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.
An FDA-commissioned study carried out through the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator agenda on advancing innovation in pharmaceutical manufacturing.
PART I: The NASEM Study and FDA Reflections
PART II: Existing Mechanisms to Enable Innovation
PART III: Challenges and Opportunities
PART IV: The Path Forward
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).
Pandemic Experience Showcases the Potential for Faster Innovation, More Collaboration, and Workplace and Operations Modernization
The potential for faster innovation, and the power of collaboration and workplace and operations modernization are emerging into high relief as the assessment of the pandemic experience continues to deepen.
Among recent venues where industry and regulators have come together to explore these themes was the February ISPE Facilities of the Future Conference. Focused on the dialogue that took place there, the IPQ story that follows is divided into three parts:
PART I: The Evolving Landscape of Pharmaceutical Operations
PART II: Government-Industry Collaboration in This and Future Pandemics
PART III: Reducing the Cost of Vaccine Manufacturing for Broader LMIC Access
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 progress in understanding and addressing the challenges of impurities was a key focal point of this year’s USP Therapeutic Peptides and Oligonucleotides Workshop, held virtually on February 28, March 2 and March 4, 2022.
PART I: US and European Regulator Perspective on the CMC Challenges of Oligonucleotides
PART II: USP Standards Development Efforts for Peptides and Oligos
PART III: Peptide and Oligo Analytical, Manufacturing and Raw Material Considerations
Pandemic Experience and Supply-Chain Risk Management Expectations Increase Attention on Excipient GMP Third-Party Auditing
The pandemic experience and the increasing expectations of regulators regarding supply chain visibility and risk-management are driving forces for incorporating more third-party auditing of excipient suppliers into user quality management systems.
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.