Contract Research, Clinical Trials and Outsourcing

A selection of articles from European Pharmaceutical Review covering Contract Research, Clinical Trials and Outsourcing:

 

Outsourcing in the analytical and microbiology area

Outsourcing in the analytical and microbiology area

20 April 2015  •  Roger A. Stroud, R Stroud Pharmaceutical Quality Solutions Limited

Increasing numbers of pharmaceutical companies are considering outsourcing in the area of analytical and microbiological testing, from the very smallest start-up, virtual, or small company up to the largest multinational. This article will examine the factors that lead to a company deciding to outsource, and provides invaluable guidance on the important considerations that should be made before, during and after the outsourcing process in order to ensure it runs as smoothly as possible...

Sheraz Gul

The evolution of the Contract Research Organisation and the future of the pharmaceutical industry

20 February 2013  •  Kevin Lustig and Maria Thompson, Assay Depot, Sheraz Gul, European ScreeningPort GmbH,

This article discusses how the pharmaceutical industry can leverage its competencies in outsourcing to accelerate time to market, improve quality and increase innovation at all stages of the drug discovery and development process. The pharmaceutical industry is being battered by a perfect storm of not just one but three major issues, any of which on its own would prove a tough nut to crack...

0813 TSP China PR

Evolving landscape of pharmaceutical outsourcing in China

22 October 2012  •  Xiaorong He, Senior Research Fellow, Boehringer-Ingelheim

China’s economic growth has shocked and awed the world, with its GDP growing at an average rate of 10 per cent for 30 years. The astonishing economic growth has also spurred rapid growth of pharmaceutical outsourcing business in China. In the past, China had been the major source of raw materials, basic intermediates and commodity bulk drugs for the pharmaceutical industry. Starting five to 10 years ago, China gradually moved up the value chain, providing a wide spectrum of services encompassing drug discovery support, preclinical development, clinical trial and contract manufacturing services to western Pharmaceutical and biotech companies...

Transforming-a-paper-based-trial-master-file-to-a-streamlined-electronic-document-management-solution-at-Sanofi

Ensuring patient safety during clinical trials; translation to preclinical drug discovery

3 September 2012  •  David Cook & James Milligan, AstraZeneca

Ensuring patient safety during clinical trials is of paramount consideration with stringent monitoring built into trials (and beyond) and the design and interpretation of safety outcomes subject to a large amount of regulation. As a result, it is rare for clinical trials to produce extreme adverse drug reactions but it is also quite common for new medicines to fail in clinical testing due to unacceptable patient safety within a given indication. This is because once a new drug reaches clinical testing, its safety profile is already ‘locked in’, and clinical testing can only discover issues that already exist. The ideal way to ensure the safety of patients is to only progress new medicines into clinical testing which do not have unacceptable safety or tolerability issues. However, to reach this ideal means using learning in the clinic to influence design and development in the laboratory. In this short article, we discuss the practical challenges in doing this and in ‘translating’ patient safety observations such that they can impact on drug design and early development...

Man on a phone analysing data and charts on computer screen

Integrating preclinical data into early clinical development

3 September 2012  •  Vikash Sinha, Clinical Pharmacology Leader, Janssen Research and Development

One of the important goals in preclinical and early clinical drug development is to reduce attrition rates and to improve our ability to pick winners and drop potential loser drug candidates. By being able to efficiently translate preclinical data and observations into possible clinical outcomes, one can make the drug development process more cost-effective. Identifying preclinical models – in silico, in vitro, in vivo – or assays that can best predict clinical observations is not trivial. It requires understanding of preclinical-to-clinical correlations and the success of translational science may vary depending on the therapeutic area where one is working. For example, anti-infectives or cancer therapeutic areas have validated biomarkers which can be useful in selecting the right drug candidate in early drug development...

Discovery chemistry outsourcing

26 April 2012  •  Luigi La Vecchia, Director of the Preparations Laboratories, Novartis Institute for Biomedical Research

In 2002, Novartis decided to create a new research centre in Cambridge, MA. This was accompanied by a significant increase in headcount in medicinal chemistry. Within two years, this resulted in a strongly increased demand for prep-scale synthesis which in turn led to priority issues and to prolonged turnaround times due to lack of resources in our Preparations Laboratories. In order to debottleneck time critical scale-up activities, the Preparations Laboratories was asked in 2004 to introduce outsourcing as an alternative option to an in-house increase of headcount...

Outsourcing in early drug discovery: Evolution and opportunities

26 April 2012  •  Jayshree Mistry, Paul Lloyd, Kevin Oliver and Peter North, GlaxoSmithKline R&D and Duncan Judd, Awridian

This article describes the evolution of outsourcing within early drug discovery at GlaxoSmithKline (GSK), specifically for chemistry services applied to developing a compound from the screening hit through lead optimisation. It will touch on different business models, factors to consider when selecting potential CROs, the benefits of outsourcing and CRO management...

 

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