From Pig Model to FDA Approval: Lessons from the ZYNRELEF Story
The gap between preclinical efficacy and clinical success in pain drug development is well-documented and widely lamented. Fewer than 2% of analgesic...
Choosing Your Preclinical Species: How Rodents, Dogs, NHPs, and Pigs Compare in Pain Research
Every preclinical pain program begins with a species decision, which shapes everything downstream, including endpoint selection, translational...
Sex Differences in Pain Research: What Your Preclinical Program May Be Missing
In 2016, the NIH mandate on sex as a biological variable (SABV) formalized what pain researchers had known for years: males and females process pain...
The NaV1.8 Era: What Journavx Means for Pain Drug Development
For the first time in over two decades, the FDA has approved a new class of pain medication. Vertex Pharmaceuticals' suzetrigine (Journavx), a...
From Preclinical Signal to Clinical Confidence: What Pig Models Reveal That Rodents Can’t
The challenge in translational research is not generating data but generating actionable confidence.
Modeling diabetic neuropathy with mechanistic and translational considerations
Diabetic neuropathy affects nearly half of individuals living with diabetes, yet its underlying biological drivers remain only partially defined....
Why Pigs Are Becoming the Preferred Large Animal Model in Pain and Wound Healing Research
Pain and wound healing research demand models that accurately reflect human tissue structure, innervation, and functional recovery. While rodents...
When Rodents Aren’t Enough: How Translational Pig Models Reduce Late-Stage Risk
Drug development rarely fails because a compound lacked activity. More often, it fails because preclinical models failed to predict clinical reality.
GLP Toxicology Studies in Neuroscience
Toxicology is a defining step between exploratory research and clinical development. As programs move toward IND-enabling requirements, the need for...