EMERGING COMMERCIALIZATION STRATEGIES FOR ADDRESSING THE NEEDS OF ULTRA ORPHAN PATIENTS
Accelerate Product Launch and Profitability by Building Regulatory Requirements into Distribution
The recent Risk Evaluation and Mitigation Strategies (REMS) requirements implemented by the Food and Drug Administration Amendments Act (FDAAA) have made the drug approval process more challenging than ever. In fact, the average delay for an insufficient REMS program is nine months. Today, many of the orphan drugs are biologics, and two-thirds of biologics approved in the past year have had a REMS requirement. REMS requirements pose significant implications for manufacturers in the ultra-orphan marketplace.
There is good news. Companies that are willing to put the right structure in place to monitor patients, collect data, and measure outcomes should find that the new regulatory model can work to their advantage. The fewer questions left open, the more thorough the planning and preparation, and the more narrowly defined the REMS plan, the simpler the FDA application process.
Execution of this planning process can provide your organization with a competitive advantage over manufacturers who fail to build REMS requirements into their distribution.
Register to attend this unique conference dedicated exclusively to the orphan and ultra-orphan marketplace. We invite you to know more about this vital marketplace and gain new insight into delivering these high-cost, low-volume drugs to patients who desperately need them, despite the increased FDA oversight. We look forward to meeting you in St. Louis!