Comparator Sourcing – An Analytical Approach to Find Best Suited Sourcing Strategies

Oct 27, 2015

Sourcing comparator drugs for clinical trials is a complex process, especially for branded drugs, and in many cases the selection process to find the best sourcing partner falls short of expectations. An analysis has shown that around 30-55% of comparator drugs are left unused at the end of the trial. This is due to issues such as disruptions in the supply chain, unexpected delays, incomplete paperwork, stock-out situations and regulatory hurdles. Mark Walls at Verastem Inc., Rahul Sodhi of Beroe Inc. and Dr Mihai Bragaru of Durbin PLC reflect on comparator sourcing. ...

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Drug Metabolite Synthesis with Human Enzymes: How Can We Utilise Microbes to Make Authentic Human Metabolites?

Oct 27, 2015

The characterisation of the metabolic fate of a new drug molecule is essential in the course of the drug discovery and development process. As a consequence, potential human drug metabolites must be available in amounts of at least a few milligrams of pure compound. Metabolite preparation can become a significant time and cost factor, if elaborate multi-step chemical syntheses become necessary. Dr techn. Margit Winkler at ACIB, Austrian Centre of Industrial Biotechnology, answers this question: how can we utilise microbes to make authentic human metabolites? ...

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Alzheimer’s Disease – Breakthrough Due Soon?

Oct 27, 2015

uggesting the cure for Alzheimer’s disease (AD) is imminent. Why is there so much buzz about a cure for AD? How close is a cure? And just why has it been so difficult to see progress in AD treatments? This article by Susan McGoldrick of QCTR reviews the recent headline-grabbing news in AD clinical trials and looks at the results we can expect in the next couple of years. ...

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Sifting Through the Sourcing Options

Oct 27, 2015

Outsourcing is now a widely accepted practice in the life sciences industry. However, choosing precisely which activities to entrust to an external supplier remains challenging. The standard methodologies are two-dimensional; therefore, they fail to address some key considerations. Here we present a new methodology that refines previous approaches and provides a rigorous framework for making such decisions. Dr Subrata K Bose of Kinpase deals with outsourcing in the life sciences industry. ...

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Entering the Homestretch for ICD-10 Transition

Oct 27, 2015

ICD-10 is the largest mandate in US healthcare history. It will require diligent, comprehensive actions to be fully prepared for the transition. Practices have until October 1 to successfully upload, test and implement ICD-10 codes, which will replace the ICD-9 code set. Whether healthcare firms are ready or not, the US government’s upcoming deadline stands firm. Hospitals and physician practices have been discussing ICD-10 for many years. Jeffrey Goldstein of Allscripts shares his thoughts on ICD-10 transition. ...

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