Pharmaceutical companies face numerous business, operational and technical challenges that are further complicated by global and local regulatory requirements. Pharmaceutical consulting firms, like those in other industries, work closely with companies to help mitigate and resolve complex challenges while remaining compliant with those regulations.
This Enterprise World’s Top 5 Successful Entrepreneurs to Watch in 2022 issue features Penelope Przekop, CEO of PDC Pharma Strategy.
Please brief us about your professional experience.
I’m a corporate quality management expert, entrepreneur, and writer. Throughout my 30+ year career, I’ve held leadership positions at and have worked with hundreds of biotech and pharma companies. These included numerous Big Pharma companies including Glaxo Smith Kline, Johnson & Johnson, Merck, Novartis, Pfizer, and Wyeth, as well as medium and small biotech, pharma, and vendor companies. I am the Founder and CEO of PDC Pharma Strategy.
I have BS degree in biological sciences, which led to my industry start in pre-clinical research. While working in the lab, I had the opportunity to do cross-training in quality assurance. That paved the way for a transition into that department a year or so later. I worked my way up through various research and development areas, all with a focus on quality assurance/management and compliance.
After learning about the science of quality management in the late 1990s, I earned an MS degree in quality systems engineering. That’s when my career took on a more distinct focus. I became passionate about the value that the science proven to result in high quality could bring to all areas of pharma, and that passion continues today.
I’m also the author of Six Sigma for Business Excellence (McGraw-Hill) and 5-Star Career: Define and Build Yours Using the Science of Quality Management (Productivity Press), In 2018, I co-founded Bra in a Box, with my daughter, Phoebe Horak, which has been featured in Real Simple and New York Magazine.
Brief us about your company and how it fits into the current pharmaceutical industry.
PDC Pharma Strategy is a consulting firm that offers services to the highly-regulated pharmaceutical industry. We develop and execute risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle.
We’re particularly interested in working with clients at the strategic level as early in the drug development as possible to start at the start to create regulatory compliance strategies that can smoothly scale and pivot with the trajectory, twists, and/or turns that come, as we all know they will.
We also work with companies at various stages in the drug development process to identify gaps and recommend strategies for improving efficiency, documentation, and compliance. All these activities support the ultimate industry goal of ensuring public safety while continuing to develop new safe, effective pharmaceutical products.
The mission of PDC Pharma strategy is to help pharma and biotech companies develop and execute practical, efficient, and scalable quality and compliance strategies and processes that ensure patient safety and data integrity while also supporting business goals and growth.
How do you decide to take the company a step further?
The major technological advances that began during mid to late 1990’s left the industry in need of new strategies. It was a natural progression, and pharma recognized the need for new strategies in the areas of finance, corporate structure, human resources, supply chain, information technology, and operational processes.
However, one critical area was left behind in terms of strategic change: regulatory compliance. For the most part, the quality and compliance approaches of the 1980s and 90s remained despite the rest of the industry morphing into the 2022 pharma landscape we have today.
This industry gap became so clear that I couldn’t stop thinking about it, how and why it developed, and how it could be filled to better align quality and compliance approaches with the current industry landscape. Although I began my consulting career in 2008, PDC Pharma Strategy was born when my professional interests and consulting work become more focused on quality and compliance strategy.
I began to realize that I had developed the unique skill set required to help companies, and the industry, develop innovative regulatory compliance strategies to ensure compliance while also becoming more scalable, efficient, and practical given changes that have resulted in a vastly different industry landscape than the one I joined in the late 1980s.
Why is it said that the workforce plays a vital role in every business’s growth? Please tell us about your team.
Each person who works for a PDC Pharma Strategy represents that company and contributes to its culture and its ability to sustain and execute its vision and mission. Setting the stage for that mindset and culture starts at the top and must have a means to filter through every layer and aspect of the organization. The larger the organization, the more challenging that is to accomplish.
The science of quality management provides a proven roadmap for that challenge. One of the key challenges is many leaders don’t realize that setting the foundation for this when the company is new and smaller is key. It’s much more difficult to mold something into what you want it to be once it’s full grown, so to speak.
PDC Pharma Strategy is a boutique consulting firm with a team of less than ten. I love working with and mentoring bright, young people; they bring a fresh perspective and have the technical skills that complement my broad and deep industry knowledge. It’s a great partnership for developing innovative approaches to create longer term change.
I’ve established a culture of collaboration, learning, creativity, and efficiency. With that said, experience is golden when it comes to executing what’s required in the short to mid-term. PDC Pharma Strategy has a large network of highly experienced industry consultants who can collaborate, as needed, to address our client’s needs. However, PDC Pharma Strategy values industry experience with a flash of innovation and a lot of common sense.
What is your favorite quote?
I’m a writer and quote addict so this is a tough question. I’ll share a quote by Dan Millman, a former world champion athlete, gymnastics coach, martial arts instructor, college professor, and author of Way of the Peaceful Warrior (adapted to film in 2006), and 16 other books. These words resonated with me. They come to mind for me often when having to make decisions making, particularly in personal matters.
“Choice means giving up something you want for something else you want more.”