Pharmaceutical Product Development (PPD) is opening a new 24-bed clinical research unit in Las Vegas, enhancing its ability to conduct complex, procedurally intensive phase I and early development clinical research on behalf of pharmaceutical and biotechnology clients.
In its location adjacent to the Dignity Health-St. Rose Dominican, San Martín campus, the new clinical research unit will utilize the facility’s hospital-based services and medical expertise to meet PPD clients’ needs for early phase trials. The new operation will offer the same extensive experience and world-class quality established by PPD’s phase I unit in Austin, Texas, but it will support trials involving healthy and patient volunteers, and will utilize registered nurses as part of the subject management team. PPD anticipates initiating its first studies at the facility in the third quarter of 2017.
“This new state-of-the art operation will provide us with the capability to include healthy and patient volunteers in first-in-human through proof-of-concept trials, which are becoming progressively more complex in nature,” said Cindy Doerfler, vice president of PPD’s early development division.
Elaine Watkins, D.O., will serve as the Las Vegas facility medical director. Dr. Watkins is an internist with 25 years of clinical experience and 12 years of experience in more than 200 patient-based early phase clinical trials. As part of her drug development background, she has experience in a variety of disciplines, including neurology, cardiovascular, gastroenterology and medical devices, and expertise in carbohydrate metabolism, glucose clamping and nonalcoholic steatohepatitis/nonalcoholic fatty liver disease (NASH/NAFLD) trials.
A global leader in Phase I capabilities, PPD is able to support studies conducted in the new clinical research unit via comprehensive early development services ranging from non-clinical consulting to protocol writing, protocol optimization, project management, laboratory services, monitoring, medical writing, data management, biostatistics and clinical pharmacology. PPD’s expertise and experience conducting complex clinical trials enable effective integrated planning and implementation for its early development clients, as well as the ability to support its clients’ efforts to increase efficiency and accelerate drug development timelines.