This edition of The Enterprise World features some of the most prominent and innovative women entrepreneurs of 2022. In this magazine, some of the visionary, exceptionally talented, women leaders, who have established their presence as true business leaders!
Today, we talk about Penelope Przekop. She is the CEO of PDC Pharma Strategy. She is also the Chief Compliance Officer (CCO) at Engrail Therapeutics. Penelope has showcased exceptional leadership, unleashing her expertise, and valuable experience in not only creating a successful company but also establishing a leading brand name!
In an exclusive interview with Penelope Przekop, CEO of PDC Pharma Strategy. Let’s get to know more about her company , its journey, and her professional journey.
1. Brief us about the PDC Pharma Strategy, what inspired you to start the PDC Pharma Strategy?
Although I began my consulting career in 2008, my professional interests and consulting work took on a more focused form when I realized that I had developed the unique skill set required to help companies, and the industry, develop innovative regulatory compliance strategies to ensure compliance and be efficient and practical in the current pharma landscape, which is vastly different than it was when I joined the industry in the late 1980s.
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.
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, 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 determine gaps and recommend strategies for improving efficiency, documentation, and compliance.
2. What are the products or services the PDC Pharma Strategy focuses on? How are your services different from those in the market?
A focus on innovative business and scientific strategies for drug development using technology has been a natural progression for most of the primary functional areas within pharma over the last 15 or so years. This includes finance, human resources, supply chain, clinical trial design, drug safety analysis, and operational processes. However, a critical area left behind in terms of strategic, innovative change has been how the industry documents and ensures regulatory compliance.
Aside from going paperless, the quality and compliance approaches of the 1980s and 90s have remained constant. PDC Pharma Strategy is different because we recognize and are fascinated with this gap, the possible reasons for it, and in developing both short- and long-term solutions. We are doing this at a micro-level with our clients and through exploring and developing potential pharma-wide solutions.
I approach each pharma company as a unique entity in a regulated environment that has created industry-standard check-the-box activities that no longer fit PDC Pharma Strategy emerging business models. I seek to understand my clients on a personal level, proactively look for ways to be helpful, and give them honesty. Often, my work requires me to point out gaps and issues to clients, which is not always easy or comfortable.
I offer a positive customer experience by helping clients visualize the future state. I build trust by being genuine and honest. They trust that although I may have a smile on my face, I will speak the truth, no matter how tough it may be to hear. They know that I’m on their team and ready to help them close gaps in a fit-for-purpose, practical way.
3. Please tell us about your team?
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 long-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.
4. Please brief us about your professional experience?
I’ve had the opportunity to work in the pharmaceutical industry for over 30 years and began consulting 13 years ago. I’ve worked with numerous top 100 pharma companies including Pfizer, Merck, & Co., Lilly, and Glaxo Smith Kline, and have held leadership positions at Novartis, Covance, Wyeth, and Johnson & Johnson. I have a BS degree in biology and got my industry start working in pre-clinical research. I had been a pre-med student until late in my junior year of college when I decided to peruse a Ph.D. instead.
I was accepted into a Ph.D. program in pharmacology but dropped out to work; I became a single parent just before starting graduate school and soon realized that the challenge I faced was much tougher than I had imagined. In many ways, I felt like a failure although I had no regrets about becoming a parent. I swore that I would continue my education as soon as I could.
While working in my first pharma position in a lab, I had the opportunity to complete a cross-training program in quality assurance. That paved the way for me to 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 and management.
Learning about the science of quality management in the late 1990s inspired me to peruse and earn an MS degree in quality systems engineering. I grew increasingly passionate about what the science of quality management could bring to all areas of pharma, and my career began to take on a more distinct focus.
When the 2008 housing crisis struck, I was a global director at Johnson & Johnson managing staff and working with colleagues across the world. I was being groomed for advancement. I thought I was on the best possible path, the one I wanted, when I was abruptly laid off along with many others, in what felt like a devastating, personal, blow to my career.
While struggling to understand what happened, I fell into consulting by assuming a role that a long-time friend was vacating to accept an FDA (Food and Drug Administration) position. It took a couple of years, but I eventually realized that I loved consulting and was well-suited for it. I’m beyond thankful now for that crushing career disappointment. It forced me down the best possible authentic path on multiple levels. Since that time, I’ve worked incredibly hard to expand my expertise, grow my business, and make a positive impact on the industry I love.
I wrote about both my personal and career experiences in my recent book, 5-Star Career: Define and Build Yours Using the Science of Quality Management (Productivity Press).
5. What is your favorite quote?
I’m a writer and quote addict so this is a tough question. I’ll share one of my long-time favorite quotes that have resonated through all the areas and stages of my life:
“But he who dares not grasp the thorn should never crave the rose.” – Anne Bronte