Dr. Jennifer Gudeman, Vice President, Medical and Clinical Affairs at Avadel Pharmaceuticals discusses new clinical data from the pivotal phase 3 REST-ON clinical trial that was presented at the SLEEP 2021 Annual Meeting. The investigational therapy, FT218, for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy is currently under review at the FDA with a PDUFA target date of October 15, 2021. She also talks about the current treatment landscape and the unmet need among patients for a differentiated treatment option.
Dr. Jennifer Gudeman was appointed Vice President, Medical and Clinical Affairs in December 2020. In 2017, Dr. Gudeman received the Healthcare Businesswomen’s “Rising Star” award. During her career, she has led or contributed to six commercial product launches and three clinical development programs, as well as led interactions with medical societies and patient advocacy organizations to help ensure that commercial medications fulfill their clinically proven therapeutic benefits to patients and providers. Dr Gudeman has published numerous peer-reviewed papers and provided domestic and international presentations on partnership with industry for drug development in high-risk pregnancies. Prior to joining Avadel, Dr. Gudeman was Vice President, Medical Affairs at AMAG Pharmaceuticals, overseeing a team of medical science liaisons and scientific communications. Prior to her time at AMAG Pharmaceuticals, she was Director of Medical Affairs at Lumara Health. Additionally, she began her industry career at Mallinckrodt Pharmaceuticals. Dr. Gudeman graduated summa cum laude with a bachelor’s degree in pharmacy and magna cum laude with a doctorate in pharmacy from St. Louis College of Pharmacy in 1999 and 2000, respectively.
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