Connect With Us
Describe your need or issue with us and a Kinexum representative will be in touch with you shortly to discuss how we might be able to assist you.
Areas of expertise : Medical Affairs strategies to launch therapeutics for diseases from those affecting hundreds (lipodystrophy) to that which affects millions (obesity and diabetes). Regulatory strategy, operational planning and writing in numerous areas, including orphan drug designation, PMA, 510(k), and clinical evaluation report.
Elaine Chiquette has over 20 years’ experience in Medical and Regulatory Affairs within the pharmaceutical, biotechnology, and medical device industries.
Dr. Chiquette was involved in developing medical strategies for numerous first-in-class launches including orlistat, exenatide the first GLP-1 agonist, the amylin analog pramlintide, the leptin analog metreleptin, the first gut bariatric device the endobarrier, and the hydrogel device Plenity, . Through the years, holding leadership positions at Hoffman La Roche, Amylin Pharmaceuticals, Aegerion, GI Dynamics and Gelesis, Dr. Chiquette has built strong expertise in regulatory affairs for pharmaceuticals, biologics, and devices. She has authored Orphan drug designations for FDA and EMEA submissions. She has developed strategies and written PMAs, 510(k) for medical devices that were successfully approved in both United States and Europe. More recently she led the strategy and execution of a Class III medical device registration to the National Medical Products Administration (NMPA) in China.
Prior to launching her career in industry, Dr. Chiquette completed her pharmacy degree at Laval University in Quebec, a Pharm.D. At University of Texas Health Science Center at San Antonio, followed by a post-doctorate fellowship in Epidemiology. Dr. Chiquette served as Deputy Director for the San Antonio Evidence-Based Practice Center program for the US government Agency for Healthcare Research and Quality and authored several highly regarded meta-analysis publications. In that capacity, Dr. Chiquette also led the supportive evidence report for the National Institute of Health Obesity Guidelines in 1998 and co-authored the associated publications. Since then, her career, publications and interest have been mostly focused on the development of a wide variety of therapeutic options for cardiometabolic diseases.