By Penelope Przekop, MSQA, RQAP-GCP
Click here to read part 1.
“On any given day, hundreds of strategic and tactical inputs ping my radar, falling in the direct path of our way forward. We must rely on quality and compliance experts canvassing the regulatory landscape to guide us around and/or through any potential industry storms ahead.” — Charles Conroy, RPh, MBA, CEO, ARTMS Products
Converging industry storm conditions are approaching. An exponential surge in vendor companies has led to the emergence of the “Big Vendor.” Increasing numbers of biopharma companies, legally required to demonstrate operational oversight of the vendors they must rely on to meet both their scientific and business goals, are outsourcing 99 percent of their GCP (good clinical practice) sponsor responsibilities, particularly as they head into early stage clinical development. There’s also a growing deficit 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.
If you’re a senior biopharma executive, your best industry bet is to incorporate compliance into your highest-level strategic planning as early as possible. Doing so will ultimately benefit the company, come rain or shine. A compliance strategy differs from a quality policy, manual, or system. Your GMP QA staff will be happy to help establish those. In fact, if your company has an IND, you likely already have these highly GMP-focused elements in place. Based on ICH E6 R2, these should already be expanded to cover clinical R&D. Herein lies the first compliance challenge many companies face: Many established GMP QA experts don’t know how to make that transition. But guess what? Senior management continue to rely on them because they don’t know how to make the transition either.
At the point when this blind spot emerges, senior leaders are often calculating the cost associated with bringing a product to the market and securing funding. Dovetailed with this challenge are strategic projections and plans regarding what type of new expertise the company needs to oversee clinical development and operations. New expertise equals additional funding. The bottom line is the bottom line, which is a practical focus. If you don’t have funding, patients will never reap the benefit of your potentially amazing product.
Based on costing models, the common conclusion is outsourcing even if you’re AstraZeneca, Pfizer, or Johnson & Johnson. But most likely, you’re not one of those. So call the biopharma vendors. They know what to do! It makes more sense to secure funding to pay for one or more vendors who have established expertise than to find and compensate highly experienced experts willing to join your yet to be fully established company with the aim of building out the various functions. Everyone is crunching the numbers and selecting their team of vendors.
REMEMBER THAT BLIND SPOT?
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance. After all, those GMP QA experts are already on board, right? Wrong. They continue to be critical to your GMP organization, but they can’t fill the expanding GCP compliance gap created by this early strategic oversight.
This is a common snafu driven by the current industry climate that is not only adding to the perfect storm ahead; it’s also driving up your cost to market in unanticipated ways including the need for unanticipated additional quality assurance headcount, consulting fees, late-to-the-party process audits, emergency gap analysis and remediation, last-minute inspection readiness activities that suck up operational staff time and energy, pricey mock inspections, storyboard development, added stress to the overall system, Band-Aids, tears, and prayers … all running up against your PDUFA date.
"Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance."
The costs associated with lack of strategic compliance planning, late attention of compliance, remediation, etc. are tough to calculate. I can tell you that it’s a lot. Oh, that’s poor business, you say. I need a number! (Perhaps that’s another article.) If you’re reading this, I’m betting you’re smart enough to realize two things: 1) The industry you work in is highly regulated, and 2) the products that your company bring to the market must be safe and effective. I’m asking that you pause and consider that you may not know what you don’t know. If you already know that, you’re far ahead of the game. But just in case you struggle with the idea that blind spots exist, I’m asking that you take a leap and trust me when I suggest that adding compliance to your initial strategy planning will not only save money in the long term, it also can:
- shorten your time to market
- improve your relationships with regulators
- improve your vendor selection
- more easily manage your vendors
- champion a more positive work environment
- cut down on headaches
- improve your sleep
- ensure that your company brings a product to the market that is supported by a fully compliant, documented safety profile and data integrity from Phase 1 through approval.
EMBRACE COMPLIANCE AS EQUAL TO OPERATIONS
“Compliance is foundational to any world-class organization and should have a seat at the table when planning the future of the organization. Being forward-looking with a compliance focus will differentiate the leaders from those struggling to avoid the storm.” — Michael Rossi, general manager, U.S., Advanced Accelerator Applications, a Novartis Company.
In Part 1 of this article, I introduced the idea of a formal compliance strategy that not only documents your vision and plan, but drives thought and spurs action by creating avenues for building compliance into every conversation beginning from your pre-IND liftoff to your NDA submission and beyond. It provides strategic direction, forecasts decision and pivot points, and helps ensure a compliance strategy is in play every step of the way.
The concept is to map out what the company needs to ensure compliance at each clinical development phase. No guessing. No trying to transform the GMP team into GCP gurus (even if they think they can handle it). No wishing it all away because you don’t want to increase your budget. No assuming your operational team is a stealthy band of GCP compliance brothers (even if they say they know the regulations). No putting it off just in case your investigational product doesn’t make it to Phase 3. No more blind spots. There should be more of embracing compliance as equal to operations when adding up the dollar signs. There should be more time accepting that clinical compliance is much more than investigator site audits and a skeletal set of SOPs that no one manages.
It’s a fantastic time in our industry for innovation, and this includes strategic creativity. Regulators are supporting risk-based decision-making. Industry regulations and guidance allow for documentation of a more formal compliance strategy by telling us that we can document the rationale for our decisions. This enables us to begin with high-level forecast and a detailed Phase 1 compliance strategy plan that can be fleshed out with each phase forward. A strategy plan that describes how quality, compliance, and vendor oversight are built into each step of the process in a way that both satisfies the applicable regulations and remains logical and practical for the organization at hand.
When asked, given the trends (noted above) and the unique business models evolving, would the FDA be favorable to biopharma companies creating a clinical development stage-specific quality system compliance strategy plan that documents how they are compliant given their business model? (Doing so could essentially provide a compliance road map for the clinical program through any business model changes, company handoffs, etc., from IND approval to NDA submission.) The FDA provided the following official answer:
“Yes, FDA would be supportive.”
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.