In this week’s roundup, we examine why more drug manufacturers are not stepping in to help produce mRNA-based COVID-19 vaccines. While some may think drug manufacturing facilities should be able to easily pivot to produce these vaccines, the reality is much more complicated.
We also look at investment patterns in gene therapy companies, a new Food and Drug Administration role that underscores the importance of cybersecurity for medical devices, and the increased use of patient assistance programs. Finally, we try to separate the hype from the reality of what is possible with the use of artificial intelligence in clinical trials and drug development.
Each week, we highlight five things you need to know about in the life sciences industry. Here’s the latest.
There is not idle mRNA drug manufacturing capacity available for COVID-19 vaccines
With the entire world anxious for vaccine production to ramp up and for doses to become more broadly available, many people are wondering why companies can’t increase production faster. This great blog in Science Translational Medicine (linked above) details the steps involved in manufacturing mRNA vaccines and why drug companies cannot quickly adapt to add capacity.
Gene therapy holds a great deal of promise and is driving investment and M&A
Investments in 2020 in gene therapy stress an important and ongoing trend – major life sciences companies continue to focus on acquiring drug candidates and entire companies in this space as a means of supplementing their internal development pipelines. This article in Endpoints News breaks down the deals in 2020 and looks at the potential impact of recent gene therapy safety issues on future deals.
FDA appoints first medical device cybersecurity chief
As more and more medical devices add connectivity features, the importance of cybersecurity for these devices continues to increase. To address this reality, the FDA has named its first chief of medical device security – Kevin Fu, an associate professor at the University of Michigan. This important role will help ensure that device security is a focus of the agency, while also continuing to support innovation and patient safety.
Amid the pandemic, more people are turning to patient assistance programs
Patient assistance programs have existed for quite some time to help offset the costs of high-priced drugs for patients that otherwise might not be able to afford them. In 2020, with broad economic pain, high unemployment, and increased poverty, PAPs became more critical than ever. As this Pharmaceutical Executive article highlights, the expansion of such programs will require increased awareness and for pharma companies to adjust their qualification criteria and update systems to support their broader use.
Artificial intelligence is moving beyond hype and starting to make an impact in clinical trials
Without closer examination, some people may write off artificial intelligence as an overhyped technology. But for some clinical trials, AI is starting to have a more tangible impact. Clinical Leader recently sat down with several experts in the clinical trial space with the goal of clarifying where AI is making a difference in clinical trials, and where it is not.
(Bonus read: Companies like Cellino, which uses AI to enhance its regenerative medicine pipeline, are drawing investment.)
