Opinion
The FDA’s proposal to offer 50% off application fees for drugs with early-stage trials conducted in the U.S. is unlikely to achieve the intended result. What biotechs really want is speed.
A career setback can teach you something useful—or teach you the wrong lesson. Executive coach Angela Justice explains how one difficult experience can quietly shape the choices that follow.
Foundation models will change the way we study the natural, applied and clinical sciences, but only under certain conditions, and not in the way that some AI leaders claim.
Last month’s FDA advisory committee meetings for therapies developed by Capricor Therapeutics and Replimune effectively illustrate the different outcomes for patients when the agency prioritizes specialization in its reviews.
Thanks in part to the revolution cell therapy brought to treating blood cancers, the modality is now showing promise in some autoimmune applications. This expansion is poised to yield even wider benefits.
Biopharmas developing CAR T therapies for autoimmune indications face major barriers to maximizing the market. Advances in the provider ecosystem and clinical infrastructure, as well as access and education, will be key to launching at scale.
Real progress happens where unmet medical need is greatest and patient impact can be clearly measured. Pediatric rare cancers exemplify these criteria and have therefore generated continued investment, even in a capital-constrained environment.
An executive who is rarely short on ideas needs someone to pull their big ideas through to implementation. Kaye/Bassman’s Michael Pietrack explains why this person, who he calls the implementer, may be the most important hire in the building.
If we guard our secrets, patients suffer. Only through a commitment to transparency and data sharing—and artificial intelligence—can we make cell and gene therapies safer and more effective.
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.