ASCO 2015 may be remembered as the year when the high cost of drugs got nearly as much attention as the major scientific breakthroughs in deadly cancers. Indeed, looking back at the presentations and conversations at this year’s oncology conference, what was clear was the growing tension between the breathtaking progress of scientific advancements in cancer therapies – even a potential cure – and what has been dubbed the “financial toxicity” of these treatments. That refers to the high cost of many innovative products.
The reality of clinical trials is that having some missing data is inevitable. As the FDA becomes more stringent on how to handle missing clinical trial data to support device and drug approvals, Sponsors should give careful consideration to pre-specified analyses that will support the robustness of the trial results. In order to understand the different approaches to account for missing data, it’s important to understand the types of missing data that can occur.
A crisis is the wrong time for an original thought! High-stakes crisis management requires time and preparation beforehand, because there is no faster way to sink your business, brand, or organization than thinking you can just “wing it”. So, how do you prepare for the unexpected? We’ve come up with a system called taking the E-A-R-L-Y Train. Here’s how it works.
Today’s biopharma industry faces more in-market risks than ever before. These include payment reforms such as bundled payments and limited global health care budgets. The industry must also manage greater provider financial risk for outcomes and resource use, as well as payer consolidation and new insurance designs that shift more costs to patients. And this is just the tip of the iceberg. In this environment, the stakes are high. Identifying and communicating the value proposition of innovative products is nothing less than critical.