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  • Feature ArticlesFeature Articles

    Interacting with competent authorities during COVID-19 – A European perspective

    This article covers direct interaction with various European authorities in regard to initial and amendment submissions and notifications related to urgent safety measures in response to the COVID-19 pandemic. The authors contacted selected European authorities to solicit data on submission events during 1 March and 30 June 2020. They found that the first 6-12 weeks of the pandemic presented challenges to numerous stakeholders but, after adjustments, the number of trials s...
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    The Canadian application process and alternate pathway for COVID-19‒related clinical trials

    This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range clinical trial submission requirements and communication with Health Canada’s re...
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    Regulatory Focus, July issue: Cell and gene therapy

    Feature articles during July focused on global regulatory strategy for cell and gene therapy, with articles on US and EU regulations and guidances and the development and manufacture of the therapies. Also included were articles on recasting the corrective and preventive action (CAPA) process as a continuous improvement process, a military-civilian perspective on real-world evidence (RWE) to support regulatory decision making, and regulatory reporting in multinational tria...
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    Advanced therapies: ‘Trip hazards’ on the development pathway

    This article concerns the development of advanced therapies and the challenges and complexities of getting them through the developmental pathway, which the authors call “the trip.” The authors examine at strategic levels the importance of some of the fundamental building blocks for the development program and highlight some commonly encountered challenges (trip hazards) for cell and gene therapies and offer “bench-to-bedside” and chemistry, manufacturing, and controls (CM...
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    A military-civilian perspective on real-world evidence to support regulatory decision making

    This article summarizes the framework promoting the collection and analysis of real-world data (RWD) in the healthcare system. The authors emphasize how the US Military Health System (MHS) used RWD during the Iraq and Afghanistan Wars to achieve historic rates of survival and describe a new era of collaboration between the US Department of Defense (DoD) and the US Food and Drug Administration (FDA). The article reviews the FDA evidentiary standards for medical product appr...
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    Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

    This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical...
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    US regulations for regenerative medicine advanced therapies

    This article examines US regulations and guidance documents for regenerative medicine advanced therapies (RMATs). The author describes the field of regenerative medicine, noting that it is expanding at an accelerated pace, and outlines some of the common terms associated with it. He also addresses the application process for these therapies, accelerated regulatory pathways, market access, and the outlook for RMATs. The author cautions that, as exciting as these therapies a...
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    Recasting CAPA as a continuous improvement process

    This article summarizes a white paper developed by the Medical Device Innovation Consortium (MDIC) under the case-for-quality program. The white paper recasts the corrective and preventive action (CAPA) process as a continuous improvement process for driving higher product quality and improved patient safety.   Introduction Today’s CAPA process has become highly focused on compliance. This focus leaves manufacturers struggling to determine which issues require a stru...
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    Designing a biologics manufacturing facility: Early planning for success

    This article reviews important steps in the manufacture of biologics. The authors provide planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC). They pose important questions manufacturers should address, from facility issues to working with a contract development manufacturing organization. They conclude that trends toward reducing the time to market put considerable stress on all aspect...
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    Regulation of advanced therapy medicinal products in the EU

    This article explains some of the terminology relating to advanced therapy medicinal products (ATMPs), including gene and cell-based therapies, tissue-engineered products, and combined ATMPs. The author explains the key EU regulations and guidance documents for each therapy type and discusses marketing authorization, accelerated regulatory pathways, and market access. He advises companies navigating this complex regulatory environment to engage with the regulatory agencies...
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    Update on RMAT designations

    This article discusses the scope and purpose of the special designation for regenerative medicine advanced therapies (RMAT) created by the passage of the 21st Century Cures Act. The authors explain the benefits expected to be realized with RMAT and provide a tally of products receiving the special designation to date and a current count, by year, of products for which RMAT designation has been requested.   Introduction Section 3033 of the 21st Century Cures Act, titl...
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    Managing uncertainty: Regulatory reporting in multinational trials during COVID-19

    This article discusses regulatory reporting challenges for multinational clinical trials during the COVID-19 pandemic. The author covers the pandemic’s impact on clinical research, national guidelines, and harmonization, as well as the challenge of assessing what is reportable and how to submit COVID-19 risk mitigation measures. She offers real-world experience on how she and her colleagues stopped and restarted recruitment in ongoing multinational clinical trials, and how...