Industry Outlook 2025: US Political Motivations and Legislative Discussions

According to Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics, there are two aspects to consider when assessing the potential impact on industry of the new administration in the United States. “One is a conservative attitude to business, which I think might have some potential positive impact. That's good [because it] will support the economy and give a certain confidence to investment,” he says.

Additionally, Forte specifies that the leadership must impact business positively while also managing to make careful decisions around technological aspects of the industry, allowing organizations, such as FDA, the ability to perform their jobs. “I would also want to see that public health and product considerations are done the right way,” he adds.

A legislative change in the US that will more than likely have an impact on the bio/pharma industry is the introduction of the BIOSECURE Act, which was passed in September 2024. “I can understand some political motivations on how to manage the flow of the data [in relation to the BIOSECURE Act],” Forte says. “Some companies may get impacted, not only the ones that are directly targeted by the BIOSECURE Act, but also the ones that had deals and partnerships and collaborations with those companies, they will have to readjust their businesses again.”

Looking at industry regulations in more detail, Forte specifies that FDA has been keen on engaging in discussions about cell and gene therapy and becoming more comfortable with these novel modalities. “I believe that regulators [are] in a much better position today to make the right decisions and support the field in terms of the development [of cell and gene therapies], and that will translate in legislation, for sure, as well,” he adds. “I think, from a new technology point of view, we saw some good decisions in terms of reimbursement into the US recently, which I think is a good signal to the field.”

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About the speaker

Miguel Forte, president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics

Miguel Forte is president of International Society for Cell & Gene Therapy, board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics—a company developing engineered cell therapies for inflammatory diseases. Miguel holds an MD and a Specialist in Infectious Diseases from the Faculty of Medicine, University of Lisbon, a PhD in Immunology from the University of Birmingham, and a certificate on Health Technology Economics from the Stockholm School of Economics. Additionally, he is Fellow of the Faculty of Pharmaceutical Medicine of the RCP in the UK.