When you procure cellular starting material or distribute a cell or gene therapy product across international borders, you must consider the country or regional regulatory requirements at play and where they diverge. Allogeneic cell therapy sponsors face common challenges when treating a global patient population with therapies using healthy adult donor starting material.
When you procure cellular starting material or distribute a cell or gene therapy product across international borders, you must consider the country or regional regulatory requirements at play and where they diverge. Allogeneic cell therapy sponsors face common challenges when treating a global patient population with therapies using healthy adult donor starting material.
The COVID-19 pandemic continued to disrupt lives across the globe in 2021, but that didn’t keep the cell and gene therapy industry from advancing. With many new regulatory approvals anticipated in 2022, the industry shows no signs of slowing down. We look back at 2021 and ahead to 2022 and beyond.
Cell and gene therapy developers are pursuing allogeneic approaches, which ideally could be produced in greater quantities and be available “off-the-shelf.” Those using natural killer (NK) cells and cells derived from induced pluripotent stem cells (iPSCs) are creating buzz in the industry. Drs. Sarah Cooley, Stephen Gottschalk and Stephan Grupp offer their insights.
The COVID-19 pandemic impacted nearly every aspect of the cell and gene therapy supply chain. That required companies throughout the cell and gene therapy industry to pivot quickly to continue to deliver for patients. Be The Match BioTherapies® was no exception.
After raising a record $19.9 billion in funding in 2020, doubling the previous year, the cell and gene therapy industry shows no signs of slowing down. Forecasters predict more record growth this year, especially in terms of regulatory decisions; at least nine new products have been approved or are up for approval in the United…
Allogeneic cell therapies are inherently complex. But they also hold the potential to scale to treat large segments of the population. Martin Maiers, MS, is the Vice President of Innovation at the National Marrow Donor Program® (NMDP)/Be The Match®. He and his team develop software and analytical methods used to predict factors that can impact…
On the last day of February, millions of people came together globally to honor Rare Disease Day. It’s a day dedicated to raising awareness of rare diseases, the impact they have on people’s lives and the importance of developing treatments to improve quality of life for patients and families around the world. The National Institutes…
For many in the field of cell and gene therapy, 2020 had a singular theme: COVID-19. Dozens of clinical and preclinical trials were launched in labs around the world to test the efficacy of cell therapies to target complications from COVID-19 infection. But while the pandemic drew most of the media attention, it wasn’t the…