This week we start with a look at the potential for gene and cell therapy to radically change health care over the coming decade. Although there are few approved drugs using these technologies today, the pipeline of candidates in all phases of clinical studies is full of potential cell and gene therapy treatments. We also highlight recent life sciences initial public offerings, holographic surgery tools, new tools for decentralized trials and recent polling on confidence in the U.S. Food and Drug Administration.
Each week we highlight five things you need to know in the life sciences industry. Here’s the latest.
Generally we bring you articles and research notes that inform on current developments in the life sciences ecosystem. This week we wanted to share a video that articulates the cell and gene therapy space, and the potential impact of developments in such technologies. According to RSM’s analysis of Evaluate Pharma data, there are only 22 approved cell or gene therapies on the market in the U.S., but there are more than 400 unique therapies in Phase 1, 2 or 3 clinical trials. While many of these drugs have a long and uncertain path to approval, projected sales of cell and gene therapies is expected to raise at 50% compound annual growth rate through 2026. Given the direction of life sciences and the development of personalized medicines, it will be critical for market participants to understand the cell and gene space.
Through July, there have been 90 life sciences IPOs in the U.S., and 11 of them took place the week of July 11. According to the IPO research firm Renaissance Capital, that week also represented the largest overall IPO total in 20 years, with 20 IPOs across all industries and more than $1.3 billion in capital raised. While the life sciences industry is on pace for its best year of IPOs ever (90 as of July 2021, 102 in 2020, 103 in 2014, according to Bloomberg), this rate of play is expected to moderate in the second half of the year as investor fatigue and the impact of the delta variant cool markets. “Combine that fatigue with increased pricing pressure, and performance starts to suffer. Three companies postponed, citing either volatility or market conditions. Of the IPOs that did get done, nearly half priced below the midpoint, and returns were a mixed bag,” said Bill Smith, chief executive of Renaissance. The public markets are a bellwether for the life sciences industry, and they should be closely watched for returns, volume and sector mix as the country and the world continue to combat COVID-19.
This week, RealView Imaging Ltd. received FDA approval for its three-dimensional interactive holographic display system. The device is an “over-the-head” display that provides an image of the patient’s organ to help surgeons visualize and prepare prior to the procedure. Additionally, the company is working on the development of its next device that will provide a real-time holographic display of inside the patient’s body during the procedure. This year, the company expanded its $10 million Series C to $15 million to support the final development and commercialization of these devices.
The COVID-19 pandemic forced the clinical research organization industry to move from an on-site to decentralized model. Industry sentiment suggests that decentralized models will provide several benefits, including decreased time to study completion, reducing overall trial costs, improved patient experience and greater trial diversity. While we aren’t sure when the economic benefits of decentralization will be recognized, the industry is investing heavily in what may become the new era of clinical trials. Supporting this investment, the Association for Clinical Research Organizations (ACRO) recently released its toolkit aimed at helping to advance decentralized clinical trials by focusing on quality-by-design.
The FDA has faced constant scrutiny in the past 18 months over everything from COVID-19 vaccines to Alzheimer’s drugs and janus kinase inhibitors (small molecule synthetic drugs). According to a new survey from Spherix Global Insights and reported in Fierce Pharma, this has led to 40% of doctors indicating a lower confidence in the agency. What is more remarkable, numerous doctors shared that they are taking a more cautious approach to new drugs and waiting for real world evidence to accumulate before prescribing them to their patients.