All Regulatory Rapporteur articles in January 2024
View all stories from this issue.
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PodcastsRegRapPod − In Conversation with TOPRA’s RegOps SPIN
BONUS EPISODE: In Conversation with TOPRA’s RegOps SPIN
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PodcastsRegRapPod − January 2024
Vol.21 #1: In January 2024’s RegRapPod, host Alan Booth talks to Issue Editors Julie Warner and Ash Ramzan about biologics.
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JournalNavigating early drug development investment: a detailed guide to due diligence
Funding is undoubtedly one of the major challenges small and medium-sized companies face when developing a new therapy from the bench to the clinic and eventually to the market. Suitable partnerships and potential mergers and acquisitions are key drivers to take a drug development programme to the ...
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JournalCell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety ...
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JournalThe changing face of oncology development – is cancer still ‘different’? A US perspective
Oncology development has traditionally been thought of as ‘different’; that the rules that applied to other therapy areas were not necessarily applicable to the development of treatments for cancer patients, who until relatively recently, had exceedingly limited treatment options. Dose finding was based on the paradigm adopted for cytotoxics and ...
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EditorialThe increasing complexity of biological medicinal products
Regulatory Rapporteur January 2024 | Volume 21 | No.1 The world of biologics is shifting rapidly. In the more than 40 years since the introduction of the first biosynthetic human insulin in 1982, advances in scientific understanding and biotechnology ...
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JournalArtificial intelligence in drug discovery
Regulatory Rapporteur January 2024 | Volume 21 | No.1 Introduction The recent publication of papers by the European Medicines Agency (EMA)[1] and the Food and Drug Administration (FDA)[2][3] has spurred the debate on ...
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JournalInnovating and harmonising access and requirements amid the global regulatory challenges of biologics
This article provides an overview of the regulatory challenges of biologics facing the biopharmaceutical industry, focusing on the need for global regulatory harmonisation. These challenges are central to ensuring the safety, efficacy and accessibility of biologic therapies for patients worldwide. To navigate these regulatory challenges, a collaborative effort will be ...
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