Rethinking the Preclinical Package for Chronic Kidney Disease: Why Pigs belong in the conversation
Drug development for chronic kidney disease has entered a more ambitious phase. SGLT2 inhibitors, non steroidal mineralocorticoid receptor...
CIPN Keeps Failing in the Clinic. The Preclinical Package May Be Why.
Chemotherapy induced peripheral neuropathy remains one of the most underserved symptoms in oncology supportive care. Estimates place the incidence at...
The Diabetic Wound Healing Model That Keeps Earning Its Keep
Chronic wounds in diabetic patients are one of the costliest quietly growing burdens in medicine. Roughly 15 to 25 percent of people with diabetes...
Stroke Models Need Diversity: What Age, Sex, and Comorbidity Change About the Data
Stroke remains one of the highest attrition areas in drug development. Despite decades of preclinical programs showing neuroprotective efficacy in...
Biomarker Strategy in Large Animal Preclinical Studies: What Actually Translates
Biomarkers have become the connective tissue of modern drug development. They anchor mechanism of action claims, support dose selection, enable...
Beyond Rodents: How Translational Pig Models Are De-Risking Pain Programs
The attrition rate for analgesic compounds remains stubbornly high. By some estimates, fewer than 2% of preclinical pain candidates reach approval, a...
The Göttingen Minipig in GLP Toxicology: A Practical Guide for Program Planning
Species selection for GLP toxicology is one of those decisions that quietly shapes everything downstream. It influences study timelines, regulatory...
In Vitro Is Not Enough: Why Large Animal Models Still Drive Pain Drug Approvals
The last five years have seen remarkable advances in in vitro and ex vivo pain research. Human DRG organoids, iPSC-derived sensory neurons,...
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...