Affygility deflects red-tape hassles for life science firms

BROOMFIELD — Affygility may be more than a friendly sounding name for small biotechnical and pharmaceutical companies struggling with environmental health and safety in cash-poor times. Because this Broomfield company is one of only a few environmental health and safety (EH&S) companies nationwide that focuses primarily on these life sciences.

“The environmental safety issues is this industry are very complex, and they are not issues they typically teach you in school,´ said Dean Calhoun, president and founder of Affygility Solutions LLC. “It’s not like EH&S for manufacturing. Typically, these are research and development companies, where the time to market is critical. For a compliance issue to slow that time to market is just unacceptable.”

Calhoun has more than 17 years in the field, beginning his career with Rust Environmental and most recently the associate director of EH&S at Gilead Sciences. A certified industrial hygienist — his bachelor’s degree was in engineering — Calhoun was faced with moving his family to the West Coast several years back. Instead of moving, however, Calhoun went back to school at age 45 to obtain dual master’s degrees in environmental policy and management, and technology management, with an eye at opening his own company.

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Early this year, he opened Affygility and pretty much began billing on day one, and he was able to attract some experienced veterans in the field. Although the company has four employees today, Calhoun is fairly confident that his head count will be close to 30 people within a year.

“There’s really only a handful of EH&S consultants, nationally, who are specializing in pharmaceutical and biotech,” he said. “We’re already cash-flow positive this year.”

While times are tight for most research and development biotech firms, Calhoun said opening his business this year was actually good timing.

“The challenges facing cash-poor biotech startup companies have never been greater than they are today,” Calhoun said. “With increasing demands on getting new products to market, companies can’t afford to have product development timelines interrupted by issues that fall under the watchful eyes of the EPA (Environmental Protection Agency), OSHA (Occupational Safety & Health Administration) or the DOT (Department of Transportation). Until now, these companies haven’t had a resource like ours — one that works to improve environmental health and employee safety while demonstrating benefits to the bottom line.”

According to one client, Array Biopharma, which has operations in Boulder and Longmont, Affygility usually exceeds its expectations.

“They know the subject matter through experience — moreover they know the underlying policy questions that need to be addressed,´ said James Lieberman, the EH&S manager at Array. “They do what they say they are going to do and provide powerful tools to make my job easier and more efficient.”

Life sciences, as Calhoun likes to call the field, is just a whole different animal when it comes to environmental safety and regulation.

“In the biotechnology/pharmaceutical fields, many times you are dealing with compounds that are completely novel — you don’t have a lot of toxicology, and you don’t know a lot about their profiles,” he said.

And if the classification of chemicals is not difficult enough, consider the regulation. The list of three-letter federal acronyms alone is enough to make one shudder, not to mention the state agencies that shoulder the mandate set by EPA policies.

“The FDA (Federal Drug Administration) process is fairly complex, but in addition you might end up working the ATF (Alcohol, Tobacco and Firearms) and the DEA (Drug Enforcement Administration), if the chemical you are working with a precursors to met amphetamine, for instance.”

Just stepping down a slightly wrong road in filing papers with any one of these agencies can mean delays of days, or weeks, Calhoun said, which today can mean the difference between life and death for some biotech companies.

“These regulatory agencies are not your adversaries, and you’d better build a relationship with them,” he said. “We can come in and very cost effectively get the permits and implement the programs. So far, everybody’s been extremely pleased.”

Because many of the researchers come straight from university settings, Calhoun said, some are surprised at the additional regulatory load that falls on the private sectors. Still, he said, there is one aspect of this field that makes his job a lot easier.

“Because there are so many advanced degrees, they may want to know exactly why something (a regulatory process) applies to them,” he said. “But they all want to do the right thing.”

Alecia Settle, the company’s senior director of business development, agreed that the pervasive attitude in the life sciences field is to protect workers. “After all, most of them are developing drugs to save lives,” she said.

One thing that Affygility has done to enhance that attitude is to provide EH&S leadership coaching and emergency response training, she said. Additionally, the company has been the first in the area to host conferences on issues that affect its industry.