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DUBLIN, Ireland, Aug. 01, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218 for narcolepsy, today announced the appointments of Courtney Wells as Vice-President, Clinical Operations and David Seiden, MD, FAASM as Senior Medical Director.
“An important aspect of our focus on advancing the development of FT218 for narcolepsy is building a clinical and medical team that can prepare a solid clinical data package to gain regulatory approval and help us position the product with differentiated data to drive its future success,” said Greg Divis, Chief Executive Officer. “Appointing Dr. Jordan Dubow as our chief medical officer in April was the first step in that process. The additions of Courtney and David strengthen our clinical development and medical affairs capabilities and give us the team depth needed to finish the REST-ON study and file our new drug application for FT218.”
As Vice-President Clinical Operations, Ms. Wells will lead all of Avadel’s clinical operations activities for FT218, including oversight of our Phase 3 REST-ON study. She joins Avadel from Levo Therapeutics, where she served as Vice President Clinical Operations, and was a key contributor in developing and overseeing clinical studies for this rare disease company. Previously, she was Vice President Clinical Operations at AveXis, Inc., where she directed and oversaw the Company’s clinical research initiatives for the first gene therapy product approved in neurology by the FDA. Prior to joining AveXis, Ms. Wells was a Senior Program Manager at Marathon Pharmaceuticals, where she led two clinical programs including planning, oversight, and execution of all compound-related clinical studies from protocol writing through site identification/feasibility, recruitment and enrollment completion, and generation of clinical study reports. Additionally, she has held clinical research and operations positions at Abbott, PPD, Novartis, Abraxis Bioscience, Sanofi and Astellas Pharma. She holds a Bachelor of Science in Biochemistry and Molecular Biology from the University of Arizona. Ms. Wells has worked on multiple successful new drug applications in her career as well as built out multiple clinical operations departments.
As Senior Medical Director, Dr. Seiden, a board-certified neurologist/sleep specialist and recognized expert in sleep medicine, will oversee clinical trials and lead all Medical Affairs and publication-related efforts related to Avadel’s lead asset, FT218. He has more than 20 years of experience in Neurology and Sleep Medicine and has been a Principal Investigator and pharmaceutical consultant for over 100 sleep disorder clinical trials. Prior to joining Avadel, he served as Senior Medical Director, CNS Neurology at Syneos Health and a Medical Director for Baptist Health Sleep Centers of South Florida. In addition to Dr. Seiden’s previous patient care responsibilities, he served as Principal Investigator at Research Centers of America and Broward Research Group, clinical drug development organizations, where he was responsible for evaluating new therapies for insomnia, hypersomnia, sleep apnea, restless leg syndrome, Alzheimer’s disease, Parkinson’s disease, peripheral neuropathy, fibromyalgia, and migraine. Dr. Seiden has published numerous manuscripts in peer-reviewed medical journals and is a regular presenter and lecturer at national meetings. He holds a Medical Degree from the Georgetown University School of Medicine and trained at Columbia University-Neurological Institute of New York.
About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a branded specialty pharmaceutical company. The Company’s primary focus is on the development and potential FDA approval for FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, Avadel markets three sterile injectable drugs used in the hospital setting, which were developed under the Company’s “unapproved marketed drug” (UMD) program. Avadel is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France. For more information, please visit www.avadel.com.
|Contacts:||Michael F. Kanan|
|Chief Financial Officer|
|Phone: (636) 449-1844|
|Phone: (212) 213-0006|