Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study and reaching regulatory approval does not necessarily translate to market success.
John D. McDermott, Jr., Vice President of Covance Market Access Services, recently shared his insights on the market access challenges in rare disease drug development and discussed key considerations for sponsors and stakeholders.
Provide early education about the disease
Even though rare diseases as a whole are getting more attention, sponsors cannot assume that their potential payers know much about the particular condition they are targeting and its importance to patients. Continue reading