Special Topic 4: PDA QbD Book and PDA Vaccine Development Lifecycle Technical Report
Quality by Design (QbD) is not a new concept in fact, the first thoughts on it date back to the 1950s, but it’s more typically associated with the FDA’s steps to include QbD concepts into cGMPs starting in 2002 and the publication of ICH Q8 in 2006. It places an emphasis on product and process understanding and process control based on sound science and quality risk management. Over the last eighteen months the true value of QbD in facilitating the rapid but effective development and safe deployment of quality vaccines to fight a global pandemic has been realized. This session will highlight specific applications of QbD in vaccine development with reference to the soon to be published PDA Technical Report, but also remind us of the value of investing in this type of approach more broadly within our industry as outlined in the PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, published in March 2021.
Moderator: Valerie Whelan, Vice President, Quality Operations, Amgen Inc.
08:30 | Strategies for Vaccines Development and Lifecycle Management: What We Are Advocating For
Sabrina Restrepo, PhD, Director, Merck & Co., Inc.
08:50 | Quality by Design: An Indispensable Approach to Accelerate BioPharmaceutical Product Development
Cristiana Campa, PhD, Technical R&D Advisor and Fellow, GlaxoSmithKline
09:10 | Q&A with Speakers and Additional Panelist
Amin Khan, PhD, Chief Science Officer, Human Health, GreenLight Biosciences, Inc.
Special Topic 5: AI Research Force (AIRForce) Group: Focus on Artificial Intelligence and Machine Learning
The exploration of the potential of Artificial Intelligence and machine learning technologies in the pharmaceutical space has gained great interest in recent years. From predictive maintenance to drug development and repurposing and virtual learning platforms, the applications seem boundless. But the question still remains: How can such technology be validated and controlled? In this session, FDA's Division of Bioinformatics and Biostatistics at the NCTR will present a model developed and implemented through their AI Research Force (AIRForce) team. Join us for a behind the scenes look at the design and implementation efforts in developing, qualifying, and piloting an AI system including the challenges faced and lessons learned.
Moderator: Rebecca E. Dombrowski, MS, Supervisory Investigator, ORA, U.S. FDA
08:55 | Q&A
08:30 | Artificial Intelligence for Regulatory Science Research
Weida Tong, PhD, Director, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. FDA
Special Topic 6: Risk Management of Non-Ingredient Suppliers
Moderator: Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA
The pandemic has no doubt created lots of shortage in our supply chain, including materials used in the manufacturing process of various drugs and vaccines. Due to the complicated supply chain management, manufacturers come to face with back orders of supplies, such as glass vials, stoppers, sterile filters, single use systems, etc. Distress grows as manufacturers learned that their supply is on back order which forced them to look for alternatives in manufacturing capability and flexibility in regulatory communication with the FDA.
At this session, you will hear from the FDA the regulatory framework for managing such situation. An example how risk-based approaches and practical quality risk management tools can play a role in the overall control strategy and change management system within the pharmaceutical quality system will also be presented.
08:30 | Risk Management of Non-Ingredient Suppliers: Current Regulatory Concerns
Patricia F. Hughes, PhD, Senior Scientific Advisor, CDER, U.S. FDA
08:45 | The Use of QRM to Ensure Process and Product Control During Non-Ingredient Material Shortage
Tiffany A. Baker, MBA, Consultant, ValSource Inc.
09:05 | Q&A with Speaker and Additional Panelist
Renée S. Blosser, MS, Microbiologist, CVM, U.S. FDA