Organizational and cultural transformation. Small-molecule pharmaceutical manufacturing organizations have been faced with the need for vast transformational change since the late 1980s. There have been various drivers for transformation, including but not limited to, loss of patent exclusivity, poor R&D productivity, increased regulatory requirements, and industry consolidation. To navigate this highly competitive landscape, organizations have had to rethink management philosophies, organizational design, and the internal environment in which they operate.

There are now myriad successful case studies that manufacturing organizations can use. Many of these success stories have common themes. They usually start with the end in mind: an agile, flexible commercially aligned manufacturing organization focused on and attaining aspirational performance goals across all key areas of the operation, not just cost. Overly ambitious targets force new thinking and ways of working whereas older operational paradigms give way to new models. A manufacturing organization often needs to build new capabilities while at the same time rationalize its operations. This dual approach is not easy, but it is paramount to establishing competitive advantage.

As companies in the small-molecule space embarked on these transformational programs, they quickly discovered that to achieve far-reaching transformation, two elements were pivotal: leadership behaviors and workforce engagement. Desired leadership behaviors included lean thinking, empowerment, ability to manage change, and a customer orientation. Workforce engagement meant people in the organization had to be fully involved at every step in the process. To compete by working smarter requires that people understand and care about the business. To facilitate this orientation, people need to feel that their voice matters, and they need to be included. Inevitably, the transformational programs that have been successful in the small-molecule arena have involved functional and cross-functional focus groups at all levels across all business organizations that were engaged in idea generation and solution delivery. Transparency in communication has been a key ingredient of these efforts.

Looking ahead

The French academic Paul Valery said, "The trouble with our times is that the future is not what it used to be." Every manager would like to know what the future holds to take the risk out of business planning. That degree of knowledge of the future, however, does not exist. Biomanufacturing organizations, however, have the benefit of what has been learned from traditional small-molecule pharmaceutical manufacturing organizations, both the successes and failures. Today, biomanufacturing finds itself in a time of great change; it is at an inflection point. The trends discussed in this article require decisive leadership on the part of biomanufacturing management. Biomanufacturing strategy needs to proactively address the large issues, such as loss of patent exclusivity, emerging technologies, localized manufacturing, and the impact of low-volume personalized medicines. The three small-molecules perspectives presented in this article (i.e., process understanding and control, operational excellence principles, and organization and cultural transformation), along with others, can certainly be helpful in charting a new course. Organizations need to be receptive to change and avoid the "not invented here" or "we've always done it this way" mentality.

Lou Schmukler is senior vice-president of the Specialty/Biotechnology Operating Unit at Pfizer.