Know Your Product Development End Goal to Avoid Regulatory Mistakes: a Q&A with Genna Jenkins

How do you assess what regions and in what order to target your clinical trial enrollment? Certainly, there are many factors involved based on scientific, regulatory, commercial, and operational considerations.

“Always make sure you know your end goal,” states Genna Jenkins, a Regulatory Consultant at Halloran (a PLG company). When it comes to assessing clinical trial regions as part of a product developer’s strategy, that’s just one piece of advice to get the data that is needed to support product approval.

Read our Q&A for more insight.

Q: Your focus is primarily on regulatory chemistry, manufacturing, and controls (CMC), working mostly with biotech companies on their Investigational New Drug (IND) Module 3. What patterns are you observing in our current regulatory climate, and how does that impact your approach with these modules?

I’ll start from the beginning. The CMC section, Module 3, of an IND submission is integral to U.S. regulatory applications. The data that is provided in the CMC sections within Module 3 of an IND application provide the U.S. Food and Drug Administration (FDA) significant information on the drug’s identity (structure), how it’s made, how it’s controlled and tested for quality, safety, and potency, how stable it is, and how pure it is. Ultimately, when done properly, and with frequent communication with the FDA, this information results in a compete and comprehensive set of CMC data that may eventually be used to support product approval and commercialization.

The challenge is that no two Module 3 sections of an IND are the same. Then add in different regulatory agency data requirements, and then the differences are compounded.

I observe many biotech companies pivoting in their geographic approach mid-stream. I’ve seen situations where they targeted the U.S. and then decided to pivot and go ex-U.S. and then pivot again. It’s a common theme.

The downside of pivoting mid-stream is that the data may not tell the full story and may be incomplete. For example, if a company decides to target Australia, then later decides to target the U.S., the risk is that they may have insufficient data (in their Module 3) that will appease the FDA’s requirements.

Pivoting is one thing, but the problem is going back to how this blog began – always make sure you know your end goal.

I recently told a client because they intend to eventually go to the U.S., it’s imperative they take into consideration the U.S. requirements as early as possible so that they will be able to meet the FDA’s requirements when it’s time. It’s important to have that mindset from the beginning. It sounds easy but can often be a challenge in an ever-changing regulatory landscape.

Q: Speaking of an ever-changing regulatory landscape, are you seeing biotech companies bypass the U.S. as a trend?

Certainly, some companies are bypassing the U.S. mostly because of faster and cheaper speed-to-IND routes elsewhere, but I still observe the U.S. as a geographical target.

For example, I’ve observed some companies are getting positive feedback on their drug, propelling them to go ex-U.S. to take a faster and cheaper development route, but often still have the mindset of eventually coming to the U.S.

Q: What challenges have you observed when working with multiple regulatory agencies on the required supporting documents? Is there any harmonization?

As far as the IMPD, the Investigational Medicinal Product Dossier, that is submitted into different regions, there is an effort to harmonize the IMPD across global regulatory agencies.

Depending on where you’re submitting, adjustments will need to be made. But the biggest challenge is around version control, so the key is to properly manage the lifecycle of the documents with an effective tracking system in place, so multiple Module 3 documents aren’t floating around without the proper home.

From the beginning, understand what can be harmonized across the agencies, while understanding what is different amongst the applications and supporting documentation.

Q: Any final advice?

I’ll mention it again. If you eventually plan to come to the U.S., you’ll need to be aware of what the U.S. requirements are even if you’re going through other regions first. You cannot cut corners to get the data that is needed and then meet the FDA’s expectations as a tack on. Simply, you must have a long-term plan that accounts for all the targeted regions’ requirements to ensure your product development success.