The FDA’s Breakthrough Therapy Designation — created when the FDA Safety and Innovation Act was signed on 9 July 2012 — is in its second year after a successful start. Enacted to provide another mechanism to accelerate the path of critical therapeutics to market, the statute has exceeded expectations. The…
In today’s global market environment, payers are looking hard to reduce reimbursement and resist paying for incremental product enhancements. On top of that, manufacturers’ revenue streams continue to be threatened by looming patent expiration dates and the simultaneous influx of generic competition. What actions should companies consider taking to protect…
Oncology drug and biologics makers face increasing demands for data that demonstrates the benefit and cost-effectiveness of their products. Not only are treatment cost increases considered unsustainable, questions about new product effectiveness are being openly raised by physicians and payers alike. Pharmaceutical companies are increasingly being expected to demonstrate the…
As payers around the world try to figure out how to get spiraling healthcare costs under control, big data has been hailed as a silver bullet. The underlying premise is that, with enough data and enough analysis, we can figure out how to best treat patients for the least amount…
While big data by definition captures a large amount of detail for a large number of patients, what it can’t do is provide a company with the big picture, “the wide angle view.” While big data sets such as SharedClarity, formed by UnitedHealthcare and several large provider systems, can be…
In our continuing series on the topic of market transformation within the pharmaceutical and medical device industry, we have highlighted the need for a more sophisticated, strategic approach to market segmentation. Several factors are combining to require successful companies to approach market segmentation more effectively. These factors include market dynamics, shifts…
