CROM Symposium Recording

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The objective of the CROM consortium is to develop guidelines to identify, develop, and validate appropriate consumer-reported outcome measures (CROM) to assess tobacco and nicotine-containing products for premarket assessment and post-market surveillance to meet regulatory requirements (see more information here).

Part of the mission of the CROM consortium is to be a recognized scientific authority on CROM-related methodologies and to promote the communication between researchers within industry and academia. To support this mission, the CROM consortium organizes a symposium once a year, with the goal of gathering researchers from various disciplines in industry and academia in order to favor knowledge sharing and dialogue on topics relevant for tobacco regulatory science.

This year, the virtual symposium focuses on abuse liability and will address multiple topics including definitions, assessment methods and study design, and interpretation.  Our desire is to have a diverse group of presenters that will provide expert insights into abuse liability  from a variety of health and public health-related fields across multiple sources (tobacco and other psychoactive substances). The symposium will act as a forum to share and discuss best practice principles to assess abuse liability and highlight some of the main challenges and opportunities that are in front of us.
 

Programme and Presenters

Part I:  Abuse liability assessment of new tobacco products

• Tobacco Product Abuse Liability
    Lynn HULL, PhD, and Megan SCHROEDER, PhD, U.S. FDA Center for Tobacco Products
• Challenges and Considerations Related to Human Abuse Liability Testing for Tobacco Products:  Opportunities to Establish Tobacco-Specific Methods, Measures, and Evaluation Criteria
    Andrea VANSICKEL, PhD, Altria Client Services and Sarah BAXTER-WRIGHT, PhD, RAI Services Company
• Assessment of the Exposure to Selected Smoke Constituents in Adult Smokers Using In-market Heated Tobacco Products: A Randomized, Controlled Study
    Dai YUKI, PhD, Japan Tobacco Inc.

Part II:  Abuse liability assessment of other substances

• Abuse Liability Assessment of CNS-active Drugs in Development: History and Overview
    Ryan LANIER, PhD, Pinney Associates
• The Development of Testing-Based Approaches to Screen for Hazardous Ingredients and Formulations Used in Heated Inhalation Devices With Particular Emphasis on Cannabis Products
    Rob O'BRIEN, PhD, Supra Research and Development
• Building a Consumer Technical Model for Cannabis Products – Insights & Considerations
    Martha BAJEC, PhD, HCD Research

Q&A and Panel Discussion

• All presenters. Chaired by Lesley GILES, PhD, JT International, and moderated by Nicholas GOLDENSON, PhD, JUUL Labs, Inc.