3.2. Objective: Generating a competetive advantage in combining QbD with a „less is better“ approach

Such a transfer of Minimalism to R&D might also be applicable to generate a competitive advantage for R&D in the pharmaceutical industry. If successful a QbD driven approach could then be set up without an increase in development costs, benefiting from both principles – the prevention of disruptions, i.e. the interruption of the flow of development, and the improvement of quality for the customer at the same time. This could then also be summarised as „right first time“!

The objective of this thesis is thus to outline the opportunities arising out of a combination of both principles, Quality by Design and Minimalism, and how these together could be used to improve success rates and timelines during drug product development, thereby addressing one of the biggest dilemmas of R&D at least at the level of CMC activities.

Eliminating disruption during R&D and manufacturing need to be combined with an improved excellence in the quality of drug products and their ability to generate a superior value proposition for the customer (patient and health care provider). Together, Minimalism and QbD, can achieve „doing the right things right and at the right time“ during drug development:

• to achieve higher success rates for new drugs
• to shorten development timelines
• to reduce costs, both during development and COGS for manufacturing
• to obtain products which generate customer delight and a real surplus in the value proposition

This then results in more, new, and better drug products on the market at lower costs and ideally allows a company to sustain profitability even with a less for more pricing strategy and to maintain profit growth by this competitive advantage of superior value innovation in R&D and manufacturing.

• Improved quality means „right first time“ during development, shorter development, reliable launch and supply planning, more flexibility in production, less OOS, less waste = reduced costs and improved time to market
• Productivity of the company increases as number/speed of NDA approvals increase
• Better quality (safety, efficacy, compliance) for the patient and reduced costs for health care systems lead to customer delight and allow company to increase market share
• Thus QbD provides a competitive advantage and increases a company’s profitability helping it to move or stay at the value creation frontier

Both Minimalism and QbD will mainly target the CMC activities of drug development focussing on development, manufacturing and testing of drug compounds and drug products and can therefore only address one part of the overall problem in the development of new and better drugs. Yet, designing drug products with the patient in mind, ensuring that these will consistently provide the same efficacy, safety and compliance throughout their lifecycle and at the same time focussing on they key activities that enable this development to be as fast and straight forward as possible will also positively influence the overall success rates of new drug products.

How this objective can be approached in real projects will be discussed in two case studies of a QbD driven development at different levels of integration and implementation. The analysis of a questionnaire on the current view on QbD in the third quarter of 2011 and how these findings compare to the findings of an FDA report from 2009 will then provide an outlook as to the current challenges and upcoming opportunities.