There is a "new normal" in the bio/pharmaceutical industry. It is undergoing transformational change because of initiatives
such as quality by design (QbD), tighter regulatory enforcement, increased supply chain complexity, patent expiration, new
drug development (e.g., biologics, generics), and changing trends in patient practices (e.g., more personalized treatments,
Being able to effectively lead an organization through these transformations is a core competence because it creates a change-agile
organization that is prepared to do things differently to achieve the most optimal result during and after a transition. Such
leadership allows organizations to avoid performance dips (see Figure 1) that may occur in productivity or morale during times of change (1). For example, research shows that organizations that
do not manage change well are four times more likely to lose talent (2). Effective change management enables successful adoption
of changes with minimal turmoil and brings to light systemic factors necessary for sustainability of results.
Figure 1: Illustration of the performance dip avoided by "change-agile" high-performing organizations during times of intense
change.FIGURE 1 IS COURTESY OF THE AUTHORS
Leaders of biopharmaceutical companies today face the daunting tasks of leading their organizations through continuous and
overlapping changes, and developing change agility throughout the organization in a world where 70–90% of strategic change
initiatives fail to achieve their business objectives (3). At the heart of change agility is the ability to judiciously, practically,
and positively shift behaviors towards new expected results.
The most effective organizations take a disciplined approach to changing behavior, leveraging the principles of applied behavioral
science, which is based on 100-plus years of peer-reviewed research and scientific theory. The goal is to consistently and
practically reinforce those behaviors that enable us to achieve our goals and win in the market faster than the competition.
The prize? Organizations that effectively use a behavioral focus to lead during times of change have experienced significant
results including: improvement in crucial preventive maintenance performance; increase in the use of plant equipment leading
to high-value product yield; improved on-time shipments; and increases in employee engagement*.
Take the example of a biopharmaceutical company that had launched several new vaccines, with revenues projected to double
from the previous year. The company was forecasting a 60% increase in units produced and a strong upside potential. However,
it was struggling with a culture that was complacent and resistant to change, as well as a laundry list of other challenges
as listed below:
- A new labor agreement was in place, but many packaging operators were unhappy with it
- Many supervisors were new, with varied levels of people-management experience
- 83% of employees had less than one year of packaging line experience
- Quality assurance reports showed too many deviations in product quality, purity, or sterility
- The right-first-time error-free data entry overall rate was only at 12%.
The company launched several efforts to address these challenges, including organizational redesigns, Lean Six Sigma methodology,
and team-based Kaizen events. These changes helped, but not everyone followed the desired behaviors because operators and
supervisors were not exactly sure how to act differently—improvements were not sustained. The leadership team realized that
something deeper was needed—a culture change.
Coaches helped company leaders and supervisors to pinpoint specific behaviors that were crucial to achieving genuine business
results. The team also provided behavior coaching, including personal action plan development and execution, with feedback
collection. Lastly, coaches helped leaders apply positive and corrective consequences, including feedback that reinforced
desired behavior and discouraged undesired behavior.
After one year, the company saw a cost avoidance (i.e., cost reductions from shortenend cycle time and rework) of $7.3 million
and when capacity improved, it was able to in-source a chemical that had previously been outsourced earlier, resulting in
$1.3 million savings. Through the capacity increase, fewer days were worked with more output, thereby reducing headcount.
Consumers benefited as well because the vaccine backlog plummeted to virtually zero. Improvements in operations enabled a
$500-million increase in the sales of vaccines.
Another example involved a biotechnology company that was looking to increase the number of high-quality drugs brought to
market by, in part, better leveraging its vendors and partners to do everyday, non-oversight work. This organization was specifically
interested in leveraging applied behavioral science to identify and reinforce the few critical behaviors that key performers
and leaders needed to consistently do to ensure the sustainability of their results to date. This company was successful in
sustaining its targeted results by integrating sustainability behaviors into their daily work and embedding them within their
business management system.
STEPS FOR LEADING CHANGE
Below are some leadership tips for change agility in the "new normal."
Communicate about the change. When major changes occur, such as a merger or an acquisition, or process changes related to QbD, questions run through everyone's
minds. Leaders need to lead from the start by helping people understand what is happening, why it is happening, and what it
means to them.
Address your personal reaction to the change. Regardless of whether you are the CEO, a quality assurance professional, or a front-line technician, when change occurs,
people in general can experience a range of reactions (e.g., active or passive resistance, or being enthusiastic about the
change but unable to develop specific action plans) (4). Ultimately, the goal is to become change-resilient and create the
best possible outcome for you, your employees, and your end users—the patients. Leaders often need to attend to their personal
reactions to a change before they are able to help others.
Support your team through the change. During times of change, leaders must focus on the business while also tending to the staff. Successfully leading in the new
environment requires helping team members by first gauging their reaction, then matching your coaching strategy to those reactions.
Focus on key priorities. Change can naturally lead to rumors, gossip, and other distractions among staff. Effective leaders need a plan to keep employees
focused on current and future priorities and to ensure that staff members feel successful about what they are accomplishing.
By focusing them on a few short-term priorities within their control, management can provide structure in the midst of uncertainty.
Make a point to catch staff members "doing it right" so that the focus on priorities is a motivating experience for all.
Retain key staff. Leaders know that it takes more than compensation to keep their best performers engaged during times of change. With an average
industry turnover of 14%, during times of stability, and the industry's current talent shortage, losing focus of key players
in times of change is not an option (5). One-on-one communication with their immediate supervisor that is personalized and
career oriented can offer a strong positive influence on a high-performer's decision to stay.
Track and resolve issues. Change creates "noise" in any system or process. Leaders can gain loyalty from their teams by tracking and resolving (or escalating)
questions and concerns.
Leading through change involves more than good project management and encouragement. Leading through change is about helping
staff perform in new ways quickly and consistently to achieve new results, and helping them to be ready for the next change
that will come more quickly than they might expect.
* Results achieved by Continuous Learning Group clients.
1. T.J. Galpin and M. Herndon, "Welcome to the Big Leagues of Change Management," in The Complete Guide to Mergers and Acquisitions: Process Tools to Support M&A Integration at Every Level, T.J. Galpin and M. Herndon, Eds. (Jossey-Bass Publishers, San Francisco, 1st ed., 1999).
2. Right Management, "Ready, Get Set...Change! The Impact of Change on Workforce Productivity and Engagement," in Leadership Insights, Right Management, Ed. (Right Management Inc., Philadelphia, 2009).
3. M. Beer and N. Nohria, Harv. Bus. Rev. (May–Jun. 2000) 133–141.
4. J.M. Smith, "When 'It' Happens! at Work: 5 Action Steps to Make Change Work for You (ChangeMatters LLC, Morgantown, WV, 2nd ed., 2009).
5. M.Duggan, DrugTopics 154 (8) 21 (2010).
Tracy Thurkow, PhD, is partner, Karen Gorman, is senior partner, and Paula Butte is senior partner, all with the Continuous Learning Group, email@example.com