At the 2020 annual conference of the Washington, D.C.-based Food and Drug Law Institute (FDLI), held virtually on October 6-8, Center for Biologics Evaluation and Research (CBER) Director Peter Marks provided valuable insights on the difficult terrain that the regulators at CBER have to navigate to reach their goal of making effective vaccines and therapeutics for COVID-19 available as efficiently as possible.
Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement Efforts
Over the last few years, FDA has ramped up its efforts to protect the public from unapproved and potentially dangerous stem cell products, while striving to create a regulatory framework and approach that is as supportive as possible for the advancement of the entire cell and gene therapy (CGT) field.
Design-Based Development Paradigm for Cell/Gene Therapies Will Significantly Reduce Costs, Timelines and Regulatory Concerns, AGT CEO Galvin Maintains
The more efficient, design-based development paradigm for cell and gene therapies, coupled with their therapeutic power, will dramatically reduce manufacturing and testing costs and timelines and significantly alter the regulatory dynamics, American Gene Technologies CEO Jeff Galvin affirmed in his plenary presentation at the PDA annual meeting held virtually in late July.
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Synthesis and Analysis Advancements Are Unleashing the Potential of Peptides and Oligos, Spurring CMC Regulatory Dialogue
Advancements in synthesis and analysis technologies are helping unleash the therapeutic potential of peptides and oligonucleotides, spurring the dialogue on how the CMC/quality regulatory expectations, guidance and standards should keep pace.
USP Convention Meets Virtually in May 2020 to Review Upcoming Priorities, with Both 200-Year Legacy and Current Pandemic in Focus
In May 2020, the USP Convention (USPC) met virtually to review how its central role in advancing public health has evolved during the broad sweep of its 200-year history on the one hand, while assessing its response to the pressing needs of the COVID-19 crisis now dominating the healthcare field on the other.
The urgency of delivering a vaccine for COVID-19 in previously unattainable timeframes and volumes is throwing the spotlight on the expanded role next-generation sequencing (NGS) needs to play to avoid the time delays and other limitations of in vivo/animal testing.
PART II: Sanofi Pasteur and Ghent University Experience with NGS [CLICK HERE]
PART III: A Decade of Regulator/Industry Collaboration on NGS [CLICK HERE]
PART IV: Stakeholder Engagement Begins on ICH Q5A Revision [CLICK HERE]
PART V: Effort to Reduce Animal Testing for Vaccines Includes Global Health Fund Support for NGS [CLICK HERE]
NIIMBL Progress Includes Partnership with Biophorum on Buffer Mixing and Global Health Fund with Gates Foundation
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is partnering with the industry consortium BioPhorum to develop a more streamlined, cost-effective, and resource-conserving way of addressing the buffers used in biopharmaceutical manufacturing.
Top FDA Drug Compliance Concerns during 2019 Included OTCs, Supply Chain Information Flow, Compounding, and Genotoxic Impurities
Over-the-counter (OTC) drugs – from raw material supply through product manufacturing and distribution – remained a central concern at the FDA Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) during 2019.