By Penelope Przekop, MSQA, RQAP-GCP
Have you heard about the perfect compliance storm forming just off the coast of biopharma? Like most senior executives, you’ve likely been too busy to notice the rain smell and darkening sky despite the foreshadowing atmospheric disturbances impacting your calendar, meeting agendas, contracts, conversations, and decisions.
A perfect storm is created by a powerful concurrence of factors. What has made the formation of this particular storm inconspicuous is that many of its factors relate to quality and compliance. Quality and her sibling compliance have traditionally played a weak role in both initial and ongoing operational and financial strategy planning at the C-suite level. They rarely have a seat at the strategy table in Big Pharma, so why would they land one in small to midsize biopharma companies? They have been relegated to the Big Pharma operational table and, from what I’ve seen, are having a tough time even making it into the conference room elsewhere.
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed. As your local forecaster would say, here’s what we’re dealing with:
- a phenomenal surge in small biopharma companies legally required to demonstrate operational oversight of the vendors they must rely on to meet both their scientific and business goals
- an exponential surge of vendor companies offering every service imaginable to those companies as well as Big Pharma
- the subsequent, not surprising, emergence of the Big Vendor that assigns their A Team to Big Pharma accounts; they ultimately provide their largest billing and long-term repeat business opportunities
- heavy dependence of small to midsize biopharma companies on new (or new to our industry) small vendor companies and big vendor B and C team staff, leading to operational teams composed of lesser experienced biopharma and vendor staff
- the growing deficient of experienced clinical quality and compliance industry professionals, particularly in the areas of quality systems and pharmacovigilance (PV) when global regulatory health authorities are simultaneously ramping up focus on risk-based everything, clinical and PV quality systems, and vendor oversight
- GMP-heavy QA focus in new companies in pre-and recent post-IND stages
- regulations and standard best practices outpaced by bullet-speed technological advancement in an industry undergoing complex organizational and business model changes.
Every biopharma company out there needs at least one experienced QA staff member, which has led to major industry outsourcing of QA activities. Good for consultants, not so good for the industry in the long term. Today, most of the busiest, seasoned QA consultants entered the industry in the late 1970s and 1980s. During our first week at Big Pharma, we were likely sent to a week of training where we learned about the drug-development process, the whole shebang. In a recent related conversation, QA industry consultant Christine Delfeld said, “Everything is so compartmentalized now; people don’t have a grasp of the whole process anymore; it hurts the research.” I replied that I was concerned about the younger generation. She shook her head as if to say, “Amen.” I was preaching to the choir. Mike Greer, QA director at a midsize pharma company out of San Diego, recently told me that he has worked for 30 companies since settling in California. According to Greer, “The majority fold or get bought, but if they do get an approved IND, it’s a whole new world for them. At that point the company and the QA staff have a GMP mindset. It’s hard to make the transition to clinical, especially when they don’t know what they don’t know.” So where does the industry go from here, and how do we ensure ongoing quality and compliance when everyone in the choir is holding a different page of the sheet music?
"Quality and her sibling compliance have traditionally played a weak role in both initial and ongoing operational and financial strategy planning at the c-suite level."
Are we all too entrenched in our longstanding industry standards to look up and see the big hazy picture forming above us? It’s a time when entrepreneurship is skyrocketing into an explosion of pharma and vendor companies. Regulatory authorities are:
- messaging risk-based solutions to add efficiencies and shorten timelines while retaining data integrity and patient safety, and
- holding companies responsible for operational vendor oversight.
And many QA professionals are either aging or highly focused on one niche with little to no opportunity to diversify. Is that rain I smell? When recently conversing with an SVP of clinical operations at an East Coast midsize pharma company about the weather, particularly with respect to vendor oversight, she said, “What’s the solution? Give us a solution! Maybe there needs to be an intermediary between companies and vendors.”
So what can our industry do to avoid storm-surging catastrophic outcomes as we continue our mission to help patients? Will there be a 21st century thalidomide surprise? Start the organ, cue the QA choir! Wait, the choir is fumbling for the right sheet music! The organ hasn’t been tuned. Holy tamale! We need a hero! We need more than one!
That’s where you come in. Senior biopharma executives have and always will drive change, set tone, and create culture. So, your mission, if you should choose to accept it, is to ensure the following as early as possible in the drug development process: (No, do not burn this. This mission is by no means secret.)
- Make sure your company has at least one board member representing biopharmaceutical industry product life cycle quality and compliance. (No, this is not a corporate lawyer, information privacy expert, or a GMP expert.)
- Incorporate compliance into the highest level of your strategic planning. Create a compliance strategy plan with the same vigor you pour into creating your financial and operational strategy plans (if you also don’t have either of those, that’s another article).
A product life cycle compliance strategy plan not only documents your vision and plan, but it also drives thought. It spurs action. It creates avenues for building compliance into every conversation beginning from your pre-IND lift off to your NDA submission and beyond. It provides strategic direction, forecasts decision and pivot points, and assures that you will always have a compliance component every step of the way.
The challenge of calculating the actual cost of poor compliance and nonquality has plagued the industry since the beginning. Amid the public outcry of high-priced healthcare, I often wonder about that number. Due to my unique window into the industry, I see dollars flying out of the window daily. In a perfect world, I could catch them and hand them back, not only to companies, but to consumers. That’s one of the value-adds QA can offer, right? The reality is that when properly infused into company culture, compliance is a vaccine. If you don’t get it as soon as possible, you’re risking not only patient health but the health of your company. Considering the approach of this storm, an industry willing to take that risk is like the camel’s nose under the tent. It’s never going to end well.
PENELOPE PRZEKOP, MSQA, RQAP-GCP, is a global GxP quality systems/assurance and regulatory compliance consultant with 25+ years of industry experience. She has held leadership positions in both Big Pharma and CROs.