Regulatory shift signals potential change for future CGT sector
Posted: 23 June 2025 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The cell and gene therapy (CGT) sector must maintain its scientific rigor despite recent changes to US policy and market conditions, says key industry body.
With the biopharma industry experiencing notable shifts in recent months and subsequent policy and market uncertainty, the pharmaceutical cell and gene therapy sector has undergone another central change.
Commenting on 19 June, the Alliance for Regenerative Medicine (ARM) stated it is “deeply disappointed” with news that two US FDA Directors have been placed on administrative leave.
Office of Therapeutic Products (OTP) Director Nicole Verdun and Deputy Director Rachael Anatol have “modernised the FDA’s regulatory approach to cell and gene therapy (CGT), earning the trust and respect of the CGT community and helping to ensure that the FDA was the global leader in this evolving field,” according to ARM.
[There are] “five regulatory decisions pending on CGT products in 2025, and a burgeoning pipeline of nearly 2,000 CGT clinical trials ongoing globally”
The organisation highlighted that since there are currently “five regulatory decisions pending on CGT products in 2025, and a burgeoning pipeline of nearly 2,000 CGT clinical trials ongoing globally, it is critical that CBER and OTP operate at the highest level of productivity, efficiency, and scientific rigor”.
Ensuring cell and gene therapy innovation in a changing biopharma landscape
This news emerges as a recent report by analytics firm GlobalData found that biopharma has experienced a downturn in optimism—a 16 percent decrease, compared to the start of the year. Key drivers include new changes by the US administration, such as the risk of pharma-specific tariffs.
To weather these challenges, strategic partnerships are key to remain resilient and ensure continued industry growth, according to GlobalData. Its survey revealed that 37 percent of respondents considered “enhanced industry partnerships” as the best approach to overcome a decrease in biotech funding over the coming 12 months.
“The biopharmaceutical industry will need to continue rethinking models from manufacturing to market access, especially under the expanding shadow of the Inflation Reduction Act (IRA) and FDA shifts,” Hannah Hans, Head of Pharma Strategic Intelligence at GlobalData remarked.
Related topics
Big Pharma, Drug Manufacturing, Drug Markets, Drug Safety, Drug Supply Chain, Gene therapy, Industry Insight, Manufacturing, Regenerative Medicine, Regulation & Legislation, Therapeutics
Related organisations
Alliance for Regenerative Medicine (ARM), GlobalData Pharma, US Food and Drug Administration (FDA)
