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From Whiteboard to Green Light: Inside the Regulatory Road to a new Vector Control Product
What are the key steps in the product development process, from start to finish?
Kelley McKissic (KM):
The process starts with our commercial team coming up with a new product idea and then submitting an NPP (new product profile) to our Stage and Gate review committee. All parties potentially involved on the project, including procurement to toxicology and regulatory to manufacturing, provide input on this new idea.
This is where we begin to determine if this product could possibly make it to market. We give a rough assessment of the likelihood of success, as well as indicate some of the potential hurdles this product may face.
Ashley Brinkman (AB):
Feasibility is a big part of what we do early on in the process. We ask questions about where the product is going to be used, and how it’s going to be used. All topics that impact safety and exposure for the end user. Those upfront questions help us better determine the product’s feasibility and what may or may not work.
What was your initial reaction to the proposal for Duovex™ Adulticide?
Kelley McKissic (KM):
An important factor we had to consider with Duovex was efficacy testing. We had to ensure we were testing for both ground and aerial applications within specific regions. Those testing parameters were a big part of the initial conversation for Duovex.
When in the process does the team begin testing?
Kelley McKissic (KM):
We start testing early in the process at Central Life Sciences. Our team contains multiple experts that are familiar with pesticide chemistries, which allows them to jump right in. Often, by the time the NPP has been submitted we already have a formulator assessing if it’s going to be feasible.
Ashley Brinkman (AB):
Yes, our team gets in there right away to start testing things. I would say the entire testing process can take several months to even up to a year because there are so many different layers involved—formulations testing, efficacy testing, toxicology testing, etc.
What distinguishes the regulatory process at Central Life Sciences from other organizations?
Kelley McKissic (KM):
We move quickly and focus on innovation.
Ashley Brinkman (AB):
Everything we touch is regulated, so there’s a high attention to detail and care across the board. We want to meet data requirements in an efficient manner, and to do this, the regulatory and toxicology team is involved at the very start of the process.
What is the testing process like with both the EPA and states, does it vary based on the product?
Kelley McKissic (KM):
Certain tests vary by the product, but the EPA has some standard test requirements. For example, product chemistry must be conducted for all products. There are other data requirements, such as acute toxicology and efficacy too. Some states require non-public health pest testing when those insects are listed on your label.
Efficacy testing is very important, but it depends on your label claims, insects, and types of applications. Toxicology testing is also important because it informs labeling language on how users can protect themselves and the environment.
Ashley Brinkman (AB):
For acute toxicology, how you fulfill data requirements might vary based on the product. In toxicology, exposure is a key piece of how products are evaluated. For example, if marketing is looking at a spray product versus a solid briquet, that is a different exposure profile, and therefore, I might approach fulfilling the acute toxicology data requirements differently.
Does a product receive EPA approval before being approved by individual states?
Kelley McKissic (KM):
Federal approval comes first. Then, once the registration is approved, we begin state submissions. Although a product might be approved by the EPA, we still have to wait until a state has reviewed and approved it before it can be sold in that state.
Does your team ever get brought back into the process after a product has received approval?
Kelley McKissic (KM):
Yes. Marketing insights could lead to additional product evolution to meet new customer needs. An example pertinent to Duovex is the addition of handheld/backpack sprayer application. We are currently conducting efficacy studies to get this use added to the label. Ashley will likely provide another assessment with this type of use to make sure there are no toxicology concerns. Lastly, we will submit an amendment to the EPA for this addition.
What made the Duovex launch such a successful process for your team?
Ashley Brinkman (AB):
It was the first product that we saw together (Kelley and I) from start to finish. It was a long process but a rewarding one to see Duovex finally receive approval.
Stay tuned for future editions of Vector Vision for more mosquito control insights.