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Military Vaccine Resource Directory.
   Agencies Scramble to Create Vaccine Market
by Breanne Wagner - National Defense Magazine - Friday June 01, 2007
When anthrax was delivered to Capitol Hill and media outlets in envelopes in 2001, the prospect of a widespread biological attack became real to the U.S. government. For Jay Cohen, undersecretary of the Department of Homeland Securitys science and technology division, its the possibility of a biological attack that keeps him up at night. [&] The relative simplicity of deploying a deadly biological agent has prompted the government to seek technological solutions from the private sector. In the aftermath of the anthrax attacks, contractors predicted that a robust biodefense industrial complex would emerge. But so far the market has lagged, experts say. Eleven government agencies now work on biodefense.

Several offices within these agencies award contracts and grants to universities and public health organizations to prepare for biological attack. Currently, the U.S. biodefense market consists of a hodge-podge of small niche players blended with very few large biopharmaceuticals and select defense contractors, said Tim Garnett and Andrew Michaels, previous partners at DFI International, a consulting firm now known as Avascent. They noted that the federal market for biodefense technologies is highly fragmented. Defense and Homeland Security are pursuing disparate vaccination programs to combat different needs for military and civilian populations.
   HHS offers plan for defense against biological threats
CIDRAP - Wednesday April 25, 2007
Apr 25, 2007 (CIDRAP News)  The US Department of Health and Human Services (HHS) recently unveiled its plan for developing and buying medical countermeasures against a range of biological, chemical, and other threats, with new anthrax and smallpox vaccines among the near-term priorities.

The 21-page implementation plan, released Apr 20 on the HHS Web site and in the Federal Register, details how the agency will acquire countermeasures against 14 threats on its priority list, which include nine category A biological agents, two category B biological agents, typhus, certain volatile nerve agents, and radiological and nuclear agents.

HHS Secretary Mike Leavitt said in an Apr 18 press release that since the Sep 11 terrorist attacks the United States has made significant progress in securing medical countermeasures against a number of threats, but much more work remains.

"This plan lays out our path forward in the coming years and will take advantage of our new authorities under the Pandemic and All-Hazards Preparedness Act to move forward with Project BioShield," he said.

Project BioShield, a $5.6 billion program, was established in 2004 to speed the development of medical treatments for the effects of biological and other unconventional weapons. But major drug companies showed little interest in the program. In passing the All-Hazards Preparedness Act last December, Congress tried to revitalize the program by authorizing partial payments to companies working under BioShield contracts before final delivery of their products.
   How One Company Lost Out on Protecting the Nation From Terrorists commentary follows
Red Orbit - Sunday March 04, 2007
WASHINGTON _ At first, Richard Hollis thought his firm would be a "poster child" for the government's BioShield program to stockpile medical antidotes in case terrorists attack with nuclear, biological or chemical weapons.

Hollis-Eden Pharmaceuticals had a breakthrough drug that promised to keep some people alive after strong doses of radiation and the government said it would provide the market.

But after nearly six years of research and an investment of more than $85 million, Hollis, the drug maker's chairman and CEO, now calls the San Diego company a "poster child" for everything that's wrong with BioShield.

Last week, the Department of Health and Human Services rejected its drug for failing to meet "technical requirements." The agency said it would start a fresh search for another treatment of radiation poisoning. HHS declined to elaborate further.

In just two days, the company's stock plunged from over $5.70 a share to $2.83. Since Hollis-Eden's radiation treatment first stirred excitement with private investors in 2003, its market value plummeted by $700 million, to under $70 million. Now, company executives are trying to assure Wall Street that they have enough cash to stay afloat.


Commentary:
"The experiences of the drug maker, corporate officials say, were an "unfair" bait-and-switch and call into question the government's massive effort to protect the public from the health effects of a nuclear attack.

