Tuesday, October 14, 2014
Since 2011 (1, 2, 3) I have postulated that pharma needs a “creative destructionist” for its manufacturing technology innovations to get out from its archaic “quality by analysis” methods to “quality from the get go methods”. Current practices have cost patients billions in excessive costs.
Generally most of the “creative destructionists” are from outside the industry, McLaren could be the one for the pharma and the chemical industry.
“What Can the McLaren Racing Team Teach the Rest of Us?(4)” is an interesting read. McLaren Applied Technologies (MAT) is analyzing generated/available information and creating scenarios that are changing the current operating models in some industries. Their analysis and methods along with human creativity take an acceptable 2+2=2.5 or 3 to a higher number, closer to 4 and are the key. Such improvements are game changers.
Methods and technologies of MAT besides winning car races have been used to train Olympic athletes, in oil drilling and improving airport operations. These are just few examples. GSK, the pharma company, is using them to improve its toothpaste production and drug discovery processes. In these applications there is complex interaction of humans and machines. Since MAT methods and technologies are being successfully applied to these complex situations, I believe that they could be very effectively used in less complex manufacturing situations e.g. reactive chemical manufacturing and their formulations.
Total revenue for these markets would soon be approaching FOUR Trillion dollars, one trillion dollar for the global pharma (5) and about three trillion dollars for the chemicals (6). Combined savings of 10% for pharma and chemicals could be about $400+ billion dollars and that would be a wonderful achievement. Savings will come from improvements in supply chain, process yields, business practices and product quality.
Significant information about the reactive processes used to produce chemicals including active pharmaceutical ingredients that are chemicals with disease curing value and their formulation is readily available. Proficient chemists/chemical engineers can combine chemistry and chemical engineering principles, creativity (7) along with “what if” scenarios to create processes that are efficient, cost effective and significantly sustainable compared to the current processes. Their application would be extremely helpful for pharma molecules before they get in to clinical trials. QbD in pharma could become a reality. We all know that once the selected molecule gets in clinical trials, process changes are difficult. “Process centricity” will overtake “regulation centricity” and for the first time quality from the get go will become way of life for pharmaceuticals.
Girish Malhotra, PE
1. Malhotra, Girish: Does the Pharmaceutical Industry Need A Steve Jobs? November 8, 2011
2. Malhotra, Girish: Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to Pharma QbD Spring? April 15, 2012
3. Malhotra, Girish: Landscape Disrupters Are Becoming Part of the Pharma’s Playing Field, August 17, 2014
4. Bennett, Drake: What Can the McLaren Racing Team Teach the Rest of Us? Business Week, October 2, 2014 accessed October 7, 2014
5. Pharma Report Predicts Trillion Dollar Global Industry by 2020 Accessed October 13, 2014
6. Chemical Industry Profile Accessed October 10, 2014
7. Malhotra, Girish: Chemical Process Simplification: Improving Productivity and Sustainability John Wiley & Sons, February 2011