“All this enthusiasm for this sector right now is evidenced by these really astonishing financing numbers… I think the drivers of that enthusiasm remain in place and make me optimistic for the second half of 2020,” ARM CEO Janet Lambert said. “We continue to see really promising clinical results. We continue to see products making it to market. We continue to see patient, regulator and payer enthusiasm for these products.”
The latest sector report from the Alliance for Regenerative Medicine (ARM), covering the first half of 2020, has a surprising finding: Despite the arrival of a global pandemic at the beginning of the year, new investment in cellular and genetic therapies (CGTs) and tissue engineering topped $10.7 billion globally—more than all of 2019. ARM expects the full-year data to exceed the previous record of $13.5 billion, set in 2018.
Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases. In an Alliance for Regenerative Medicine (ARM) webinar on the topic, Michael Lehmicke, director, science and industry affairs at ARM, noted that developers are utilizing mesenchymal stem cells (MSCs) and other stromal cells to treat ARDS caused by COVID-19.
Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases. In an Alliance for Regenerative Medicine (ARM) webinar on the topic, Michael Lehmicke, Director, Science and Industry Affairs at ARM, noted that developers are utilizing mesenchymal stem cells (MSCs) and other stromal cells to treat ARDS caused by COVID-19.
At the public meeting to kick off negotiations for renewing the Prescription Drug User Fee Act (PDUFA) before the current program expires in September 2022, patient advocates, research experts, and industry similarly called for more user fee revenues to support CBER programs to advance these innovative therapies.
More than 1050 clinical trials are registered at FDA.gov that explore multipotent mesenchymal stromal cells (MSCs) for nearly every clinical application imaginable, including neurodegenerative and cardiac disorders, perianal fistulas, graft-versus-host disease, COVID-19, and cancer. In this review, we discuss the major clinical challenges with MSC therapies, the details of these challenges, and the potential bioengineering approaches that leverage the unique biology of MSCs to overcome the challenges and achieve more potent and versatile therapies.
The European Commission’s forthcoming Pharmaceutical Strategy could help stop advanced therapy medicinal product (ATMP) development moving away from the EU if it removes obstacles that impede access to and development of such products, says the Alliance for Regenerative Medicine.
The COVID-19 crisis could be a proving ground to legitimate the still early-stage technology of mesenchymal stem cell therapy, but only if clinical trials are of high quality – blinded and randomized – in a context of regulatory clarity.
