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Recorded Webinar
FDA approvals of Orphan Drugs and Rare Diseases: An evolving competitive landscape
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
FDA approvals of orphan drugs for rare diseases is at an all-time high with over 41 novel and innovative medicines approved in 2014. Numerous FDA programs are in place to encourage development of orphan drugs to treat rare diseases. Once the domain of small biotech companies many large pharma manufacturers are now actively engaged in development of rare disease treatments. The result has been year over year increases in FDA submissions and approvals per rare disease category.
Evolution of competitive landscapes in previously untreated rare diseases is to be expected and should not be underestimated. The value of these new, and often costly medicines, must be clearly supported with meaningful clinical outcomes, clear patient populations, and relevant comparators despite small patient populations. The proliferation of products coming to market to treat rare diseases further elevates the importance of establishing evidence that supports not only clinical differentiation but also affordable access for patients upon FDA approval and Payer evaluation.
This webinar will provide participants a high level understanding of:
- FDA programs to encourage clinical trials for rare diseases
- Trends in FDA approvals for new orphan drugs for rare diseases
- Ideal time to consider payer evidence needs in clinical trial planning processes
- Trial design as the foundation of access management criteria
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