ANN ARBOR, Mich.--(BUSINESS WIRE)--Millendo Therapeutics, Inc., a company developing novel therapies for endocrine diseases caused by hormone dysregulation, today announced the appointment of John Kirk, Sc.D. as Vice President of Regulatory Affairs, Naidong Ye, Ph.D. as Vice President of Chemistry, Manufacturing and Controls (CMC), and Jennifer Minai-Azary as Vice President of Finance. Dr. Kirk will be responsible for the development and implementation of the Company’s regulatory strategies including submissions, quality and registrations, and joins Millendo from Amicus Therapeutics. Dr. Ye will assume management and leadership of all CMC-related activities, including pharmaceutical manufacturing and product development, and joins Millendo from AstraZeneca Pharmaceuticals. Ms. Minai-Azary was previously Senior Director of Finance and Administration at Millendo; in her new role, she will be responsible for the Company’s finance functions, including controllership and treasury.
“John, Naidong and Jen are highly skilled and motivated individuals who will provide significant value to our organization as we continue to build our portfolio of potentially first-in-class product candidates for endocrine diseases,” said Julia C. Owens, Ph.D., President and Chief Executive Officer of Millendo. “Their collective expertise will be instrumental to the advancement of our programs, and we look forward to their contributions as we progress in our mission to improve the quality of life for patients who have limited or no approved treatment options.”
Dr. Kirk most recently served as Vice President of Regulatory Affairs and Quality Assurance at Amicus Therapeutics, where he was responsible for the preparation and submission of the marketing authorization application for GalafoldTM, an orphan product indicated for the treatment of patients with Fabry disease. Prior to Amicus, Dr. Kirk served as Executive Director of Regulatory Affairs at Aegerion Pharmaceuticals, where he was responsible for all regulatory activities in the metabolic disease therapeutic area. Previously, Dr. Kirk held positions of increasing responsibility in regulatory affairs within the Parke-Davis Pharmaceuticals and Pfizer organizations, where he was directly involved in original marketing applications for successful branded products including Accupril®, Accuretic®, Rezulin® and Lipitor®. Early in his career, Dr. Kirk served as Senior Manager of Regulatory Affairs at Cetus-Ben Venue Therapeutics and Manager of Scientific Affairs at Eurand America. Dr. Kirk holds a Sc.D. in outcomes research from the Tulane University School of Public Health and Tropical Medicine, Department of Health Systems Management. He earned his M.S. in chemistry and B.S. in biological sciences from Wright State University.
Dr. Ye most recently served as Senior Director, Head of CMC Operations at AstraZeneca Pharmaceuticals, where he led CMC for all small molecule development projects in Neuroscience Innovative Medicines (NS iMed). Prior to AstraZeneca, Dr. Ye was Chief Technology Officer at Dongguan Jinmeiji Pharmaceutical Co. and Guangzhou Techkeen Pharmaceutical Co., where he led company R&D. Previously, he served as Senior Director of CMC Operations at Pharmos Corporation and Director of CMC & DMPK at Vela Pharmaceuticals, Inc., which was purchased by Pharmos. Prior to Vela, Dr. Ye was a Senior Scientist, first in Analytical Chemistry and then in CMC Operations, at ViroPharma Incorporated, where he initially created and grew the analytical chemistry group and brought the laboratory into cGMP compliance. Early in his career, Dr. Ye served as a Senior Research Investigator in Analytical/Pharmaceutical Sciences at Nycomed, Inc. Dr. Ye holds a Ph.D. in chemistry from The Ohio State University and completed postdoctoral training at the University of Kansas. He earned his B.S. in chemistry from Zhongshan University in Guangzhou, China.
Ms. Minai-Azary joined Millendo in 2013 and most recently served as Senior Director of Finance and Administration. Prior to joining Millendo, Ms. Minai-Azary was Director of Technical Accounting at PAREXEL International, where she was a key member of the Corporate Accounting group responsible for worldwide consolidation, SEC reporting, SOX compliance, and overseeing the external audit. Previously, Ms. Minai-Azary held positions of increasing responsibility at Ernst & Young LLP, where she managed financial statement audits for publicly and privately held clients within the consumer, industrial products and retail markets. Ms. Minai-Azary holds a Masters of Accounting and a B.B.A. from the University of Michigan and is a Certified Public Accountant.
About Millendo Therapeutics, Inc.
Millendo Therapeutics is focused on developing a portfolio of disease-modifying treatments for endocrine diseases caused by hormone dysregulation. Our product candidates seek to improve the quality of life for patients with orphan and specialty diseases with limited or no approved treatment options. Our clinical programs are designed to address:
- Polycystic Ovary Syndrome (PCOS) – the most common endocrine disease in women
- Congenital Adrenal Hyperplasia (CAH) – a recessive genetic defect of cortisol synthesis
- Endogenous Cushing’s Syndrome (CS) – a condition resulting from chronic cortisol excess
- Adrenocortical Carcinoma (ACC) – a rare endocrine malignancy of the adrenal cortex
Our experienced team is committed to bringing these first-in-class
therapies to market.