Jul 31, 2024
Pushing the 505 (b)(2) Envelope
Vivpro Corporation has partnered with experts and industry leaders to discuss critical pharma and biotech topics. Our goal is to share valuable information and allow the audience to engage with questions while they receive real-time feedback.
For our July session, we are joined by:
Dr. Joga Gobburu, Co-Founder, Vivpro Corp & Executive Director, Center of Translational Medicine, School of Pharmacy. University of Maryland, Baltimore
Dr. Patrick Marroum, Distinguished Research Fellow, Abbvie
At this WebChat you will gain insights into the following:
What is 505(b)(2) registration pathway?
Are there ways to accelerate approval?
Are safety and efficacy always required for this pathway?
Is a pre-IND meeting recommended?
What are the top 3 questions from regulatory authorities?
About Dr. Patrick Marroum
Dr. Marroum obtained his pharmacy degree from the University of Pittsburgh in 1984 and a Ph.D. in pharmacokinetics from the University of Florida in 1990. In 1991, he joined the FDA as a reviewer in the Division of Biopharmaceutics. In 1995, he became the team leader in clinical pharmacology and Biopharmaceutics for the Cardio-Renal team.
