Publications - 2012

Published in ACRP Monitor.

This article delves into the newly illustrated focus of regulatory inspectors on the relationship between sponsors and monitors and on recommendations to build quality risk management into the clinical trials process.

Published in Xconomy.

"Finding a drug that provides a therapeutic benefit at doses that are much lower than those that cause toxic side effects is probably one of the most challenging jobs on earth. For many years, drug researchers have all been hopeful that the genome would reveal its secrets for some of the tough diseases like MS, and that they'd find drug targets that allowed them to develop precise, targeted, 'heat-seeking missile' type therapies, even if for just a subset of all patients. 

So we are left with a key question: How much more data (and what kinds of data) would we need to collect to better differentiate the genomes like mine, which (so far) have proved unaffected, while there are similar risk factors in genomes like that of my cousin, who developed the disease at 28 years old?"

Published in Bioentrepreneur.

"Although we tend to blame pressures outside the industry, such as the recent economic crisis, for such failures, in truth, unfavorable business conditions may just accelerate the failure of companies destined to falter anyway. One avoidable reason for failure is that entrepreneurs do not do their homework on the external forces that affect the adoption of breakthrough science in their R&D programs. Instead, they lock onto an idea or technology and become mesmerized by its uniqueness rather than its utility—a trap that snares many."