There can be no mistaking that we are entering a new era in the pharmaceutical and biotech marketplace. The escalation of the pharmaceutical emerging markets in India, China, and the remaining BRICK nations has changed the landscape from both a strategic and tactical perspective. It has even spawned its own buzz word, called the “Pharmerging” markets. The progression of these markets has put unmistakable pressure on pharmaceutical companies to reinvent the way they think about product development, clinical efficiency, and manufacturing performance.

In response, the established markets in the U.S. and Europe have embraced the principles of Operational Excellence as a catalyst for change. Big pharma has taken up the basic principles of Lean Manufacturing and Six Sigma as frameworks for driving business performance, with tangible results. While wholesale transformation may take decades to accomplish, public pressure together with market pressure from these Pharmerging markets are hastening the transformation, spawning a “survival of the fittest” business environment. While many large pharma organizations explore the potential for leveraging the low cost intellectual horsepower and low labor cost the Pharmerging markets promise, they have chosen to move forward cautiously in part due to their perceived difficulty in adopting the U.S. and European concepts of cGMP and also the risk exposure from quality management systems which are still maturing.

The question remains, is it possible to extend the benefits of operational excellence and its subsequent heightened business performance, to the principles of sustainability in this current competitive marketplace? I believe it is not only possible but also in an organization’s best interest to do so.

SUSTAINABILITY
What is sustainability? Sustainability is “meeting the needs of the current generation without compromising the ability of future generations to meet their needs.”¹ While the U.S. has historically been a powerhouse from a GDP perspective, it has been notoriously inefficient in how we feed our manufacturing engines. Across industries, only 1% of all of the raw materials we use actually end up in our final products.² Similarly, if China used the same amount of oil as the U.S. per capita, it would consume the entire world’s oil capacity of 83 billion barrels in just one year.³ Simply put, sustainability is the Golden Rule applied across generations, and it is easy to see how the principles of Lean can lead us toward sustainability initiatives. Originated by Taiichi Ohno to analyze processes within the Toyota Production System, Lean principles have evolved into a development philosophy that strives to identify and eliminate waste by concentrating on what is valuable to the customer.