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The News in Depth

IPQ Monthly Update – July/August 2020 in Review

The first story provides thought-provoking insights from Jeff Galvin, the CEO of California-based American Gene Technologies (AGT), on the implications of the design-based development paradigm and therapeutic power that comes into play for cell and gene therapies. The multipart story that follows takes our readers inside FDA’s efforts to adapt its CMC regulatory processes and expectations to the CGT needs. Addressed are the various ways in which CBER has been seeking to fulfill the two complementary sides of FDA’s mission in the CGT arena – protecting the public from unapproved and potentially dangerous products, and striving to create a regulatory framework and approach that is as supportive as possible for advancing the field.

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 Affirms

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.

IPQ Monthly Update – June 2020 in Review

In this issue, IPQ explores the dialogue on how the CMC/quality regulatory expectations, guidance and standards can keep pace with and best support the expanding therapeutic potential of peptides and oligonucleotides. The second story focuses on the discussion at USP’s five-year meeting in May by its leadership of the key challenges that the world faces in assuring the supply of quality medicines and the role that USP can play in addressing the challenges through its standards setting, advocacy, and capability building efforts.

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.

IPQ Monthly Update – April/May 2020 in Review

The need for intensive collaboration to address the complex challenges of assuring the quality and availability of the world’s medicines has only deepened in the face of the global pandemic we are now facing, as the two stories in our review of April and May make clear. ● The first story is a five-part exploration of the collaborative efforts now going on globally to advance in vitro testing in assessing and controlling adventitious viruses for vaccines and biotherapeutics – and to unleash the potential of next-gen sequencing in particular. ● The second story explores how the National Institute for Innovation in Manufacturing Biopharmaceuticals has been evolving and some of the challenges now drawing the attention of the public/private partnership.

COVID-19 Vaccine Urgency Throws Spotlight on Next-Gen Sequencing for Virus Control

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.

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.

IPQ Monthly Update – March 2020 in Review

The first story in the March Monthly Update explores recent FDA global field inspection and enforcement operations. In focus are: ● the impact of the pandemic ● the field office’s API and drug product inventory and enforcement tools ● recent warning letter and import alert data and trends, and ● progress on the goals of reducing the timelines for inspection classification/notification and warning letter issuance. The following story provides insights from FDA’s drug compliance management on the recent global developments and trends of significance across the API, OTC, sterile product, compounding, and supply chain arenas.
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