The clinical trials status quo is a roadblock. They're slow, inefficient, and expensive. On this episode of the Business of Biotech, friend and frequent guest Allan Shaw shares some strong opinions on what's wrong with clinical trials, and what the industry (read: you) and the FDA need to do to make them right. Listen now and subscribe so you never miss an episode.
Remote regulatory inspections were a significant change that occurred during the COVID-19 crisis. Considering that these will continue even after the pandemic, we’ve compiled some tips on how to prepare for and what to expect from a remote inspection.
ISR’s CDMO Outsourcing Models report dives into three approaches to contracting manufacturing work, the motivations behind using each approach, and details on which methods earn the greatest satisfaction among users.
Biotech M&A was slow in the first half of 2021, but that may be changing, with emerging trends indicating that a biotech M&A boom could be on the horizon. If your biotech is hoping to be acquired by a larger pharma company, it’s crucial that you start preparing now.
In this executive virtual roundtable (EVR) component, Bryan Butman, Ph.D., head of CMC, Precigen, provides perspective on how early work in gene therapy benefitted the development of viral vector vaccines for COVID-19.