The Orphan Drug Act (ODA) was passed in 1983 to financially incentivize pharmaceutical companies to develop drugs for rare diseases or conditions, defined as a disease or condition that affects less than 200,000 people in the US.1 The financial incentives offered by the ODA are substantial and include tax credits up to 50% of the qualified clinical testing expenses for the taxable year, waived Prescription Drug User Fee Act (PDUFA) user fees that may be upwards of $3 million in 2022, and an extended market exclusivity period of seven years after approval.2 A recent analysis found that receiving an orphan drug designation does, on average, positively impact companies’ value as […]
Innovative Therapies Deserve Innovative Strategies
With more than 7,000 distinct types of rare and genetic diseases and 400+ million individuals suffering from a rare disease, regenerative medicine holds the hope for a cure – transforming healthcare by revolutionizing patient care from conventional treatment models to curative therapy models. With the advancement of new technologies coupled with the creation of new companies offering a range of innovative products and treatments, regenerative medicine constitutes one of the fastest-growing fields of research and the promise of commercial success for all patients.
Creating better patient experiences and bringing effective therapies to patients around the world
In the value-driven healthcare environment, rare and orphan drug manufacturers are becoming increasingly aware that new models and new approaches are needed for a successful product launch. At EVERSANA, we understand the complexities of developing products for small populations that require global reach. That’s why we are focused on an end-to-end process that’s connected and assures that patients are identified, diagnosed and onboarded and that they stay adherent to their therapies.