Congressional committees, disturbed by the development, are expected to conduct hearings soon examining the procurement and the entire BioShield program, which also recently halted an $877.5 million contract for a second-generation anthrax vaccine and another pending award for a third-generation anthrax vaccine."
   Democrats to destroy Burrs bioterrorism panel
by Barbara Barrett, Rob Christensen, Bill Kruger - TheNews and Observer - Friday January 19, 2007
The Senate subcommittee charged with overseeing the implementation of a bioterrorism law written by U.S. Sen. Richard Burr will be dissolved under the new Democratic leadership. Burr, a Winston-Salem Republican, had been chairman of the Bioterrorism and Public Health Subcommittee of the Senate Health, Education, Labor and Pensions Committee.
   Project BioShield Fails to Motivate Biotechs to Protect America
Seeking Alpha - Friday January 05, 2007
. . .The problem is with the way the government wants to fund research. The $6 billion were not exactly intended to fund research into new vaccines. Rather, the government would purchase vaccines after the research had proven them safe and effective. So for little biotech companies to reap the rewards of a contract, they would have to put up funding from internal sources, carry out the research to prove the effectiveness and the safety of the vaccines, and only then would the government pay out the cash. This focuses the financial risk squarely on the companies themselves, as the government can cancel any contract under the Termination for Convenience clause. VaxGen (VXGN) is a perfect example of how the project could prove to be a financial disaster for a little biotech. The company won a $1 billion contract to provide a stockpile of 75 million doses of anthrax vaccine for the government. But after securing funding, and increasing its staff and research efforts, VaxGen received the bad news; the Department of Health and Human Services [DHHS] canceled the contract. This of course had a devastating effect, and forced the company to cut half of its staff and replace the CEO shortly after. . .
   Project BioShield Fails to Motivate Biotechs to Protect America
Seeking Alpha - Friday January 05, 2007
. . .The problem is with the way the government wants to fund research. The $6 billion were not exactly intended to fund research into new vaccines. Rather, the government would purchase vaccines after the research had proven them safe and effective. So for little biotech companies to reap the rewards of a contract, they would have to put up funding from internal sources, carry out the research to prove the effectiveness and the safety of the vaccines, and only then would the government pay out the cash. This focuses the financial risk squarely on the companies themselves, as the government can cancel any contract under the Termination for Convenience clause. VaxGen (VXGN) is a perfect example of how the project could prove to be a financial disaster for a little biotech. The company won a $1 billion contract to provide a stockpile of 75 million doses of anthrax vaccine for the government. But after securing funding, and increasing its staff and research efforts, VaxGen received the bad news; the Department of Health and Human Services [DHHS] canceled the contract. This of course had a devastating effect, and forced the company to cut half of its staff and replace the CEO shortly after. . .
   Biotech industry awaits legislation to help combat bioterrorism
by Laura Cutland - Silicon Valley/San Jose Business Journal - Monday December 04, 2006
The biotech industry is closely watching a pivotal piece of legislation it hopes will become law before Congress adjourns this year... Called the Pandemic and All-Hazards Preparedness Act, Senate Bill 3678 is authored by Sen. Richard Burr, R-N.C., and is said to enjoy broad bipartisan support... The proposal, passed by the House of Representatives in September, is meant to reform Project Bioshield, a $5.6 billion program established in 2004...

[I]f we want to have the tools to detect bioterrorism, diagnose it and treat victims, we need to have partnership. Otherwise companies can't afford to take the risk[,]" [said Jim Greenwood, president and CEO of the trade group Biotechnology Industry Organization (BIO)]. The current proposal aims to do that by allowing companies to access up to 50 percent of the value of their procurement contract in 5 percent increments through the drug development process, provided they meet certain performance milestones.
   Bioshield Funding Insufficient for Drug Companies
Global Security Newswire - Wednesday September 13, 2006
Funding available under the U.S. Project Bioshield is not sufficient to prompt large pharmaceutical companies to develop countermeasures against biological, chemical or radiological weapons, Investors Business Daily reported Friday (see GSN, June 7).
The Bush administration in 2004 designated $5.6 billion over 10 years for production of vaccines and antidotes.
The country would benefit immeasurably from pharma getting involved, said Tom Inglesby, deputy director of the University of Pittsburghs Center for Biosecurity. But when a single drug can cost $1 billion to develop, $560 million a year for counterterrorist products isnt enough for them.
The funding levels are more appealing to smaller biotechnology firms. However, to date only six companies have received contracts.
   Lawmakers press improvements to Project Bioshield
by Chris Schneidmiller, Global Security Newswire - GovExec.com - Wednesday June 07, 2006
Legislation is being introduced again this year intended to go beyond Project Bioshield in promoting development of drugs that would be needed to treat victims of an act of biological terrorism.

Reps. Mike Rogers, R-Mich., and Anna Eshoo, D-Calif., on Tuesday submitted the House Biodefense and Pandemic Vaccine and Drug Development Act of 2006. Senator Richard Burr, R-N.C., filed a largely identical bill in April, following a failed initiative last year.

