Plans up to 40 jobs; challenge to attract talent
PETALUMA — A Long Island, New York-based company that runs clinical trials mainly for skin-based treatments plans to greatly expand its contract-research capabilities with the move of its formulations laboratory to Petaluma this spring.
When it is fully operational, the 12,000-square-foot Dow Developmental Laboratories at 1031 N. McDowell Blvd. could employ up to 40, drawn from a biotechnology talent pool of related companies in the region, according to Debra Dow, PharmD, vice president of scientific affairs and co-founder of Symbio, LLC (631-474-8531, symbioresearch.com), parent company of the labs venture. The goal is to start hiring soon for about 10 employees envisioned this year, she said.
“Symbio has been doing testing of products once they have been developed,” said Dr. Dow, a local resident. “This is a step ahead. Symbio will be more front-loaded in services for pharma, generics and medical-device companies.”
Dr. Dow is the niece of Gordon Dow, founder of Petaluma-based Dow Pharmaceutical Sciences, and she worked her way up from its early days to become vice president before starting Symbio with Richard Panico in 2002. But she said Symbio and Dow Developmental Laboratories aren’t affiliated with Dow Pharmaceutical Sciences, which Orange County-based Valeant Pharmaceutical bought in late 2008 for $285 million.
Yet Symbio’s plan to become more vertically integrated coincided with the planned retirement of Bob Lathrop, whose one-person formulation lab in Fort Collins, Colo., has served Symbio since 2005. And it came as Dow Pharmaceutical told the Business Journal in October it would no longer handle contract research and development, focusing instead on projects for Valeant companies.
Whether any existing Dow Pharmaceutical contract R&D clients move to Dow Developmental Laboratories will have to be seen after the facility gets federal Food & Drug Administration licensing, according to Mr. Panico, president of Symbio, which remains based in Port Jefferson Station, N.Y.
The Petaluma labs are set to be ready to occupy by April. The manufacturing area, which is set to be half the space, is designed to meet the federal class 100,000, or ISO 8, level of air cleanliness. The facility will also have packaging and labeling capabilities, functions Symbio has had to provide via contractors up to this point.
Outfitting the labs is estimated to cost at least $750,000. Operating on lines of credit so far, Symbio secured its first loan to construct the labs, Mr. Panico said.
As a contract research organization, Symbio manages and monitors clinical trials, mainly for topically applied treatments used by dermatologists. The company prepares the trial protocol, which is a blueprint for how it will be conducted, works toward a green light from an FDA investigational review board that the trial is deemed safe, selects physicians and specialists who fit the trial, distributes the test product to them along with monitoring paperwork, visits test sites to review methodology then prepares the final report for the FDA.
At that point, it may be three or more years before the FDA approves or rejects the treatment. Symbio handles 20 to 24 trials in various stages at any point in time. Since the company started, 20 of the products tested has been approved, according to Mr. Panico. Symbio only works with testing for FDA approval.
Symbio has 65 to 70 employees. But because of the need to regularly visit test sites and review records and methods, two-thirds of the workforce work remotely, according to Mr. Panico.
Symbio’s establishment of a contract lab in Petaluma is the latest in a slowly emerging biotechnology cluster in the North Bay, according to Teresa Johnk, who worked with Symbio to find a North Bay lab location. She worked at Dow Pharmaceutical Sciences and San Rafael-based BioMarin Pharmaceutical in the 1990s then in 2007 started Greenbrae-based Business Development Connections, which works like a salesforce on commission or retainer for CROs like Symbio and contract manufacturing organizations like Dow Developmental Laboratories.
“In Petaluma, the challenge will be getting talent to move up here,” Ms. Johnk said. “That was a challenge when I was at Dow.”
That has changed now that BioMarin has 1,500 Marin County employees, BioMarin spinoffs Raptor Pharmaceutical and Ultragenyx have been rapidly growing in Novato and Petaluma has attracted Biosearch Technologies, Oculus Innovative Sciences and Optime, she noted.
In Symbio’s Petaluma lease, signed Dec. 11, James Manley of Keegan & Coppin/ONCOR International represented the company. Brian Foster, Trevor Buck and Steven Leonard of Cassidy Turley represented McDowell Business Center owner PB&J Partners, LLC. Symbio considered more than a dozen sites in Santa Rosa and Petaluma before settling on a more southern location, according to Mr. Manley.
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