The workshop, Biomarkers of Tobacco Exposure, is the latest in a series of workshops hosted by the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP), to which BAT’s senior scientists have regularly contributed.
This workshop discussed the identification and implementation of biomarkers that are currently appropriate for regulatory use, and identification of biomarkers for which more data is required but which may viable for use in the future. Dr. Proctor’s contribution focused on lessons from three clinical studies, each using biomarkers of exposure to assess toxicant exposure. In a six-month long study of reduced toxicant prototype cigarettes, reductions in exposure to some tobacco smoke toxicants did not result in reductions in biomarkers of biological effect.
Biomarker studies are likely to be important to modified risk tobacco product (MRTP) application, and, as the last session of the workshop discussed, the evaluation of the potential for reduced risk product categories such as smokeless tobacco, tobacco heating products and e-cigarettes.
Engaging with the FDA and other regulators to share our transparent approach to scientific research is important to BAT. We are always pleased to contribute an industry perspective to these workshops, to demonstrate the expertise and credibility of our scientists, and the relevance of industry as a stakeholder in these discussions.
BAT’s senior scientists are regularly asked to attend and present at the FDA CTP’s public workshops, acknowledging their experience and expertise in the field of tobacco and nicotine science.
Earlier in 2015, Dr. Sandra Costigan (Principal Toxicologist) and Dr. Sudhanshu Patwardhan (International Scientific Affairs Manager) at Nicoventures (part of the British American Tobacco Group) presented at the FDA CTP’s public workshop on electronic cigarettes and public health. These presentations included a discussion of Nicoventures’ latest consumption and puffing topography data, and best practice in e-cigarette flavour stewardship.
In December 2014, Dr. Patwardhan presented at a public workshop on the public health impact of electronic cigarettes, also attended by Dr. Chris Wright, Head of Analytical Sciences at British American Tobacco.
In August 2013, Dr. Proctor presented at a joint meeting of the FDA Risk Communication Advisory Committee (RCAC) and Tobacco Products Scientific Advisory Committee (TPSAC), the aim of which was to consider how to better communicate quantities of harmful smoke constituents in tobacco products in a manner that is comprehensible yet not misleading. Dr. Proctor presented findings from a BAT clinical study that highlighted the need for clear and easily understandable communication about potentially reduced risk tobacco products, and that effective communications would be critical to optimising potential public health benefits of such products.
In July 2013 the FDA’s Tobacco Product Analysis Scientific Workshop hosted four presentations by BAT senior scientists, including research on PAHs (polyaromatic hydrocarbons) and TSNAs (tobacco-specific nitrosamimes) in tobacco filter and cigarette smoke, the validation of TNCO (tar, nicotine and carbon monoxide), TSNAs and PAHs, and BAT’s TNCO testing procedures, presented by Mark Williams (Head of the Analytical Development Centre at British American Tobacco ), Dr. Wright, and Dr. Proctor. BAT’s senior scientists presented alongside other experts from industry, government, academia, and contract research laboratories (CROs). The attendees agreed that there is a need for better reference products and materials to test low-level toxicants.
In March 2013, Dr. Justine Williamson represented BAT at a two-day FDA public workshop that focused on the Institute of Medicine (IoM)’s view that research carried out by the tobacco industry needs to be governed by a third party. Dr. Williamson explained that BAT “has a new generation of tobacco industry scientists that have developed significant expertise in areas of tobacco regulatory science’’. She showcased our transparent approach, demonstrating how BAT seeks to engage with the mainstream scientific community, through regular presentations at conferences and ~130 peer-reviewed journal publications since 2008.
In the very first of the workshops, held in August 2011, which focused on the science needed to evaluate modified risk tobacco products, Dr. Proctor shared a panel with Dr. David Burns, a key contributor to many US Surgeon General reports, and Dr. Tim McAfee of the Centers for Disease Control (CDC).
Continued active engagement by BAT’s senior scientists to these global debates highlights the diversity of scientific topics to which BAT’s senior scientists contribute to.