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IndoUSrare Webinar – Rare Disease Patients Engagement with FDA
October 15, 2020 @ 8:00 am - 5:00 pm
Indo-US Organization for Rare Diseases (IndoUSrare) fills a critical gap for the global rare disease communities’ common goal of accelerating life saving therapies by engaging Asian-Indian diaspora with global clinical trials. Why this is important?
- 97% of drug discovery and development happens outside of the Indian subcontinent.
- ~23% of the World’s population lives in the Indian subcontinent.
- Patient identification and recruitment into clinical trials is the biggest barrier in the development of therapies.
- A majority of the FDA or EMA approved drugs are not commercialized in the low- and middle- income regions such as Indian subcontinent.
- Most of the large-scale long-term investments leading to the discovery and development of novel therapies happens in the Western World.
- Recent trends indicate that most of the “low-hanging fruits” for novel drugs have been exhausted and novel therapies for rare diseases will require innovative solutions outside the traditional process.
- Most of the biomedical and clinical research databases are filled with predominantly data of Caucasian origin. This needs to be updated with data from the genetically diverse population from the Indian Subcontinent.
- Progress in the 21st century will require global cooperation with a particular emphasis on the Indian subcontinent.