Ayse Baker, PhD, MBA, FRAPS
VP of Regulatory Affairs at Almatica
Ayse Baker has over 25 years’ experience in pharmaceutical industry with focus on building and leading regulatory affairs teams worldwide. Before joining Almatica, she was the Head of Regulatory Affairs and Pharmaco-vigilance at Chugai responsible for development of novel drug products in immuno-oncology, immuno-neurology, diabetes, infectious disease and dermatology.
Previously Head of Global Regulatory Affairs in Life-Sciences segment of GE Healthcare responsible for registration and lifecycle management of all of GE’s imaging agents worldwide. Before joining GE, as a Director of Regulatory Affairs she was responsible for development diabetes drug products in Lixisenatide Franchise which led to registration of in the lixisenatide globally. Prior to joining Sanofi, Ayse held regulatory positions with increasing responsibilities at Baxter, Bayer and Hoffmann-La Roche. Her expertise includes leading scientific and regulatory strategies for registration of small molecule and biologic drug products in therapeutic areas: oncology, neurology, hematology, diagnostic imaging, diabetes and inhalation products. Ayse started her career in pharmaceutical industry at Abbott Laboratories as a research scientist responsible for research and development, regulatory filing and launch of progesterone immune assay.
Ayse Baker received a PhD in Chemistry from University of Illinois at Chicago. MBA from Lake Forest Graduate School of Management. She completed her post- doctoral fellowship at Loyola University Stritch School Medicine in Department of Hematology and Oncology. She was awarded Outstanding Young Investigator Award of Biochemistry /Biophysics for elucidating mechanism of action for light activated drugs in treatment of cancer. Ayse is active and a frequent speaker in national and international trade organizations and academic institutions. She was recognized for her contributions to the Regulatory Affairs profession by the trade organization and became a Fellow of the Regulatory Affairs Professional Society in 2016.