“Revolutionizing the Quality & Compliance Arena”

Penelope Przekop, CEO of PDC Pharma Strategy, focuses her pharmaceutical industry expertise on quality and regulatory compliance. Global regulatory health authorities such as the FDA require pharmaceutical companies to follow numerous highly technical regulations to develop, test, manufacturer, and market medications. “The regulations are designed to ensure patient safety and data integrity throughout the drug development lifecycle including post approval,” explains Penelope. “After nearly 20 years in the industry, which included developing groups and functions from the ground up at Covance, Wyeth, and Johnson & Johnson, I moved into the world of consulting. As I continued to build my industry experience, I gravitated towards more strategic work; doing so enabled me to utilize my creative side.”

"“Developing great relationships with my clients is important to me. For this reason, we are selective about who we work with. We look for win-win scenarios,” explains Penelope."

Penelope is also an accomplished writer and artist alongside being a steadfast pharma industry leader. “Strategic projects allowed me to dovetail my technical expertise with my creative mindset. Over time, I began to recognize that a gap shared by many of my clients was indicative of a disconnect in across the industry,” she explains. “Changes driven by the ten to fifteen-year wave of major technological advances that began during the mid to late 1990’s left the pharma industry in need of new strategies.” However, a critical area was left behind in terms of strategic change: regulatory compliance. PDC Pharma Strategy was born when Penelope realized that her technical pharma work coupled with her creative work positioned her with a unique skill set required to help companies develop regulatory compliance strategies throughout the development lifecycle.

PDC Pharma Strategy is growing, although the goal is to remain a boutique consulting company. “Developing great relationships with my clients is important to me. For this reason, we are selective about who we work with. We look for win-win scenarios,” explains Penelope. “I’m particularly interested in working with clients at the strategic level as early in the drug development as possible to start at the start, and create regulatory compliance strategies that can scale and pivot smoothly in tandem with the trajectory, twists, and/or turns that come, as we all know they will.” PDC Pharma Strategy also works with clients who, for whatever reason, realize that they did not start at the start, and are faced with identifying, prioritizing, and remediating compliance gaps. PDC Pharma Strategy advises on and develops strategies based on company specifics; every company is different although regulatory expectations are the same.

Penelope is currently writing a book (Productivity Press, 2021) that focuses on how the science of quality management can be applied to career development. “It starts with identifying what 5-stars means to you. Trying to satisfy someone else’s definition never works. If the goal is to reach your unique leadership potential, it is critical to identify what you are uniquely capable of leading, regardless of scope. Once you can clearly define that for yourself, leadership becomes authentic and real.”

Penelope is also working on an exciting project related to data mining with a couple of brilliant university students from Stanford and Northwestern. “We want to impact the industry by shifting the current mindset around quality and compliance. Industry history can be used to develop new concepts and strategies that better align with current and evolving drug development processes and approaches,” she explains. “Quality and compliance strategic expertise needs to be developed within the industry and given a seat at the table as early as possible.” She adds that one way that this can be achieved is through the role of the Chief Compliance Officer. Development of this role has gained has interest across industries over the last few years. Penelope is working with companies to redefine the role of the Pharma Chief Compliance Officer, clarify how it differs from and dovetails with the role of Corporate Legal, and establish the skillset required to help drive the industry toward a new era. “My vision is that we’ll look back to 2020 and see how embracing regulatory compliance strategy from the top down resolved or removed more industry challenges than was thought possible.” IE