senior Consultant

Nacy Bordelon, PhD, DABT

Dr. Nancy Bordelon is a board-certified toxicologist with more than 20 years of experience leading the nonclinical development of investigational small molecules, biologics, and gene therapies across multiple therapeutic areas, including ophthalmology, neurology, and metabolic diseases. She provides strategic nonclinical, regulatory, and due diligence support to pharmaceutical and biotechnology companies across all stages of drug development.

Throughout her career, Nancy has led the nonclinical components of multiple IND and CTA submissions and contributed to more than 30 additional regulatory filings with the FDA, EMA, and MHRA. She is recognized for her expertise in regulatory strategy, toxicology, and cross-functional program leadership, helping organizations navigate complex development and regulatory challenges.

With specialized experience in small molecule and AAV-based gene therapy programs, Nancy has supported the advancement of numerous ophthalmology, neurology, and metabolic disease assets. Her background provides extensive experience in ophthalmic drug development, including IND-enabling programs for multiple ocular indications.

As a trusted advisor to executive leadership and development teams, Nancy has wide-ranging experience supporting global development programs and regulatory interactions with health authorities, including the FDA, EMA, and MHRA, helping organizations advance innovative therapies efficiently and strategically.