| Name | Title | Contact Details |
|---|---|---|
Anavelys Ortiz-Suarez |
Associate General Counsel | Profile |
Anavelys Ortiz--Suarez |
Associate General Counsel | 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.
Dragonfly is a company that specializes in the production and distribution of cannabis products in Michigan. They offer a wide range of products including prerolls, infused prerolls, vape cartridges, and High Tide.
Informed RX is a Lisle, IL-based company in the Healthcare, Pharmaceuticals, & Biotech sector.
IPS-Integrated Project Services, LLC is a global leader in developing innovative solutions for the consulting, architecture, engineering, project controls, construction management, and CQV of technically complex facilities worldwide. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends, and regulatory environment to successfully deliver capital projects and improve operations.