Feasibility is not (anymore) A Plain Search for Investigational Sites

Dec 21, 2016

Conceptual Evolution of Feasibility Studies in Pharmaceutical Development The sole term ‘feasibility’ has multiple definitions in a clinical environment, leading to certain bias with all stakeholders involved, including pharma companies (sponsors) and all types of contract research organisations (CROs). The most common perception is related to a never-ending argument between pharma outsourcing 58 departments and CRO commercial groups, with sponsors expecting CROs to run a (non-defined) feasibility study prior to proposal submission and CROs undertaking a series of schematic actions to create an impression of fulfilled expectation. Anna Baran MD, Chief Medical Officer at KCR, shares her thoughts on feasibility.. ...

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Natural Born Killers

Dec 21, 2016

Immunotherapy is currently one of the most actively pursued areas of research by biotechnology and pharmaceutical companies. “Control of immune activation can save us,” believes Markku Jalkanen, CEO of Faron Pharmaceuticals. Cecilia Stroe, Staff Editor of IPI, explains that at present, the interest in immunotherapy is largely driven by recent compelling efficacy data in cancers with historically bleak outcomes, and by the potential to achieve a cure or functional cure for some patients. ...

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The Devil in the Detail: Five Routine Recall Risks Faced by Modern Pharma

Dec 21, 2016

With the steely eyes of the regulators firmly trained on everything that life sciences organisations do, the last thing firms want is to incur fines, market delays or worse because of overlooked mistakes in labelling and product information. Growing complexity in life sciences is raising the risk of product mislabelling, potentially putting lives in danger and leaving companies open to hefty fines and delays in product availability, warns Marc Chaillou of Schlafender Hase. ...

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Tipping Point: The Regulatory Year in Review

Dec 21, 2016

As big an issue as it has become, compliance is the least of life sciences companies’ concerns as 2016 gives way to 2017. But the right approach will equip companies to successfully navigate everything from market consolidation and new market entry to marketing innovation and operational transparency, which will set them in good stead for years to come, says Adam Sherlock, CEO of ProductLife Group. ...

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Regulatory Transformation: Cloud Reality Check

Dec 21, 2016

What role can cloud services such as SaaS play in driving the next generation of regulatory information management, and what are the practical considerations for potentially sensitive data? Siniša Belina, senior life sciences consultant at Amplexor Life Sciences, reports from a recent industry debate. ...

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