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REMS are FDA-mandated, post-marketing safety programs that can be required to appropriately balance a drug's benefits and risks to support safe use. These safety programs are most often required during the NDA or biologics license application (BLA) process to address risks identified in development. If not planned for, this one requirement can set the launch back months, possibly a year, depending on the complexity of the REMS. This reality hits [...]

"We've deepened our bench of experts by adding some of the most experienced REMS professionals to our team, including Melissa Landers," said Howard Miller, CEO of Two Labs. "Melissa joins the Two Labs family as a preeminent expert in the design, FDA approval, and ongoing consultative management of REMS programs. We've always been committed to the patient, and the addition of REMS and Melissa's deep expertise will provide immense value to [...]

Emerging manufacturers have a strength in how close to and how passionate they are about the science they are developing. But because they are hyper-focused on the groundbreaking science they're working on, it can be hard to come up from the weeds to put together the launch support that their product needs. And often, one of the most underestimated parts of that launch plan is medical communications. Read our recent article [...]

As the cell and gene therapy market has exponentially grown in recent years — with some reports predicting it will reach $24.4 billion with 54 to 74 approvals by 2030 — many manufacturers are learning the hard way just how complex it can be to launch these products, and that’s after already making it through the arduous development and clinical trial process. Among the many things to navigate, a manufacturer [...]