Our Team
-
Willie McKinney Ph.D.
Founder & CEO
A tobacco industry regulatory executive and inhalation toxicologist who’s spent more than two decades conducting research and developing product and regulatory strategies that bring better products to market.
Meet Willie
-
Kim Hesse M.A.
Vice President, Sales and Marketing
A nicotine and cannabis industry executive with more than 15 years of industry experience who’s equally comfortable in the lab or a board room building organizational processes and growing the business.
Meet Kim
-
Karin M. Gilligan, CSM, PMP
Director Regulatory Operations
Certified Scrum Master (CSM) and a Project Management Professional (PMP) with more than 15 years in the tobacco and consumer products industries.
Meet Karin
Our Experts
Our team is your competitive advantage. Learn more about the people who should be at your regulatory table.
-
Scott Appleton Ph.D.
Senior scientific and regulatory affairs practitioner who helps clients assess their toxicological and regulatory strategies. Dr. Appleton also is curious about the health and behavioral affects of tobacco use.
Meet Scott -
Autumn Bernal Ph.D.
Toxicologist and electronic nicotine delivery system (ENDS) expert helping nicotine and cannabis manufacturers develop, prioritize and asses strategic scientific projects in their regulatory roadmap.
Meet Autumn -
Doug Burton ASQ CQE, CRE, CQA, CQM, CSSBB
World-renowned e-vapor and ENDS safety and reliability engineer with extensive experience in risk assessment, mitigation, hazards and human factor analysis, manufacturing process assessment and development, and battery manufacturing and testing.
Meet Doug -
Les Edinboro Ph.D.
Forensic and clinical toxicologist and fractional Chief Science Officer who can provide laboratory process improvements, leadership development, and risk management reviews.
Meet Les -
Melissa Erekson
Higher education marketer and research relations expert turned writer who leverages her experience in proposal development and grant seeking to tell compelling data stories for regulatory submission.
Meet Melissa -
Ian Fearon Ph.D.
Clinical R&D expert and scientist who’s spent 16 years in tobacco harm reduction providing end-to-end support developing and implementing pre-clinical and clinical research programs for tobacco regulatory submissions in the EU and US. Ian is also a technical writer and subject matter expert in all tobacco harm reduction areas.
Meet Ian -
David Kane
Multidisciplinary Scientist with expertise in consumer product chemistry and physics, specializing in harm reduction. Leads a consulting firm that supports tobacco and cannabis industries in R&D and regulatory strategies. Holds advanced degrees in physics and chemical physics, with a focus on aerosol science.
Meet David -
Ranulfo Lemus Ph.D.
Toxicologist with a focus in inhalation, combustion, metals and genetic toxicology. Dr. Lemus is also well versed in regulatory stakeholder engagement through his International Tungsten Association work.
Meet Ranulfo -
Inge Lundegaard
Regional government project manager with experience developing policies, regulations and projects related to cannabis regulation.
Meet Inge -
Helen Miller
Biologist and clinical laboratory specialist – with more than 30 years experience in methodology development, QA/QC and validation – who helps clients navigate state and FDA testing requirements.
Meet Helen -
Cheryl K. Olson Sc.D.
Harvard Medical School psychiatry professor, renowned qualitative and quantitative behavioral researcher and tobacco industry columnist with deep experience in smoking cessation and prevention.
Meet Cheryl -
Reynaldo Quintana M.S.
Biomedical engineer and inventor with more than 20 years of technical, product development leadership; mechanical design; research and development; and global product stewardship.
Meet Reynaldo -
Ryan Seltzer Ph.D.
Public health researcher, with an expertise in research design, data analysis and clinical trial program evaluation, who uses AI and traditional statistics to reveal meaningful patterns.
Meet Ryan -
Neil Sherwood Ph.D.
Psychopharmacologist studying the relationship between product use and consumer health who translates those findings into scientific and regulatory overviews, and ultimately public health advocacy.
Meet Neil -
Marissa Smith Ph.D.
Physiologist, pharmacologist and toxicologist with end-to-end experience designing in vitro and in vivo studies, from both the laboratory and client side, giving her a unique perspective.
Meet Marissa -
Elisabeth Upton
FDA regulatory consultant who can lead clients through all phases of development – from strategy to research, systems implementation, quality assurance and operations.
Meet Elisabeth -
Jessica Zdinak Ph.D.
Behavioral Science Researcher with extensive experience in public health and the tobacco industry whose work produces impactful insights and advances in tobacco harm reduction.
Meet Jessica
Contact Us
"*" indicates required fields