Gene and cell therapy regulatory and CMC expert. Until November 2016, Andra was the Director of Cell and Gene Therapies at Biologics Consulting Group where she provided consultation for the development of regulatory strategies to facilitate rapid development of cell, gene and regenerative therapies using a science based approach. Additionally, she supported efforts for CMC submission, interpretation of FDA and NIH/RAC guidelines, pre-IND, IND and BLA preparation, phase I, II and III product development strategies and assessment of cGMP, cGTP and quality system compliance.
From 1993-2000 Dr. Miller was an Expert Microbiologist and Gene Therapy Group Leader in the Division of Cellular and Gene Therapies at the Center for Biologics Evaluation and Research for the FDA where she was responsible for IND review, policy issues, and development of industry guidance and regulation for cellular and gene therapies and related products. Dr. Miller’s experience includes cell and stem cell products (including embryonic and induced pluripotent stem cells), viral and non-viral vectors, combination products, tissue products, ex vivo modified cells such as CAR-T cells and review of product jurisdiction issues.