A Visit to Encelle, Inc...
On May 15 and 16, a group of us paid a visit to Encelle, Inc. in Greenville, North Carolina. What we saw exceeded our expectations and raised hopes that a cure for diabetes may see the light of day sooner rather than later.
Our visiting group included Ron Brenners and Robin Harrison of the Gray Ribbon Campaign, Randy Dorfman who sits on the board of both the Juvenile Diabetes Foundation and the Diabetes Research Institute, and Al Gordon of The Islet Foundation.
At Encelle, we met Dr. Anton-Lewis Usala, founder and inventor of many of the novel processes that represent the company's unique technology (description of Encelle). Jim Woodward, President & CEO, is a seasoned biotech executive from California. Mark Metzger is Director of Engineering and is bringing the type of discipline needed for manufacturing consistent implants under FDA approval. Dr. Richard Klann assures that the implants are pathogen-free. Dr. Shane Ray manages special projects, of which there is no shortage at Encelle. And Marilyn Smith keeps the whole place running smoothly. My apologies to anyone who has been left off the list – we were so overwhelmed by what we saw, we are certain to forget someone.
Dr. Usala has had diabetes since age one. After 40 years of having the disease, and with a pediatric endocrinology practice of 500 children, he knows first hand the science and tragedy of diabetes. Dr. Usala started Encelle in 1985 and personally financed the company for 5 years with money earned working evenings as an emergency room doctor. Since 1991, Encelle has achieved its amazing accomplishments with less than $3,000,000, and with no support from the major diabetes funding organizations.
Today, Encelle has reached milestones which many believe will lead soon to a means of restoring normoglycemia in people whose islets have been destroyed by diabetes. The company has considerable patent protection on its unique and proprietary technologies and processes.
What we saw was the marriage of commitment, inventiveness, frugality, and intellect. Encelle has created a facility for the small-scale manufacture of insulin-producing implants. At every step of the process, there were examples of innovation to solve problems for which no off-the-shelf solutions existed. Today, they have a sterile product development facility with computerized process and environmental controls.
At Encelle, we saw the steps that hopefully will translate into large scale manufacturing of implants that can restore normoglycemia. In their clean room complex, technicians isolated islets, tested for pathogens, manufactured capsules, applied stealth polymer, inserted islets and acinar into finished capsules, and made extensive use of computers and specialized instrumentation to assure a repeatable and documented process.
If animal trials proceed as planned, Encelle should be starting human trials within a year. This small and talented group is focused on that goal to the exclusion of almost everything else.
Perhaps the most moving moment of the day came late in
the afternoon when one of the visitors asked Dr. Usala, "So, I guess you're
doing all this to cure your own diabetes?" Dr. Usala hedged, and said,
"Well, I've had diabetes so long that I don't know any other life." He
was asked again, "What are you doing it for?" It was then that he said,
"Because I'm left. So many of the kids I went to diabetes camp with...."
He could not finish the sentence.
|From left to right:
Jim Woodward, President & Chief Executive Officer
Anton-Lewis Usala, M.D., Chairman & Chief Technical Officer
Mark Metzger, Director of Engineering