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IPQ Monthly Update – September/October 2020 in Review

The impact of the COVID-19 pandemic remained central to IPQ’s coverage during September and October. The three stories in this issue focus on: ● the insights from CBER Director Peter Marks on the difficult terrain that regulators have to navigate with industry to reach the goal of getting effective vaccines and therapies for COVID-19 available as efficiently as possible ● USP’s global collaborative efforts to strengthen the standards and accelerate innovation in the biologics arena, and ● the attention FDA is putting on risk management plans (RMPs) to help in the drug shortage prevention and mitigation part of the pandemic response.

Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation

The stresses of the COVID pandemic on the drug supply chain have thrown a spotlight on the importance of risk management plans (RMPs) in preventing and addressing drug shortages.

USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement

Direct engagement in the ICH guideline development and revision process is helping USP prioritize its related compendial standard setting, revision, and harmonization efforts, and, in turn, enriching ICH awareness of the pharmacopeial standards and approaches that can help inform its guidelines.

CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference

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.

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.
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