Carlsbad-based Agility Clinical Inc.'s employees wear many hats. One of its physicians, for example, acts as the chief medical officer of several biotechs in California.
The specialty consulting and clinical research organization, founded in April, fills executive-level slots at small and virtual pre-clinical and clinical stage companies that are developing drugs and devices.
Agility's employees are hired on a temporary or contract basis.
“We’ve assembled an impressive network of experts that can help very small and virtual biotech companies that don’t have much in the way of infrastructure," said Ellen Morgan, CEO of Agility. “We can be a one-stop shop for them.”
Its consulting services cover all stages of the clinical development process, from regulatory strategy to electronic submission. Other offerings include expertise in chemistry, manufacturing and controls (CMC), toxicology and pharmacokinetics.
Agility's advice aims to ensure that product development programs are successful and within timelines and budget constraints.
The company just expanded its stand-alone consulting services to more broadly serve the unmet needs of small and virtual biopharma and device startups.
One of its clients doesn’t have an in-house statistician. So, Agility’s statistician helps with their statistical strategy.
Most of its clients are based in California, but Morgan said she wouldn’t turn down companies located elsewhere.
Several of its client companies are developing treatments for arthritis. It’s also working on several orphan drug projects, which fight rare diseases that occur in less than 200,000 people in the United States.
“The regulatory requirements are often different than for products that apply to a much larger population. The regulatory pathway may be easier, but it’s more difficult to find patients so trials are usually smaller,” she said.
Morgan, a 30-year veteran in the pharmaceutical industry, started out as a research chemist and worked for two big pharma companies on the East Coast, including Pfizer Inc. (NYSE: PFE) in New York.
In 1995 she co-founded Synteract Inc., which provided clinical services to 200 biotechs during her tenure.
She left the Carlsbad-based company two years ago and declined to comment about whether she recruited at Synteract for her new venture.
She's currently looking to expand her 47-person staff of employees and consultants at Agility, and she's finding there are lots of candidates to choose from.
“Because there’s a trend toward this virtual model, so many companies are laying off,” she said. “There are a lot of experienced people out there now who are consulting.”