Maryam Mokhtarzadeh | Senior Director Regulatory Strategy
REGENXBIO

Dr. Maryam Mokhtarzadeh joined Regenxbio as Senior Director for Regulatory Strategy leading global regulatory teams and also heading the Ocular Center of Excellence. Her current roles build on her prior leadership experience at AbbVie as Medical Director of Clinical Development. Before joining industry, Maryam spent over a decade at FDA where she held leadership roles in the Office of the Commissioner, CDRH, the Office of Combination Products, and served as the FDA IRB Chairman. While at FDA, Maryam also participated as a physician and surgeon providing direct patient care in the Ophthalmic Genetics and Visual Function Branch of the NEI/NIH for over a decade while also contributing to clinical research. Maryam is a board-certified ophthalmologist and graduated from the Johns Hopkins University School of Medicine and Princeton University with over 25 years of research experience and collaboration with and within industry.

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

Rumi Desai, Director, Global Regulatory Strategy, Amgen, Inc.

Reenie McCarthy, Chief Executive Officer, Stealth BioTherapeutics