Congress Must Reform Broken IND Process for FIH Trials
Great to see FDA & the administration prioritizing FIH (First in Human) reform. The current IND process is broken & has shifted FIH trials overseas. Countries like Australia have relied on a more flexible, notification-based pathway for years. Now Congress has to act. https://t.co/hKc3vvlr0I
Decade-Long Quest to Break Blood-Brain Barrier Highlights Biotech Challenges
When we seeded Denali the idea was to break the curse of the blood/brain barrier. It took a decade and tons of faith and money. Biotech is hard. Curing diseases is hard. This is a good summary. ...
Sauna Benefits Need BDNF Study; Cold Post‑Sauna Weak
Sauna data interesting. Need a study that actually measures BDNF etc and clinical outcomes to really prove. But I am doing it. Low risk. The evidence for cold afterwards is weak
Stable FDA Rules Essential for Patient Safety and Investment
To invest the billions it costs to make new medicines, companies need to be able to trust the word and actions of the FDA. To capaciously change the rules at the end of the game ultimately hurts patients.
