The departure of Dr. Vinay Prasad, a high-profile FDA regulator known for his strict adherence to traditional clinical trial standards, has renewed debate about how the agency should balance scientific rigor with timely patient access to emerging therapies. Rather than framing this moment as a binary choice between rigor and…
Mike Ryan and I often discuss various U.S. and Global healthcare payment policies that are insufficiently thought through. When modeling is inadequate prior to implementation or is based on faulty assumptions, the unintended consequences and impacts can be quite negative. We’ve decided to share our thoughts periodically on some of…
In a previous column, I discussed how pharmaceutical and medical device companies are adapting their commercial model approaches in critical areas to address growing economic, market and other competitive pressures. This adaptation is underscored in our new Numerof & Associates 2023 Commercial Model Report, which reveals the strategic changes that…
More than 175 biotech layoffs were announced in 2023, easily surpassing 2022’s number of 119. While this is not a new trend, the current trajectory is concerning, as it portends more difficult times ahead for the pharmaceutical industry–already in the midst of a major upheaval. It should also be another…
For years, lawmakers have been chomping at the bit to reduce the perceived power of the pharmaceutical industry — once the crown jewel of American business. Their efforts have finally come to fruition with the signing into law of the misnamed Inflation Reduction Act. The law, in part, allows Medicare…
