The Federal Trade Commission’s new acting chair, Rebecca Kelly Slaughter, has initiated a review of the agency’s processes for approving pharma mergers. This is expected to result in a tougher road for these mergers, as we explain below. We also look at the top drugs losing their exclusivity this year, artificial intelligence-powered hearing aids and the use of digital twins to model treatment options. Plus, cloud computing company Veeva’s annual survey of contract research organizations highlights 2020 challenges and how CROs are responding.
Each week, we highlight five things you need to know about in the life sciences industry. Here’s the latest.
With a new administration comes a new FTC chair and promises of increased scrutiny for large mergers of life sciences companies. The life sciences industry often focuses on the FDA as its primary regulatory concern, but for acquisitive companies the FTC can also play a major role. In recent years, the agency has asked merging companies to divest specific drugs or drug families to win approval. However, this article in the Wall Street Journal highlights that with new leadership, the commission is warning it may not be supportive of such narrow resolutions.
This article from Fierce Pharma has pulled together data from multiple sources to identify the 10 most significant drugs losing patent protection this year. Although these drugs are all losing their exclusivity, that doesn’t mean there will be a generic or biosimilar on the market to immediately replace them. What it does mean is that the clock is now ticking as specialty pharma companies and other competitors work to capture some of this revenue.
It is becoming difficult to find areas of the life sciences industry that are not impacted by the increasing power and availability of artificial intelligence. Take new hearing aids from Oticon and Whisper. Both companies are working on adding AI to their devices to help patients hear better in noisy environments where traditional hearing aids have struggled.
A digital twin is a computer model of a complex, real-world system. They have been used in industrial settings to predict the maintenance and failure of devices like jet engines. This article from Science Magazine examines how digital twins could be useful when treating viral diseases and the work that remains before that can happen. Using models built from clinical trial data and specific testing, as well as patient details, a digital twin would allow doctors to simulate complex courses of treatment to determine which is most likely to be effective.
Clinical Leader reports on the results of Veeva’s 2020 Unified Clinical Operations Survey. Although it is unsurprising to see that most respondents faced trial disruptions during the pandemic, it is noteworthy that 99% of respondents identified a need for better tools for unifying clinical trials. This includes improved tools for collaboration with sponsors, systems to support study start-up and better integration across the many systems used to manage trials.