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New GDP guidelines: looking beyond
Regulatory changes of Good Distribution Practice (GDP) of Medicinal Products increase complexity
In 2013, the EU-guidelines on GDP of Medicinal Products for Human Use have been augmented: Now for example, the required storage conditions of pharmaceuticals are to be maintained during transportation. In addition, new requirements apply concerning cleanliness and security of any intermediate storage facility. Although increasing complexity these specifications create space for opportunities such as differentiation or benefit from cost advantage over competition. [...]
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Launch excellence for new medicines
Global challenges require new approach for market entry
After years of low productivity, R&D in leading pharmaceutical and biotech companies is starting to deliver on its promises and the number of New Molecular Entities (NMEs) approved by the US FDA has leveled out. Once approval has been gained there needs to be a launch. However, complexity of global market access has substantially increased. In this viewpoint, Arthur D. Little assesses the key success factors for launch excellence in times of global market access challenge. [...]
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Capturing Value in the mHealth Oasis
An Opportunity for Mobile Network Operators
mHealth has been hailed as the next major development for mobile networks operators (MNOs), but could it be just wishful thinking from a sector desperately seeking additional revenues to offset margin erosion? While few commercial offers currently exist, mHealth is firmly on the agenda for many MNOs. In this viewpoint, Arthur D. Little assesses the key success factors that lay the foundations for operators to successfully navigate the mHealth minefield. [...]
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