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Webinars Articles and Insights

The Value of Real World data in Orphan and 505(b)(2) Drug Development

DownloadDate: October 9th, 2019 Presented by: Ken Phelps, president and co-founder, Camargo In orphan drug development, smaller patient populations present unique challenges when it comes to demonstrating safety and efficacy to support regulatory approval. Similarly, 505(b)(2) drug development by definition utilizes publicly available data sources

The 505(b)(2) Pathway: Getting to the Clinic Faster

Download Date: July 17th, 2019 Presented by: Ken Phelps, president and co-founder, Camargo You’ve identified your product as a candidate for approval via the 505(b)(2) pathway and completed a successful pre-IND meeting. What comes next? In part two of this webinar series on the 505(b)(2) pathway, Ken