Name | Title | Contact Details |
---|---|---|
Alban Ivezaj |
Director of Legal and Compliance | Profile |
At Shire, we enable people with life altering conditions to lead better lives. We focus on developing and delivering innovative treatments for patients with rare diseases and other specialty conditions.To realize our aspiration to become a leading global biotech, our efforts are concentrated on four key strategic drivers: growth, innovation, efficiency, and people. Our priorities are to drive optimal performance of our existing products, increase patient access to these medicines, and to build our pipeline through research and development and partnerships in order to deliver new medicines to patients.
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.
Great Lakes Drug Development is a Brighton, MI-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Ocularis Pharma, Inc. is a Riverside, IL-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
Aridis is a privately held biotechnology company located in San Jose, CA, USA which is focused on infectious diseases. Aridis has a strong portfolio of anti-infective product candidates, a human monoclonal antibody discovery platform technology, and best-in-class formulation technologies available for partnering. Our product portfolio comprises two monoclonal antibodies currently at Phase 2 clinical testing in patients, and two additional anti-infective drug candidates entering the IND development stage. Aridis’ suite of anti-infective monoclonal antibodies offers opportunities to profoundly impact current approaches to infection control. Aridis has raised over $20m in grant funding from leading institutions such as the National Institutes of Health, US Dept. of Defense, US Dept. of Health & Human Services’ BARDA, USAID, PATH/Gates Foundations, and Regional Centers of Excellence.