Donna Cowan | Director Expanded Access Program and Registry
Stealth Biotherapeutics

Donna Cowan, Director Expanded Access Program and Registry, Stealth Biotherapeutics

Donna Cowan is a Certified Clinical Research Coordinator and Project Manager with more than 20 years of biopharmaceutical experience.  For the past several years Donna has concentrated on the management of Investigator Initiated Studies and Expanded Access Programs (Compassionate Use, Managed Access, Named Patient), leveraging her passion for patient care into providing early access to investigational therapies to those with serious or life-threatening conditions who may have no other treatment options. She has experience in various therapeutic areas including rare, ultra-rare, and pediatric and orphan diseases, oncology, endocrinology, neuroendocrinology, and infectious disease. Ms. Cowan is Director of the Expanded Access Programs and Registry at Stealth BioTherapeutics (SBT), also overseeing Investigator Initiated Studies. SBT is a Boston area-based biopharmaceutical company developing therapies to treat the mitochondrial dysfunction associated with genetic mitochondrial diseases and many common age-related diseases.

Appearances:



Day 2 - World Orphan Drug Congress USA 2026 @ 11:40

The Rocky Road to Approval

In a small Biotech all of the best laid plans for becoming a commercial company can go out the window in a minute.  This session will discuss the possible roadblocks and how to navigate them through innovative solutions using lessons learned and heightened communication and education.   

  • When to start planning an EAP exit strategy 
  • You got approval!  Now what happens to your EAP? 
  • It takes a village 
  • Compliant transition: Rules, rules, and more rules 
last published: 11/Mar/26 19:05 GMT

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