The March issue provides a wealth of insights shared by FDA, EMA and PMDA biotherapeutic and vaccine regulators on the challenges, opportunities, and learnings as they have sought to support the accelerated product development and review called for by the pandemic, while assuring that CMC/quality standards are met and keeping up with their non-COVID-related workload. Included are updates on the guidances and other quality-related initiatives impacting vaccines and biotherapeutics that have been forthcoming during the first quarter of 2021.
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
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
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.
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.