Regulatory approval is the final hurdle sponsors face when launching an in vitro diagnostic (IVD). After spending many years and millions of dollars on development, it can prove frustrating when the finish is in sight, but there are barriers to success. Fortunately, many of those barriers can easily be avoided. In more than 30 years managing regulatory and compliance for medical device/IVD, & pharmaceutical companies — and interfacing with agencies in 167 countries — we have seen one approach work again and again:

Think about the end at the beginning.

What does that mean? You know your IVD will require regulatory approval. Pinpoint the requirements that each regulatory agency will impose during the final submission process, then ensure you meet them along the course of development. That includes which clinical trials will be required, what risks may potentially occur, how you will mitigate those risks — and, critically, precisely what form of evidence each regulatory body will require.

Regulatory oversight vs compliance: Twinned approaches to successful regulatory submissions

Ultimately, regulatory submissions and regulatory approval are a retrospective form of regulatory oversight. They ensure that the people who create and execute the product development plan understand and are trained to meet requirements established by a specific regulatory body. This, in turn, helps ensure that the IVD is safe and effective, as defined by each agency’s standards.

Such regulatory oversight and compliance go hand in hand — and advance planning simplifies them. Compliance becomes automatic by designing data capture protocols that meet regulatory expectations and then building them into clinical trial roles. An investigator doesn’t have to wonder, “Which form should I use?” because as much as possible, every piece of necessary information is already embedded in the form. They fill out the form and place it in the Trial Master File, the process and data capture are designed into the process so that the information is then readily available for incorporation into the regulatory submission and subsequent inspection when/where required.

Of course, verification is still required, but it is simpler. Meanwhile, investigators as they follow the protocol/data capture comply with the clinical trial protocols, the sponsor’s protocols, and thus the regulatory requirements.

Pre-planning for regulatory submission: A case in point

What does this look like in action? We recently worked with a major IVD company that had an IVD with potential breakthrough status, a significant improvement over existing methods. When the company came to us, they had proof of concept and some suggestive information, but they needed to create a more robust preclinical package in preparation to apply for an Investigational Device Exemption (IDE).

We always recommend taking a holistic approach. We leverage our entire team to provide full-service, 360-degree support. That includes clinical trial planning, clinical trial management, data management, statistics, and analysis—even oversight training. We approach every aspect as an extension of the sponsor, focused on being thorough and cost-effective. And we communicate intensively, ensuring that as each piece of new information is developed, we understand the impact it may have on both past and future decisions, so we can take appropriate action(s).

The IVD in question detects colorectal cancer; the sponsor needed to prove that it is as effective as the gold standard approach to clear a path for regulatory approval. We suggested testing in animal models or using discarded tissue. These approaches would enable them to make tremendous progress during preclinical development in identifying their product’s effectiveness. It would also reduce the later burden of testing in humans, lowering the overall cost of development and speeding the time to market.

Slow-downs at the FDA: Mitigating the impact of COVID-19

Of course, no matter how proactively a sponsor plans, they cannot control everything. While it seems the FDA and other regulatory bodies are always back-logged, COVID-19 has exacerbated the problem. Agencies have been focused on COVID-related products — vaccines, diagnostics, and therapies — and have naturally prioritized those. All other products have fallen further down their list. We have addressed this by working with the FDA and other agencies to familiarize them with our sponsors’ products ahead of submission, enabling us to proactively address any questions or concerns the agency may have, leading to more timely plan execution.

Comprehensive planning: The key to smooth regulatory submissions

After years of development — from work on the bench through multiple phases of clinical trials — regulatory approval is the final step before commercializing your IVD. Even though it is a big step, at Premier Consulting, we believe it can be a relatively simple one. Through comprehensive planning, we ensure that all requisite data is collected, managed, and documented so that every prospective regulatory question can be answered swiftly and satisfactorily. In short, we think about the end at the beginning.

Author:

Matthew Nowland
Vice President, Regulatory Affairs