Our Science-based Approach to New Tobacco Products

Kurt Gottfried

Director
Regulatory Affairs

Altria Client Services

I’m fortunate enough to lead a team responsible for developing successful new and modified risk tobacco product applications for smoke-free oral products like on!® – Premarket Tobacco Applications (PMTAs) and Modified Risk Tobacco Products (MRTPAs).

Achieving our
Vision by 2030 to responsibly lead the transition of adult smokers to a smoke-free future requires a portfolio of satisfying, potentially reduced risk products. Ultimately, my goal is to help bring the right products to market through the PMTA process to meet that Vision. Tactically, I assemble and lead cross-functional teams tasked with developing the evidence necessary to demonstrate that the products are appropriate for the protection of public health and should be granted market authorization.

We follow a rigorous scientific framework for evaluating potentially reduced risk products in our applications that enables us to assess them from design, to individual risk, to overall population impact.

 

I never cease to be amazed by the sheer brain power of our scientists and researchers.

 

From Analytical and Population Sciences to Clinical and Pre-clinical, we have a world class team that’s laser focused on moving the science of harm reduction forward and using those insights to meet adult smokers where they are with satisfying, smoke-free alternatives.

In 2020, we faced multiple challenges with the on!® PMTA process that were largely out of our control. From a Court ruling accelerating our submission timeline to the publication of a new PMTA rule, we had to pause our work more than once to navigate and adapt to the complex timelines. Then, COVID hit right at the critical point when we were beginning to pull our narratives together and publish our applications – processes that typically require multiple people in the same room. Needless to say, we had to quickly pivot and rethink the process given remote work.

Fortunately, the team pulled together, navigated the remote working environment and submitted our PMTAs that May. As challenging as the process was, we most certainly gained some learnings. Specifically, we gained insights into how we can drive efficiencies into the PMTA process by streamlining work and condensing timelines.

Submitting our on!® PMTAs was undoubtedly my proudest moment last year. Those applications represented thousands of hours of work from employees across the company dedicated to making our Vision a reality. And even though we hit obstacle after obstacle, the team rose to the challenge together to submit compelling PMTAs. I still smile thinking about the insane amount of teamwork and coordination it required.

As I look to the future, I’m most excited about the potential of our next generation products still in development. Our Product Development group is working on various smoke-free product platforms that can expand our portfolio of potentially reduced risk offerings to transition even more adult smokers who would have otherwise continued smoking.


Patricia Miller Photo

Our Focus on Responsibility Before and After FDA Authorization

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We are re-evaluating our foundation for cessation support, making sure that what we're doing makes sense for the time that we're in.