Mike Orr, PhD, DABT

CEO, Orr Nonclinical Consulting LLC, North Potomac, MD, USA

Senior Advisor, Non-clinical Development, Isha Therapeutics LLC

Board-certified toxicologist, 10 years of US FDA pharmacology and toxicology regulatory experience and greater than 19 years of experience in directing high priority public health programs and complex research initiatives. For 6 years in CDER, Dr. Orr gained extensive pharmacology and toxicology regulatory experience with a particular focus in oncology encompassing both biopharmaceuticals and small molecule drugs.

He has pharmacology/toxicology experience with CDER submissions that include Pre-INDs, INDs, BLAs, sNDA, NDAs and meeting packages including Pre-IND, EOP1, EOPII, Pre-NDA/Pre-BLA, Annual Reports, Safety Reports, FDA advisory committee meetings, and PMC submissions.

Dr. Orr developed specific review expertise in new cytokines, monoclonal antibodies, fusion proteins, antibody-drug conjugates, and small molecules. Dr. Orr has experience with estimating the maximum safe starting dose for first-in-human clinical trials with new molecular entities, MABEL approach, dose-escalation, pharmacology, safety pharmacology and general toxicology. In addition, Dr. Orr acquired additional regulatory experience in the use of genomic data and biomarkers in the US FDA regulatory environment as a genomic reviewer. For 4 years in CTP, Dr. Orr supervised and participated in development of product standards, guidance documents, and rules for tobacco products including ENDS (Electronic Nicotine Delivery Systems). Prior to joining the US FDA and as the Scientific Director of Toxicogenomics, Dr. Orr supervised a team of scientists involved with designing and analyzing toxicogenomic studies from rat, dog, primary rat hepatocytes, and human hepatocytes. He has experience analyzing Affymetrix microarray data in conjunction with classical toxicology endpoints such as clinical chemistry and histopathology information. Dr. Orr has experience with reviewing and interpreting toxicogenomic information in the context of drug development programs.