Stephen Shrewsbury
Fractional Chief Medical Officer, Lionbio & TransformBio
Stephen B. Shrewsbury, qualified as a Doctor in 1980 from the University of Liverpool, UK and worked in primary care and pulmonary medicine, before joining the Industry. In 2000, he moved to the US and led Glaxo’s inhaled fluticasone and Upper Respiratory Inflammatory Disorders programs and led Chiron’s Inhaled Antibiotic Core Team. Steve has been CMO to several biotech companies including MAP, Adamas, AVI BioPharma (now Sarepta Therapeutics), Aquinox, and Impel and now in fractional CMO roles for TransformaBio and Lion Bio. At Impel he led several programs delivering drugs to the upper nasal space and since 2023 he has run Shrewd Consulting helping multiple companies with nasal delivery programs.
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
