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.

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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.

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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.

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VIRTUAL TEAMS MANAGE SUBMISSION DOCUMENT AUTHORING PROCESS

A small Australian pharmaceutical company engaged Facet to help complete development for a new chemical entity (NCE) culminating in a new drug application (NDA) for a dermatological indication. The Sponsor team was comprised of four people who collaborated with external vendors around the globe to complete all documents required for the submission.

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COMPLIANT DOCUMENT MANAGEMENT CAPABILITIES FOR SMALL TEAMS

Small European diagnostics company engaged Facet Life Sciences to help complete development for a new chemical entity (NCE), culminating in the submission of a new drug application (NDA) to the US Food and Drug Administration. The Sponsor team consisted of three resources. Research
and development activities were being outsourced to contract research organizations with oversight by the Sponsor team.

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