Efficient Use of 505 b(2) Pathway to Enter US Market

October 21, 2021 | WEBINAR

When: Thursday October 21 2021, 6:30 - 7:30 AM Eastern Time (US)
Where: Online
Presenter: Dr. Joga Gobburu, UMB and Pumas-AI, Inc.

505 b(2) provides a hybrid registration pathway to obtain market approval in the US. However, its use does not come with a manual. Sponsors often face challenges determining the studies to be conducted for approval via 505(b)(2) pathway. Questions include:

  • "Do we need to conduct two efficacy trials?"
  • "What should be the regulatory communication strategy?"
  • "Does Model-Informed Drug Development expedite my time to market?"

A renowned scientist in the area of quantitative disease models and their application to decisions, Dr. Joga Gobburu addresses these questions and many more in this webinar, outlining a methodical approach to achieve a successful drug development pathway.

During his illustrious tenure at the US FDA, Dr. Gobburu oversaw the review of thousands of Investigational New Drug Applications (INDs), over 250 New Drug and Biological Licensing Applications, numerous FDA guidances and policies and was part of the committee responsible for the 21st Review Process. He led both the formation of the Division of Pharmacometrics and a Pharmacometrics Fellowship Program at the FDA.

Dr. Gobburu is on the editorial boards of several journals and a Fellow of ACCP, AAPS and International Society of Pharmacometrics. He has published over 100 papers and book chapters, and has held various positions at the US FDA between 1999 and 2011. He is currently a Professor with the School of Pharmacy and the School of Medicine, University of Maryland, Baltimore and a co-founder of Pumas-AI.

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