By Penelope Przekop, MSQA, RQAP-GCP
In decentralized pharma, the phrase “the pharma ecosystem” has begun to pop up here and there. An ecosystem is a biological community of interacting organisms and their physical environment. It can also refer to a complex network or interconnected system. The phrase does not capture what is happening around us for a couple of reasons.
A biological ecosystem includes death, which contributes to the churning flow of life. In nature, there is a hierarchy, a food chain. Do we really want to compare our industry to the food chain and, if so, who is devouring whom? One could describe decentralized pharma as a complex network or interconnected system, yet there are hard stops between the various, and growing, entities trying to connect and often failing. What pharma needs is one interconnected quality system, which, based on the laws of nature and governments, may be impossible. The science of quality management teaches us how to build a quality system within the bounds of what each entity can control. If everyone did that properly, the pharma landscape would begin to untwist, untangle, and point us forward.
So, who is going to lead the way? Who is best suited to envision, support, and strategize such a vision in our current faux “ecosystem” where comprehensive trust in patient safety and data integrity may be dying even before it hits its prime? It is not the chief executive officer or clinical operations. It is the dwindling number of experienced quality and compliance (Q&C) professionals with the breadth and depth of industry knowledge that affords them detailed understanding of both health authority regulations and regulators and the drug development process from early phases through commercialization. In my last article, “Your New 6-Step Approach for CRO Section In 2022,” I discussed the hidden value Q&C professionals can bring to CRO selection. Here are a few more reasons why our industry, your company, and employees should value the unique skillset of these individuals more than ever in decentralized pharma:
Decentralized Pharma Has Led To Decentralized Knowledge
Due to the fracturing of roles and responsibilities for operational activities within pharma, the aging employee population, and increasing use of electronics, our industry has evolved into one where vast groups of professionals have developed expertise in highly specific areas. This includes many who have been in the industry for less than 15 years. Many of our colleagues have spent their careers working in a particular niche or function for small pharma and vendor companies that do not provide ongoing general development programs that span the drug development process. While they may be excellent at what they do, they have been doing it in a vacuum. They are rising in the ranks, moving to other companies, learning how to be leaders, often not knowing what they do not know. More than ever, during audits and mock inspections, pharma professionals are unable to articulate the required regulations for their assigned responsibilities and tasks. They are unable to connect the dots between their step(s) in the drug development process and the rest and understand how their deliverables impact those down the line. It is time to realize and recognize that it is Q&C professionals who are asking the questions and who know the answers.
Outsourcing Has Increased The Depth And Breadth Of Experience And Knowledge Of Q&C Professionals
Quality and compliance professionals have been asking the questions all along, often doing so at company after company, moving across the industry landscape, soaking up both the bigger and detailed pictures. Outsourcing has also impacted them. Large Q&C consulting firms have evolved, as well as niche firms and independent professionals. Those who were best able to morph into consulting roles were those who came up during the height of Big Pharma. They had more opportunities for learning and growth early on. This leaves those newer to the industry to fill the permanent entry- and mid-level Q&C positions across the industry, which have increased due to the increased use of vendors. They are often struggling to develop on their own in small organizations that often do not value their cost center roles. They are calling upon Q&C consultants for support because they know, more than anyone, the value their experience can bring, not only to them but also to their companies.
Q&C Professionals Speak Truth To Power, Are The Soul Of Pharma
Who can you truly trust to speak the truth, all in the spirit of goodwill? Quality and compliance professionals are the benevolent soul of our industry. Not since the early days of burgeoning regulation have we needed that soul to guide us more. We have all heard that “quality starts at the top,” so why is quality not at the top? At the inception of new pharma companies, compliance is not often a key concern. It falls into the murky realm of, “We don’t need that now.”
Where is Q&C representation in the C-suite of every company and in our boardrooms? When the topic begins to surface on board meeting agendas, do those listening understand? Who on the board has the skills and experience required to interpret and explain the importance and ramifications that compliance has to all areas of the business, and, furthermore, why it is important that it is part of the earliest discussions? Who there can and will speak truth to power in the spirit of preserving the underlying mission of our industry while keeping the overarching scientific and financial goals of the company intact? Who will explain why an early focus on compliance can blast away headaches, sleepless nights, stress, and additional costs the others cannot foresee at day one?
It is time to realize and accept that the soul of a company or of an industry is not something to add later. It should exist from the start and outlive every other piece of an entity. Its unique value is deserving of recognition, respect, and a seat at the table. As we all know, ignored, cast aside, and devalued souls form cracks that often require a lifetime to patch. Such is the case with the drug development life cycle and of our industry.
For the reasons noted above, this niche of experienced Q&C professionals is our hidden gem, the one with potential to offer the answers we need to ensure that decentralization does not go off the rails, driving pharma toward the edge of a cliff over the next 15 or 20 years. More than anything else, including reducing time to market, lowering costs, building financial success, fostering artificial intelligence, or mining big data, we must preserve quality and integrity in clinical development. This has been the sole vision and goal of the Q&C professional all along. These are the individuals you can rely on to foster the fundamental goal of our industry through thick and thin, in sickness and in health.
Q&C professionals may very well be the stakeholders who can help ensure that anything that dies in this “pharma ecosystem” are the best elements to exit, practices and behaviors whose time has come to leave and make way for new, brighter beginnings across the industry. Stay tuned for my next articles on how Q&C professionals add value to (1) corporate strategy and leadership and (2) industry training and awareness.
About The Author:
Penelope Przekop is a corporate quality management expert. Throughout her 30+ year career, she has worked with numerous Fortune 100 pharma companies, including Pfizer, Merck, Lilly, and Glaxo Smith Kline, and held leadership positions at Novartis, Covance, Wyeth, and Johnson & Johnson. She is the founder and CEO of PDC Pharma Strategy and serves as the Chief Compliance Officer for Engrail Therapeutics. She is the author of Six Sigma for Business Excellence (McGraw-Hill). Przekop earned a BS in biology from Louisiana State University and an MS in quality systems engineering from Kennesaw State University. She is a graduate of the Smith College Program for Women’s Leadership and the Rutgers University Senior Leadership Program for Professional Women. Her new book, 5-Star Career: Define and Build Yours Using the Science of Quality Management launches in November 2021 from Productivity Press.