Combination Products Conference

Where regulators and industry share insights on leveraging regulatory and technological change to advance combination products.

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Session 7: Regenerative Medicine and ATMPs: Combined Product Perspectives and Watch-Outs

Session Chair(s)

James Wabby, MHS

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products

AbbVie, United States

Advancements in cellular and molecular biotechnology has resulted in a new segment within biological medicinal products which has led to the development of Combined Advanced Therapy Medicinal Products (CATMPs). Although they offer ground-breaking treatments for unmet medical needs, these products also present challenges within the development and manufacturing space.

Learning Objective : At the conclusion of this session, the participant should be able to:
Identify combined stability and shelf-life program considerations and opportunities
Outline best practices in drug delivery change control for post-approval evaluations
Describe challenges and opportunities in lifecycle management programs for complex CATMPs

Speaker(s)

Regenerative Medicine and ATMPs: Combined Product Perspectives and Watch-Outs

Iris K. Marklein, PhD

FDA, United States

Biomedical Engineer