At PMI, research and development (R&D) is the catalyst for our business transformation. The rigor with which we conduct our research—and the openness with which we share our methodologies and findings—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, brings relief to skepticism and helps address mistrust, fostering an environment where collaboration and partnership can blossom. Evidence and findings from robust scientific assessments advances 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 important part of our R&D focuses on researching, understanding, and confirming that eliminating combustion can reduce levels of exposure to harmful and potentially harmful chemicals compared with smoking. In conducting R&D, we strive for excellence in our scientific methods or their execution.
Decision-making on R&D strategy and direction is handled by designated committees at the product assessment, project design, Company Management, and Board levels. Among other responsibilities, the Board’s Product Innovation and Regulatory Affairs Committee monitors the company’s internal scientific research, including our efforts to substantiate the health risk-reduction potential of our smoke-free products.
We regularly interact with an extensive network of stakeholders, including long-term study partners, research partners, production site personnel, universities, suppliers, consumers, and regulators.
We adhere to high scientific standards, and our research is aligned with the U.S. Food and Drug Administration’s draft guidance on Modified Risk Tobacco Products (2012).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 nonclinical and clinical studies.
Sharing our methods and findings
Scientific research from any corporation may be met with skepticism. Sharing our science and listening to feedback are critical to both encourage debate with experts and the broader public) and build trust. We produce a regular briefing through our Scientific Update publication (see here), which complements what we share throughout the year via articles in peer-reviewed journals, presentations at conferences, and our PMI Science website. Since 2008, we have published over 450 papers on smoke-free products and related science in peer-reviewed publications.
In 2022, 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 continued to present their findings throughout the year at external conferences and virtual events in the fields of toxicology, aerosol engineering, and respiratory drug delivery.
By sharing our scientific data and papers, we allow the research community and broader public to gain an in-depth perspective into PMI’s research methodologies and findings. We welcome objective studies by external stakeholders who seek to contribute to a science-based debate on the critical societal question of tobacco harm reduction.
INTERVALS
To address concerns over the reproducibility of research results, we created INTERVALS, a platform specifically for sharing tobacco harm reduction science. INTERVALS is intended to be a comprehensive reduced-risk product research repository, housing data from PMI and a variety of third-party sources.
By promoting the sharing of protocols, tools, and data, this platform enables independent data reanalysis and collaboration. It was designed to allow all relevant stakeholders to share and explore toxicity assessment data produced in relation to cigarette alternatives. As of the end of 2022, a total of 91 studies, 142 protocols, and 691 datasets had been published on INTERVALS since 2018.
Animal testing
Animal studies allow us to confirm in vivo what pharmacology and toxicology studies show in vitro. We use human-derived cells in vitro, but the animal studies in vivo enable us to assess scientifically the consistency of our findings.
Toxicology standards accept the use of rodents in scientific research. Nevertheless, we are working, to the extent possible, 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 Animal Welfare Committee, composed of veterinary and scientific PMI professionals with ample experience in animal testing, is responsible for reviewing protocols and examining them for compliance with scientific and animal welfare criteria. Our in vivo facility is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), which sets the gold standard for the humane use of animals in scientific research.
Our strategy highlights the importance of governance-related topics, which cannot be overstated. Our company’s policies, rules, and procedures define our ability to implement sound strategies that successfully address environmental and social issues.
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Read MoreThis online content about our Integrated Report should be read in conjunction with PMI’s Integrated Report 2022. Unless otherwise indicated, the data contained herein cover our operations worldwide for the full calendar year 2022 or reflect the status as of December 31, 2022. Where not specified, data comes from PMI financials, non-financials, or estimates. Unless explicitly stated, the data, information, and aspirations referenced do not incorporate PMI’s Vectura Fertin Pharma business (consolidating the 2021 acquisitions of wellness and healthcare companies Fertin Pharma A/S, Vectura Group plc., and OtiTopic, Inc.), nor the late 2022 acquisition of Swedish Match AB. Please also refer to 'This report at a glance' on page 2 of the Integrated Report 2022 for more information. Aspirational targets and goals do not constitute financial projections, and achievement of future results is subject to risks, uncertainties and inaccurate assumptions, as outlined in our forward-looking and cautionary statements on page 214. In the Integrated Report 2022 and in related communications, the terms “materiality,” “material,” and similar terms, when used in the context of economic, environmental, and social topics, are defined in the referenced sustainability standards and are not meant to correspond to the concept of materiality under the U.S. securities laws and/or disclosures required by the U.S. Securities and Exchange Commission.