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Regernon Pharmaceuticals Inc. is a Tarrytown, NY-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
Vical Incorporated is a San Diego, CA-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
Velocity Clinical Research, headquartered in Durham, NC, is a leading integrated site organization for clinical trials, offering dedicated site capabilities to help biopharmaceutical and contract research organization customers find the right patients for their studies. The company has 18 sites across 12 US States. We place the care of the patient at the heart of everything we do. With over 35 years of experience running sites and more than 5500 studies completed, Velocity has refined its patient recruitment strategies while maintaining a focus on delivering timely and reliable data quality.
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.
Sumitomo Pharma is a pharmaceutical company that develops innovative pharmaceuticals and healthcare solutions for the betterment of healthcare and fuller lives of people worldwide.