You’ve finally arrived. You’re the head of quality at a pharmaceutical company. They’ve developed a next-generation drug that’s about to change the world by improving the lives of millions of people. It’s time to sit back, kick up your feet and enjoy some smooth sailing, right?
Not so fast - your job, is about to get a lot harder. You’re going to be up against challenges your predecessor never could have imagined. And there’s no map to help you make your way through these uncharted waters.
Before we plot a course for success during your first 100 days, let’s have a look at the storm that’s forming just over the horizon.
Consumers, Legislators, and Regulatory Agencies are Demanding Change
You’re probably familiar with the scandal Mylan faced last summer over the price of the EpiPen. The cost of the EpiPen, used to treat life-threatening allergic reactions, had increased 500% since 2007. Fair or not, it fed the public perception that biotech companies were charging unjustifiably high prices for drugs. And along came cries for increased transparency.
That perception then made its way into the realm of politics. Just last week, president-elect Donald Trump was quoted saying that the drug industry was “getting away with murder,” and that he would change the way the country bids on drugs to bring prices and spending down. Additionally, the U.S. Senate took steps toward repealing the Affordable Care Act, and replacing it with a plan that has yet to be unveiled.
Finally, the 21st Century Cures Act, enacted in December of 2016, will expedite the drug and device approval process in exchange for summarized data from studies, insurance claims, and clinical trials. All of this comes on top of the recently released FDA quality metrics guidance. Both measures will require you to collect and share quality metrics with the FDA.
Whatever your views on these events, one thing is clear: big changes are on the way. Those changes are going to require your company to become more compliant, streamlined, and efficient. Lucky for them, you’re there to lead the way.
Preparing for Change, and the First 100 Days Ahead
Preparing for these changes, some of which appear unpredictable, may seem daunting. But, these same challenges also present an incredible opportunity. To comply with the FDA, companies will need to make an honest assessment of their quality management system, and lay out a plan to ensure it meets new regulatory requirements.
Through that same process, companies will become leaner and more efficient. That alone will help them to prepare for an uncertain future. But beyond that, it will also help them to gain a competitive advantage over companies that dawdle toward those changes.
Now, let’s see how you’re going to navigate through your first 100 days, and beyond.
Your first 30 days
Start by assessing your most important assets: your people. Make a concerted effort to understand how far along the organization is with compliance. Mark the finish line, and determine what it will take in terms of time, money, and resources to get there. Raise awareness of the issues and ultimate goal to gain buy-in.
The next 30 days
Now that you know where your company stands, it’s time to focus on process. Your system needs to ensure that the appropriate metrics are collected. That means they’ll need to be standard across the organization. And while you’ve already established a clear goal, it’s important to focus on the day-to-day improvements that will slowly but surely move you closer.
The final 30 days, and beyond
Congrats! You’ve got support from the entire company, and the processes you’ve put in place have taken root. It sounds like you’re in the clear. But before you can finally settle-in, there’s one last thing to do: automate your processes. Investing in an automated quality management system will streamline your quality data collection and submission processes, and improve overall efficiency.
Companies that are pre-commercial stand to see greatest ROI, especially by adopting solutions that offer built-in quality processes from more established companies. That’s because it gives them a chance to make additional refinements to their homegrown systems. Or even establish an entirely new process that hadn’t been conceived.
But even a more established mid-size company, with a deeply rooted QMS system, will see benefits from automation. By working out of a single integrated end-to-end environment, there’ll be greater visibility and more consistent quality. That helps to insulate companies from the risk of falling out of compliance, or allowing an unsafe drug or device to reach the market. Identifying a centralized system to collect your quality events, CAPA, change control, audits, supplier interactions and controlled documents will help to put a bow on this 100-day journey.
There are no guarantees in these uncertain times. The world is changing at frenetic pace never witnessed before. But with the right strategy and execution, you can be the one to keep your company – along with all its life saving potential – afloat.