Manage episode 292545053 series 2926147
Dr. Jennifer Gudeman is the Vice President, Medical and Clinical Affairs at Avadel Pharmaceuticals. In this episode, Dr. Gudeman and Claire discuss how Avadel Pharmaceuticals is seeking FDA approval for a once-nightly form of sodium oxybate (FT218) for the treatment of EDS and cataplexy in people with narcolepsy.
Dr. Jennifer Gudeman was appointed Vice President, Medical and Clinical Affairs at Avadel in December 2020. Avadel is a global biopharmaceutical company committed to improving the standard of care for people with narcolepsy. Dr. Gudeman and her team are focused on publications of primary and secondary data from the phase 3 REST-ON trial of investigational once-nightly FT218 and building out the medical affairs programs. They are also leading an ongoing open-label extension clinical study, called Restore, to evaluate the long-term safety and tolerability of investigational once-nightly FT218.
Dr. Gudeman has published numerous peer-reviewed papers and provided domestic and international presentations on partnership with industry for drug development. 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. Prior to joining Avadel, Dr. Gudeman was Vice President, Medical Affairs at AMAG Pharmaceuticals, overseeing a team of medical science liaisons and scientific communications. 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.
To find out more information about Avadel’s Restore Study please go here.
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