Laura is a regulatory science specialist with over 15 years of experience across FDA CDER, pharma, and biotechnology. She advises global biotech and pharmaceutical teams on immunogenicity strategy, CMC comparability, and regulatory positioning for biologics and advanced therapies.

As a former CMC and immunogenicity reviewer within the Center for Drug Evaluation and Research (CDER), she brings first-hand insight into how regulatory agencies evaluate data, assess risk, and interpret development strategies. She later served in translational sciences and CMC regulatory leadership roles within industry, shaping development programs for novel biologics, including cell and gene therapies.

Laura’s expertise spans:

• Immunogenicity risk assessment and ADA strategy

• Integration of CMC and clinical data

• Comparability assessments and lifecycle management

• EMA and FDA regulatory interactions

• Preparation of Immunogenicity Risk Assessments (IRA) and Integrated Summaries of Immunogenicity (ISI)

Before joining FDA, Laura completed academic research in biochemistry, molecular biology, and immunology, including postdoctoral work at the National Institutes of Health (NIH) and Children’s National Medical Center (GWU).

Since 2020, she has provided independent regulatory consulting through LAIZ Regulatory Science Consulting and Immunogenicity Integrated.