This week we highlight a slow start to the year for life sciences initial public offerings, Medicare’s decision on Alzheimer’s disease reimbursement, the use of machine learning and artificial intelligence in clinical trials and the rapidly growing market for virtual trials. Finally, we look at how the tools used for rapid drug development and synthesis could result in concerning outcomes. Each week we highlight five things you need to know about in the life sciences industry. Here’s the latest.
IPOs in the first quarter were down to the lowest count since the start of the pandemic and the amount raised is the lowest since the third quarter of 2019. Given the high volatility of the stock market and poor performance of life sciences stocks recently, this is to be expected but presents significant challenges as companies consider their options for funding ongoing development.
This week, Medicare finalized restrictive guidelines for reimbursements for Alzheimer’s drugs. Although Abduhelm from Biogen was the catalyst, the rules will apply to any new drugs with a similar mechanism. Generally, Medicare is planning to only pay for the drug when it is being used by a patient in a clinical trial which will have the effect of substantially reducing the number of patients with access to this treatment. However, there was good news for companies focused on this disease in that the rules include an exception for drugs whose trials meet their primary endpoint to allow access by a broader group of patients.
Applications of AI and machine learning in the clinical trial space are growing but still in their infancy. IQVIA deployed its algorithms during the pandemic to model COVID-19 case growth and predicted the best locations to set up COVID-19-related trials. A few examples of the many potential opportunities include helping identify future locations for clinical trials as well as automating the company trial master file development. IQVIA is quick to note that the logic is still developing and that these solutions should be viewed as augmented intelligence rather than fully automated AI.
As we noted in our article in Clinical Leader, virtual trial companies are seeing significant growth. A recent study has estimated the virtual clinical trial market at $8 billion with a 10% annual growth rate. While the capital invested in virtual clinical trials has slowed during the first quarter this year, we are continuing to monitor growth as virtualization presents significant opportunities to reduce trial duration and overall trial cost.
New AI-powered tools are allowing scientists to rapidly design new chemical compounds and synthesis techniques for use in medicines. A group of developers who create those tools recently performed a thought experiment to see if they could also be used to create compounds designed to harm instead, with dire results. They were able to quickly generate novel compounds that looked likely to be dangerous if they were actually synthesized.