08.17.22 -- Drug Development: Flexible Dosing For A Diverse Patient Population

When companies are looking to combine two or more APIs into a single fixed dose combination product — whether for the purpose of improving convenience and patient compliance, reducing manufacturing costs, repurposing proven compounds, or extending a product’s patent life — several factors require consideration. Working with a flexible outsourcing partner with a broad range of capabilities and advanced know-how can provide an advantage.

Regular assessments of a partnership’s value in terms of supply chain, operational efficiency, data analysis, and more can optimize and extend the product life cycle. This need is particularly pressing for pharma companies operating in the generics or branded over-the-counter (OTC) spaces, since extending the product life cycle depends on lowering costs in response to competition-driven price pressure.

A global biopharmaceutical company with a successful adult anti-infective product franchise was looking to create a pediatric formulation to meet U.S. FDA regulatory requirements, expand patient access to children in an appropriate dosage form and strength, and extend patent protection of its flagship product line.