Cell and gene therapy advocates believe they can make the case that the products are a good fit with the incoming Trump Administration’s health care vision.
Cell And Gene Therapy Field Sees Opportunity Under Trump
The cell and gene therapy field has reached an inflection point in the US as the second Trump Administration begins and advocates argue the sector could fit well with the “MAHA” agenda.
More from Cell & Gene Therapies
• By
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
• By
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
• By
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
• By
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
More from Legislation
• By
The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
• By
Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.
• By
Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.