In a conference room in downtown Baltimore, F. Blix Winston compared the Food and Drug Administration to a "slow-moving bulldog."
"You don't want to get bitten," Winston, an expert on the federal regulation of medical devices, told a crowd of about 50 entrepreneurs and academics recently.
"You don't want to tangle with the FDA," he warned. "The FDA has the power to come in and padlock a company's doors."
Winston's presentation was part of a new approach by Maryland economic development officials to promote the state's life sciences industry.
They are pitching the state's talent pool —corporate executives, academics and consultants who deal regularly with the federal government — as a resource for supporting existing companies and attracting new ones.
In the high-cost, high-stakes world of biotechnology innovation, navigating the FDA and the National Institutes of Health — a major source of government research funding — can make or break a company. Devices that treat heart problems or scan for diseases can take months or years to approve and cost millions of dollars in development and safety testing.
These days, the message from state economic development officials to these biotech companies from all over the world is: Let us help guide you.
"This is a distinguishing factor for Maryland," said Judith A. Britz, executive director of the state's Maryland Biotechnology Center and an entrepreneur who started two companies and shepherded medical products through the FDA approval process.
Gov. Martin O'Malley created the center two years ago to unify the state's efforts in advancing a 10-year plan for the biotech industry, known as BioMaryland 2020.
"Maryland is the gateway to U.S. markets" in biopharmaceuticals and medical devices, Britz said. "The FDA is in our backyard."
The life sciences sector, which includes private companies, academia and federal agencies, provides direct employment to 71,000 in Maryland, according to a Department of Business and Economic Development report released last week by O'Malley. Nearly half are in the private sector.
About $14 billion in research and development is conducted annually in the state, DBED reported.
Economic development officials and biotech business leaders made the state's proximity to the federal government — both a customer and funder of research — a key selling point at the BIO international convention last week in Washington.
Competition within the growing global life sciences industry was clearly evident at the event, one of the world's largest in the world. Representatives from hundreds of companies, states and countries made their pitches to one another in a cavernous hall.
Also participating were officials from Baltimore's two biotechnology parks, operated by the University of Maryland on the west side and the Johns Hopkins University on the east side.
"It's a marketing challenge on a global scale" to promote Maryland's biotech industry, said Thomas E. Colonna, associate director of bioscience regulatory affairs at the Center for Biotechnology Education at Johns Hopkins.
The Hopkins center is educating about 300 people in a master's program on bioscience regulations — one of only about two dozen such programs worldwide.
The proximity to the FDA and NIH, which are based in Montgomery County and have offices across the Baltimore-Washington area, "is certainly a big selling point," said Colonna, who also works as a consultant.
DynPort Vaccine Co., one of the companies featured at the Maryland exhibit, was at the conference looking for partners that could bring new technologies to its federal customers, including the departments of Defense and Health and Human Services.
"The market of working with the government is quite different than commercial enterprise," said Dr. Robert V. House, president of the Frederick-based company. "There are a number of companies that would like to work with the government but don't know how."
Rob Galioto, business development director of Gaithersburg-based Integrated Biotherapeutics, said his company is looking to partner with firms that want to tap their experience with government customers.
Integrated Biotherapeutics produces a vaccine for the Ebola virus and treatments for staph infections for the consumer and biodefense markets. Some of the technology the company uses was licensed from the U.S. Army, he said.
"A lot of our ongoing research is done in collaboration with Fort Detrick," Galioto said. "We have connections."
Of course, there are the major biotech success stories in the state, such as MedImmune and Human Genome Sciences, and the existence of a highly trained life sciences workforce. And an existing constellation of small and large biotechnology companies means multiple job opportunities for life sciences workers.
"What's really exciting about Maryland is that once you get more great companies, you can attract more great people to come here," said Susannah Budington, a spokeswoman for Human Genome Sciences in Rockville.
More than 5,700 people work for the FDA in Maryland, and more than 16,000 work at the National Institutes of Health, according to the Department of Business and Economic Development. Another 3,200 people work at Fort Detrick in Frederick, home to the U.S. Army Medical Research and Materiel Command.
Many of these government research and regulatory experts eventually end up working in the private sector. The Baltimore-Washington region is populated by former FDA and NIH professionals who work as consultants, and the region is likely home to the largest national concentration of lawyers who specialize in FDA regulatory work, industry observers say.
Consultants such as Winston and Colonna are increasingly in demand for their expertise in advising companies worldwide on how to deal with the FDA's requirements on manufacturing processes and medical device designs.
"I probably have as many clients outside the U.S. as inside the U.S.," said Colonna. "I wind up all over the world."
International companies target different countries, but most eventually try to break into the U.S. market. The U.S. market is the "honey pot" for most biotechnology companies, Colonna said, because they can make more money for their products here.
"The U.S. health care system," Colonna said, "ends up driving innovation for the whole planet."
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