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Drug Development for Commercial Success
Session Chair(s)
Michele Sharp, PHARMD
Senior Director, Global Regulatory Affairs
Eli Lilly and Company, United States
Many companies make development plans based on the shortest path to filing a marketing application. This may mean doing the minimum number of trials required to gain approval and designing trials to maximize the probability of gaining a positive clinical outcome. This panel will describe and discuss an alternative approach. By understanding the promotional claims necessary for successful commercialization before pivotal trials are initiated and by involving all the relevant regulatory disciplines in designing a development program, the probability of commercial success can be maximized.
Learning Objective : Describe and discuss internal company roles and processes for targeted drug development resulting in successful registration, differentiated labeling and impactful promotional claims.
Speaker(s)
Panelist
Darshna Patel
Neurocrine Biosciences, Inc., United States
Executive Director, Global Regulatory Affairs
Panelist
Lynette Hopkinson
Vertex Pharmaceuticals Incorporated, United States
Vice President, Commercial Regulatory Affairs, Global Regulatory Affairs