Webinar – The Do’s and Don’ts of Orphan Drug Development

Date/Time
Date(s) - 15 Oct 2013
7:00 AM - 8:00 AM

Location
Webinar

The Do’s and Don’ts of Orphan Drug Development

Tuesday, Oct 15, 2013 @ 10:00 am EDT/7:00 am AZ

Register Now!

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