This session presents cases studies and practical experiences from industry on implementing the advanced concepts of patient-centric quality standards. This includes challenges observed and examples from protein therapeutics as well as cell & gene therapies. The perspective and experience from regulators will be shared. The presentations will be followed by a plenary discussion to improve mutual understanding and establish good practices to ensure a robust, safe and efficacious patient experience.

Session Speakers:

A High Threshold of Aggregate Numbers Is Needed to Induce Immunogenic Response in Vitro, in Vivo, and in the Clinic

Kimya Nourbakhsh, Amgen Inc.

Strategies for Defining Specifications in Autologous Cell Therapy Products

Daisy Nie, Novartis Pharmaceuticals Corporation

Case Studies for Patient-Centric Specification Setting for a Therapeutic Protein and IQ Readout on Endotoxin Acceptance Criteria

Katrina Kearns, Pfizer, Inc.

Allowable Excess Volume and Gross Content Requirements and Challenges For Injectable Drug Products in Vials

Ehab Moussa, AbbVie Inc.

Additional Panelist:

Fiona Cornel, Health Canada

Markus Blümel

Appearances