Russia’s Medtech Revolution

Russia’s health care authorities are building a modern system to meet the needs of a growing population and better regulation of entry into the $6 billion medical device market is an important element of this wider aim. Alexandra Tretiakova, executive director of Russia’s International Medical Device Manufacturers Association, weighs in on how the complex new set of rules will impact the medtech industry.

Imperfectly clumped together with other BRICs – a term that is now falling rapidly out of favor as the differences between these four “founder” emerging economies become more defined – Russia is something of a conundrum. It is an emerging market, with an aging population, a chronic disease burden, and low life expectancies. But 68% of its population of 143 million is classified as middle class (interestingly, the population rose in 2013 for the first time since the collapse of the Soviet Union), it has a highly educated workforce, and its GDP is among the highest of the emerging markets.

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Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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