The numbers are daunting – 15% of the global population suffers from hearing loss, including a significant number of children, teenagers, and the elderly. Hearing loss presents a growing public health problem, due to ageing and an urban way of life that features excessive noise exposure.
The average cost of bringing a new drug to market is $2.6 billion, according to a 2014 report published by Tufts Center for the Study of Drug Development. This is a rise of 145%, adjusted for inflation, compared to just a decade earlier and is driven in part by the increasing complexity of clinical trials.
Biotechnology and pharmaceutical companies within the United States and Europe face an increasing number of hurdles when undertaking clinical trials within their own country or region; problems such as over saturated patient pools, difficulties meeting and maintaining enrollment numbers, increasing costs and lengthy time delays.
Despite the wide array of information systems available for biopharmaceutical manufacturing, we need to adopt a “follow-the-workflow” approach to overcome the process inefficiencies generated by quality and production silos.
Stem cell science has made huge progress since the early 1960s when Canadian researchers James Till and Ernest McCulloch discovered blood stem cells and advanced medical research across the globe.
In late 2015, I was approached by the board of Nativis, Inc.to take on the leadership of the company, by then a 13-year-old “startup.”