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Tuesday, June 20 • 2:00pm - 3:15pm
#262: Clinical Relevant Specifications: Leveraging Principles of QbD

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Laurie Graham


FDA Perspective
Sarah Pope Miksinski, PhD

Using QbD Principles to Establish Launch Program Specifications
John Joly, PhD


Laurie Graham

Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States
Laurie Graham is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER). DIPAP is responsible for... Read More →

John Joly

Senior Director Analytical Development and Quality Control, Genentech, A Member of the Roche Group
John Joly is the head of Analytical Development & QC at Genentech within the Pharma Technical Development organization. John has been at Genentech for 24 years and led the Early Stage Cell Culture department for 10 years. John was the Technical Development Team Leader for Lucentis... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance, OPQ, CDER, FDA
Dr. Miksinski received her B.A. from Earlham College (1994) and her Ph.D. from Oklahoma State University (1999). She served as an NIH postdoctoral fellow from 2000-2002, and began as a CMC reviewer at the FDA in 2002. She is now the Acting Director of ONDQA/DNDQA 2.

Tuesday June 20, 2017 2:00pm - 3:15pm CDT
S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  11: Quality, Session
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  • Credit Type CME, IACET, RN
  • Tags Session