Speakers’ comments at the Parenteral Drug Association’s Annual Meeting, held in Las Vegas on Apr. 20-24, 2009, reflected the crisis that pharmaceutical and biopharmaceutical industries face. Presenters alluded to a cloud of challenges (e.g., cost pressures, products that can be duplicated by competitors, and quality-control failures) that has been gathering for some time. Several speakers claimed that small- and large-molecule manufacturers must change now to survive in the short and long terms. But change how?
In one of the most interesting talks, Martin Van Trieste, vice-president of quality at Amgen (Thousand Oaks, CA), said that pharmaceutical companies could learn from other industries. Fifteen years ago, the electronics industry faced many of the same challenges now confronting drug companies. Today, computer and electronic products are cheaper, of high quality, and more powerful than before. Van Trieste named the automotive industry, now seeking government assistance, as a cautionary example of the consequences of not adapting to new conditions.
The globalization of the supply chain and the end-product market require quality systems to evolve, Van Trieste said. From the research phase through the entire product life cycle, companies must focus on meeting global quality requirements. Like the electronics industry, drugmakers should take advantage of automation to improve efficiency. This strategy will enhance product quality and reduce the cost of achieving that quality, Van Trieste said. He added that manufacturers should shift from a reactive, people-dependent approach to an active, process-dependent strategy. And industry must collaborate with regulators all the while.
Van Trieste’s recommendations, though general, seem sound and practical. The industry’s problems are not without precedent, and he persuaded me that many of the solutions are “in front of our eyes.” His talk should at least provoke lively debate about concrete ways for drugmakers to change their procedures and operations to survive the times.