Healthcare Reform and Pharmaceutical Development

We would like to welcome guest blogger Ronald Norton of Global Clinical Research Solutions, LLC to the Partnerships in Clinical Trails blog. You can visit the his webpage here. He can be reached at 850-556-7239.

With healthcare reform all over the news and an unending stream of 'pundits' offering their opinions, the question on my mind lately is, "How does this affect Pharma?" Specifically, " How does it affect product development costs and timelines?" And more to the point here, "How does it impact partnering in the business of planning and executing clinical trials?" Most of the chatter predicts a negative impact with forecasts ranging from minimally 'no help' on one hand to 'total meltdown' on the other. It shouldn't be too surprising that few are predicting improvement. Adding this kind of uncertainty to an environment already unsettled by the past year and a half of economic downturn, historically dwindling pipelines, recently increased FDA scrutiny, and seemingly unending layoffs at best lowers everyone's morale. Unfortunately, it also helps create a business environment where doing nothing seems better than acting on any new initiative. And, since pharma is a very conservative industry, the attitude is likely to be, "Let's just wait and see what falls out."

Our industry has a number of reasonably unique characteristics that exacerbate the effect of uncertainty like that associated with a regulatory change. Focusing on the financials, the cost of bringing a new drug to market of approximately $1 billion, and a timeline that can exceed a decade are among these characteristics. Targeting these characteristics produced the contract research industry and while those imperatives have not changed they are more pronounced now than they were a decade ago. Clearly successful partnering will still incorporate improvements to speed and costs on the one hand while retaining high quality on the other. However, creating meaningful partnerships in the clinical trials industry in today’s climate is a bit like going on a quest for the Holy Grail. There are lots of grails out there. Not many of them seem to be producing the desired effect. Why? And, will the much-discussed Healthcare

Reform initiative, if passed, create new opportunities? One thing is certain; it will bring speed, cost, and quality in clinical trial partnerships into higher relief.

With the Democrats claiming to be poised to pass the bill this week we will certainly hear more on this topic during the upcoming Partnerships in Clinical Trials Meeting next month in Orlando. You can expect that there will be more to post more on the subject.