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GAO critiques anthrax vaccine procurement, management

first_imgOct 31, 2007 (CIDRAP News) – The US government’s attempt to add a next-generation anthrax vaccine to its stockpile failed because of a premature contract award, unrealistic expectations, and confusion about how the vaccine would be used, according to the Government Accountability Office (GAO), the investigative agency of Congress. Dissecting a failed procurementHHS awarded its first contract to VaxGen for the rPA vaccine at a very early development stage, before critical issues such as stability could be addressed, the GAO says. The award also interrupted an existing development contract VaxGen had with the National Institute for Allergy and Infectious Diseases (NIAID). GAO investigators assert that VaxGen took several “unrealistic” risks in accepting the HHS contract: the delivery deadline was too aggressive, the company lacked in-house technical expertise to address vaccine stability and formulation issues, and it had few resources to pay for additional testing to meet regulatory requirements. The GAO’s second concern about management of the existing anthrax vaccine stockpile is that HHS planned to use vaccine that had expired in 2006 and 2007, which would violate FDA rules. “The failure of this procurement effort raised larger questions regarding the country’s ability to develop a new anthrax vaccine and robust and sustainable biodefense medical countermeasure industry,” the GAO report states, adding that the problems cast doubt on the government’s ability to clearly spell out the requirements of future contracts with its pharmaceutical and biotechnology industry partners. HHS officials told the GAO that they felt an urgency to tell the public an improved anthrax vaccine was on the horizon and that they were 80% to 90% confident in VaxGen’s ability to successfully develop and produce the vaccine. Both HHS and DoD generally concurred with the investigators’ findings, the report says, but each added detailed technical responses to the report. “If this is not done, the government risks future interest and participation of the biotechnology industry,” the report says. The VaxGen vaccine was based on a recombinant form of protective antigen (rPA), a key anthrax protein. It was expected to provide immunity in 3 doses, rather than the 6 doses required for the licensed vaccine, and to cause fewer side effects. Avecia, a biotechnology company based in Manchester, England, is also developing an rPA anthrax vaccine with grant support from the National Institutes of Health. Industry experts told the GAO that, given the early stage of development, the expectation that VaxGen could deliver 75 million doses of the vaccine was unrealistic, and would have been so even for a large pharmaceutical firm. The GAO said using expired vaccine could undermine the public’s confidence and that HHS should destroy the expired lots. Oct 23 GAO report on anthrax vaccine procurementhttp://www.gao.gov/cgi-bin/getrpt?GAO-08-88 VaxGen announced in May that it hoped to license its rPA vaccine to another company in hopes that the product could someday be added to the national stockpile.center_img The contract, awarded in 2004, was the first under Project BioShield, a program meant to spur the development and production of medical countermeasures for chemical, biological, and radiological weapons. Licensed vaccine going to wasteIn examining how the government manages the current anthrax vaccine in the national stockpile—anthrax vaccine adsorbed (AVA), developed in the 1950s—investigators raised two main concerns. One is that HHS doesn’t have a strategy to minimize wasted vaccine. The report says $12 million worth of vaccine has already expired, and without an effective management plan, $100 million more per year could be lost as vaccine lots in the stockpile expire. Another problem was that HHS did not tell VaxGen how it planned to use the vaccine, because at the start of the contract the Food and Drug Administration (FDA) was still defining the data and testing requirements for the rPA anthrax vaccine as part of its new guidance on emergency use authorization for unlicensed products in the Strategic National Stockpile. HHS recently announced that it awarded the manufacturer of the AVA vaccine, Emergent BioSolutions, based in Gaithersburg, Md., a contract worth up to $448 million for 18.75 million doses of the AVA vaccine, which would allow the agency to maintain a 10 million-dose stockpile through 2011. Dec 20, 2006, CIDRAP News story “HHS cancels VaxGen anthrax vaccine contract” The findings were detailed in a 41-page report the GAO released on Oct 23. Four members of Congress had requested the investigation after the Department of Health and Human Services (HHS) cancelled an $877 million contract with VaxGen, a small biotechnology company based in Brisbane, Calif., last December. The company had failed to meet certain project milestones. See also: The GAO says HHS has announced that it will issue another rPA anthrax vaccine proposal but has not formally reviewed what went wrong with the VaxGen contract. “They may repeat their mistakes in the absence of a corrective plan,” the report says. Sep 26 CIDRAP News story “HHS orders 18 million doses of anthrax vaccine” The GAO also concluded that the government lacks a strategy for preventing waste and duplication in managing its stockpile of the existing anthrax vaccine, which could result in annual $100 million losses as stored vaccine lots expire. The GAO report says HHS could minimize the waste by developing a single inventory that can be shared with the Department of Defense (DoD), which has a mandatory anthrax vaccination program. However, HHS responded in the report that it explored the vaccine rotation option in 2004, but identified funding, legal, and logistical obstacles.last_img read more

