra rare disease indication.
A small ex-US company asked Facet to provide US regulatory affairs and strategic development guidance regarding their product for a predominately pediatric ultra rare disease. Facet reviewed the nonclinical and CMC work done on the product to date and recommended 1 phase 1/2 trial in adult patients diagnosed with the disease and 1 phase 3 global trial, based on regulatory precedent. Facet also helped the company select a target indication and trial endpoints. The company is working with Facet to submit an orphan designation request and a rare pediatric disease designation request.
DEVELOPMENT PROGRESS WITH COST SAVINGS:
Facet helped a small pharmaceutical company save time and money. A pre-IND stage start-up company asked Facet to help design a streamlined development program to help them to get to IND. Facet noted that the company was spending a lot of time and money juggling many nonclinical CROs and boutique labs. On Facet’s recommendation, the company consolidated the activities to a few strategic CROs enabling them to shave months off their development plan and avoid the need to seek an additional capital raise prior to IND submission. If you are a small company who is trying to do more with less, click here to talk to a Facet regulatory expert about your program.