Sponsors hope the legislation would fill gaps in the 2-year-old Bioshield program, which critics say has failed to spur industry to develop new vaccines and countermeasures. Lawmakers propose to create a single point of contact within the Health and Human Services Department to work with pharmaceutical and biotechnology companies on determining the priorities for biosecurity funding and research.
   More Drug Makers Are Losing Patience Over Bioshield Funds
by Peter Benesh - Investor's Business Daily - Friday February 17, 2006
Richard Hollis is prepared to bite the hand he hopes will feed his company, Hollis-Eden Pharmaceuticals. (HEPH)
The hand belongs to Project Bioshield, a program designed to stockpile drugs and vaccines in the event of a large-scale terrorist attack.
President Bush announced Bioshield in January 2003 and signed it into law in July 2004.
The program is run by the Health and Human Services Department. It allocates $5.6 billion over 10 years to create a market for products to counter the effects of chemical, biological and nuclear terrorism.
But Hollis says Bioshield hasn't kept its promise. He's written, cajoled and lobbied lawmakers in an effort to find out why the money being allocated isn't being spent.
   Inside the Spore Wars
TIME magazine - Tuesday January 03, 2006
Had you listened to President Bush on Jan. 28, 2003, you might think the U.S. would have a bustling biodefense industry by now. In a State of the Union speech laced with references to terrorism, Bush asked Congress for nearly $6 billion to fund Project BioShield, a program he said would "quickly make available effective vaccines and treatments against agents like anthrax, botulinum toxin, Ebola and plague." . . . Yet BioShield hasn't transformed much of anything besides expanding the federal bureaucracy. Most of the big pharmaceutical and biotech firms want nothing to do with developing biodefense drugs. The little companies that are vying for deals say they are being stymied by an opaque and glacially slow contracting process. . .
   Senators Say GOP Seeks To Shield Drug Makers
by Thomas "Dennie" Williams - Hartford Courant, Connecticut - Thursday November 17, 2005
Two Democratic U.S. senators on Wednesday accused GOP senators of trying to slip through a measure that would shield the makers of experimental drugs authorized for use in national health emergencies from being sued even if such drugs prove harmful.

The senators, Christopher Dodd, D-Conn., and Edward M. Kennedy, D-Mass., said powerful legal immunities being pushed by the GOP would deny people legal recourse for injuries or deaths arising from the use of such drugs.
   Consumer Group Says Congress Set to Bail Out Big Pharma in Secret
National Vaccine Information Center - Tuesday November 15, 2005
WASHINGTON, Nov. 15 /PRNewswire/ -- A behind-the-scenes plan is reportedly taking shape in Congress to attach language to an unspecified conference report giving drug companies blanket immunity from liability for vaccine injuries and deaths. The National Vaccine Information Center (NVIC), a watchdog consumer advocacy group critical of provisions in "The Biodefense and Pandemic Vaccine and Drug Development Act of 2005" (S. 1873) sponsored by Senator Richard Burr (R-NC) and a similar bill in the House (H.R. 3970), calls the reported plan "an end-run by Pharma's friends in Congress to take away the civil rights of the American people."
   DOR BioPharma Plans FDA NDA and European MAA Filing Strategy for orBec commentary follows
Business Wire - Tuesday November 15, 2005
DOR BioPharma, Inc. (AMEX:DOR) ("DOR" or the "Company"), announced today that following written communications and meetings with the FDA and with the comparable regulatory authorities of the German, French and UK governments, it has established an expanded strategy for the submission of a New Drug Application (NDA) and Marketing Authorization Application (MAA) for orBec(R) for the treatment of intestinal Graft-versus-Host disease ("iGVHD").


Commentary:
Further quote: About DOR BioPharma, Inc. DOR BioPharma, Inc. is a biopharmaceutical company focused on the development of therapeutic products and biomedical countermeasures for areas of unmet medical need. Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax(TM), has completed the clinical portion of its Phase I clinical trial in normal volunteers. We have also announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design.
   AGENT ATTACK
The Associated Press - Sunday November 13, 2005
In a world full of microbes, will billions of dollars build biodefenses? CAIRO, Egypt  The bacteria lie dormant, freeze-dried in sealed ampules, in a refrigerator on a teeming university campus beside the Nile. Theyre among Earths most common germs  clostridia perfringens, a cause of food poisoning, a specimen for research. But this pathogen can also be a weapon: Iraqi scientists worked for years to mobilize this "Agent G" for Saddam Husseins wars. . . . "We have to be alert," he said, but not "unreasonable." After all, Magdoub said, any hospital is also rife with dangerous microorganisms. "The American people have become so sensitive towards a lot of normal, ordinary matters," he said, echoing a sentiment heard increasingly in America, where microbiologists fear that ever-stricter controls might stifle their ability to exchange samples and conduct research. . . . The fear is reflected in the U.S. budgets bottom line as well: Spending on civilian "biodefense" has leaped 18-fold since 2001, to $7.6 billion this year. Project Bioshield, to develop bioterrorism countermeasures, awarded its first contract last November, $877 million for 75 million doses of a new anthrax vaccine.
   Govt Flu Plans Assailed as Inadequate, Pro-corporate
by Michelle Chen - The NewStandard - Friday November 11, 2005
With a possible bird-flu pandemic on the horizon, critics warn that responses pushed by the federal government are more about protecting and favoring big business than actually addressing critical public health needs. Fear of a looming flu pandemic has goaded Congress and the White House to ramp up the countrys capacity to deal with the threat. But watchdog groups and healthcare advocates warn that instead of preparing and protecting the public, recent federal initiatives would fail to resolve shortages of medical resources, encourage corporate profiteering and flout drug-safety regulations
   An anti-disease agency without public oversight commentary follows
by Mark Tapscott - Knight-Ridder Tribune - Friday November 11, 2005
Members of Congress are moving rapidly to create a new federal agency designed to manage the government's anti-bioterrorism research and encourage private companies to bring more drugs and vaccines to market quicker. Sounds good. But there's a catch. The proposed Biomedical Advanced Research and Development Agency (BARDA), intended to be part of the U.S. Department of Health and Human Services, would be exempt from the federal Freedom of Information Act. It also would be exempt from rules designed to ensure efficiency and protect against waste and fraud.


