Indita is the largest retail fashion company in the world, best known for its Zara brand. Suzy Hanson in The New York Times points out that Zara’s success derives largely from willingness to embrace process change, quoting Nelson Fraiman of Columbia Business School on this point. Zara took a century-old biannual fashion cycle and cut it to only 2-to-3 weeks. Pharma needs similar transformation of its 7-to-8 year clinical development cycle.
In 2 to 3 weeks, Zara’s processes transform an idea into clothing on the showroom floor. Stages along the way include continuously tracking what sells and supplying the products that sell just in time to retailers worldwide. That doesn’t rival the complexity of clinical development, but the original 6-month fashion cycle doesn’t rival our 7-to-8 year cycle either. The point is that process change can slash timelines in pharma just as it did in fashion.
Slashing an industry’s 6-month cycle to 2 or 3 weeks is about as disruptive as change can get. Disruption is the price of innovation, as Clayton Christensen observes in The Innovator’s Solution and other books. Needless to say, there will always be resistance to disruption. Even now, according to the Times article, Zara’s critics say its approach to fashion is unsustainable. Yet in the last five years, while Europe’s economy struggled, Zara’s revenues grew from € 9.4 billion to € 13.8 billion.
In fashion, Zara’s innovation and disruption triumphed. In clinical development, resistance has prevailed to date against innovations that threaten similar disruption. Just about everybody in pharma bemoans the high cost of developing drugs, but the industry remains committed to high-cost methods. To pharma’s old guard, reducing a > 7-year clinical development cycle by even a fraction of the proportion that Zara shrank the fashion cycle seems beyond the realm of possibility.
The industry’s struggles to develop new drugs have made the old guard too pessimistic. A recent book (with which I have a passing acquaintance) points out that pharma has the capabilities required to embrace process change and transform clinical development:
- The ability to collect data in real time;
- The ability to track and understand the status of trial operations at sites anywhere in the world in real time;
- The ability to understand not only the current status of a trial, but to project where you are headed.
These ideas are at work in a current global study. Real-time data provides continuously updated understanding of current study status. Predictive algorithms provide a likewise continuously updated understanding of where the study will likely end up. All this information allows direct centralized management of the global study, far more efficient and less personnel-intensive than a traditional hierarchical bureaucratic management structure. The global phase III trial will be locking its database when similar trials are just completing enrollment. Process change in clinical development is not only coming, it is here.
As always with innovation, the price is disruption. But pharma also pays a high price for the status quo: endemic delays that add up to long timelines, reduced returns and missed opportunities. Disruption is exactly what the industry needs.