All drugs approved in the US marketplace went through an extensive, multi- million dollars, multi-year journey before being available to patients. In order to bring a new drug to the market place requires extensive resources, technical acumen, and an unbendable commitment to the goal. CDMOs are alongside pharma companies helping them navigate the process and mitigate risk. By choosing the right partnerships, you can give your drug production the competitive advantage it brings to the marketplace. Listen to Soojin Han, Director of the CLD group at Samsung Biologics, as she talks about what is the CDMO partnership and how Samsung Biologics can help many scientists for drug development to speed up the drug product to the marketplace and support many people's health life.
Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.