Mike's Blog

Over the past several years, there has been increasing recognition that the United States is losing ground to other nations – particularly China and Australia – as the preferred location for pharmaceutical and biotech companies to conduct clinical research activities. Primarily as a result of regulatory innovation in those countries,...

Translating discoveries from early human trials into effective real-world health solutions is central to the CTSA Program mission. As translational science continues to evolve, rigor and reproducibility remain essential research pillars. Real-world data (RWD) and the resulting real-world evidence (RWE) are increasingly important for advancing research across the translational spectrum,...

A recent Stat article highlighted early results from the CMS’ WISeR (Wasteful and Inappropriate Service Reduction) Model, an AI-enabled prior authorization pilot now underway in six states. The program is being piloted in Arizona, New Jersey, Oklahoma, Ohio, Texas, and Washington, which includes ten CTSAs. The...

One advantage of a long career in medicine is the opportunity to witness the emergence and development of new concepts that advance from curious observations to routine clinical practice. One area of growing interest is the microbiome and its potential for manipulation. Its reach now appears far broader than we...

Gotta admit, the groundhog was right this year. DC is digging out of its second snowfall of the year. Typically, we get at most one snow event where enough snow falls and sticks around to impact the area. This latest was smaller than the previous but still closed schools and...