Newsday, Monday, November 24, 1997

MERRILL GARNETT says he's discovered the world's first nontoxic chemotherapy agent for treating brain tumors, and he wants to manufacture it on Long Island.

Garnett, a dentist by profession but a research scientist by avocation, operates a tiny biotechnology company, Garnett McKeen Laboratory, in the Long Island High-Technology Incubator near the State University at Stony Brook's Health Sciences Center.

After many years of painstaking investigation, frustration and plenty of money, Garnett's startup is close to the stage where it will need to manufacture the experimental drug in larger quantities than can possibly be made in the company's lab.

Garnett went only as far as next door, to Collaborative BioAlliance's contract biomanufacturing facilities, for help in turning out the quantities required to begin the long, expensive clinical testing programs required by the government before the drug can be approved for marketing.

BioAlliance and Garnett McKeen Laboratory officials are talking seriously about their future manufacturing relationship. "We have agreed to make the first batches in the BioAlliance facility," Garnett says. "It will help out with proximity and cost and time."

But first the company must satisfy the Food and Drug Administration on a variety of other regulatory requirements. The dentist-turned-scientist and his son, Wade Garnett, a Stony Brook chemistry graduate student who works with his father, still have much developmental work to do.

"When you have a new medicine you have new biology, new biochemistry and new pharmaceutical chemistry," Garnett said, "so you have to work with a variety of consulting labs to be in compliance with the FDA's GMP [good manufacturing practices] guidelines."

The product development cycle in the high-risk, high-cost biotechnology field is notoriously long, with new drugs often more than 10 years in the pipeline. But the potential benefits to humanity--and the profits--could  be enormous.

He has three patents on the new molecule. Eventually, if his drug proves to be safe and effective, many people would benefit, and commercial pharmaceutical houses would be beating on Garnett's door. So the pressure is on.

Says Garnett, "I'm going as fast as I can."

-- Unger
Newsday Photo / John Cornell
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