Tag: PASE

Medical and Regulatory Affairs

The FDA’s New Guidance on Natural History Studies in Rare Diseases: What You Need to Know

In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases. The document, Rare Diseases: Natural History Studies for Drug Development,[1] addresses one of the major challenges sponsors encounter when developing therapies for rare disease: the lack...

Patient and Stakeholder Engagement

Patient Engagement Expert to Address Orphan Drug Congress April 11

DURHAM, N.C., March 25, 2019 — Premier Research’s head of patient engagement will discuss a patient-centered look at drug development at the World Orphan Drug Congress (WODC) USA in Oxon Hill, Maryland. Juliet Moritz, Premier Research’s newly appointed vice president of patient and stakeholder engagement (PASE), will present From the End to the Beginning: A Patient-Centric...

Patient and Stakeholder Engagement

Premier Research Champions Patient Advocacy Community

DURHAM, N.C., February 28, 2019 — As part of its commitment to supporting the patient advocacy community and as a kickoff to Rare Disease Day on February 28 and March as Rare Disease Month at the company, Premier Research is announcing both a new scholarship for rare disease patient advocates in partnership with Professional Patient...