Meet with regulatory affairs professionals early and often. That’s the message from Neelu Gibson, VP, regulatory affairs, at BD, speaking at Biocom’s June virtual meeting, “Regulatory Affairs…Engagement Do’s & Don’ts.”
Meet with regulatory affairs professionals early and often. That’s the message from Neelu Gibson, VP, regulatory affairs, at BD, speaking at Biocom’s June virtual meeting, “Regulatory Affairs…Engagement Do’s & Don’ts.”
Engaging with regulatory affairs (RA) shouldn’t be a ‘once and done’ conversation, Gibson stressed.
“Remember that RA is your strategic business partner. Building a relationship with it is a long-term investment. Therefore, engage with regulatory affairs as early as possible. We’re not just the submissions folks,” Gibson said.
Early-stage drug and device developers tend to delay meeting with regulatory affairs professionals because the regulatory submission step seem so distant, she said. Yet, gaining regulatory insights early – even at the ‘back of the envelope’ stage – can help frame the thought process and thus shape development programs in ways that minimize missteps and save time and resources. This is a good time to outline the regulatory strategy and determine which submissions will be necessary.
Partnering with RA early during pre-market development can help companies identify their target markets, determine the claims they are seeking and even determine whether this is a new product or a modification.
“Changing scope is fine, but understand that you may have to change the regulatory strategy, too,” she said.
For example, one client from Gibson’s consulting days was developing a drug/device combination product.
“Initially, the company focused on the drug aspect and was planning for a new drug application (NDA). Then it switched gears and made the device the primary focus. I had to remind the team that focusing in the device aspect didn’t negate the advice it had received from the regulator,” Gibson said.
Post-market input is important, too. Often this involves change management for designs and manufacturing.
Gibson recounted her experience at a company that was making a process change. “The regulatory affairs assessment indicated there was no need to submit a letter of registration with the FDA. One person in the meeting said, ‘Huh. I wasn’t expecting that.’ Afterward, I called him and asked about his comment.”
As it turned out, RA was aware of 5 changes, but 25 others also were being made.
“That turned a simple letter into a 510k submission,” she said. “Not knowing about those additional changes could have caused a huge issue for the company, and could have rippled throughout all its regions.”
RA professionals provide insight into pending changes in the global environment, too. “Regulations are like the Saharan desert…always shifting,” Gibson said. “Keep an eye on what may be coming (on the global regulatory front) and determine whether changes may affect your products today, tomorrow, or a year from now.” Some changes have affected companies’ entire portfolios.
Even the website and advertising claims should be checked by regulatory affairs staff, she said, to ensure they meet the requirements of each jurisdiction in which they will appear.
“Do you have the data to support your claims, and are they the right data? Is the type font correct?” Gibson said. “This is all the purview of the regulatory representative.”
Thinking beyond pre- and post-marketing, companies also need to establish processes and best practices for new product development, new iterations of existing products and changes triggered by acquisitions, divestitures and other events.
“Having written procedures outlining how you did something successfully helps you navigate the landmines when you need to do it again,” Gibson said.
For RA professionals, Gibson advised them not only to “speak the language of the tech team (to understand the processes)” but to also match their communication styles with those of their business leaders.
“Our role is to flag risks to the business and offer solutions where possible,” Gibson said. “Rather than shooting down great ideas with a phrase like ‘but there’s a problem,’ try to change the ‘but’ to ‘and,’ so you’re saying, “great idea…and it could work if we do X.”
That alone can change the perception of RA from negative to positive within the organization.
Likewise, she advised RA professionals not to simply direct leaders who have questions to Google. “Our value to business leaders is in interpreting and understanding the multiple regulatory requirements.”
That said, leaders must disabuse themselves of certain assumptions about RA.
“Don’t assume that reading a guidance document is all it takes or underestimate the regulatory burden. Listen to your RA partner and pressure test strategies.” Trying to cut corners on a battery of tests – for example, needing eight, performing two, and trying to justify not performing the remaining six – can cause more delays than conducting the tests initially.
Likewise, don’t believe the ideal submission or clearance timelines you may be presented. Too often, they’re based on goals. Missing the timeline can affect planning throughout the entire company, so only base timelines on data-driven estimates.
Many companies are too small to hire in-house regulatory professionals. Consultants can fill the gap…if they are screened carefully and if the company is clear with itself about its needs and what it plans to do with any recommendations.
A common outsourcing stumbling block involves mapping and tracking deliverables. It’s imperative to have good communications so that both sides are aware of any delays – such as files that weren’t delivered to the contractor.
Another issue is assignment creep.
“Leverage the contractor’s strengths. For example, one contractor excelled at writing submissions and knew the deliverables that she needed, but had no experience supporting the core team to produce those materials.” Put into that role, she failed. “We did her a disservice by not playing to her strengths,” Gibson said.
Regulatory affairs professionals can contribute far more than submissions advice. When companies engage with them early, they can help craft a strategy that fulfills the key program objectives while minimizing missteps.
