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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
As 2011 comes to a close, a new paradigm of product development is ever more important.
The end of a year is a time for reflection and in reviewing 2011, what were the issues of greatest importance to pharmaceutical manufacturers? We posed that question to executives in the pharmaceutical industry (see "Views from Pharma Leaders") and several important themes emerged: a move away from the industry's traditional blockbuster drug-development model to smaller volume, specialty products; increased generic-drug incursion; and a resulting need for more flexible internal and external manufacturing approaches in an effort to keep product supply in line with demand. At the same time, the pharmaceutical industry continues to see potential in emerging markets, greater complexity in the global pharmaceutical supply chain, and the attendant need for supply-chain integrity and security measures that maintain product quality amidst that globalization.
Patricia Van Arnum
As the pharmaceutical industry faces these challenges, it also faces an even more daunting task: improving its product-development model. Earlier this year, John C. Lechleiter, chairman, president and CEO of Eli Lilly, spoke to this challenge. "Ironically, the crisis in our innovation model comes at a time when we have vastly more scientific knowledge and data than ever before," he said in a speech on Mar. 9, 2011, before the US/Japan Business Council. "But unless we change the way we do research, we won't translate this knowledge into advances for patients. In the face of diminishing results, we can't simply perform the same old rituals and hope for a different outcome. We must truly 'reinvent invention.'"
In the end, the ability of the pharmaceutical industry to collectively and as individual companies to "reinvent invention" will be the underlying measure of its success in 2012 and beyond.
Patricia Van Arnum is a senior editor of Pharmaceutical Technology.