5th PQRI FDA Conference on Advancing Product Quality

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Day 3 – December 3, 2021

Product Quality Track– Innovation in Quality & Technology Beyond the Pandemic

In a post-pandemic world, developing agile and innovative solutions that adapt to the pace of change is critical for all aspects of the pharmaceutical product lifecycle including regulatory, manufacturing, and quality. This Track will explore current developments in modernization of regulatory submissions, in advanced manufacturing, and in remote site evaluations which are each evolving in real-time to address these future challenges.

Bios for December 3, 2021 Speakers

Topic/Speaker		Abstract
SESSION 1: Knowledge-aided Assessment and Structured Application (KASA) and Pharmaceutical Quality/CMC (PQ/CMC) Update
Moderator: Nina S. Cauchon, Ph.D., Director Regulatory Affairs, Amgen Inc.
An Overview of FDA’s KASA System Susan M. Rosencrance, Ph.D. Director, Office of Lifecycle Drug Products, OPQ/CDER, FDA	Knowledge-aided Assessment and Structured Application (KASA) is a system being designed to modernize FDA’s assessment using structured data, advanced analytics, and knowledge management. This presentation will provide an overview of the KASA system, give an update on what has been accomplished thus far, and share the vision for the future as we continue to expand the system.
KASA for Biologics Steven Kozlowski, M.D. Director, Office of Biotechnology Products, OPQ/CDER, FDA	Knowledge-aided Assessment and Structured Application (KASA) is a structured framework being used for small molecule drugs to capture and manage product lifecycle knowledge, establish rules, algorithms and analyses to manage product quality risks, and to compare risks across a portfolio of products and facilities. The KASA structured framework stores information in a useful manner and radically eliminates text-based narratives. The benefits of KASA apply to large as well as small molecules and efforts to develop KASA for biological products will be shared.
FDA Pharmaceutical Quality Electronic Standards (aka PQ/CMC) Geoffrey Wu, Ph.D. Deputy Office Director, Office of Lifecycle Drug Products, OPQ/CDER, FDA	FDA has been striving to standardize and structure the quality information in regulatory submissions in order to take the full advantage of the 21st IT technologies (e.g., machine learning and other advanced analytics) and eventually to improve its effectiveness in decision-making. In 2014, the Pharmaceutical Quality Chemistry Manufacturing and Controls (PQ/CMC) initiative was launched, affecting three centers (CDER, CBER and CVM). This presentation will provide an update on this initiative, elaborate on how it is related to other initiatives inside and outside FDA, and discuss how it can advance knowledge management throughout product lifecycle.
Accumulus Synergy and Data Exchange: A CMC Application Using Structured Data and a Cloud-Based Eco-system Michael Abernathy, MS, RAC Data Exchange Product Owner Accumulus Synergy	Accumulus Synergy, a non-profit sponsored by leading biopharmaceutical companies, is developing a cloud-based collaborative platform intending to facilitate real-time data exchange and global health authority review. The platform under development proposes shared and locked spaces providing sponsors and regulators a collaborative and communicative workspace to share and exchange information. The Accumulus platform looks to utilize common core data entities that can be mapped into eCTD modules to unlock re-usability and enable standardization. Sponsors can utilize Structured Content and Data Management (SCDM) systems to automate the compilation of data and electronic narrative that can be “pushed” to the Accumulus cloud to facilitate efficient data exchange, collaboration and parallel reviews. In addition, to ease access and exchange of information, Accumulus also prioritizes data privacy and security to protect patient, sponsor, and regulator information. Accumulus is currently assessing platform capabilities through two use cases; 1) Parallel Review Shared-Space, and 2) Data Exchange through a CMC Application. Providing a platform by which data can be exchanged in usable format enables more efficient filing processing and improved assessment capabilities. Once the data exchange platform is established, the technologies and principals can extend to clinical, nonclinical and safety data.
Cloud-based Assessment and M4Q(R2) Revision Lawrence X. Yu, Ph.D. Director, Office of New Drug Products, OPQ/CDER, FDA	The future of regulatory review is the cloud-based assessment, which would enhance benefit-risk considerations, increase access to quality data and information, streamline regulatory assessment, facilitate oversight of pharmaceutical product quality, increase consistency and efficiency in regulatory decision-making and actions, and improve communication. This presentation will describe the cloud-based assessment. This presentation will also update the progress of ICH M4Q(R2) revision.
HOT TOPIC: Remote Interactive Evaluations (RIEs)
Moderator: Cat Vicente, Johnson & Johnson
Remote Interactive Evaluations Lane Christensen, Ph.D. Branch Chief Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA Stelios Tsinontides, Ph.D. Director, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA	Earlier this year, the US Food and Drug Administration published a Guidance for Industry titled “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency” in response to the ongoing Public Health Emergency. This presentation will discuss how the FDA is incorporating RIEs as an alternate tool to be used in its oversite of drug manufacturing facilities. An overview of the guidance will be provided addressing the roles of the FDA and pharmaceutical industry. Examples will be provided on lessons learned to date from the implementation efforts of this guidance.
SESSION 2: Advanced Manufacturing Concepts Beyond Continuous Manufacturing
Moderators: Robert Meyer, Ph.D., Merck & Co., Inc. and Rajan Jog, Ph.D., FDA
Combined Slides for Session 2
A Vision for Agile Manufacturing Celeste Frankenfeld Lamm, Ph.D. Director, Merck & Co.	Industry, regulators, and government agree: We need agile pharmaceutical manufacturing. The recent and on-going pandemic has emphasized the challenges to manufacturing and supply chains, but also demonstrated that through innovation, we can meet great logistical and regulatory challenges. Portable and distributed manufacturing are important tools for agility. They can ensure medicine is delivered quickly and reliably to patients by enabling speedy response to changing volume needs, delivering short-lived or small volume products, and providing manufacture in close proximity to patients. However, challenges to implementation remain, and will require the ingenuity and cooperation of industry, regulators, and government to realize the full promise of agile manufacturing.
Pre-Fabricated Solutions for New Facilities Peter Makowenskyj, MEng. Director of Design Consulting G-CON	Within the biopharmaceutical industry, there has been a rapid migration to prefabricated solutions for new facilities to enhance speed to market and maximize return on investment. We will look at the evolution of pre-fabricated cleanrooms and how they are de-risking new projects.
Decentralized Pharmaceutical Manufacturing: The Next Big Thing? Christine M. V. Moore, Ph.D. Executive Director, Organon	Current traditional pharmaceutical manufacturing relies on centralized facilities with complex supply and distribution chains that transverse the globe. Both the advent of cell and gene therapies and COVID pandemic supply chain challenges have increased interest in moving pharmaceutical manufacturing closer to the patients. This brief presentation will review new technologies to support decentralized and point of care pharmaceutical manufacturing and discuss current regulatory challenges.
Regulatory Perspective on Advanced Manufacturing Sau (Larry) Lee, Ph.D. Deputy Director of Science Office of Pharmaceutical Quality/ CDER, FDA	This presentation will describe FDA experience in pharmaceutical manufacturing innovation, discuss technical and regulatory challenges related to development, implementation, and regulatory assessment of new technologies, and explain current FDA/CDER’s effort to address these challenges.