NEW YORK - FDA Commissioner Mark McClellan's face projected on a huge screen in the American city hit hard by terrorists on 9/11 gave him the appearance of a commander exhorting his troops, as he offered details regarding Project Bioshield.
McClellan, speaking to the Biotechnology Industry Organization's CEO & Investor Conference here, only was piped in by satellite because an impending ice storm prevented him from flying out of Washington to address the crowd in person, but his remarks carried military weight.
McClellan "fleshed out a lot of the questions we've been asking," said Carl Feldbaum, BIO's president, after the speech. "It was good news."
The commissioner said federal officials were "transmitting to Congress today detailed legislative specifications for Project Bioshield," the anti-terrorist initiative proposed by President Bush, who has estimated the anti-terrorist spending at $6 billion, although McClellan told conference attendees "the exact amount will depend on the opportunities we identify and what the private sector is able to deliver."
Project Bioshield would bring about "a fundamental change from the way our financing system for medical treatments works today," he said. "It includes a permanent, indefinite funding authority to spur development of medical countermeasures for [inclusion] in our national stockpile."
Under the program, the government could buy vaccines and other therapies "for which no significant commercial market now exists" - a setup that "should encourage, we hope, the private sector to make the investment needed to bring these next-generation countermeasures into existence," McClellan said.
The offices of the secretary of Health and Human Services and the secretary of Homeland Security will collaborate in identifying the best candidates, and then offer a "sort of advance contract" for the research, he said.
"The first to market in this sense - the first one to produce an effective countermeasure - could receive a substantial bonus," McClellan added. "As the government has not been able to do before, we will provide a guaranteed payment on delivery of effective new countermeasures. If you succeed, you will be appropriately paid for technology development."
McClellan said the National Institutes of Health would be given "improved authority and flexibility in contracts and grants. Funding awards will still be subject to a rigorous peer-review process, but we will implement techniques that enable us to make those awards much more quickly than can be done through standard NIH methods."
Another provision in Bioshield allows for an emergency-use authorization for anti-terrorist products, even if a particular product is still in development, as long as no alternative is available and the benefit is believed to outweigh the risk.
Feldbaum noted conference attendees at a luncheon on the final day of the event gave appropriate weight to McClellan's remarks in the first part of his speech, which dealt with anti-terrorist efforts.
"I've been asked if the Bioshield program is going to be a major factor in the biotech industry, and I don't think so," Feldbaum said. "But it will certainly be a major factor for the companies that participate."
More of interest to more company officials were phrases from McClellan such as, "Biological products have arrived, they're an integral part of mainstream medicine," along with his plans to streamline the FDA, finding ways to make it more efficient at reviewing applications without slowing down in order to implement new methods.
"I'm not going to be satisfied with hiring a bunch of consultants, having them come in and take a look at what we're doing, and giving us a report back in a few years," McClellan said. Instead, "quality systems performance measures" will be built in as the agency proceeds, he said.
Feldbaum said he is confident not only about McClellan but about the industry as well, and conference attendees seemed of the same mind.
The event "was pretty upbeat," he said. "I can't believe the resilience of these folks." With 1,854 registrants, the conference set a record, beating last year's attendance by 300.
"They've been through [intermittent hard times] for so long now," Feldbaum told BioWorld Today. "I think it was less gloomy than it was last year. Right now we're under this cloud of war, but we're going to get out from under it. Hopefully we won't get under a new one."
In panel talks and roundtables, Feldbaum said, he was encouraged by the frankness of participants. "These people are just out there," he said. "They'll tell you exactly what's happening to them, very little boilerplate."
New this year: prearranged one-on-one meetings between companies, investors and other concerned parties. "They take the [company] presentations one step further," Feldbaum said. "For the most part, they work out. The meetings happen and there are opportunities."
But the conference always has been that sort of event, he noted. Sessions are decided according to matters that are deemed important by industry leaders - disease indications, financing options and the like - and much other activity takes place behind closed doors.
"They tell us what subjects they want to organize around," Feldbaum said. "That's the magnet, and then they conduct their own business."