Case Studies

LASER FOCUS ON CLINICAL DEVELOPMENT

A pharmaceutical company with one employee based in the United States was developing a novel drug combination product. Since 1995, a considerable amount of theoretical research on the product had been completed and dozens of publications were generated. The combination product showed promise in several animal models for serious diseases, some with unmet medical need. These results triggered several investigator-initiated clinical trials (using compounded drug product) with the goal of demonstrating proof-of-concept in several different disease states.

SAVE TIME AND MONEY FOR EUROPEAN DIAGNOSTICS SPONSOR

Founded in 2014, a European medical imaging diagnostics company sought guidance on the development of a novel Positron Emission Tomography (PET) radiopharmaceutical product. Data from over 800 patients had been collected from a variety of sources including medical centers, academic institutions, and independent investigators.

IDENTIFY & FILL RESOURCING GAPS WITH BIOMETRICS EXPERTISE

A small (less than 20 person), innovative pharmaceutical company based in the United States was in late stage (Phase 3) development with a drug device product that was targeted for a 505(b)(2) submission within 12 months of engagement with the Facet Life Sciences Team.

AWARDS & RECOGNITION

great place to work certified badge for may 2023 to may 2024 USAtop regulatory services provider 2023 award awarded to facet life sciences by life sciences review.great place to work certified badge for april 2024 to april 2025 USAtop regulatory services provider 2024 award awarded to facet life sciences by life sciences reviewtop regulatory services provider 2025 award awarded to facet life sciences by life sciences review