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European Biopharmaceutical Review

Safety First

 

When it comes to safety, drug manufacturers take responsibility for unknown outcomes. To minimise risk, safety planning and assessment should be key components of every drug development programme, especially when it comes to high-risk medicine. By definition, high-risk medicine includes biological molecules with novel mechanisms, new agents with a highly species-specific action, and drugs directed towards immune system targets.

In March 2006, a clinical study involving a group of healthy volunteers in the UK demonstrated the need to take responsibility for safety in order to minimise risk. The volunteers were given an intravenous (IV) dose of an experimental immunotherapeutic as a part of an ascending single dose safety and tolerability study. Within a few hours of administration, all subjects exhibited severe reactions which progressed to multiple organ failure.

As a result of this tragedy, sciatic and regulatory initiatives focused on designing a comprehensive approach to the safety assessment of ‘high-risk’ medicines have been enacted. For example, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) published the ‘Guideline on Requirements for First in Human (FIH) Clinical Trials for Potential High-Risk Medicinal Products’ in July 2007 (see Figure 1). In addition to the CHMP guideline, which applies to both biologics and New Chemical Entities (NCEs), the International Committee on the Harmonisation of Technical Requirements for Registration developed guidance documents on the development of biologics. This article offers recommendations and strategies to address these new safety requirements, from preclinical and first-inhuman study design to monitoring.

PRECLINICAL STUDY DESIGN

The preclinical testing strategy encompasses pharmacodynamic (PD), pharmacokinetic (PK), toxicology and safety pharmacology studies. Key objectives of these studies are to establish a safety profile, demonstrate the relevance of the animal model, and provide a scientific basis for the calculations of the first human dose. Pharmacodynamic studies assist in the characterisation of the pharmacological effects and identification of the most appropriate animal model.


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Peter Thomas is a Senior Programme Manager responsible for the planning and conduct of nonclinical development programmes for pharmaceutical and biotechnology clients. He previously served as the Director of Toxicology and has been with Covance since 1996. Peter has a PhD in microbiology from the University of Wisconsin-Madison. Prior to joining Covance, Peter was the Head of Microbiology, Immunology and Molecular Biology at IIT Research Institute, Chicago. His laboratory helped develop and validate immune function tests that currently form the basis for the FDA and ICH guidance on immunotoxicology testing. Peter has authored more than 70 peer-reviewed scientific publications and book chapters on the impact of drugs and chemicals on the immune system.

 

Karen Cornelissen is the Scientific Director of the Covance Clinical Research Unit in Leeds, UK. In this role, Karen leads the pharmacokinetics team and advises on study design and data interpretation. Karen is also in charge of the seamless implementation of procedural and scientific changes arising from the enactment of the European Clinical Trials Directive. She has a PhD in preclinical and clinical metabolism from Bath University and previously served as a study director in metabolism and project manager at the Phase I Clinical Research Unit. Before returning to Covance in 1999, Karen worked in the drug kinetics group at Zeneca.

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Peter Thomas
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Karen Cornelissen
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