As the Head of Clinical Operations at AbCellera, I am passionate about and proud to be working on clinical trials because they help to improve and save the lives of patients in need. I have more than 20 years of experience in Clinical Research. Before joining AbCellera, I spent 5 years as a Director of Clinical Operations at Merck, working in Oncology and General Medicine portfolios. Before moving to Merck, I worked as a Clinical / Sr. Clinical Project manager on the Asthma/Allergy, Cardiovascular, and HIV portfolios at Schering Canada. I completed a master’s degree in Drug Development from Université de Montréal.

Melanie Cote works as a Senior Manager, Global Regulatory Affairs at Otsuka and has been in the industry for more than 20 years. After graduating with a bachelor's degree in biochemistry, she worked for a few years in analytical development for various biotechnology companies. She later completed a DESS in drug development, focusing on CMC, and has a Master of Pharmaceutical Sciences from the Université de Montréal. In 2010, Melanie fell into the field of Regulatory Affairs and moved to the UK shortly after where she worked in European regulatory for 2 years. Back home since 2013, Melanie has focused on Canadian and Global regulatory. She is thrilled to be part of DIA Canada Annual Meeting program committee for her third year.

Andrea is a Senior Clinical Evaluator in the Office of Clinical Trials (OCT) at the Pharmaceutical Drugs Directorate at Health Canada. Andrea completed an Honours Bachelor of Science in Biochemistry and Immunology at the University of Ottawa, followed by a Masters of Science in Cancer Therapeutics at the Barts Cancer Institute in London, United Kingdom. Upon moving back to Ottawa in 2015 and prior to joining OCT in 2020, Andrea's experiences include clinical research at the Ottawa Hospital Cancer Center, clinical review at Canada's Drug Agency, and quality review at the Biologic and Radiopharmaceutical Drugs Directorate.

Audra has over 19 years of regulatory experience in the pharmaceutical industry across a broad range of activities with both small and large size pharmaceutical companies. Her experience in regulatory affairs includes activities from clinical development through marketed product/post-marketing activities. She has prepared scientific and regulatory documents for inclusion within Health Canada submissions, managing a number of New Drug Submissions through to approval. Her regulatory role has provided her the opportunity to interface directly with Health Canada for both pre-CTA and pre-NDS meetings. In recent years, Audra has focused her career on supporting small to midsize companies through their clinical development programs.

Mr. Rousselin has over 17 years of experience in drug development and regulatory writing. He holds a B.S. of Biomedical Science from Texas A&M University. His experience includes the authoring clinical and nonclinical documents in the electronic Common Technical Document (eCTD) format for global regulatory submissions. Prior to working in the regulatory space, he was an analytical and a formulation chemist. As a career scientist in drug development, he has significant experience in authoring chemistry, manufacturing, and controls (CMC) and other complex technical documents. He is a subject matter expert in various CMC aspects and pharmaceutical formulation for topical and parenteral drugs. He has served clients at Certara for 7 years.

Rachel has 14+ years of experience in regulatory operations and helping sponsors achieve their eCTD submission goals. She has led the eCTD submission publishing of a variety of application types for different regions, from small amendments to large-scale original marketing applications, as well as mentored and trained others in eCTD publishing and submission management. She has also spoken at industry conferences on topics pertinent to investigational and marketing related submissions and produced a variety of blogs, presentations, and other materials to share valuable industry insights.