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The Realities of Late Life Cycle Management for Very Old Legacy Brands

Track:
Regulatory Affairs and Submissions

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
389

Room Number:
1B

Level:
Intermediate

Type:
Forum

Title:
The Realities of Late Life Cycle Management for Very Old Legacy Brands

Chair(s):
Bijal Pandhi, PharmD
Global Program Regulatory Manager
Novartis Pharmaceuticals Corporation, United States

Description:
This forum will provide a recent case study that illustrates the challenges sponsors face when managing the life cycle of legacy brands. A panel of experts will provide their perspective and discuss ways to mitigate these challenges.

Learning Objective(s):
Define a general understanding of the challenges of late product life cycle management; Describe a perspective of how industry and regulators manage these challenges; Restate a recent case study that provides examples of managing such changes (benefit-risk review of calcitonin-salmon drug class).

Presentation(s) & Speaker(s):
Industry Perspective
Paul Aftring, MD, PhD
Global Program Head, Established Medicines
Novartis Pharmaceuticals Corporation, United States

FDA Perspective
Theresa Kehoe, MD
Clinical Team Leader, Div. Bone, Reproductive and Urologic Products, OND, CDER
FDA, United States

Development of An Integrated Response
Steven M. Weisman, PhD
Head of Clinical and Regulatory Support
Innovative Science Solutions, United States