Stuart Madden
Chief Scientific Officer Neurelis
Stuart Madden, PhD, has over 30 years of experience in the pharmaceutical industry, working on drug development programs from proof of concept through to commercialization for new chemical entity (NCE) and 505(b)(2) products that have encompassed small molecules, biologics and combination products. He is Chief Scientific Officer at Neurelis, Inc. Previously, Dr. Madden was Vice President, Scientific Affairs at ICON PLC.
Dr Madden received his BS in chemistry and his PhD in physical chemistry from the University of Wales (Swansea, UK). He is a Chartered Chemist and Fellow of the Royal Society of Chemistry and a past special government employee for the US FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology.
Seminars
This interactive workshop brings together industry experts to explore evolving FDA and global regulatory expectations, providing practical guidance on building development programs that reduce regulatory risk and accelerate progress toward the clinic.
Discussion Areas:
- What evidence do regulators actually require to support nose-to-brain claims?
- Understanding FDA expectations for powders, biologics, and novel delivery technologies
- Bioequivalence vs in vitro bioequivalence pathways
- Addressing regulatory uncertainty surrounding direct CNS delivery
- Bridging conflicting expectations around animal testing, modeling, and safety packages
- Learning from successful INDs, NDAs, and regulatory interactions
- Understanding the value of systemic exposure for nose to brain delivery
- Reducing regulatory risk by aligning device reliability, human factors, and manufacturing strategy early in nasal combination product development
- Identify the critical scientific, translational, and clinical evidence gaps that remain before nose-to brain delivery can achieve widespread regulatory acceptance and commercial adoption
- Understand what regulators still need to see regarding reproducibility, biodistribution, imaging, clinical outcomes, and direct CNS exposure before confidently supporting nose-to-brain claims
- Debate whether current preclinical models, analytical tools, imaging technologies, and translational approaches are sufficient to predict human outcomes and support development decisions
- Separate genuine scientific progress from industry hype by examining which technologies, pathways, and approaches are producing meaningful evidence versus those that continue to face significant validation challenges
