A highly regulated environment for biomarker and biopharmaceutical testing

Apr 28, 2012

Nicola Gaskell, Client Manager in Bioanalytical Sciences at Quotient Bioresearch, explains that this article provides a current overview of how high throughput diagnostic analyser platforms and research-based analysis within a regulatory environment can be used to seamlessly deliver high quality data to the pharmaceutical industry, helping to drive the drug development process for the pharmaceutical industry. ...

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Insect Models for Drug Discovery

Apr 28, 2012

Is the insect hemolymph-fat body-Malpighian-metabolising-excretion system a relevant model for highly efficient documentation of some key ADMET parameters in the early drug discovery phase? Peter Aadal Nielsen, CEO at EntomoPharm, and Gunnar Andersson, CSO at EntomoPharm, answer this question and direct us to how in the future insect models could potentially be used as a filter between in vitro and in vivo models, filling the gap between the ‘quick’ in vitro models and the ‘slow, expensive but more reliable’ in vivo models. ...

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Recent trends in Personalised Medicine

Apr 28, 2012

Steve Poile, the founder and chief executive officer of Wildwood Ventures Ltd explains in this article that personalised medicine has recently grown in importance as drug companies and regulators alike come to terms with optimising resources on the right interventions for responsive patients, as well as improving early diagnosis of those patients susceptible to certain diseases before they become manifest. ...

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The challenges of e-Publishing in regulatory affairs

Apr 28, 2012

The change to e-publishing has brought about many challenges for regulatory affairs professionals. Conventionally, the end result was the focus of consideration – the electronic submission, and therefore the capability of a company to submit electronically. But e-publishing is much more. As an end-to-end process, it defines the critical capability a company needs to create and fine-tune. The move towards e-publishing has come in waves, and went hand in hand with the advancements in technology and the evolution of standards. Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group, expands further in this article. ...

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Risk Management of Drug safety: Pre-Approval Planning and Research will Ensure Success

Apr 28, 2012

Dr William C. Maier and Dr Carl de Moor of Registrat-Mapi explain that the last decade has witnessed an increase in the power of national regulatory authorities to require explicit programmes to control and mitigate risks related to the use of new and existing drugs. The impact on the pharmaceutical industry is substantial, because these new laws and regulatory powers will require a significant change in the way drugs are developed and supporting research is done prior to the filing of new drugs. This detailed article concludes that this new era of risk control and accountability requires that companies obtain ...

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