It would be hard to overstate the need for new therapies that target unmet medical needs, especially in rare disease. After all, there are only about 400 approved “orphan drugs,” meaning that 95 percent of rare diseases lack a single approved treatment. Now the good news: U.S. and European regulators, recognizing the size and severity...
DURHAM, N.C., June 27, 2016 — Small biotechnology companies taking new biopharmaceutical products from benchtop to bedside need an informed regulatory strategy and a close working knowledge of the Food and Drug Administration and other regulatory agencies. So when it sought a new head of regulatory affairs, clinical development service provider Premier Research found its ideal...
DURHAM, N.C., March 15, 2016 — Premier Research announces the appointment of Lisa Pitt as Vice President of Global Regulatory Affairs. Joining Premier Research from the U.S. Food and Drug Administration, where she was a senior regulatory project manager, Dr. Pitt provides strategic guidance and oversees the company’s regulatory affairs service offerings in rare diseases...
Join Nach Dave and Carol Huntington of Premier Research for Orphan Drug & Rare Disease Development: Understanding the European and US Regulatory Landscape. The hour-long event, beginning at 11am EDT, 4pm BST, and 5pm CEST, is aimed at researchers and pharma companies tackling some of the 7,000 rare diseases identified by the National Institutes of Health.
A new survey of clinical trial decision makers commissioned by Premier Research reports that nearly two-thirds (64%) of respondents said that among the most difficult factors in recruiting for a rare disease or orphan drug clinical trial was not only finding patients to join and remain in trials, but identifying and setting up investigative sites for studies.