Dr. Andra Miller has joined Biologics Consulting Group as Director, Cellular and Gene Therapies in July 2000.

Dr. Miller, a molecular biologist, brings to the group 9 years of experience with the U.S. Food and Drug Administration (FDA ). As Gene Therapy Group Leader and Expert Microbiologist in the FDA's Division of Cellular and Gene Therapies, CBER, Dr. Miller has been very influential in the development of policy in the cell and gene therapy areas. She had a major role in writing the 1998 Guidance for Industry for Somatic Cell and Gene Therapies and in developing new policy on testing for replication competent retrovirus. She also served as CBER lead on development of proposed regulations on disclosure of gene therapy and xenotransplantation products. Additionally, Dr. Miller's experience with the FDA includes serving as technical contact for recent inspectional activities at gene therapy investigational sites.

Dr. Miller has actively participated in national and international meetings in the field of gene therapy where she frequently represented the FDA as an invited speaker. She has planned and moderated regulatory and scientific sessions at the FDA Gene Therapy Conferences and most recently at the American Society of Gene Therapy annual meeting. Her earlier experience included research into control of gene expression during development using transgenic mice and Xenopus models at NIH and FDA.

For the past several years Dr. Miller has served as the FDA Alternate Representative to the Recombinant DNA Advisory Committee (RAC) and CBER Liaison to the Office of Biotechnology Activities (OBA), NIH. In this capacity she coordinated activities between the two agencies, was responsible for discussion of FDA policy issues at RAC meetings and performed analysis of adverse event reporting to FDA and the RAC. Through these activities Dr. Miller has acquired in-depth expertise in the RAC process and requirements. In addition, she has also participated in activities with the National Gene Vector Labs and is a member of the USP Advisory Panel on Gene and Cell Therapies which recently drafted a general informational chapter published in the Pharmacopeial Forum, Previews.

Dr. Miller's recognized expertise in the regulation of cell and gene therapeutic products, her extensive experience and active participation in the gene therapy community and her acknowledged understanding of the biologics development process will significantly enhance the expertise and service provided by the Biologics Consulting Group. Dr. Miller can be contacted by phone or fax at the numbers given below or by Email through the BCG web site.

View Dr. Miller's Curriculum Vitae...

Page Updated: August 27, 2007