Spaulding Clinical Research has begun $5 million of clinical trial work as part of a five-year contract with the U.S. Food and Drug Administration.
The West Bend-based research center runs a 200-bed facility and conducts and analyzes first-in-human, clinical proof-of-concept, cardiovascular safety and NDA-enabling clinical pharmacology studies.
Spaulding Clinical’s contract includes work for an FDA department that is charged with approving all new drug applications in the U.S. Recent work of the FDA’s Division of Applied Regulatory Science has included examining drugs of abuse, including opioids; methods for evaluating new drugs; generics and biosimilars; and over-the-counter products, such as sunscreen.
“We’re really touching all of those,” said Spaulding Clinical chief executive officer Cassandra Erato. She declined to disclose specific therapeutic areas of focus.
Spaulding Clinical is responsible for conducting the trials and providing support services, including clinical trial recruitment, conduct and laboratory assessments.
“We are happy to partner with the FDA to help address agency questions about various classes of drugs,” Erato said. “Spaulding Clinical is perfectly suited to conduct these trials as we have the right-sized project management and principal investigator team that will be able to give the FDA office the attention they need.”
Founded in 2008, Spaulding Clinical has been working with the U.S. government on clinical trials over the past seven years.
“We began conducting clinical trials for the FDA to explore a model to screen new drugs for prolongation of QT,” said Dr. Jay Mason, chief medical officer at Spaulding Clinical. “Through this work and resulting publications, we have developed a productive partnership.”
Beyond its government contract work, Erato said it’s a busy time for the company, and the pharmaceutical industry in general, as biotech startups benefit from a recent influx of private equity funding.
“San Francisco, San Diego, Boston are just booming with new drug developments and we’re seeing the highest number of new drug applications that we have in many, many years,” she said. “…Everybody is well funded right now and everybody is doing a lot of work.”
Spaulding Clinical projects its sales this year will be at least double last year’s numbers.
“We’re growing very rapidly,” she said.
With increased consolidation in the market, Spaulding Clinical’s position as a mid-size company has been an asset in landing clients, Erato said.
“We have these project management teams that are very dedicated to their (clients),” she said. “We work well together to get them the attention they need on the project.”
Erato said Spauling Clinical’s relationship with the FDA’s Division of Applied Regulatory Science has allowed the company to lend its expertise in particular therapeutic areas and has informed the company’s work with private sector pharmaceutical clients to ensure their clinical trials meet FDA requirements.
Erato recently was named CEO of Spaulding Clinical, succeeding her father, Randy Spaulding, who founded the company. He is now chairman and chief visionary officer of the company.
“He’s still incredibly active in the company,” Erato said. “…He’s working a lot on our future innovations; he’s always been a major visionary for our company.”