Quality by Design: The Case for Change (Part II) - A rigorous cost-benefit assessment can help to chart a cost-effective path forward. - BioPharm International


Quality by Design: The Case for Change (Part II)
A rigorous cost-benefit assessment can help to chart a cost-effective path forward.

BioPharm International
Volume 24, Issue 5, pp. 20-24


Running parallel with the benefits assessment is the assessment of potential cost in the cost-benefits analysis. The same issues apply relative to building a credible estimate to enlist top management, particularly finance, in the opportunity QbD presents.

The assessment of cost is more challenging to nail down than the estimate of benefits, however. When assessing benefits, a company has the advantage of historical perspective of costs incurred due to delays and product losses in areas with well documented budgets.

In assessing implementation costs, one needs to estimate the cost of transitioning the organization from its current level of technical and organizational readiness to that which will be necessary to effectively execute a QbD strategy.

The FMEA developed in the benefits assessment can be useful in assessing potential costs as well. Identifying mitigation strategies to address potential failure modes and risks identified in the FMEA will, in turn, highlight gaps in organizational readiness and design for which corrective action costs can be estimated.

Figure 1: Cross-functional coordination involves support across all divisions.
Figure 1 illustrates the major considerations in functional coordination associated with mitigating risk and executing a transition to a QbD strategy. Each organization will be at different places on the continuum of readiness to implement these elements and each has its own associated costs.

Considerations include not just the gap in technical know-how, but also issues related to change-management and the speed with which the organization can make the transition. Organizational transformation to adopt QbD will probably involve changes in organizational design and in cross-functional interactions. Such changes can encounter strong resistance by those attached to the status quo.

Temporary outside assistance to smooth these issues and facilitate change may help accelerate transformation and reduce cost. Particularly complex products or processes may require extensive experimentation and more time in development to adequately characterize the process and present acceptable data. Inexperience both internally and within FDA may cause delays in first-time QbD-based submissions, a potential cost that should not be overlooked.

Finally, upgrades of software and data-management systems may be required to allow integration of historical data and to facilitate cross-functional coordination. These potential costs need to be considered as well.

In the weighing of costs and benefits, it has been our experience in working with many life sciences companies that the organization-specific benefits of QbD almost always far outweigh the costs, yielding an ROI that continues to grow year after year.

However, the great magnitude of the potential benefits does not mean that the organization should immediately undergo massive transformation, a giant step that many leaders and decision-makers may be unwilling to take up front. Instead, one can adopt a phased approach that allows the company to move confidently toward a fully integrated QbD strategy.

Organizations can begin by building technical competence in basic process characterization, designed experiments, and hypothesis testing ahead of full scale QbD-submission preparation. Once those methods and techniques have been mastered, the organization can undertake QbD process development but also can continue to file with FDA in the traditional way. In the final phase of development, a company can embark on QbD-based filing.

It is important to understand, however, that there is a balance which needs to be achieved. Yes, there are costs and risks associated with organizational transformation but the full benefits of QbD will not be realized until the final phase, in which filings are fully QbD-based. Organizations that evolve slowly will reap some benefits along the way but will remain at a competitive disadvantage to those with a more aggressive transition strategy.

James P. Catania is a managing consultant at Tunnell Consulting,
, 610.337.0820.

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