Working with the FDA is apparently so difficult that one federal device regulation expert compared the FDA to “a slow-moving bulldog,” reported Gus Sentementes of the Baltimore Sun. (His article Maryland’s Biotech Pitch: We know the Feds is well worth reading.)
It’s fascinating that the requirements of the FDA are so intricate that being able to waltz with the government is a selling point for an entire state industry. And yet, dealing with the government, communicating with the government, and delivering exactly what the government asked for (and nothing they didn’t want) is crucial for success in biodefense (or medical countermeasure development) — an area in which the government will always be the primary customer.
In fact, one Maryland biodefense contractor, DynPort Vaccine Company (DVC), @Dynport, has a popular presentation by DVC president Dr. House, @DrRobertHouse, — Never Assume Anything: Successfully Developing Vaccines For US Government Customers.
“Never assume anything” is a good thing to keep in mind when working with the US Government. But is “we know the feds” the best of Maryland’s biotech qualifications? What do you think?