Kate Rawson
Latest From Kate Rawson
AI In Drug Development: Avoid The ‘Flashiness,’ And Simply Ask ‘Does It Fit?’ – US FDA’s ElZarrad
The Center for Drug Evaluation and Research’s medical policy chief says artificial intelligence can aid patient recruitment and increase trial diversity, but warned of “unique” potential pitfalls for sponsors.
Three Gene Therapies, Moderna Metabolic Drug In Inaugural START Class; CBER Oversubscribes
Seven rare disease programs make up the first round of participants in the US FDA’s ‘Operation Warp Speed’-style program. Sponsors will benefit from ‘rapid, ad hoc’ communication with the agency.
Beyond CAR-Ts: Cell-Based Gene Therapy Sponsors Are ‘Branching Out,’ CBER’s Marks Says
As sponsors explore development in autoimmune and infectious diseases, plus a range of hematologic and solid tumors, manufacturing processes can be centralized or decentralized, but Marks says the FDA is ‘neutral’ on that decision.
Pazdur’s Big Moment: ‘Project Odyssey’ Webinar Gives Oncology Chief External Buy-In On His Ideas To Revamp ODAC
OCE Director Richard Pazdur is known for cultivating 'Pazdur moments' during advisory committees when he feels the conversation has gone off track. A recent webinar with ODAC members created a perfect opportunity to promote his agenda.
Another Chance For VALID? Negative Reaction To FDA’s LDT Proposal May Reopen Legislative Talks
All of the witnesses testifying to a House E&C Committee hearing said they preferred the flexibility and targeted enforcement of the VALID Act to FDA’s proposed rule. Will Congress finally be spurred to act?
US FDA Advisory Panels May Look Different Across Centers, Despite Efforts To Standardize Process
As FDA is readying to go back to in-person advisory committee meetings this fall, the centers have different ideas about how to use their expert panels.