pertise informs the work of our engineering/analytical-chemistry group.
Caroline Cobb is an experimental psychologist with a
specialization in biopsychology and experience with clinical
laboratory evaluations of tobacco products and assessing
population patterns of tobacco use. Her expertise in assessment at both the individual and population levels is an
essential element of cross-project collaboration.
Thomas Eissenberg is an experimental psychologist and
is the team’s director. His primary area of research is the
behavioral pharmacology of drugs of abuse. His expertise in
product design, preclinical methods, tobacco user behavior,
user toxicant exposure, and population-level assessment of
tobacco use allow him to foster cross-project collaboration.
Pebbles Fagan is a public health scientist and her research
focuses on the social, behavioral, and biobehavioral factors
associated with tobacco/nicotine use, with an emphasis on
tobacco-related health disparities. She leads a research
group that uses quantitative and qualitative methods to
evaluate tobacco products and user behavior as well as
changes in product design and marketing. Her expertise
ensures that our work generalizes to the population.
Jonathan Foulds is a clinical psychologist and an expert in
nicotine psychopharmacology and the treatment of nicotine
addiction. His expertise as a clinical psychologist ensures
that we maintain a focus on individual-level health outcomes.
J. Randy Koch is a community psychologist with experience in community-based research, the translation of research into practice and policy, and organizational leadership. In his role directing our pilot research program, he
helps to ensure that we consistently are engaged in new
projects that address emerging needs in tobacco regulatory
Thokozeni Lipato is a physician specializing in internal
medicine. He is a medical monitor for our clinical research
and his focus on participant health helps ensure the continued safety our research participants.
Najat Saliba is an analytical chemist with extensive experience in the analysis of airborne particles, including
tobacco. She oversees chemical assays in our work focused
on characterizing tobacco product aerosol emissions and is
responsible for using our study results on product design to
inform the development of new methods for assessing nicotine yield and previously unexplored toxicants (e.g.,
Alan Shihadeh is a mechanical engineer with expertise in
the chemistry, physics, and exposure science of particle
pollutants, with an emphasis on tobacco smoke. His experience with product-specific factors that influence tobacco
product emissions, as well as his appreciation of the role
user behavior plays in influencing these emissions, allow
him to collaborate directly and effectively with all other
Shumei Sun is an expert in modeling complex cross-sectional and longitudinal data. She leads the biostatistics
support group. This group assists in clinical trial design,
sample size and power calculations, analysis of repeated
measures data, and longitudinal modeling.
Six psychologists, with expertise in behavioral pharmacology, nicotine pharmacology, abuse liability, biopsychology, tobacco product evaluation, research design, tobacco
user behavior, and the translation of research into policy,
form a critical core component of our 11-member multidisciplinary team. The psychologists’ expertise is enriched by
the other team members, who bring expertise in public
health, medicine, chemistry, engineering, and statistics.
Since core funding began in 2013, this multidisciplinary
team has collaborated to complete four interlinked projects
to study ECIGs as an exemplar of MRTPs: (a) studying
ECIGs and other tobacco products in the engineering laboratory to determine emissions profiles and the factors that
influence them; (b) studying ECIGs and other tobacco products in the human laboratory to determine their nicotine
delivery profile, user behavior patterns, and other effects
under controlled conditions; (c) conducting a randomized
controlled trial (RCT) to determine the effects of ECIG use
on cigarette smoker toxicant exposure and concurrent other
tobacco product use; and (d) conducting mixed qualitative/
quantitative research to understand effects reported by
ECIG users, ECIG use motivation, and product marketing/
packaging. This work is conducted using a multidisciplinary
evaluative model, described next. In addition to this work,
team members lead several other federally funded research
grants on topics related to tobacco regulatory science. Also,
our team developed a training program in tobacco regulatory science as well as a pilot grants program to facilitate the
initiation of complementary areas of research. One of the
keys to building and maintaining our multidisciplinary research program has been the interaction with other federally
funded regulatory science teams, which, considered together, represent an even larger multidisciplinary effort for
informing tobacco product regulation. There are biannual
meetings of these teams as well as shared knowledge dissemination, and these meetings have led to the formation of
working groups that have helped shape our research and
training programs as well as our participation in collaborative research projects across teams.
Evaluative Model for Potential Modified Risk
The Food and Drug Administration’s (FDA’s) mandate to
regulate tobacco products, including novel tobacco products
like ECIGs and other potential MRTPs, arises from the
Family Smoking Prevention and Tobacco Control Act
(2009; FDA Deeming Tobacco Products To Be Subject to
the Federal Food, Drug, and Cosmetic Act, 2016). Accord-
370 BRELAND ET AL.