Recently, in the twilight on a balmy summer’s evening in DC, an irrationally passionate cell therapy war room convened over meze, ouzo and retsina. And considered the meaty question posed by Lonza’s Jon Rowley: “Where do you think you and the cell therapy industry will be in fifteen years?”
I anticipate there will be three major issues that will shape the cell therapy industry in 2027: new business models, best practices and big data.
The search for innovative and viable business models is a pressing challenge for established and emerging healthcare industries given long-term declines in the productivity of therapeutic pipelines. However, the cell therapy industry has been here before and successfully built viable business models around innovative healthcare products and services.
Cell therapy can trace its roots back to transplantation techniques and technologies, led by pioneers including Shumway, Lower and Barnard (heart, 1967); Mathé (bone marrow, 1959) and Murray, Harrison and Merrill (kidney, 1954). Initially, these novel clinical procedures were more examples of the art of medicine than healthcare products and services. However, over the intervening decades, a range of transplantation related infrastructure has been developed and successfully commercialized; for example, immune suppressants and donor suitability testing kits.
As stakeholder familiarity with new technologies is established, new business models will also be identified for cellular therapeutics, as has been the practice in the past. While some degree of convergence with the conventional biotech industry is to be expected, I regard pharma’s historic “pills in a box” business model — that is to say, the sale of an identical non-personalized product to all customers in the market — as under threat.
Not only will we see new and successful business models appear over the next fifteen years, I predict there will also be a range of robust scientific, biomanufacturing and regulatory best practices. For example, platform biomanufacturing processes as have emerged historically for small molecules and monoclonal antibodies. Further, as more cellular therapies navigate the regulatory pathway, and the expectations of regulators become clear, clinical trial best practices are likely to emerge, reducing trial costs, durations and attrition rates.
However, a caveat to our pursuit for best practices is that the healthcare ecosystem in which they are being developed and implemented is currently under threat from impending “big data” innovations, including genome-wide target screening. Such big data tools will be essential in demonstrating the value proposition of novel therapeutics and their amenability to innovations in technology adoption, such as value-based pricing and stratified medicine.
Therefore, a degree of long-term flexibility in business models and industry best practices will be essential if the industry is to successfully manage the poorly understood competitive threat posed by novel big data collection and analysis tools.
I call upon the cell therapy industry 2012 to unite, and build a foundation for a prosperous cell therapy industry 2027 — an industry I firmly believe can offer sustainable solutions to the most pressing challenges in global healthcare.
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