Open Forum Information: Sunday, June 22
1:30 pm - 5:00 pm
RS Open Forum: Comparability Protocols for Biologics - How Can They be Leveraged to Obtain Regulatory Relief?
An additional fee is required to attend this open forum.
Funded by a Grant from 
Chemistry, Manufacturing and Control (CMC) changes are necessary to continuously improve the quality of drug or biologic products during their development and post-approval lifecycle. Demonstration of comparability is needed to show that the CMC improvements/changes have no adverse impact on the identity, strength, quality, purity and potency of the drug substance or the drug product which has relevant impact on the safety and efficacy of the drug. Ideally, it is preferred to demonstrate comparability by in-vitro tests such as physico-chemical characterization and biological assays. However, due to the complex nature of some pharmaceutical products some changes might require non-clinical (animal) and even human studies. The complexity of products increases significantly for manufacturing complex biologics, such as those derived from living cells or live virus products. Regulators have issued guidance on demonstration of comparability of biological products (FDA in 1996, ICH Q5E in 2005). In 2003, the FDA also issued separate draft guidances on “Comparability Protocols” for Drugs and biologically derived products, which provides recommendations for preparing and using comparability protocols for CMC changes. A comparability protocol is a comprehensive written plan detailing how a company will assess the impact of specific CMC changes and demonstrate that the specified changes have no adverse affect on the product. By seeking regulatory approval of a comparability protocol during development or in the eCTD (NDA/MAA), the company will more clearly and prospectively define the criteria for a change in agreement with FDA may achieve regulatory relief of a reduced reporting category and be able to implement CMC changes sooner.
This open forum will address the merits and practical challenges of using comparability protocols, how biotech companies are utilizing them and how it can be leveraged to achieve better regulatory relief.
Moderators
Richard Lowenthal, M.S.
MSEL
Sanjay Sehgal, Ph.D.
Gilead Sciences Inc.
Introduction: Comparability Protocols, ICH / FDA Guidance, and Opportunity for Regulatory Relief
Sanjay Sehgal, Ph.D.
Gilead Sciences Inc.
Demonstration of Comparability for CMC Changes in Biologics Manufacturing
Richard Riggs, PhD
Comparability Protocol and Regulatory Relief: FDA perspective
Kathy Lee, DTP
Office of Biotechnology Products, CDER, US FDA
Comparability Protocol and Regulatory Relief: EU/EMEA Perspective
Dr. Anne Cook
London, UK
Pharmaceutical Assessor, Biologicals and Biotechnology Unit Medicines and Healthcare products Regulatory Agency (MHRA)
Comparability Protocol and Regulatory Relief: Industry perspective / Case Study
Richard Lowenthal, MS
San Diego, CA
MSEL, Pacific-Link Consulting