I am a medical affairs and patient safety professional. I have successfully led patient safety from phase 1-4, and the launched new products in market. I am generally known to remain calm when others are freaking out.
Uncategorized
The Phase 2b REZOLVE-AA data is statistically messy but strategically pristine. By decoupling efficacy from toxicity, Nektar Therapeutics has identified the precise wedge needed to break the JAK inhibitor monopoly. See Disclaimer below * The Statistical Mirage and the True Signal In the high-stakes theater of immunology drug development, the difference
Metabolic
In a crowded obesity market, WVE-007 emerges as a distinct 'Body Composition' asset, offering significant visceral fat reduction and lean mass gains that defy the typical GLP-1 trajectory. * These analyses reflect my personal opinions and may include input from multiple sources. They are for informational purposes only and
Oncology
With a 100% response rate (small sample size) in AR-mutant patients, MRT-2359 validates the GSPT1 degradation thesis, signaling a major disruption for the post-taxane mCRPC landscape. * These analyses reflect my personal opinions and may include input from multiple sources. They are for informational purposes only and do not constitute professional
Oncology
Immunome’s Phase 3 RINGSIDE trial delivers a potential best-in-class profile, combining profound tumor shrinkage with a convenient once-daily regimen. * These analyses reflect my personal opinions and may include input from multiple sources. They are for informational purposes only and do not constitute professional advice. * A New High-Water Mark in
Oncology
In a crowded HR+/HER2- landscape, Relay Therapeutics has potentially delivered the 'Holy Grail' of PI3K inhibition—demonstrating robust PFS benefits without the metabolic penalties that have plagued the asset class for a decade. * These analyses reflect my personal opinions and may include input from multiple sources. They
Oncology
In a decisive move to disrupt the stagnation of salvage therapy, MAIA Biotechnology initiates a pivotal Phase 3 trial. With a mechanism that turns 'cold' tumors 'hot' and survival data tripling the standard of care, Ateganosine is poised to be a major target for Big Pharma—
Neurology
AC Immune’s Phase 2 interim analysis delivers a rare trifecta in neurodegeneration: 100% target engagement, biomarker stabilization, and clinical efficacy signals. * These analyses reflect my personal opinions and may include input from multiple sources. They are for informational purposes only and do not constitute professional advice. * In a therapeutic
Oncology
The Phase III lidERA study marks the first significant advancement in adjuvant endocrine therapy in nearly 25 years, offering a superior oral SERD alternative to standard-of-care. * These analyses reflect my personal opinions and may include input from multiple sources. They are for informational purposes only and do not constitute professional
paltusotine
Paltusotine aims to replace depot octreotide and lanreotide injections with oral daily dosing for carcinoid syndrome. The SST2 agonist targets the same pathway while eliminating the burden of clinic-administered shots.
Oncology
Phase 1 data confirms extracellular FLT3 binding efficacy regardless of mutational status, offering a potential breakthrough for refractory subsets. * These analyses reflect my personal opinions and may include input from multiple sources. They are for informational purposes only and do not constitute professional advice. * Clinical Perspective Data presented today at
Neurology
Kallyope's first-in-class oral antagonist meets co-primary endpoints, offering a distinct non-CGRP mechanism for refractory patients. * These analyses reflect my personal opinions and may include input from multiple sources. They are for informational purposes only and do not constitute professional advice. * Clinical Impact Analysis The landscape of acute migraine
Metabolic
Phase 2b results confirm high efficacy and safety, but the pivot to a slower titration protocol pushes Phase 3 to mid-2026, widening the gap with lead competitors. * These analyses reflect my personal opinions and may include input from multiple sources. They are for informational purposes only and do not constitute