As regulators around the world prepare for an influx of new advanced therapy applications for cell and gene therapies (the Alliance for Regenerative Medicine predicts 10 to 20 applications annually by 2025), leaders at the FDA and EMA are now calling for more harmonization around their respective regulations.
Speaking at the Meeting on the Mediterranean, a conference on cell and gene therapies organized by industry group Alliance for Regenerative Medicine, Bușoi said that the COVID-19 pandemic had provided an “inflection point” in health care.
From re-examining the FDA’s place in the broader US government to how fast and flexible it can be clearing therapies in non-emergency times, the COVID-19 EUA experience is expected to have a long-lasting impact on the agency.
The Alliance for Regenerative Medicine, an industry group representing developers of gene and cell therapies, said it welcomed EU-wide HTA — which could “eliminate duplicative reviews” and reduce the time and cost of bringing new medicines to market. In fact, it likes the idea so much that it wants it to arrive as quickly as possible.
The Alliance For Regenerative Medicines is calling for advanced therapies to be given greater priority where joint clinical assessments are concerned.
Cash is flooding into biopharmaceuticals, but regenerative medicine companies in particular have raked in large sums of cash – in part, because of the high upfront investment in manufacturing, but also because of the potential to cure intractable diseases. In 2020, that meant a record-breaking $19.9bn was invested in cell and gene therapy developers globally – double the $9.8bn raised in 2019 and substantially higher than the prior record of $13.5bn in 2018 – according to a new report from the Alliance for Regenerative Medicine (ARM).
Nearly $20 billion in funding flowed into biotech companies developing cell-, gene- and tissue-based therapies last year, widely eclipsing the total invested in 2019 and ending up 50% higher than the previous record of $13.5 billion set in 2018.
Experts share what they believe are the solutions to key manufacturing challenges, such as lowering cost of goods and centralized manufacturing, in the cell and gene therapy sector.
