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Regulatory
Rapporteur

Write to the Editor at publications@topra.org

January 2024 | Vol. 21 | No.1

EDITORIAL

The increasing complexity of biological medicinal products

The world of biologics is shifting rapidly. In the 40+ years since the introduction of the first human insulin in 1982, advances in scientific understanding and biotechnology have occurred at breakneck pace, resulting in the development of hugely novel products which have the potential to give patients a significant treatment advantage.

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By Julie Warner and Ash Ramzan

FOCUS

Innovating and harmonising access and requirements amidst global regulatory challenges of biologics

Innovation around biologics is advancing at a rapid pace, and the pharmaceutical industry faces complex regulatory challenges in delivering these medicines to patients. This article provides an overview of these challenges, focusing on the need for global regulatory harmonisation.

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By Danielle Helton Corwin and Baily Thomas

FOCUS

Cell and gene therapy - navigating complexities in CMC development for optimisation of global regulatory strategies

In the evolving field of cell and gene therapies, breakthrough treatments have emerged for previously incurable diseases. This article explores the complexities involved in chemistry, manufacturing and controls development for these products from lab to market.

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By Sateesh Babu, Rajendra Kunda, Achuta Raju Samala, Sakshi Singh, Praveen Basavaraja, Deepti Jagga, Vivek Tomar and Allison Gillespie

FOCUS

A weight of evidence approach for non-clinical evaluation of complex biologics

Despite an abundance of guidance documents and papers, there are still many non-clinical challenges when developing a complex biological product. This article provides guidance on non-clinical safety evaluation as well as exploring the challenges involved.

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By David Jones

FOCUS

Navigating early drug development investment: a detailed guide to due diligence

Due diligence activities should be conducted to ensure the return on the investment is plausible and holds a level of risk the investor is willing to undertake. This article explores some of the main challenges in the due diligence task performed for a drug in early development.

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By Zeb Younes and Angeles Escarti-Nebot

STANDALONE

The changing face of oncology development – is cancer still ‘different’? A US perspective

Cancer treatments have progressively become more targeted as understanding of the biology of individual tumours has evolved, leading to subsequent development of targeted medicines and immunotherapies. This article explores the regulatory challenges and opportunities of the changing environment of oncology development, with a focus on the FDA’s perspective.

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By Katherine Bowen

STANDALONE

Artificial intelligence in drug discovery

The emergence of guidance from the EMA and the FDA on how artificial intelligence can be applied across the medicines lifecycle has spurred the debate on how it can be used to bring novel medicines to market. This article explores the capabilities of AI in the drug discovery process.

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By Paula Maguire, Bruno Speder and Liam Tremble