At PMI, research and development (R&D) catalyzes our business transformation. The rigor with which we conduct our research—and the openness with which we share our methodologies and results—builds confidence in our science among
the scientific community, regulators, and our consumers, protects our company from reputational risk, and, most importantly, allows us to commercialize our smoke-free products around the world.
Conducting our R&D responsibly and sharing our R&D methods and results openly and transparently is of utmost importance. Transparency, when coupled with scientific integrity and rigor, alleviates skepticism and mistrust, fostering an fertile environment for collaboration and partnership. Evidence and results from our robust scientific assessments advance the debate on public health and tobacco harm reduction to the benefit of adult smokers.
Our R&D work is focused on developing and scientifically substantiating smoke-free alternatives to cigarettes for adults who would otherwise continue to smoke. An essential part of our work is demonstrating that we have eliminated combustion when it comes to our smoke-free alternatives. Eliminating combustion significantly reduces levels of exposure to harmful and potentially harmful chemicals compared with smoking. And it is these chemicals that are the root cause of smoking-related diseases.
Management
We review and update our strategy and long-range planning on an annual basis. Projects created based on this planning are governed by designated committees at product innovation, development and assessment, Company Management, and Board levels. Among other responsibilities, the Board’s Science and Technology Committee monitors the Company’s internal scientific research, including efforts to establish and substantiate the health-harm reduction potential of our smoke-free products.
We continuously strengthen our quality assurance and internal governance processes to ensure a robust internal, cross-functional scientific peer-review process that leverages external experts and key opinion leaders. Furthermore, we prioritize targeted investments in a digital strategy that protects data integrity and scientific credibility, and leverages artificial intelligence to optimize resources and accelerate the delivery of robust, credible science substantiating new and innovative smoke-free alternatives to cigarettes and the health-harm reduction potential of these products.
We regularly interact with an extensive network of stakeholders, including research partners, contract research organizations, universities, and individual key opinion leaders as well as production site personnel, suppliers, consumers, and regulators.
We adhere to high scientific standards, and our R&D is aligned with the U.S. Food and Drug Administration’s draft guidance on modified risk tobacco products (2012).
In conducting our studies, we also aim to align with available international standards, such as applicable ISO standards, Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice, and Good Epidemiological Practices. Importantly, all our clinical studies are conducted in accordance with the Declaration of Helsinki and the principles of Good Clinical Practice. These standards aim to ensure the quality and integrity of our science.
Sharing our methods and results
Regardless of industry, scientific research from a corporation may be met with skepticism. The best way to address skepticism and build trust is through transparency. Hence, we share our science and listen carefully to feedback. This is critical to encouraging debate with experts and the broader public. We publish our findings in peer-reviewed journals, conference presentations, and on PMIscience.com. We also produce a regular briefing through our Scientific Update publication which complements what we share throughout the year. Since 2008, we have published 531 papers on smoke-free products and related science in peer-reviewed publications.
In 2023, we continued our Open Science conference series, hosting webinars and in-person events and making the recordings available on PMIscience.com. In addition, our scientists regularly present their results at external scientific conferences and virtual events in the fields of aerosol chemistry, toxicology, clinical and real-world evidence studies, as well as consumer research and product standards and oral and respiratory drug delivery.
By sharing our scientific data and papers, we allow the research community and broader public to gain an in-depth understanding of PMI’s research methodologies and findings. We welcome objective studies by external parties seeking to contribute to a science-based debate on the critical societal question of tobacco harm reduction and nicotine science. Read about how we engage with our stakeholders, including the public health community, here.
In 2018, we launched INTERVALS, a mechanism through which to share tobacco harm reduction science. INTERVALS was designed for hosting and sharing raw data and descriptions of PMI preclinical studies to facilitate independent verification of our results by the scientific community. The choice of public data repositories accepting multiple data modalities has greatly increased over the years, allowing PMI to now share its own data on independent public repositories, which will be more effective in achieving our data transparency goals. Accordingly, we plan to decommission the INTERVALS platform in 2024.
Animal testing
Regulators continue to require animal studies to confirm in vivo what pharmacology and toxicology studies show in vitro. Toxicology standards accept the use of rodents in scientific research. Nevertheless, to the extent possible, we are working to replace animal testing with other approaches.
We apply the “3R” guidelines: replacement, reduction, and refinement (see our Standards for Animal Testing).
In time, we hope to replace most, if not all, animal testing with alternative methods. Our in vivo facility is accredited by AAALAC International, which sets the gold standard for the humane use of animals in scientific research.
