A New Era in Precision Gene Editing
October 16th 2015Medicine is entering a new era of “gene editing.” Instead of simply being able to “read” our genes, practitioners will be able to adapt and modify DNA sequencing in living cells to treat, cure, and even prevent disease. Defective genes responsible for life-threatening diseases can be rendered harmless by gene editing; it can also be used to develop new, precisely targeted biological drugs based on an individual’s distinct genetic markers. The full list of possibilities, in every area of the life sciences, is simply beyond imagination.
Knowledge is Value: Navigating Biopharma’s New IP Terrain
October 11th 2015Driven by knowledge advances and the importance of a more collaborative commercial model, intellectual property (IP) has morphed from an arcane, specialized function dominated by technicians to a showcase strategic priority of the “c-suite.” This trend is hardly restricted to the life sciences. In fact, some of the most creative work in using IP tools to extract more value from knowledge assets is taking place among businesses that operate across multiple sectors.
Competitive Trial Management: Winning with Clinical Studies
October 9th 2015For years, many companies have competed to demonstrate that their products could achieve the holy grail in type 2 diabetes (T2D): cardiovascular (CV) risk reduction. According to the American Diabetes Association, pharma companies to date have spent over $2 billion and tested 138,000 patients in company-sponsored CV-risk reduction T2D trials, including the recent large-scale TECOS, SAVOR, EXAMINE, and ELIXA studies.
Licensing Approval in Europe: New Options for a New Era
October 8th 2015In the midst of a leadership vacuum at the European Medicines Agency, Pharm Exec talks with the organization’s top medical officer, Hans-Georg Eichler, about its potentially game-changing drug approval program-one designed to balance safety requirements with faster patient access to the strong science now emerging from industry labs.