Guided, Then Penalized: A Deep Dive into the FDA’s MDMA Ruling and What it Means for Psychedelic Clinical Trials
In August 2024, the FDA rejected the New Drug Application for MDMA-assisted therapy for PTSD, sponsored by Lykos Therapeutics,...
Moe Alsumidaie
How Cybin is Shifting Psychedelic Clinical Trial Execution and Regulatory Strategy
In the dynamic field of mental health, Cybin is pioneering psychedelic therapies. Amir Inamdar, Cybin’s Chief Medical Officer, discusses...
How FDA’s Guidance on Decentralized Trials Applies to Community-based Research Execution and Compliance
In September 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance titled Conducting Clinical Trials with Decentralized...
Tonix TNX-102 SL: Innovating Fibromyalgia Treatment in Development
In this interview, we sit with Seth Lederman, CEO of Tonix Pharmaceuticals, about their new drug in development for...
Breakthroughs in Post-Polio Syndrome Treatment: Grifols’ Innovative Approach
In this discussion, Dr. Jörg Schüttrumpf, Chief Scientific Innovation Officer at Grifols, delves into the promising results of their...
Durect Transforming AH Treatment with Larsucosterol’s Promise
In this interview, Jim Brown, CEO of Durect Corporation, shared insights into the treatment of Alcohol-Associated Hepatitis (AH) with...
Macro Trends in Pharma: AI, Innovation, and the Impact on Outsourcing Strategy
At SCOPE Summit 2025, a panel discussion explored the industry’s macro trends, focusing on AI, innovation, and outsourcing strategies....
Hacking the Placebo Effect: How AI Is Reshaping Clinical Trial Variability
AI is making significant strides in the rapidly evolving field of clinical trials. Dominique Demolle, CEO of Cognivia, shares...
Did the FDA Just Redefine Real-World Evidence Without Telling Anyone?
Real-world evidence (RWE) is increasingly referenced in regulatory conversations, particularly following the FDA’s 2023 guidance. Roche’s recent FDA clearance...
What Experts Are Saying About RWD in Clinical Trials
At the 2025 SCOPE Summit Conference, industry leaders gathered to discuss the integration of real-world data (RWD) into clinical...