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The News in Depth

Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021

This four-part story explores the significant impact of the pandemic during 2020-2021 on the CMC review processes for vaccines and biotherapeutics at FDA, EMA and Japan’s PMDA in their efforts to support accelerated product development and review, while assuring that quality standards are met and the ongoing non-COVID-related workload addressed.

Part I: EMA Perspective

Part II: FDA CBER Perspective

Part III: FDA CDER Perspective

Part IV: Panel Discussion Among US, Europe, and Japan Regulators

IPQ Monthly Update – February 2021 in Review

The issue focuses on how academia and industry are collaborating to address the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them. The six-part coverage explores the dimensions of these challenges and the collaborations that are being formed and strengthened to address them.

Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development

Academia and industry are collaborating more intensely on addressing the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them.

Part I: NIIMBL’s Engagement with Academia on Workforce Development Needs

Part II: ISPE Workforce of the Future Traction at UMBC and UC Davis

Part III: Keck Institute’s Behrens on Biopharma Talent Needs and KGI/Industry Partnering

Part IV: Xavier’s Phillips on Sharable Quality and Regulatory Science Curriculum

Part V: CASSS Panel on Opening Up Biopharma Career Pathways

Part VI: European and Global Workforce Development Collaborations

IPQ Monthly Update – January 2021 in Review

Drawing attention in the January issue are: ● how the research, technologies and partnerships that have been gelling in recent years made possible the rapid development of a coronavirus vaccine in 2020 ● how USP has intensified its focus on supply chain vulnerabilities and vaccine/treatment development to help support the pandemic response, and ● FDA’s ongoing progress in improving the usefulness and user-friendliness of its inactive ingredient database (IID).

Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure

FDA’s latest efforts to improve the functionality of its Inactive Ingredient Database (IID) include a quarterly log to track changes in the records and the use of the term “maximum daily exposure” (MDE) in lieu of “maximum potency.”

Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference

The precision and speed of COVID-19 vaccine development was made possible by recent R&D advancements and a strengthened network of public-private partnerships, NIH National Institute for Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VCR) Deputy Director Barney Graham affirmed in his keynote presentation at the opening session of the CASSS Well-Characterized Biotechnology Products (WCBP) conference in late January.

Pandemic Intensifies USP’s Focus on Supply Chain Vulnerabilities and Vaccine Development

Improving understanding of supply chain vulnerabilities and providing support for vaccine development and delivery are two focal points of the USP effort to help address the pressing challenges that the COVID-19 pandemic has brought to the fore regarding the availability of quality medicines.

IPQ Monthly Update – November/December 2020 in Review

IPQ’s attention during November and December remained centered on the impact of the COVID-19 pandemic. In focus in the two stories in the issue are: ● insights from European experts on the myriad of complex issues that have to be addressed in getting the vaccines from manufacturers into the arms of the billions of people around the world that will need to receive them, and ● how the internal operations and external communication processes among pharmacopeias, industry and regulators are being adapted and collaboration expanded.

Pandemic Spurs Deepening of Pharmacopoeia/Regulator/Industry Communication Channels

The pandemic is prompting all of those involved in medicine production, regulation, and standards-setting to take a hard look at their operations for how they can be: ● adapted to continue being productive and address the pandemic exigencies, as well as ● potentially improved on a longer-term basis. It is also significantly deepening communication and cooperation channels.

Part I: EDQM Pandemic Actions Continue Apace in Fall 2020

Part II: Pharmacopeia, Regulator and Industry Expert Panel Explores Pandemic and Nitrosamine Communications

Part III: Second Panel Focuses on Pandemic Organizational Impacts and Key Learnings

Part IV: EDQM and Ph. Eur. Evolution Addressed by Leaders Keitel and Vielle

COVID Vaccine Global Distribution Challenges Explored by Bio Supply Management Alliance (BSMA) Panel of European Experts

A panel of leading experts, assembled virtually for the 2020 Bio Supply Management Alliance (BSMA) Europe symposium on November 12, seized on the analogy of a Formula One race pitstop in assessing the expertise, cooperation, and timing that will be needed for successfully delivering COVID-19 vaccinations.
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