To address the unmet medical need for orphan diseases, the US Congress passed the Orphan Drug Act of 1983 (ODA) to encourage the development of products for orphan diseases which would otherwise be too costly or inefficient to pursue. The ODA created an FDA application program known as Orphan Drug Designation (ODD), which supports innovation through incentivizing the research and development of products for orphan diseases. Since its inception, the ODD has proved critical in the development process for orphan products.
In this whitepaper, we'll discuss crafting a successful ODD, reviewing the application and maintaining designation, and the benefits of ODD.
Isaiah Manoogian, PharmD, Senior Regulatory Affairs Scientist
Dr. Isaiah Manoogian graduated from the University of Connecticut School of Pharmacy in May 2021. After earning his doctorate, he moved to DC to begin his career in the pharmaceutical industry as BioPharma Global’s inaugural Post-doctoral Regulatory Affairs Fellow. Following the completion of the 1-year Fellowship, Isaiah is now a Senior Regulatory Affairs Scientist with the company. In his current role, Isaiah has solely authored and supported numerous successful applications to FDA and EMA, including orphan drug designations, rare pediatric disease designations, and fast track designations.
He has also helped develop several meeting requests and briefing packages in various disease states to assist clients meet with FDA to increase the likelihood of their program’s success. Outside of work, Isaiah enjoys working out at the gym to destress and improve his health, as well as being outside in the sun (with sunscreen of course), watching and rating films, and listening to podcasts and music.