Reenie McCarthy | Chief Executive Officer
Stealth BioTherapeutics

Reenie McCarthy is the Chief Executive Officer and a member of the Board of Stealth BioTherapeutics. Reenie also serves on the Board of BIO (Biotechnology Innovation Organization). Reenie is a 20+ year veteran of the investment team of Morningside, Stealth’s principal investor, with extensive experience working with private nonclinical and clinical stage companies developing drugs across a broad spectrum of therapeutic areas.

Appearances:

Day 2 - World Orphan Drug Congress USA 2025 @ 12:00

Panel: Finding the optimal pathway to market and moving the bar for regulatory approval

Navigating the regulatory landscape is one of the most complex and critical aspects of bringing new therapies to market, especially in the context of innovative treatments, rare diseases, and cutting-edge technologies. This panel will delve into strategies for finding the optimal regulatory pathway to bring life-saving drugs and biologics to market faster and more efficiently, while maintaining the highest standards of safety and efficacy.

The discussion will explore the evolving regulatory frameworks, from accelerated approval programs to adaptive trial designs and breakthrough therapy designations, and how these pathways can be leveraged to speed up the development of groundbreaking treatments. Panelists, including regulatory experts, industry leaders, and policymakers, will share insights on how regulatory agencies are evolving to meet the challenges of rare drug development, and how companies can navigate these changes to achieve faster approvals.

Moderator: Maryam Mokhtarzadeh, Senior Director Regulatory Strategy, REGENXBIO