Teresa Brandt | VP, Regulatory Affairs
Avidity Biosciences

Teresa A. Brandt, PhD, Vice President, Regulatory Affairs, Avidity Biosciences. Dr. Brandt is a pharmaceutical executive with a strong foundation in molecular biology and drug development. She earned her PhD in Molecular and Cellular Biology from Arizona State University focused on mechanisms of programmed cell death and conducted postdoctoral research at Johns Hopkins University in virus-induced CNS pathogenesis. Dr. Brandt has successfully led clinical development programs and regulatory successes across numerous therapeutic areas (neurology, cardiovascular, endocrinology) and therapeutic modalities (small and large molecule) at multiple biotech and pharma companies including Avanir Pharmaceuticals, Ionis Pharmaceuticals and Acadia Pharmaceuticals, advancing new products to patients. Currently, she serves as Vice President of Regulatory Affairs at Avidity Biosciences, where she oversees global regulatory activities and incorporates patient-focused drug development initiatives into AOC (antibody oligonucleotide conjugate) product development.

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