| Name | Title | Contact Details |
|---|---|---|
Luke Gordon |
Vice President of Network Development | Profile |
Fastrack Pharmaceuticals is a San Diego, CA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
Developing high-value, global products for patients with significant unmet medical needs in niche indications
Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) with a passion for solving problems. Pii`s Hunt Valley, Maryland, campus includes 70 manufacturing suites with four integrated aseptic filling lines. We offer contract analytical development and support formulation and manufacturing of oral solid dosage forms. Our professionals have extensive experience with small and large molecule compounds, developing and manufacturing complex parenteral drugs, extended-release formulations, non-aqueous injectable drug products, lyophilization, and DEA scheduled drugs.
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.