Remove Clinical Development Remove Clinical Supply Remove Drug Development Remove International
article thumbnail

How to Optimize Drug Development by Combining FSO and FSP Models

PPD

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Often working directly within client’s systems and SOPs.

article thumbnail

A Biotech Midsummer’s Madness

LifeSciVC

Drug development is a long process, and patients are waiting. As the CEO of Lifordi Immunotherapeutics, an ADC company developing treatments for autoimmune and inflammatory diseases, there are three components to manufacture, multiple international CDMOs to manage, and complex supply chains to navigate.

article thumbnail

Tech Transfer Tools: The Requirements and Uses of Manufacturing Process Descriptions

The Premier Consulting Blog

technical operations, product development or process development) to an internal or external receiving unit (e.g., clinical manufacturing, commercial manufacturing, or contract manufacturing organization). Development of the manufacturing process description The development of the MPD is an iterative process.