Published online in Xconomy.
"Disruption isn't a word normally associated with clinical drug development, but nevertheless it is coming. We can feel the rumblings of it. New technologies and technology-enabled techniques for productivity in mainstream business applications are slowly making their way into the clinic. There are signals that drug development is starting to catch up with the general trend toward open collaboration and innovation. This trend is enabling tremendous advances in other industries, so why not ours?"
Published in The Monitor.
Published in Life Science Leader.
"Almost two years ago, the FDA issued a draft guidance document "letting us off the hook" from what had been standard practice in most registrational clinical trials: source document verification, the procedure commonly called "100% of 100%", or in layman's terms, a complete verification of every data point for every patient in every clinical trial where data is included to support approval.
Source document verification (SDV) requires significant resources in terms of time and cost. It tends to be the key activity of CRAs or monitors during routine site visits, although there is widespread agreement it should be only part of a monitor's focus to ensure a high performing site. Reducing the practice to a quantitative risk-based model would free up the monitor's time so that s/he may more effectively manage the activities that often cause a research site to veer off track from a regulatory perspective."
Published online at BiotechStart.
"After 9 months on the road during a recent sabbatical, I can attest that you learn a lot from your fellow travelers. You learn what food stalls to avoid in the Jamaa El Fnaa square in Marrakesh. You discover the best surf spot for beginners in Nicaragua. You also learn coping skills required for long-term travel: how to diffuse tense situations with a travel partner, how not to get into a street brawl with an aggressive "unofficial" guide, and how to keep a budget without sweating every single financial decision you make. It turns out that these skills are just as apt for the life sciences industry (however the travel partner may be a business partner, the aggressive guide might be a vendor, and the monthly financial close may still be tense). However, one lesson I learned from a fellow traveler named Brie revolutionized the way I think about decisions on project teams."