HHS awards $102 million for new flu drug

first_imgJan 5, 2007 (CIDRAP News) – In an effort to expand the pool of antiviral drugs for influenza, the US government yesterday awarded a $102.6 million contract to BioCryst Pharmaceuticals Inc. of Birmingham, Ala., to develop peramivir, a new neuraminidase inhibitor.The Department of Health and Human Services (HHS), in a press release, said peramivir has been effective against several influenza strains in laboratory studies. HHS said the contract will cover production of the investigational drug, phase 2 and 3 clinical studies, and validation of manufacturing processes.Research under the contract will include tests involving the deadly H5N1 avian flu virus and may include research on the possible preventive use of the drug, according to HHS. BioCryst officials said the drug has been shown to help animals survive H5N1 infection.”Antivirals are an important element of our pandemic influenza preparedness efforts,” said HHS secretary Mike Leavitt in the press release. “Our antiviral strategy includes not only stockpiling existing antiviral drugs but also seeking out new antiviral medications to further broaden our capabilities to treat and prevent all forms of influenza.”Licensed drugs in the neuraminidase inhibitor class are taken orally (oseltamivir) or by an inhaler (zanamivir). However, peramivir is under development as a parenterally administered drug, meaning it can be given through intramuscular and intravenous routes.HHS said a parenteral neuraminidase inhibitor may be particularly useful in hospital emergency departments for treatment of patients who have life-threatening flu. Parenteral injection could permit rapid buildup of peramivir to high levels throughout the body and allow treatment of people too ill to take medications by mouth, the agency said.In a news release, BioCryst said its laboratory tests have shown that peramivir, an inhibitor of influenza A and B neuraminidases, is more potent than currently available drugs in its class and is active against antiviral-resistant flu strains. The company said high doses of injectable formulations have been safely administered to healthy people, and the drug has been found to promote survival in animals infected with the H5N1 virus.At a BioCryst teleconference that followed the HHS announcement, Charles Bugg, PhD, the company’s chairman and chief executive officer, said the contract allows the company to move peramivir as quickly as possible through clinical development.HHS said awarding the contract to BioCryst is part of a larger initiative to support the development of new treatments and vaccines that would allow the United States to respond quickly to a flu pandemic.Bugg said both the intramuscular and intravenous formulations of peramivir will go through phase 2 and 3 clinical trials. The intramuscular formulation will be tested against a placebo in outpatients, and the intravenous trial will likely test peramivir against oseltamivir in hospitals.Enrollment of patients for the phase 2 trials will begin this flu season in the United States, Canada, and Europe, Bugg said, adding that the company has identified sites in the southern hemisphere that could be used to fill this year’s phase 2 study groups or facilitate an early start on phase 3 studies. He said BioCryst is also identifying sites in Southeast Asia, where flu outbreaks occur year-round, that might be added to the study.Bugg said the HHS contract to develop peramivir is subject to an emergency use authorization that would allow the department to stockpile the drug before approval by the Food and Drug Administration (FDA) if clinical data show it to be beneficial.Jonathan Nugent, vice president of corporate communications at BioCryst, told CIDRAP News that the company hasn’t ruled out developing oral or inhalational formulations of peramivir in the future. He said the company couldn’t speculate on how long it might take for the drug to win FDA approval. HHS said the FDA has given peramivir “fast track” status, which would expedite the agency’s review of BioCryst’s application.See also:Jan 4 HHS press releasehttp://www.hhs.gov/news/press/2007pres/01/20070104a.htmlJan 4 BioCryst press releasehttp://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=224367last_img read more

Ask the Mayor — August 7, 2019 — Mason City councilman Tom Thoma

first_imgMason City at-large councilman Tom Thoma was our guest on “Ask the Mayor” on August 7, 2019. Listen back to the program below.last_img

What Is Your Technical Debt Ceiling

first_imgThis is a guest post by Isaac Shi,  CTO and Chief Software Architect, Prognosis Health Information SystemsThe U.S. Congress and White House are currently engaged in a historic debate about the federal debt ceiling. Problems like these tend to accumulate over time, with longtime negligence and lack of action due to political inconvenience one reason for the current federal debt crisis.  As it happens, software development shares a remarkably similar pattern. Technical debt is a lot like government debt; it carries an interest cost, it comes from short-term rapid enhancements without long-term planning, and is ultimately caused by a lack of balanced approach to addressing urgent issues vs. important issues.Now believe it or not, some level of technical debt actually allows for an accelerated development time frame, as it reduces the tendency of over-engineering and generates immediate ROI in delivering features to clients quicker. After all, the market needs those features yesterday.Once the technical debt is accumulated to a certain level, however, it leads to performance issues and restrains the flexibility of adding new features. This will eventually hinder the scalability, reliability and flexibility of the entire software system.In order to achieve a balanced technical debt, or technical surplus, you should first be able to measure it. For this, I’d like to introduce a technical debt measurement concept within the Scrum framework: a software system’s technical debt can be measured by the user story points that could be created but are not due to the time used to serve all existing technical debt by code refactoring. Gross Development Product (GDP) should be the annual user story points output for a software company. So the technical debt ratio should be calculated as so:Technical debt ratio = User story points used to serve technical debt / GDPIf a development team can produce 12,000 user story points per year, but is forced to devote effort that is equivalent to 3,000 user story points to refactor existing codes, then the technical debt of this software system is 3,000 user story points. Therefore, the technical debt to annual GDP ratio for this company is 25%, which may actually be at a sustainable level, depending on the industry you are in.Every software company needs to establish its comfortable technical debt ceiling, as it can vary from industry to industry. But it’s important that companies reach a consensus on the technical debt ratio and have a plan to reduce technical debt once they approach that ceiling.Development teams should always use evolutionary product design in feature development and continuous refactoring for the code base rather than resorting to a situation that requires stopping all feature development to only work on technical debt. Through this effort, one can reduce the technical debt while creating and maintaining a decent architectural pattern. Coders following these solid software design patterns can avoid software debt in the first place, even under the heavy pressure of deadlines. This is how technical surplus is created.Scrum not only offers guidance for us when building new features, it also provides a similar principle to address technical debt  through incremental iterations by weaving architectural improvement inside feature building.Of course, the best way to avoid crisis is to never get into one in the first place. If you do find yourself in a crisis, try to use it as an opportunity. In other words, you should always use it for the greater good of the software system. The solution created to respond to the crisis should not only solve immediate issues, but also address the underlying long-term architectural deficit so you don’t find yourself kicking the can down the road.The economy can be boom or bust, and software companies rise and fall. A repeating scenario is that legacy software systems become so obsolete (with too much debt and baggage) that it’s much easier for a new company to build a new software platform to replace the old one.Management of technical debt should be part of every software company’s strategic thinking, and it’s time for your company’s Barack Obama and John Boehner to reach an agreement on this.Isaac Shi is Chief Technology Officer and Chief Software Architect with Prognosis Health Information Systems, a company focused on delivering solutions and services for hospitals and health care professionals. Isaac Shi of Prognosis Health Information Systems explains why technical debt management should be part of every software company’s strategic thinking in this guest post.AddThis Sharing ButtonsShare to FacebookFacebookShare to TwitterTwitterShare to PrintPrintShare to EmailEmailShare to MoreAddThislast_img read more