Commentary:
Further quote: Of course, without FOIA, how will we ever know if BARDA is making real progress fast enough on the terrorist and natural threats most likely to do the worst harm to largest number of Americans?
   Bush Flu Plan Eases Firms' Liability
by Diedtra Henderson - The Boston Globe - Monday November 07, 2005
Nov. 7--WASHINGTON -- The Bush administration says the nation can better prepare for a global flu outbreak if private industry is protected from the threat of multimillion-dollar liability lawsuits, but critics fear that could shield companies that act negligently. A draft bill prepared by the administration not only protects manufacturers of vaccines, antiviral therapies and devices, but also distributors, healthcare facilities where inoculations would be given, and the doctors and nurses who administer the shots. They would be largely protected from lawsuits if someone died or suffered serious side effects from therapies rushed to market to stave off a flu epidemic. In most cases, laboratory researchers working on a potential pandemic cure would be granted the same immunity.
   Chimerix, Inc. Supports Biodefense Legislation to Accelerate and Innovate Counterterrorism Products
Chimerix, Inc. - Thursday November 03, 2005
RESEARCH TRIANGLE PARK, N.C., Nov. 3 /PRNewswire/ -- Chimerix, Inc., a biotechnology company developing orally available, targeted medicines to treat smallpox infection and other viral infections, announced today support for S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, authored by Senator Richard Burr, passed by the Senate Committee on Health, Education, Labor and Pensions and recently sent to the full Senate. The bipartisan legislation will provide the Department of Health and Human Services with the necessary resources and authority to rapidly develop drugs and vaccines to prepare and respond to bioterrorism and natural disease outbreaks. Under the bill, the Biomedical
   Measure Eases Vaccine Rules
by THOMAS D. WILLIAMS - Hartford Courant, Connecticut - Thursday October 27, 2005
Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people. The bill would also make it almost impossible for anyone harmed by these substances to sue the manufacturer or drug researchers. Supporters say protecting producers from potential liability would bring more drug makers to the table. Opponents warn the proposal would render everyone little more than a "guinea pig" for the drug industry.
   A defensive strategy
by Corie Lok - Nature Jobs - Wednesday October 26, 2005
Fearing that it will be the target of future bioterrorist attacks, the United States has been ploughing huge amounts of money into biodefence. The result is a reinvigorated market for microbiologists. . . . The US government has since poured hundreds of millions of dollars into academic and industrial research to develop bioterrorism countermeasures, such as drugs and vaccines. The main agency behind many of these projects is the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The NIH has invested a growing amount of money  more than $1.5 billion in 2003 and a requested $1.7 billion for 2006  in new academic research centres, biocontainment labs, research grants and contracts to biotechnology companies. More recently, the agency has begun handing out funds as part of the Project Bioshield Act of 2004, which provides $5.6 billion over ten years to buy vaccines and drugs, and to finance research.
   Bioshield Act of 2004
The US Congress - Tuesday January 20, 2004
   A shot in the dark?
Newsday.com - Sunday November 20, 2005
America's homeland defense program is spending more than $1 billion on anthrax vaccines earmarked for wide civilian use despite uncertainty about their effectiveness and an ongoing debate about potential health problems, Newsday has found. The vaccine stockpiling is a key element of the federal Project BioShield program, which was awarded $5.6 billion in funding in 2004 to develop drugs and vaccines to protect Americans against biological and chemical attacks. It constitutes the largest federal effort ever to protect civilians from an anthrax attack.


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