Date(s) - 15 Oct 2013
7:00 AM - 8:00 AM
The Do’s and Don’ts of Orphan Drug Development
Tuesday, Oct 15, 2013 @ 10:00 am EDT/7:00 am AZ
Join BioPharm Insight, as we speak with industry experts, Tim Cote, Principal and CEO of Cote Orphan Consulting, LLC and Kurt Karst, Director at Hyman, Phelps & McNamara, P.C. about the orphan drug approval process. Topics to be discussed include:
- Common misconceptions of orphan drug development such as shorter, more lenient approval pathways are prevalent, but it is not quite that simple
- Various classifications of rapid approval: “accelerated approval” is not the only pathway for post-Phase I or Phase II approval
- What happens when there is no validated biomarker for an orphan disease? What are the alternative pathways for rapid approval in this case? What are the hurdles to actually validating a biomarker?
Kurt R. Karst Director Hyman, Phelps, & McNamara
Jennifer Smith-Parker Assistant Editor BioPharm Insight
Anusha Kambhampaty Senior Healthcare Reporter BioPharm Insight
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