MIAMI-Pharmaceutical companies could gain new choices over site selection for the development of human testing facilities if the Miami-Dade County Commission adopts a new land-use classification at today’s regularly scheduled meeting.

First introduced about two months ago, the new county ordinance would create a land-use classification that allows development of “medical observation dormitories” in commercial areas that now already authorize development of medical clinics. It would also authorize construction of such facilities in areas zoned for high-density residential apartment and hotel use.

“Outside the usual use for clinics and medical offices, we don’t have a specific issue in the code to address medical observation dormitories,” Alberto J. Torres, acting assistant director for Miami-Dade zoning, tells “This is a need, but our code doesn’t provide for it.”

It is uncertain if any pharmaceutical company is specifically pushing for the land-use change, since Torres says he is unaware of any pending applications that might take advantage of the proposed land-use classification.

The office of Gwen Margolis, the commission chairperson and ordinance sponsor, did not respond to a public records request from for committee or commission reports on the subject.

Most development of facilities like this now is mostly undertaken in or around the large medical centers, says Randall Greene, director of development for Palm Beach Gardens-based Catalfumo Construction & Development Inc., which specializes in the construction of medical-related facilities.

“Although we’ve built these type of facilities before, we’ve never constructed them as stand-alone facilities,” Greene tells

Catalfumo most recently completed a 58,000-sf medical observation facility for AstraZeneca PLC, a London-based pharmaceutical company, at JFK Medical Center in Atlantis, FL.

“The products we’ve completed in the past have been mostly small-unit testing facilities,” Greene says. It is possible, he says, that the action in Miami-Dade could be signaling a new trend in the development of such facilities.

“It seems to me that maybe they’re getting larger and larger, incorporating new economies of scale,” he says.

The proposed land-use classification is coming at a time when the pharmaceutical industry is looking for ways to reduce the time and cost it takes to bring a new drug to market.

Increased use of human testing is considered a key element in achieving new efficiencies, especially as the industry relies more and more on outsourcing through contract resource organizations to facilitate drug testing.

Citing research produced by CenterWatch, a Boston-based clinical trials publishing and information service, the Washington, DC-based Association of Clinical Research Professionals estimated in a 1998 research report that CROs accounted for about 60% of all clinical studies as 1997–up from 28% in 1993.

The same study also cited clear reasons for the increased use of these mostly privately owned CROs. Spending by pharmaceutical and biotechnology companies grew to about $33 billion through the end of 1997, with about $16.32 billion devoted to clinical research and development.

If approved, the new ordinance would define a medical observation dormitory as a facility where pharmaceutical and pharmaceutical device companies initiate clinical investigations as governed by the U.S. Food and Drug Administration. It would allow overnight stays by human subjects for testing purposes and not therapeutic services.

The proposed ordinance would require the site of any such development to contain at least three net acres, and sites larger than 10 net acres would be subject to a public hearing.

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