Given the high volume of mergers and acquisitions in life sciences, changes in the leadership and focus of the Federal Trade Commission will be closely watched in the coming months as scrutiny could shift to the technology industry. We examine the possible impact below.
We also look at CureVac’s COVID-19 vaccine trial results, how events at a plant in New Jersey led to the disposal of 75 million doses of the Johnson & Johnson vaccine, new tools for decentralized clinical trials, and the efforts of the National Institutes of Health to reduce systemic racism in medical research.
Each week we highlight five things you need to know about in the life sciences industry. Here’s the latest.
In March, the FTC announced it would be taking a more stringent look at mergers in the biopharmaceutical industry, which was quickly followed by a legal challenge to the proposed Illumina and Grail merger. The life sciences industry will have continued interest in the M&A landscape with the announcement of Lina Kahn as the new chair of the FTC.
Kahn was confirmed with an unusually high bipartisan vote in the Senate, which may be an apparent nod to a “big tech” focused agenda. Kahn (age 32 and the youngest FTC commissioner in history) sparked her career with a widely distributed Yale Law Review article, “Amazon’s Antitrust Paradox,” and is expected to focus on anti-competitive activities in the tech industry.
While big tech may take center stage for the FTC, the life sciences ecosystem comes under similar consumer protection scrutiny and will be keeping a close watch on the agency’s rulings over the coming months.
While Pfizer and Moderna have achieved greater than 90% efficacy with their messenger RNA (mRNA) COVID-19 vaccines, preliminary results of CureVac’s candidate have disappointed with 47% efficacy. CureVac’s trial involved more than 40,000 participants across Latin America and Europe, and was seen as another important component of addressing global COVID-19 vaccination needs, especially in low- and middle-income nations.
The European Union had agreed to purchase 405 million doses, conditional on authorization, which now is unlikely to come to fruition. Scientists were caught off guard by the results given that the company’s therapy is based on the same technology as other successful vaccines. One potential factor for lower than expected efficacy is the presence of new variants that would be have more of a presence in the trial nations, according to Franz-Werner Haas, CureVac’s CEO. The company intends to complete the trial over the next several weeks and make a determination after the final readout.
The U.S. Food and Drug Administration released a memo on June 11 highlighting its assessment leading up to the disposal of approximately 60 million additional (approximately 75 million cumulative) Johnson & Johnson/Janssen COVID-19 vaccines. The vaccine, manufactured at the same Emergent BioSolutions facility as the AstraZeneca COVID-19 vaccine, had been under investigation by the FDA after a March 26 notification from Janssen that the company had detected the AstraZeneca COVID-19 vaccine virus in a Janssen COVID-19 vaccine drug substance batch.
The memo highlights “a significant increase in production coupled with a lack of segregation of media preparation activities, waste flow, and personnel handling waste” which led to the potential contamination. Prior to Janssen’s March notification, the FDA had conducted pre-emergency use authorization visits where it identified “concerns regarding many personnel changes and new hires in Quality and Manufacturing… as well as the need for better documentation and procedures, and consistency with established practices.”
One of the challenges of adopting decentralized and hybrid trials is that a different set of tools is needed than for traditional site-based trials. These include tools for safety monitoring, coordinating drug delivery to patients’ homes and for keeping patients engaged both before and after they participate in a trial. The companies providing these new tools range from established industry players like Medidata and a crop of startups like Medable and Curebase.
The NIH has published a new report in the journal Cell that examines the impact of structural racism in medical research. The report’s findings include that less than 2% of NIH senior researchers are Black. In addition, it finds that Black researchers are funded at much lower rates than white researchers. Unfortunately, this disparity has remained mostly steady over time. This report represents a concrete step the NIH is taking and is complemented by a variety of other initiatives.