8.4. Minimalism and a real industry business case as an alternative promotion for QbD

Despite the additional guidelines, publications, mock submissions for QbD, and authority initiatives that tried to clarify open questions, a lot of essential details as to the final use and benefits of a QbD driven development still remain unanswered and have so far prevented the widespread adoption of this new paradigm throughout the industry.

While acceptance of some principles has started to rise during 2009 and 2010 and most of the large companies have by now started to implement at least some aspects of QbD, many of the smaller companies are still waiting to see the full benefits of this approach, especially as the immense costs associated with the roll out and implementation are not yet seen to be paying back at some point.

Among other gaps it became also clear that the most powerful promoter of a widespread adoption will eventually be a clear business case calculating the ROI for a company that has implemented a QbD driven development approach in its R&D organisation as Migliaccio predicted during the 2011 FDA workshop with the industry.⁸⁰

This also emphasises that the business case hypothesised by McKinsey in 2009 has so far not been transformed into real savings for the majority of companies and this becomes also apparent from my own survey presented in this thesis.

The impetus of QbD so far significantly lacks behind its true potential and the huge improvements gained by DFSS or Six Sigma in other industries - despite the immense potential of a QbD driven development to improve the quality of drug products and the quality of development itself. Both are realised not only by the authorities but also by most pharmaceutical companies. However, without a clear business case how QbD can improve a company’s long term profitability and profit growth the efforts needed to overcome the initial hurdles and to install the required changes in the structures and systems will continue being hard to justify.

The benefits are clearly there, but still need to be converted into measurable numbers in order to provide a tangible competitive advantage for a business.

This could be done most effectively by demonstrating that QbD can either reduce development costs (and/or development times) or increase the number of successful projects, by fostering higher success rates by a systematic assessment of which activities to do or not to do at which time, thereby, increasing chances for success during pre-clinical as well as clinical and technical development phases. „Doing the right things right and at the right time“, can provide both, a reduction of costs and increased success rates and thereby provide a strong justification for QbD.

This approach is attempted by the roll out strategy for QbD for Pharma Example Ltd. However, real data for projects and drug products are needed to eventually confirm the concept of such a combination of QbD with a Minimalism strategy for development, supported by risk based decision making and a systematic application of sound science.

⁸⁰ Migliaccio; The Impact of Quality by Design (QbD); 2011