| Name | Title | Contact Details |
|---|---|---|
Tim Saunders |
Head Of Information Technology | Profile |
Diane Ireland |
Head of Facilities, IT and Operations | Profile |
Momenta is a biotechnology company with a product pipeline of both complex mixture generic and novel drugs. Our complex mixture generics and follow-on biologics effort is focused on building a thorough understanding of the structure-process-activity of complex mixture drugs to develop generic versions of marketed products. While we use a similar analytical and development approach across all of our product candidates, we tailor that approach for each specific product candidate. Our first objective is to apply our core analytical technology to thoroughly characterize the structure of the marketed product. By defining the chemical composition of multiple batches of a marketed product, we are able to develop an equivalence window which captures the inherent variability of the innovator`s manufacturing process. Using this information, we then build an extensive understanding of the structure-process relationship to design and control our manufacturing process to manufacture reproducibly an equivalent version of the marketed product. Where necessary, and as required by the U.S. Food and Drug Administration, or FDA, we will supplement an application with additional supportive structure-activity data (e.g., immunogenicity, pharmacodynamics). Our goal is to obtain FDA approval for and commercialize generic or follow-on versions of complex mixture products, thereby providing high quality, safe and affordable medicines to patients in need.
Rocky Mountain CARES – HIV / AIDS Advocacy Group – Denver, Colorado
Secura Bio™ is a pharmaceutical company committed to giving patients access to innovative therapies. Headquartered in Henderson, Nevada, Secura Bio™ has operations in the U.S. and Offices in San Diego.
We are a medical group of physicians and health professionals that specialize in gastrointestinal disorders, nutrition and digestive health. Our offices are conveniently located throughout South Florida, Orlando and Fort Myers.
Bloomios is a U.S. based leading hemp and nutraceutical GMP manufacturer specializing in product development, formulation, packaging, and design. They provide white label and private label services for businesses looking to expand into the hemp industry.