NOW: Pensions CEO exits as part of Cardano acquisition

first_imgTroy ClutterbuckPatrick LuthiJoanne Segars, chair of NOW: Pensions’ trustee board, said: “Patrick brings a wealth of skills and experience that will be vital to our success as we move into a post-authorisation world.“I would like to thank Troy for his leadership of the organisation over the last few years. He has made a huge contribution to NOW: Pensions’ future success and I wish him well.”Although NOW: Pensions has grown to become the UK’s third largest auto-enrolment provider, with 1.7m savers, it has been beset by operational problems in recent years.A change of administration provider in 2014-15 led to problems processing and investing contributions. The provider removed itself from TPR’s list of approved providers in 2017 and was fined £70,000 (€79,920) by TPR in 2018 in connection with the problems.NOW: Pensions is the pension provider for IPE International Publishers. Clutterbuck took over as CEO on an interim basis from Morten Nilsson in August 2017, having previously been CFO, and was appointed to the top job permanently in May last year. Auto-enrolment master trust NOW: Pensions has appointed Patrick Luthi as its CEO as it prepares for regulatory authorisation.The multi-employer defined contribution scheme’s current CEO Troy Clutterbuck has stepped down “with immediate effect”, according to a statement published this morning.The move comes after Cardano bought NOW: Pensions from Danish pension provider ATP in February. The acquisition is subject to NOW: Pensions receiving regulatory authorisation from the Pensions Regulator.Luthi is currently group chief financial officer at Cardano, where he has worked since 2015. He has also been a non-executive director on NOW: Pensions’ commercial board since the acquisition was announced.last_img read more

Edmonton Oilers’ Leon Draisaitl, Connor McDavid just cannot stop scoring

first_imgMORE: What makes the Draisaitl and McDavid duo so good?In fact, the pair barely post games with just one point or none; McDavid has gone only 12 games with such numbers, and Draisaitl nine — not to mention, the Cologne, Germany, native has gone scoreless in just two games through his campaign so far.As of right now, the only thing we can do is wait and see if they can keep it up. But right now, the numbers show that they’re the hottest combination the league has right now — and has seen in a long time. We’re 22 games into the 2019-20 campaign, and absolute NHL ridiculousness is in bloom in Edmonton as Oilers forwards Connor McDavid and Leon Draisaitl cannot stop scoring — and it makes us wonder if they really are human.The duo combined for five points in Saturday’s 5-4 overtime loss to the Dallas Stars and is now producing at 3.77 points per game, having already combined for 83 points through 22 games this season. Edmonton is also benefiting greatly, as the team leads the Pacific Division with a 13-6-3 record and 29 points on the season. “[Draisaitl’s] a fun guy to play with,” McDavid said earlier in the season of his linemate. “Obviously, he can shoot it or pass it and play any type of game you want him to play. Great teammate, we’ve played together a lot over the years and I like where our chemistry’s at.”WATCH: McDavid nets second hat trick of week, six points vs. ColoradoTheir on-ice synergy is something of a fine art, analogous to rock music that goes by the beat of a different drummer.First off, the Oilers’ captain’s performance, which combines speed, outstanding hands and vision, is helping him producing at the rate of 1.81 points per game. He has nine points over his last two games and 14 over his last five to move up the stat sheet and all the way up to second behind Draisaitl in the NHL scoring race.This season, he’s already hit the 400-point mark of his NHL career with 412 points in 309 career games, with three straight 100-point seasons. His performance thus far puts the 22-year-old on pace for a fourth-straight 100-plus point campaign with 141 points.Okay, Connor McDavid (@cmcdavid97). WHAT PLANET ARE YOU FROM? pic.twitter.com/CFtOGyIlEZ— NHL (@NHL) November 11, 2019No one’s surpassed the 140-mark since Mario Lemieux, who had 161 points in 1995-96.Now, Draisaitl. The “Deutschland Dangler” takes advantage of a lethal shot, great passing and hockey IQ shift by shift.  Some may have been wary of signing the winger to a long-term, multi-million dollar extension that pays him a hefty $8 million over eight seasons, insinuating that it was possible his success was due in large part to McDavid.He’s proven this season — and over the last few years to boot — that that’s far from the case. After registering his first 100-point season last year, his star-studded 2019-20 campaign has him at a league-leading 43 points as he also rides a 12-game point streak. Besides his Oilers counterpart, Draisaitl has 11 points over the next leading scorer in Brad Marchand, who has 32 points in 19 games heading into Saturday night.1️⃣2️⃣-game point streak has been extended for Leon Draisaitl! pic.twitter.com/mZrqSv6UY0— NHL (@NHL) November 16, 2019Draisaitl’s scoring at a rate of 1.95 points per game, which sets him up to record 160 points this season.In total, he and McDavid are on pace to combine for a grand total of 301 points this year, as the Oilers look to put past seasons of demons and disappointment behind them and potentially return to the postseason for the first time since 2016-17 — and the third time in the last 14 years.With each game that passes, many wonder if they can keep up the pace; after all, those numbers just seem. . . too high, right? Well, it’s over 25 percent through the season already, and they’re both proving capable of multi-point performances on a nightly basis.last_img read more