Tagged: risk

Risk in Outsourcing: The Three Horsemen of the (Potential) Apocalypse

As the CEO of a CRO, I’m frequently asked about the role of risk in outsourced drug development. There’s no definite answer to this, but as we develop strong, long-term relationships with our partners, I suggest there are three ways of looking at this issue. First, every sponsor faces the risk of launching a drug… Read more »

The Rhetoric of “Risk Sharing”

Derek Lowe’s observation about AstraZeneca’s bracing for change also applies to the pharma industry as a whole: “…things can’t go on the way that they have been.” AstraZeneca is not alone in failing to get enough new drugs approved to sustain their business model, but they’ve made themselves the poster child for that dilemma. Somehow… Read more »

Why is Enrollment So Hard?

Although enrollment is one of the most pivotal determinants of study success, most researchers acknowledge doing poorly yet seem unable to improve their methods. As an industry, our performance is shockingly feeble: on average, a paltry 15% of studies enroll on time. In most businesses, that kind of performance would be a clear definition of… Read more »

The Importance of Information-Flow: The Case of the Thwarted Startup

In my last post, I discussed the cultural problem of excessive risk-aversion preventing pharma and CROs from using methods that could improve R&D productivity. This issue is never more evident than when applied to the critical area of information flow and decision making. Here’s an example of how a potentially important drug failed in a… Read more »

Breaking with Bad Culture: Trading Risk-Aversion for Efficiency

A recent article in Nature Reviews Drug Discovery by Jack Scannell and his colleagues at Sanford Bernstein identifies four primary causes of declining pharma R&D productivity, including the “throw money at it” tendency. Scannell and co-authors list the increasing number and scale of clinical trials as secondary symptoms. David Shaywitz provides an excellent recap, and… Read more »