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.
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.
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.
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.