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The experience of the pandemic has underscored the criticality of assuring that regulatory processes keep pace with innovation in the manufacturing and control arena and has spurred the efforts that were underway in Europe to assess the issues involved and implement the adaptations needed to address them. Β The three parts of the IPQ story featured in IPQ’s October 2022 issue address the progress of these efforts.
The story featured in IPQ’s October 2022 issue focuses on how EMA’s toolbox on CMC flexibilities has been evolving to incorporate industry input and learnings from the pandemic. The three parts of the story center around the discussions that took place at a session of the October 2022 CASSS CMC Strategy Forum at which regulator and industry leaders shared their experiences and learnings in applying flexibility tools from a regional and global perspective.
The two stories featured in IPQ’s August/September 2022 issue explore: ● the dialogue now going on among regulators, pharmacopeias, and industry on the challenges associated with the manufacturing, characterization, and QC of nanoparticle-based formulations, and ● how CBER’S Advanced Technologies Program (ATP) is being strengthened through the expansion of internal and external funding, scientific and regulatory expertise, and CBER Advanced Technologies Team (CATT) collaboration, and the recent experience of CDER’s Emerging Technology Team (ETT).
The four-part story featured in IPQ’s June/July Monthly Update explores how an FDA-commissioned study carried out though the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator dialogue and agenda on advancing innovation in pharmaceutical manufacturing. With a workshop held on the study report as a central point of reference, the four parts cover: ● the study’s focus, aim, process, organizations involved, and recommendations ● the mechanisms that are now in place to enable innovation ● the challenges and opportunities that are presenting themselves, and ● the path forward. Included are updates on related developments and discussions since the workshop was held.
The three-part story featured in IPQ’s May Monthly Update explores how the pandemic and longer-term trends are converging to spur pharma innovation, collaboration, and operations modernization. In focus in the three parts are: ● insights on these trends from key thought leaders ● the coordination role the US government is playing in addressing the pandemic and other health crises, and ● how the Gates Foundation is helping support the development of new technologies for improving vaccine access in low- and middle-income countries (LMICs).
The two stories in IPQ’s March/April 2022 issue explore: ● the drivers for and progress in incorporating more third-party auditing of excipient suppliers into user quality management systems, and ● updates from regulator, compendial and industry experts on the CMC challenges of peptides and oligonucleotides.
The two stories in IPQ’s January/February issue explore: ● FDA, industry consortium, and ICH efforts to modernize the way quality information is collected, submitted, and managed, and ● the efforts to strengthen the interface between FDA and industry around manufacturing modernization, with insights from two innovation champions, Janet Woodcock and Jeff Baker.
The two stories in IPQ’s December Monthly Update explore: ● the recent efforts of the USP and European Pharmacopeia to meet the needs of the emerging biotech product modalities and their complex analytical challenges, and ● recent developments in the European GMP arena as its regulator and industry stakeholders work with their counterparts globally to digest and deploy the experience and learnings from the pandemic.