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Turbocharging drug production
MARLBORO, Mass.—Xcellerex Inc. recently announced that it is part of two Phase I contracts awarded by the Defense Advanced Research Projects Agency (DARPA) for the Accelerated Manufacture of Pharmaceuticals (AMP) program. For the first grant, the company is the prime contractor and on the second grant, it is a subcontractor. Both AMP grants are for a one-year time frame, with the goal of producing emergency therapeutics and vaccines, rapidly and cost effectively, to respond to a wide range of biological threats. The total funding for the two Phase I contracts is more than $13 million, and both contracts involve development of technology based in part on Xcellerex's FlexFactory and PDMax systems.
Overall, the U.S. Army's AMP program is designed as a three-phase program, but there is no guarantee that DARPA will fund the remaining two phases, notes Parrish Galliher, the founder, president and CTO of Xcellerex. Also, he stresses that there are no guarantees that his or any other companies that won Phase I contracts would be brought back for Phase II or III.
Dr. W. Dorsey Stuart, founder and CEO of Neugenesis Corp.—one of Xcellerex's collaborators in the second grant—reports that the ultimate goal of DARPA is to create a commercially viable system that can produce up to 3 million doses of a vaccine or a monoclonal antibody therapeutic in a 12-week period.
"DARPA is famous for setting what seem to be impossible targets," Galliher says, "and they tell you up front this is part of their mission."
"But you cannot look at the end or you'll just give up," he jokes. "Assuming the program continues past Phase I, the targeted speed of production goes up tenfold in Phase II and then tenfold again in Phase III. You have to see that you can achieve the first set of goals by doing some innovative kinds of thinking, and then once you do that, the next goal will seem more achievable. Then when you achieve that second goal, the final result doesn't seem so crazy anymore."
The breakthroughs the companies make, regardless of whether they meet the DARPA goals, will ultimately lead to significant advances in rapid, cost-effective biopharmaceutical manufactur-ing, says Kurt Hoeprich, commercial director for the biopharmaceutical business of Dowpharma, a business unit of The Dow Chemical Co. that is collaborating with Xcellerex in the first grant.
Also, there is a long-term payoff in working with DARPA in terms of other agencies' buy-in, Galliher says. "DAPRA is working with many organizations within the government, including regulatory agencies like the FDA," he notes. "This is a conservative industry because of all the regulatory oversight of pharmaceuticals, so having support or at least awareness among the agencies now is going to be critical to getting whatever breakthroughs we come up with for the military out to the industry as a whole.