Does Bilski Threaten BIO’s Bread and Butter?

Erik Greb PharmTech editorLast Thursday, the Biotechnology Industry Organization (BIO) weighed in on a patent issue that will soon be before the Supreme Court. In an amicus brief, BIO argued that the Court should overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit. The case involved Bernard L. Bilski’s method for hedging risks in commodities trading. Read more »

AAPS National Biotech Conference: Refocus on Science and QbD

Maribel Rios PharmTech editorInnovation, innovation, innovation .. and a call to focus on science and quality-by-design (QbD) principles. Such was much of the talk yesterday at this year’s AAPS National Biotechnology Conference in Seattle. Speakers discussed the tools the biotechnology industry will need for future innovation and how the industry must center on QbD principles, using lessons learned from small-molecule development and even nonregulated industries. Read more »

Big Funds for Small-Business Innovations

Maribel Rios PharmTech editorWhile we at PharmTech are very proud of our peer-review process for ensuring quality scientific articles, I was a bit humbled to learn of a massive endeavor by the National Institutes of Health to enlist the help of more than 18,000 scientists to help in their peer-review process. To put things in perspective, the process is in response to NIH receiving nearly 20,000 applications for Challenge Grants, a new program under the American Recovery and Reinvestment Act (ARRA). According to the organization, the number of applications is about equal to the total number of applications it receives in one of its three major review rounds every year. The number of applications and the peer review process is the largest response in NIH history, according to acting NIH director Raynard S. Kington. Read more »

Is it Too Early to Start Swine Flu Therapies?

Maribel Rios PharmTech editorThe almost overnight public concern and media attention over the swine flu outbreak has again turned the attention to pandemic preparedness. Officials continue to encourage preventive actions and precautions, noting that, as of yet, it is still unknown whether current vaccines and antivirals will have any effect against the strain responsible for this outbreak. It is also unknown whether those who received a vaccination during the 1976 US swine flu outbreak will have some protection against the current strain. Read more »

Virus Changes Pose New Difficulties

Maribel Rios PharmTech editorIt is inspiring to read news about the advancements being made in the fight against viral infections, including those against influenza and HIV. However, as comments to recent blog posts have reminded me, the struggle to develop antiviral therapies is highly complicated because viruses have the infamous tendency to mutate and adapt in their fight for survival and conquest of healthy cells. A major part of formulating and developing antivirals is trying to get some handle on a virus’s unpredictable nature, how it will change, and how these modified forms will strengthen our understanding of its interworkings. Read more »

Is A Biotech Bailout in the Offing?

Patricia Van Arnum PharmTech editor Another sign of the troubling economic times and its impact on the life-science sector comes from the United Kindgom, where industry representatives are requesting government assistance, according to a Times of London article. Read more »

Renewed Hope for Stem-Cell Research

Maribel Rios PharmTech editorBiotechnology pundits have pointed out the similar views current major presidential candidates share on stem cell research even including embryonic stem cell research. So far, it appears the issue has not played quite the major role in politics as it did in 2004. Perhaps this has to do with the increased familiarity with the purpose and promises of stem cell work within medical research and development. Read more »

Biology is Perverse, Part I

hoffman.jpgPeople always giggle when I say that, but it’s true. Of all the “basic” sciences, biology is the most slippery. By that I mean that, while the tendency is to study biomolecules and cells in isolation, the total animal, be it a bacterium or a human being, is a federation of molecules, organelles, or organs (depending on how big and multicellular you are), and they all act together to create a phenotype, a behavior, a syndrome, or a disease in the intact organism.
So it should hardly be a surprise to anyone who recognizes this fact that drugs for complex conditions, developed with reductionist biological models, yield disappointing results in the clinic. And yet it is. Read more »

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