Penny Arnold

Background

About Penny Arnold

In 1987, I started my career in pharmaceutical research and development at Glaxo, Inc, after working as a registered nurse in the Neurosurgical Intensive Care Unit at Duke University Medical Center, and then managing the UNC Oral Surgery Faculty Practice at Chapel Hill, NC. While at Glaxo, I monitored clinical trials in multiple therapeutic areas, including cardiovascular, neurological, respiratory, gastroenterology, anesthesia, anti-infectives and dermatology. In 1989, I accepted a position as a Drug Surveillance Associate in the Drug Surveillance Department and was responsible for monitoring and reporting adverse event reports for marketed products. In 1992, I was promoted to Manager and was responsible for establishing and managing a new group, Clinical Trials Safety Review, within Drug Surveillance. This group was responsible for monitoring, analyzing and documenting adverse event data for inclusion in NDAs and other regulatory submissions to FDA. I later managed the Cardiovascular and Anesthesia team within Drug Surveillance, which was responsible for providing a comprehensive approach for monitoring the safety profile of Imitrex and remifentanil. I authored the final serious averse event safety update for the sumatriptan tablet NDA and the final safety update for sumatriptan tablet NDA. In 1998, I began monitoring clinical trials as an independent CRA consultant and have been monitoring clinical trials in all phases of development in numerous therapeutic areas. Most recently, I have monitored studies in the following therapeutic areas: • end-stage alcoholic hepatitis • chronic lymphocytic lymphoma • acute myelogenous leukemia • primary focal segmental glomerulosclerosis • immunoglobulin A nephropathy • diabetic peripheral neuropathy • Irritable Bowel Disease • Alzheimer’s Disease • Chronic anemia in patients on hemodialysis • Multiples Sclerosis • Blood replacement product for trauma patients • Hypercholesterolemia • End Stage Renal Disease From OCT2021 to JAN2020, I was a Clinical Trials Liaison at Travere Therapeutics, formerly Retrophin, Inc, and provided oversight and guidance for site CRAs, and site support for recruitment for two Phase II clinical trials in patients with primary focal segmental glomerulosclerosis and immunoglobulin A nephropathy. Most recently, I monitored a Phase study in patients with diabetic peripheral neuropathy and provided oversight to site CRAs monitoring a Phase 2a study in patients with Amyotrophic Lateral Sclerosis.