While Big Pharma historically has kept development activities and CMC management in-house, unpredictable pipelines and increasing drug complexity have compelled the industry to look more seriously at outsourcing drug development and manufacturing to increase productivity and throughput.
In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.
Use of recombinant proteins as therapeutics has become an attractive strategy for altering the biology of disease progression and offers significant commercial opportunities. However, bringing a recombinant protein to market requires a substantial investment of time and resources, and the process is generally complex and subject to technical pitfalls.
The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries. This is due to the complexity that has come with new drugs, more complex production technologies and evolving regulatory requirements. In this environment, integrating and aligning the supply chain makes it more flexible, bolstering operational performance and financial competitiveness.
Supply chain management has advanced rapidly over the past decade, evolving from what was once dubbed “materials management” into the essential glue that binds all aspects of a business’ internal and external collaborations.
Trevena, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, recently announced the successful completion of the End-of-Phase 2 Meeting process with the United States Food and Drug Administration (FDA)