The paradigm shift to an “open” model in drug development

• Drug development—then and now
• How systems biology is accelerating drug development and approval.
• The new business model: pharma/biotech is going “open”
• FDA is going “open”—what does this mean for drug approval?

The rising cost of healthcare, the rising cost for drug development, the patent cliff for Big pharma, shorter patent protection, decrease reimbursement, and the recession have made it more difficult for the pharmaceutical and biotechnology industry to develop drugs. Due to the unsustainable amount of time and money in developing a drug that will have a significant return on investment (ROI) it has become hard to sustain a robust pipeline. The industry is transforming its business model to meet these challenges. In essence a paradigm shift is occurring; the old “closed” model is giving way to a new “open” business model.