This week we look at how start-ups are rethinking how clinical trials are designed and managed to improve efficiency and accuracy. We also examine biosimilar versions of a blockbuster biologic, what to expect for cell and gene therapy companies, and why the U.S. government may pay lower prices after accelerated approvals. Finally, there are vaccines being developed based on new approaches and technology.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
New York-based startup Paradigm is developing a software solution to simplify the clinical trial process. The software is designed to synchronize medical records maintained by health care providers with data used and analyzed by contract research organizations who are managing clinical trials. The goal is to improve the efficiency of the trials and the accuracy of the data obtained. The company raised over $200 million in a recent Series A financing.
Patent protection has ended on one of the best-selling pharmaceutical products of all time. Several competitors have now launched biosimilar versions of AbbVie’s auto-immune drug, Humira. The biosimilar drugs are priced significantly cheaper than Humira. Analysts project that sales of Humira will drop by at least 50% because of the availability of competing products.
From manufacturing capacity limits to gene editing advances and talent challenges, this year looks to be another challenging one for cell and gene therapy companies. But the number of therapies nearing regulatory approval continues to grow and each year the industry solves more of their challenges to reach large-scale commercial volumes.
For drugs approved under accelerated approval pathways, there is always a chance that confirmatory trials will fail and the drug will be removed from the market. This uncertainty is why the U.S. Department of Health and Human Services may be considering new demonstration policies that pay lower prices for these drugs.
With several approved vaccines for COVID-19, it might not be obvious why research would be ongoing to develop additional vaccines. However, annual boosters are expected to be the norm going forward and variants continue to emerge. The next generation of vaccines targeting these variants could be based on very different technologies than existing vaccines.