Dr Kishor Wasan on a drug development strategy to treat neglected tropical diseases
Adjunct Professor, Faculty of Medicine, University of British Columbia Kishor Wasan
Dr Kishor Wasan discussed a drug development strategy to treat neglected tropical diseases
SASKATOON, SK, CANADA, November 17, 2021 /EINPresswire.com/ – Distinguished university scholar and assistant professor of the Faculty of Medicine of the University University of British Columbia Kishor Wasan, who is also Scientific Director for Skymount Medical US and AmphB Tech Inc., has spent much of his career promoting the development of new drugs to treat relatively rare conditions that affect the poorest and most underserved populations of the world. tropics. He advises manufacturers that cooperation with the United States Food and Drug Administration can both reduce research and development costs and speed up the delivery of new drugs to people who need them most.
A path to success, Assistant Professor Kishor Wasan says, begins with the FDA’s Office of Orphan Products Development (OOPD).
OOPD works with drug manufacturers to identify neglected diseases, diseases for which less than 200,000 people per year would receive treatment in the United States, as well as treatments for diseases that affect more than 200,000 people per year but which should not yield research and development. costs. The OOPD also identifies rare pediatric conditions and conditions of humanitarian concern that might otherwise not meet a pharmaceutical company’s criteria for potential market size.
Once neglected conditions have been identified and prioritized, the US FDA awards grants for research. Drugs that the US FDA approves for orphan status earn credits from their manufacturer against US taxes. administered by the US Internal Revenue Service. They are eligible for exemptions from registration fees for users of prescription drugs, averaging US $ 2 million, and seven years of market exclusivity. During these seven years, the US FDA will not approve another regularly approved drug for the same orphan indication.
Designation of orphan drug status is a separate process from drug approval to market. Drugs that have been approved for other indications may be reviewed for approval as treatments for neglected diseases, resulting in the same incentives for drug companies as drugs developed de novo.
The world’s most lucrative major pharmaceutical market regulator, the United States, offers strong incentives to address hitherto unmet therapeutic needs. However, even with these incentives, more than a billion people are at risk of contracting a neglected tropical disease. Less than 5% of research dollars are spent on finding treatments for 15% of the world’s population. Using all available resources provided by the US FDA, Assistant Professor Kishor Wasan thinks, is essential to finally develop treatments for neglected tropical diseases.
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