*Dr. Gerlach is not licensed to practice law in North Carolina. Her activities are supervised by attorneys licensed to practice in North Carolina.

Karen Gerlach is a regulatory scientist with years of experience in the public, private, and non-profit sectors. She has experience in all aspects of science from conducting basic laboratory research to applying scientific evidence to advance regulatory decisions and public policy. She has assisted clients and clients’ vendors in the design, implementation, analysis, and reporting of behavioral research efforts in support of regulatory submissions for tobacco harm reduction products. She has also been involved with the design, implementation, and reporting on all aspects of post-marketing surveillance required under Risk Evaluation and Mitigation Strategies (REMS) imposed by the FDA for certain classes of scheduled opioid and sleep medications.

Publications

  • Gerlach K., S. Shiffman, D. Battista, M. Polster, G. Curtin. Assessing likelihood of product use for snus with modified-risk information among adult current cigarette smokers, former tobacco users, and never tobacco users. Addictive Behavior Reports 2019;10: 100208.  
  • Coe M.A., J.L. Pillitteri, M.A. Sembower, K.K. Gerlach, J.E. Henningfield. Kratom as a substitute for opioids: Results from an online survey. Drug and Alcohol Dependence 2019; 202: 24-32. 
  • Shiffman S., M.A. Sembower, J.L. Pillitteri, K.K. Gerlach, J.G. Gitchell. The impact of flavor descriptors on nonsmoking teens' and adult smokers' interest in electronic cigarettes. Nicotine and Tobacco Research 2015;17(10): 1255-1262. 
  • Gerlach, K.K., N. Dasgupta, S.H. Schnoll, J.E. Henningfield. Epidemiology of stimulant misuse and abuse: Implications for future epidemiologic and neuropharmacologic research. Neuropharmacology 2014;87(12): 91-96. 
  • Shiffman S., K.K. Gerlach, M.A. Sembower, J.M. Rohay. Consumer understanding of prescription drug information: an illustration using an antidepressant medication. Annals of Pharmacotherapy 2011;45(4): 452-458. 
  • Tsai, A.G., T.A. Wadden, J.L. Pillitteri, M.A. Sembower, K.K. Gerlach, T.K. Kyle, V.J. Burroughs. Disparities by ethnicity and socioeconomic status in the use of weight loss treatments. Journal of the National Medical Association 2009;101(1): 62-70. 
  • Gerlach, K.K., J.M. Rohay, J.G. Gitchell, S. Shiffman. Use of nicotine replacement therapy among never smokers in the 1999-2006 National Health and Nutrition Examination Surveys. Drug and Alcohol Dependence 2008;98(1-2): 154-158. 
  • Marks, J.S., C.T. Orleans, K.K. Gerlach. On the threshold of a dream. Cancer 2006;107(2): 217-220. 
  • Castrucci, B.C., K.K. Gerlach. Understanding the association between authoritative parenting and adolescent smoking. Maternal and Child Health Journal 2006;10(2): 217-224.
  • Castrucci, B.C., K.K. Gerlach. The association between adolescent smokers' desire and intentions to quit smoking and their views of parents' attitudes and opinions about smoking. Maternal and Child Health Journal 2005;9(4): 377-384. 
  • Shopland, D.R., Anderson, C.M., Burns, D.M., Gerlach, K.K. Disparities in smoke-free workplace policies among food service workers. Journal of Occupational and Environmental Medicine 2004;46(4): 347-356. 
  • Castrucci, B.C., K.K. Gerlach, N.J. Kaufman, C.T. Orleans. Tobacco use and cessation behavior among adolescents participating in organized sports. American Journal of Health Behavior 2004;28(1): 63-71. 
  • Kaufman, N.J., B.C. Castrucci, P. Mowery, K.K. Gerlach, S. Emont, C.T. Orleans. Changes in adolescent cigarette-brand preference, 1989 to 1996. American Journal of Health Behavior 2004;28(1): 54-62. 
  • Morgan, G.D., K. Kobus, K.K. Gerlach, C. Neighbors, C. Lerman, D.B. Abrams, R.K. Rimer. Facilitating transdisciplinary research: The experience of the Transdisciplinary Tobacco Use Research Centers. Nicotine and Tobacco Research 2003;5(Suppl 1): S11-19. 
  • Castrucci, B.C., K.K. Gerlach, N.J. Kaufman, C.T. Orleans. Adolescents' acquisition of cigarettes through noncommercial sources. Journal of Adolescent Health 2002;31(4): 322-326. 
  • Krevor, B.S., A. Lieberman, K. Gerlach. Application of consumer protection authority in preventing tobacco sales to minors. Tobacco Control 2002;11: 109-111. 
  • Kaufman, N.J., B.C. Castrucci, P.O. Mowery, K.K. Gerlach, S. Emont, C.T. Orleans. Predictors of change on the smoking uptake continuum among adolescents. Archives of Pediatric and Adolescent Medicine 2002;156: 581-587. 
  • Castrucci, B.C., K.K. Gerlach, N.J. Kaufman, C.T. Orleans. The Association among adolescents' tobacco use, their beliefs and attitudes and friends' and parents' opinions of smoking. Maternal and Child Health Journal 2002;6(3): 159-167. 
  • Shopland, D.R., K.K. Gerlach, D.M. Burns, A.M. Hartman, J.T. Gibson. State-specific trends in smoke-free workplace policy coverage. The Current Population Survey Tobacco Use Supplement, 1993-1999. Journal of Occupational and Environmental Medicine 2001;43(8): 680- 686. 
  • Kaufman, N.J., B.C. Castrucci, K.K. Gerlach. Investing in substance abuse research: The Robert Wood Foundation story. Drug and Alcohol Dependence 2000;59(Suppl 1): S5-S8.