According to estimates, manufacturing costs for major pharmaceutical companies now eat up approximately 25 percent of revenues—an unacceptable level in the face of downward pressures on prices, diminishing returns from flagship products, and shrinking cash flows. Pharmaceutical companies simply must bring costs under control–a major change for companies that have for many years been cash-rich, and therefore, worried little about efficiencies and cost pressures.
ENHANCING CAPABILITIESDealing with such pressures and responding appropriately and efficiently is a whole new game for many pharmaceutical companies. Such transformation and such skills are, however, the stock-in-trade of consultants; and the right consultants can help pharmaceutical companies rapidly negotiate this unfamiliar terrain.
Through the International Conference on Harmonisation process, the regulatory bodies of the European Union, the United States, and Japan have been moving steadily toward a science-based approach to drug development that will revolutionize the way pharmaceutical companies validate processes and ensure product quality. Concepts such as Process Analytical Technology (PAT), Quality by Design (QbD), and Design Space (DS), which figure prominently in ICH Q8 and ICH Q9, entail a rethinking of how process development is done, integration of a new approach to validation, and a drive for continuous process improvement–all with FDA envisioned as a partner in improving processes and reducing costs.
This is a dramatic break from the past. Like cost control, it puts pharmaceutical companies in unfamiliar territory, where experienced guides could lead them to seize what is an unprecedented opportunity to speed development, reduce the cost of quality, increase inventory turns, reduce capital investment, move to a science-based approach to risk, and ultimately lighten regulatory burdens.
Tunnell Consulting, founded in 1962, integrates technical processes and organizational skills to boost the operating performance of manufacturing and service firms with a focus in the life sciences industry. The firm implements value-added, cost-effective solutions that fit the unique needs of each client it serves.
Conrad Heilman is senior vice president of Tunnell Consulting. He can be reached firstname.lastname@example.org