Janine Pillitteri is an accomplished regulatory scientist with more than 20 years of experience in the pharmaceutical industry and tobacco control field. She has extensive experience working with clients on FDA-­regulated products and applying scientific evidence in the development of regulatory submissions. Janine’s experience includes the design, implementation, data analysis, and reporting of behavioral research studies in support of numerous regulatory submissions for different classes of drugs and tobacco harm reduction products. She has been involved in several Rx-to-OTC switch efforts throughout the entire switch process, including developing OTC Drug Facts labels and instructions for use; designing research studies required to support Rx-to-OTC switch efforts; analyzing and interpreting data from studies; and writing reports for regulatory submissions. She has also provided strategic guidance and support for meetings with the FDA, and she has been involved with the design, implementation, and reporting of post-market surveillance for drugs and tobacco products.

Publications

  • Pillitteri JL, Shiffman S, Sembower MA, Polster MR, Curtin GM. Assessing comprehension and perceptions of modified-risk information for snus among current cigarette smokers, former tobacco users, and never tobacco users. Addict Behav Rep 2020;11:100254.
  • Coe M, Pillitteri J, Sembower M, Gerlach K, Henningfield J. Kratom as a substitute for opioids: Results from an online survey. Drug Alcohol Depend 2019;202:24-32. 
  • Nelson PR, Chen P, Battista DR, Pillitteri JL, Shiffman S. Randomized trial to compare smoking cessation rates of snus, with and without smokeless tobacco health-related information, and a nicotine lozenge. Nicotine Tob Res 2019;21(1):88-94. 
  • Shiffman S, Sembower MA, Pillitteri JL, Gerlach KK, Gitchell JG. The impact of flavor descriptors on nonsmoking teens' and adult smokers' interest in electronic cigarettes. Nicotine Tob Res 2015;17:1255-1262. 
  • Shiffman S, Sweeney CT, Pillitteri JL, Sembower MA, Harkins AM, Wadden TA. Weight management advice: What do doctors recommend to their patients? Prev Med 2009;49:482-486. 
  • Tsai AG, Wadden TA, Pillitteri JL, Sembower MA, Gerlach KG, Kyle TK, Burroughs VJ. Disparities by ethnicity and socioeconomic status in the use of weight loss treatments. J Nat Medical Assoc 2009;101:62-70. 
  • Fabricatore AN, Wadden TA, Rohay JM, Pillitteri JL, Shiffman S, Harkins AM, Burton SL. Weight loss expectations and goals in a population sample of overweight and obese US adults. Obesity 2008;16:2445-2450. 
  • Pillitteri JL, Shiffman S, Rohay JM, Harkins AM, Burton SL, Wadden TA. Use of dietary supplements for weight loss in the United States: Results of a national survey. Obesity 2008;16:790-796. 
  • Shiffman S, Brockwell SE, Pillitteri JL, Gitchell JG. Individual differences in adoption of treatment for smoking cessation: Demographic and smoking history characteristics. Drug Alcohol Depend 2008;93:121-131. 
  • Shiffman S, Brockwell SE, Pillitteri JL, Gitchell JG. Use of smoking cessation treatments in the United States. Amer J Prev Med 2008;34:102-111. 
  • Shiffman S, Hughes JR, Ferguson SG, Pillitteri JL, Gitchell JG, Burton SL. Smokers' interest in using nicotine replacement to aid smoking reduction. Nicotine Tob Res 2007;9:1177-1182. 
  • Shiffman S, Jarvis MJ, Pillitteri JL, Di Marino ME, Gitchell JG, Kemper KE. UK smokers' and ex­smokers' reactions to cigarettes promising reduced risk. Addiction 2006;102:156-160. 
  • Ellis CN, Pillitteri JL, Kyle TK, Ertischek MD, Burton SL, Shiffman S. Consumers appropriately self-treat based on labeling for over-the-counter hydrocortisone. J Amer Acad Dermatol 2005;53:41-51. 
  • Shiffman S, Di Marino ME, Pillitteri JL. The effectiveness of nicotine patch and nicotine lozenge in very heavy smokers. J Subst Abuse Treat 2005;28:49-55.
  • Hughes JR, Oliveto AH, Riggs RL, Kenny M, Liguori A, Pillitteri JL, Maclaughlin MA. Concordance of different measures of nicotine dependence: Two pilot studies. Addict Behav 2004;29:1527-1539. 
  • Hughes JR, Pillitteri JL, Callas PW, Callahan R, Kenny M. Misuse of and dependence on over­the-counter nicotine gum in a volunteer sample. Nicotine Tob Res 2004;6:79-84. 
  • Shiffman S, Pillitteri JL, Burton SL, Di Marino ME. Smoker and ex-smoker reactions to cigarettes claiming reduced risk. Tob Control 2004;13:78-84. 
  • Shiffman S, Hughes JR, Pillitteri JL, Burton SL. Persistent use of nicotine replacement therapy: An analysis of actual purchase patterns in a population-based sample. Tob Control 2003;12:310-316. 
  • Kozlowski LT, Pillitteri JL. Beliefs about "Light" and "Ultra Light" cigarettes and efforts to change those beliefs: An overview of early efforts and published research. Tob Control 2001;10(Suppl 1):12-16. 
  • Shiffman S, Pillitteri JL, Burton SL, Rohay JM, Gitchell JG. Smokers' beliefs about "Light" and "Ultra Light" cigarettes. Tob Control 2001;10(Suppl 1):17-23. 
  • Shiffman S, Pillitteri JL, Burton SL, Rohay JM, Gitchell JG. The effect of health messages about "Light" and "Ultra Light" cigarettes on beliefs and quitting intent. Tob Control 2001;10(Suppl 1):24-32. 
  • Shiffman S, Burton SL, Pillitteri JL, Gitchell, JG, Di Marino ME, Sweeney CT, Wardle PA, Koehler GL. Test of "Light" cigarette counter-advertising using a standard test of advertising effectiveness. Tob Control 2001;10(Suppl 1):33-40. 
  • Riggs RL, Hughes JR, Pillitteri JL. Two behavioral treatments for smoking reduction: A pilot study. Nicotine Tob Res 2001;3(1):71-76. 
  • Hughes JR, Grass JA, Pillitteri JL. Treatment resistant smokers: A pilot study of nicotine nasal spray and inhaler. J Addictive Dis 2000;19(1):95-100.