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Patent Parameters

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Supreme Court Finds Naturally Occurring DNA to Be Patent Ineligible Last summer, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., which concerned the patent eligibility of the BRCA1 and BRCA2 genes. In Myriad, a unanimous Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. The Court also determined, albeit with one caveat, that Read More >

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Reimbursement Considerations for Early Stage Companies

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Panelists at Tuesday’s breakout session – Reimbursement Considerations for Early Stage Companies – overwhelmingly agreed that emerging biotech companies must consider reimbursement at the earliest stages of development. Christopher de Wolff, MSFS, Consultant, Numerof & Associates, Inc. moderated the panel and kicked it off by pointing out that many drugs achieve regulatory approval yet fail when they reach the market because of a lack of data and evidence directed at reimbursement. He asserted that the Read More >

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Turning the Tide on STEM Education

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According to the US Department of Education, only 16 percent of American high school seniors are proficient in mathematics and interested in a career in a Science, Technology, Engineering or Math (STEM) field. Even among students who do major in a STEM field, only about half go on to work in a related career. As an industry, we have a responsibility to not only prepare today’s students for careers in STEM fields but also to Read More >

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Syringes for Clinical Trials

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Today’s pharmaceutical and biotechnology companies are under pressure to remain competitive. To do so, they require innovative approaches to manage drug development, particularly early development work. Any competitive advantage in the development process is highly prized – and one approach is to begin the development of the compound in a prefilled syringe earlier in the process, rather than later. Traditionally, biopharmaceutical companies have almost exclusively used vials in drug development. There are good reasons for Read More >

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Precision Drugs for Bad Bugs

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Awareness is high that antibiotic resistance is a critical problem, but many still don’t appreciate the role played by antibiotics themselves in accelerating this problem’s spread. Single antibiotics capable of killing multiple bacterial species – a class of drugs termed “broad spectrum” – have long been seen as a panacea and a cure for all bacterial infections. Today, essentially all marketed antibiotics kill multiple species of bacteria. Unfortunately bacteria that become resistant to a particular Read More >

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