Dr. Marcie Wood is the Director of ToxStrategies’ Biopharmaceutical/Pharmaceutical/Medical Device Practice, and works with the Center for 21st Century Toxicology from Houston, Texas. She is a toxicologist with more than 12 years of experience in drug discovery and development, including 7 years at the U.S. Food and Drug Administration. She has nonclinical experience with biologic, biosimilar, and small-molecule products for a wide variety of pulmonary, allergy, rheumatology, oncology, and ophthalmology indications, as well as multiple routes of administration (e.g., inhalation, oral, intravenous, subcutaneous, intra-articular, intranasal, and dermal).
In the Center for Drug Evaluation and Research (CDER) at FDA, Dr. Wood served as both pharmacology/ toxicology supervisor and reviewer in the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). As a supervisor, she was responsible for providing leadership and guidance to the Division’s team of pharmacology/ toxicology reviewers with respect to the evaluation of nonclinical data submitted in pre-Investigational New Drug Applications (INDs), INDs, and New Drug Applications (NDAs)/Biologics License Applications (BLAs), ensuring that the regulatory recommendations of the team were scientifically sound and in line with applicable guidance documents. More recently, Dr. Wood was responsible for implementing Pregnancy and Lactation Labeling Rule (PLLR) changes in approved product labels. She also evaluated and presented recommendations on challenging scientific and regulatory issues to CDER senior management, including nonclinical hold deficiencies, complete responses to clinical holds, and other issues with the potential to influence clinical development; represented the Division’s nonclinical expertise at internal, industry, and Advisory Committee (AC) meetings; and provided recommendations to the Executive Carcinogenicity Assessment Committee (ECAC) on dose selection for rodent carcinogenicity studies and carcinogenicity study outcomes. Through attendance at Pharmacology and Toxicology Coordinating Committee (PTCC) meetings and interactions with other review divisions within CDER.
As a reviewer, Dr. Wood was responsible for reviewing nonclinical data packages (i.e., pharmacology, pharmacokinetics, and toxicology) of biologic, biosimilar, and small-molecule products submitted in support of the safety of pulmonary, allergy, and rheumatology indications (e.g., allergic rhinitis, asthma, chronic obstructive pulmonary disease, cystic fibrosis, idiopathic pulmonary fibrosis, rheumatoid arthritis, lupus, etc.). She prepared comprehensive written reports of nonclinical data, including inhalation toxicology data, and provided regulatory conclusions and recommendations for preINDs, INDs, and NDAs/BLAs, including recommendations for approved product labeling. Dr. Wood also worked on multidisciplinary teams, addressed cross-discipline review issues (e.g., excipients, impurities, and leachables and extractables), and participated in meetings with industry representatives to provide regulatory advice and guidance on nonclinical drug development programs.
Dr. Wood spoke at FDA educational courses on nonclinical considerations for the review of inhalation drug products and participated in the Oligonucleotide Subcommittee of the PTCC. As a result of her time at FDA and experience as both a nonclinical supervisor and reviewer, Dr. Wood has a comprehensive understanding of current regulatory requirements and Agency expectations for nonclinical drug development.
Prior to her time at the FDA, Dr. Wood was a research scientist in the areas of neurodegenerative disorders and addiction at the Roskamp Institute, in Sarasota, Florida, for over 4 years.