Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Continuous process improvement can benefit all aspects of life — from personal New Year’s resolutions to complex drug development. In a world where two-thirds of planned improvement initiatives fail, ...

There’s no doubt that large language models and generative AI tools have taken the world by storm. Their ability to create, ...

Solubility is an essential characteristic for any oral medication, directly governing the drug’s bioavailability and efficacy. However, this requirement is running up against the growing ...

Outsourcing is driving biopharma efficiency and scale, including in the drug discovery area and early phase development.

At the heart of every biological process, from the replication of cells to the functioning of the human brain, lies the intricate world of proteins. Understanding the structure of these molecules, ...

Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...