One question we hear regularly from emerging biotechs is: Do we really need a formal Target Product Profile right now? Like many good answers to regulatory questions, “it depends.” A great TPP that is grounded in data and stra...
Commercial
Why Separating Regulatory and Commercial Strategy Can Kill an Otherwise Promising Biotech
For many small biotech teams, regulatory and commercial strategies are treated as sequential activities: first secure FDA approval, then figure out how to sell the product. Chronologically, that seems reasonable. Strategically,...
Understanding the Impact of the 2025 CPT Code Updates on Healthcare Innovation
By Randy Goodman, Ph.D., MHA, FACHE, PMP, BCMAS The American Medical Association (AMA) has officially released the updated Current Procedural Terminology (CPT) codes for 2025. This release marks a significant update reflecting ...
Why Do You Need a Life Sciences Product Landscape Assessment?
A life sciences product landscape assessment – also known as a pharmaceutical landscape assessment for drug and biological products and a device landscape assessment for medical device products – arms Sponsors as we...
The Growing Importance of Real-World Evidence in Product Development
At Facet Life Sciences, we understand that the product development landscape is evolving, and one of the key drivers of this evolution is the growing importance of real-world evidence (RWE). It has the potential to accelerate a...
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