Lisa is a seasoned regulatory strategist and accomplished departmental/functional leader with an extensive background spanning more than 25 years in regulatory affairs, scientific affairs, and medical writing. Leveraging her knowledge and experience to support clients in various development stages, focusing primarily on regulatory strategy in Early-phase/Pre-IND, End of Phase 2, and Pivotal/Phase 3.
Lisa has effectively managed a diverse portfolio, including gene therapies for rare neurodegenerative diseases, ocular indications, and neuromuscular diseases as well as a comprehensive understanding of anti-infective, neurology, and cardiovascular products.
Key areas of expertise
- Development and execution of regulatory strategy from preclinical to pivotal phases of product development (most recently in gene therapy products and previously in small molecules)
- Partnering with cross-functional contributors to regulatory submissions to drive alignment on global clinical/regulatory development plans and submission content
- Meeting facilitation with internal/company and external (health authority, KOL advisory boards, etc) stakeholders
- FDA/EMA/PMDA meeting preparation and execution – defining strategy, outlining meeting objectives, briefing package authoring, project planning, and post-meeting follow-up
- Submission process development and project planning for both major submissions (IND, CTA, BLA/NDA) and maintenance submissions (protocols, IBs, DSURs/safety reports, orphan annual reports)
- Therapeutic areas: rare neurodegenerative, neuromuscular, ocular, orphan products
- AAV gene therapy product development and global regulatory strategy
- Orphan product development (US/EU ODD and Pediatric Rare Disease Designation)
- Special regulatory designations (RMAT, Fast Track, ATMP)
- Conduct regulatory due diligence exercises as requested to support strategic objectives
Before NDA
Lisa served as Vice President of Regulatory Affairs at REGENXBIO, overseeing all aspects of the regulatory function, including US and international regulatory strategy, regulatory operations, medical writing, and regulatory CMC teams responsible for global submission content.
Prior to her 8-year tenure at REGENXBIO, Lisa spent the majority of her early career at Otsuka Pharmaceuticals in a variety of roles with increasing responsibility across general regulatory affairs, medical writing, and scientific affairs. She has also held roles in the government and non-profit sectors as well as at a private orphan consulting firm.
Lisa holds a BS in Biochemistry from NC State University (magna cum laude) and an MS in Medicinal Chemistry and a PhD in Pharmaceutics both from the University of North Carolina. She completed postdoctoral studies at the National Institutes of Health in the Laboratory of Immunogenetics where she investigated molecular therapeutic approaches in virology.
Lisa Carlton