Pharmaceutical Executive-10-01-2015

Medicine 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.

Driven 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.

For 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. 

A new and more compelling strategy must be crafted to engage critics on drug pricing and bolster biopharmaceuticals as a leader in technological innovations that lower health costs overall.

In 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.

Managing the nomination of new FDA commissioner adds to packed agenda

The rising focus on difficulties in swallowing tablets spells a big opportunity for pharma.

Adoption of joint procurement agreement signals new effort from EU to better understand drug pricing issues.