Scientific Advisory Board
Joy Cavagnaro, PhD, DABT, Fellow ATS, RAC, RAPS Fellow
President of Access BIO
Dr. Cavagnaro consults on preclinical development and regulatory strategies for drug, biologics and device combinations. Her career spans academia, the CRO and biotechnology industries and government. During her tenure at CBER/FDA she wasappointed to the SBRS and served as FDA’s safety topic lead and rapporteur for “ICH S6.” She was the first to advocate the “case-by-case” science based approach for preclinical safety evaluation, which is consistent with traditional principles but embraces new practices, is questions-based, data driven and targeted based on product attributes to obtain maximum information with judicious animal use. Prior to joining FDA, Dr. Cavagnaro was principal study director for biotechnology products at Covance. She is Past Chair of RAPS and the National Capital Area Chapter of SOT. In 2011 she received SOT’s Biotechnology Specialty Section first Career Achievement Award. She is
Founder, Past Chair and current ex officio member of the leadership committee of BioSafe, an expert preclinical science committee within BIO. She is past North American Chair of DIA’s Biotech Community, past Chair of the Clinical and Regulatory Affairs Committee and Translational Science & Product Development Committee of the ASGCT. She was a member of the Scientific Advisory Committee on Alternative Toxicological Methods and is currently an advisor and member of the Grants Working Group of the California Institute of Regenerative Medicine. Dr. Cavagnaro is currently a Chair of Advarra, an independent IRB. She serves on multiple SAB’s and consults and lectures internationally on translation and risk assessment of novel therapies. She has co-authored numerous white papers and chapters related to various aspects of preclinical safety assessment. The book she edited “Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials” published by John Wiley & Sons, NJ, 2008 is commonly referred to as the “BioBible”.
Bruce L. Levine, Ph.D.
Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania
Dr. Levine received a B.A. in Biology from the University of Pennsylvania and a Ph.D. in Immunology and Infectious Diseases from the Johns Hopkins University. The CVPF develops and tests novel cell and gene therapies in single center and multi-center clinical trials in patients with hematologic malignancies, solid tumors, HIV infection, and genetic disease. Twenty clean rooms and Quality Control laboratories staffed by 60 clinical laboratory scientists and regulatory professionals support the mission. Several CVPF trials have been first-in-human trials, including the first use of a lentiviral vector, the first infusions of zinc finger nuclease genome-modified cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 2700 cellular products administered to >1000 patients in clinical trials since 1996. Through these technologies, personalized and enhanced immunity has been engineered. T lymphocytes from HIV+ subjects have been rendered resistant to HIV infection and reinfused. T lymphocytes from cancer patients have been redirected with chimeric antigen receptors to hunt and destroy their malignancies, an investigational therapy that received the first Breakthrough Designation from the FDA for an academic institution and is currently in commercial development. Dr. Levine is co-inventor on 20 issued US patents and co-author of >120 publications.
Andra Miller, Ph.D.
President of VectorCell Bio Consulting
Dr. Miller provides regulatory consulting and product development strategy to early and late phase companies and academic investigators worldwide who are targeting the US market in the fields of gene therapy, cell therapy, and other advanced/regenerative medicines. Until November 2016, she 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.
Gary C. du Moulin, Ph.D., M.P.H.
Adjunct Associate Professor of Regulatory Affairs, Massachusetts College of Pharmacy and Health Sciences University
Previously, Dr. du Moulin served as senior director of Quality Aseptic Control for Genzyme (A Sanofi Company) where he participates in the development and execution of robust quality systems for Genzyme’s products. Dr. du Moulin joined Genzyme in 1995 after working for six years developing quality systems for cellular therapies for the treatment of renal cell carcinoma. Prior to his industrial experience, he spent 15 years on the faculty of Harvard Medical School in the Department of Anesthesia at Beth Israel Hospital. He has more than 150 publications in the areas of microbiology, epidemiology, and the regulation and quality control of living cells as a therapeutic modality. Dr. du Moulin received his B.S. in 1969 from Norwich University, an M.S. degree from Northeastern University, and M.P.H. and Ph.D. degrees from Boston University. He is retired from the U.S. Army Reserve at the rank of Colonel after 38 years of service. Dr. du Moulin currently serves on U.S. Pharmacopoeia’s expert committee for Biological Analysis and formally on the Gene Therapy, Cell Therapy, and Tissue Engineering Expert Committee and chaired the ad hoc advisory panel for fetal bovine serum. He serves on the editorial board of Regenerative Medicine and is RAC certified and past Chairman of the Editorial Board of the Regulatory Affairs Professionals Society Magazine, RAPS Focus and was appointed to the Grants Review Working Group of the California Institute for Regenerative Medicine.
Gabor Veres Ph.D.
Vice President Preclinical Research, bluebirdbio Inc.
Dr Veres joined the bluebird bio team in July 2010 as vice president of Pre-clinical Research and Development. He has 20 years of experience in the development of cell and gene therapy products for the treatment of Severe Genetic Disorders, HIV and cancer. He initiated and coordinated multiple research programs including: viral gene delivery to correct genetic and acquired diseases, cancer vaccines, oncolytic viruses, Led several projects from pre-clinical research to clinical development. Prior to joining bluebird bio, he served as vice president of Research and Development at Applied Genetic Technologies Corporation, a gene therapy company focusing on ophthalmology and for the treatment for Alpha One Antitrypsin Deficiency. Dr. Veres has managed biotechnology companies from discovery through late stage development, including cell and gene therapy platform technology. He worked at Sangamo as a senior director, at Genthon in France as Director of Research, senior director at CellGenesys Inc. and director of research at Novartis/Systemix.