Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.
Freed from the burden of paper reviews, the US Food and Drug Administration is plotting an escape from legacy free text that burdens electronic reviews with drug quality narratives.
As innovation accelerates, the time required to write and read these chemistry, manufacturing and controls narratives has become a luxury...
Chimeric antigen receptor T-cell (CAR-T) therapies have revolutionized the treatment of blood cancer, but scalability remains a major challenge. Experts explain how technologies such as chip-based miniaturized models and automation could be part of the solution.
Co-founder and CEO of Cellino Biotech, Nabiha Saklayen, discusses the company’s innovative platform which uses automated technologies to overcome challenges in the development of regenerative medicine.
Rising star Agnė Vaitkevičienė is juggling roles as the CEO of an emerging Lithuanian biotech, with work for a partner company, the national biotech trade association and much more.
Could health sector players encounter issues similar to those facing Tesla in China, a country which virtually saved the electric vehicle maker but where it is now facing challenges? Are there any lessons to be learned from a success story under China's volume-based procurement scheme? A partner at EY looks at these and other issues.
Launching In Vivo’s oncology therapeutic review series, this first instalment provides a data-led primer on the global cancer landscape. Future instalments will explore market dynamics, pipeline evolution and the innovations set to define oncology therapeutics through 2032.
Launching In Vivo’s oncology therapeutic review series, this first instalment provides a data-led primer on the global cancer landscape. Future instalments will explore market dynamics, pipeline evolution and the innovations set to define oncology therapeutics through 2032.
