| Name | Title | Contact Details |
|---|---|---|
Vickie Mccormick |
VP, North America Commercial Health Care Compliance and CIA Operations | Profile |
Bethany Paxson |
Vice President, North America Regulatory Affairs Oncology and Diagnostics | 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.
Charleston Laboratories Inc is a Charleston, SC-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
OutcomesMTM is a West Des Moines, IA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Rodeo Dental & Orthodontics has 100+ dental experts from several specialties! Your one-stop shopping in STYLE for all your oral health needs.
physIQ is the leader in digital medicine, dedicated to generating unprecedented health insight using continuous wearable biosensor data and advanced analytics. Its industry-leading, enterprise-ready cloud platform continuously collects and processes data from wearable biosensor using a deep portfolio of FDA-cleared analytics. The company has published one of the most rigorous clinical studies to date in digital medicine and are pioneers in developing, validating, and achieving regulatory approval of Artificial Intelligence-based analytics. With applications in both clinical trial support and healthcare, physIQ is transforming continuous physiological data into insight for health systems, payers, and pharmaceutical companies