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Clinical Relevant Specifications: Leveraging Principles of QbD
Session Chair(s)
Laurie Graham
Director, DIPAP, OPPQ, OPQ, CDER
FDA, United States
Quality specifications are established to confirm and demonstrate that all product critical quality attributes are in control, reliably deliver consistent product and guarantee appropriate safety and efficacy for the patient. However, current in vitro methods for evaluating product quality are not always biorelevant or predictive of product performance. The challenge is how to effectively develop product specifications that provide appropriate relationships to in vivo product performance. Suggested topics for presentation and discussion include: biopharmaceuticals assays that demonstrate predictive product performance, using clinical study results to support quality specifications , the regulatory acceptance of in silico methods to establish in vivo/in vitro relationships and ICH M9 BCS-based biowaivers .
Learning Objective : Discuss industry and regulatory (Office of Pharmaceutical Quality) perspectives on clinical relevance; Describe approaches, for both small molecule and biotechnology products, to establishing clinically relevant specifications, including leveraging quality by design; Discuss case studies that demonstrate the establishment of or challenges associated with clinically relevant specifications.
Speaker(s)
FDA Perspective
Sarah Pope Miksinski, PHD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Using QbD Principles to Establish Launch Program Specifications
John Joly, PHD
Genentech, A Member of the Roche Group, United States
Senior Director Analytical Development and Quality Control