Shannon has served as our Vice President of Regulatory Affairs and Quality since 2018. Shannon has over 20 years of research and drug development experience with over 15 years as a leader in regulatory affairs. Shannon began her career through a drug development fellowship with Cato Research, a specialty contract research organization, and then transitioned into medical writing and regulatory affairs specializing in neurology and oncology product development from nonclinical studies through marketing approval. In 2010, Shannon moved to Pearl Therapeutics to focus on inhaled respiratory drug products, drug-device combination products, and product development through the US 505(b)(2) approval pathway. In addition to her regulatory leadership at Pearl, Shannon provided key inputs to Pearl’s nonclinical and clinical programs. Pearl Therapeutics received the FierceBiotech 2011 Fierce 15 award and was acquired by AstraZeneca in 2013 for $1.15 billion. Shannon has led global regulatory strategy programs including regulatory health authority interactions and approval of multiple new drug applications, including most recently approvals of Bevespi Aerosphere® and Breztri®. Shannon received a B.S. in biology from Duke University and holds a PhD in pharmacology from the University of North Carolina at Chapel Hill.
Mic Iwashima
Mic was intimately involved in founding and spinning out Satsuma from Shin Nippon Biomedical Laboratories, and he has served as Vice President & Head of Operations since then. Mic has more than 15 years of experience in the field of nasal drug delivery and was involved in developing the technologies incorporated in Satsuma’s lead product candidate, STS101, as well as in preclinical development, early clinical evaluation and CMC development of multiple nasal-route, drug-device combination product candidates. Prior to joining Satsuma, Mic served in a variety of management roles at Shin Nippon Biomedical Laboratories, encompassing operations, product development, quality, regulatory affairs, business development and intellectual property management. Mic received a B.S.E. degree in engineering from North Carolina State University, where he also did research in the area of computational fluid dynamics of nasal airflow.
Robert Schultz
Rob joined Satsuma in 2017 and currently serves as our Senior Vice President and Head of Chemistry, Manufacturing, and Controls (CMC). He has over 32 years of drug development experience, focused primarily on the CMC development of orally inhaled products, including VENTOLIN® inhaler and ADVAIR® metered dose inhaler (MDI) products. Rob began his career developing MDIs at Muro Pharmaceuticals (acquired by ASTA Medica). He then joined GlaxoSmithKline, followed by KOS Pharmaceuticals (acquired by Abbott). In these companies, he led CMC development initiatives for multiple inhalation products, including ADVAIR®, Serevent®, Flovent®, Ventolin®, Azmacort® and an insulin MDI product, while advancing into roles of increasing responsibility. Prior to joining Satsuma Pharmaceuticals, Rob was an early member of the senior leadership team at Pearl Therapeutics (acquired by AstraZeneca), where he led CMC and global project teams developing Pearl’s MDI products, including Bevespi Aerosphere® and Pearl’s triple combination product Breztri®. Rob received a B.S. degree in Biochemistry from Dartmouth College.