Pre-clinical
Cardiome’s technology focus is on modulating ion channels, which are specialized cellular proteins that gate the movement of ions such as Na+, K+, and Ca++ across the cell membrane. These ions channels play a critical role in controlling essential functions ranging from the contraction of muscles and the discharge of nerves, to the secretion from glands, and even responses to foreign bodies and inflammation. The wide variety of such proteins provides a broad area for the development of therapeutics useful in a large number of human disorders.
Cardiome’s preclinical research division provides the full range of preclinical operations including drug discovery and target validation, bioanalytical methods development and assays, and safety pharmacology and toxicology. Our laboratories are staffed with highly trained and skilled scientists having expertise in medicinal and synthetic chemistry, molecular biology, electrophysiology, and pharmacology.
Clinical Development
Cardiome has fully-integrated strategic and operational capabilities that enables the progression of programs rapidly and cost effectively through clinical development to marketing submissions on a global basis. These in-house capabilities include clinical trial strategy, project management, safety and medical monitoring, data management, biostatistics, programming, medical writing and quality control/assurance. We have completed 26 clinical trials from phase 1 to 3, and have enrolled over 3000 patients. Cardiome has managed an international registration trial on behalf of its partner and has global experience of regulatory submissions in US, Canada, European Union, Eastern Europe, South Africa, Australia and Asia.
Regulatory Affairs
Cardiome has global experience with Agency communication and regulatory submissions in the US, Canada, European Union, Eastern Europe, South Africa, Australia, and Asia. The team has regulatory experience of bringing new drugs to market in a variety of disease areas. The group is focused on establishing successful and productive relationships with regulatory Agencies and providing input into drug development and risk management planning based on current regulatory policy and guidelines. On behalf of our pharma partners, we have completed a marketing application in the CTD format along with over 200 CTAs, INDs, supplements, annual reports and related submissions.
Commercial
Cardiome’s commercial team works with researchers, clinicians, industry leaders, patients, and partners to evaluate and provide commercial input into drug development programs and new therapeutic targets. Cardiome is dedicated to taking a product focused approach to drug development by creating cross-functional teams and ensuring that the commercial group is involved with all programs and through all stages of development. The commercial team is led by experienced professionals who have successfully brought new drugs to global markets for the treatment of diseases with high unmet needs. This group also works closely with the business development group to identify and evaluate new business and partnership opportunities.