AGENDA 3rd MEETING

January 30-31, 2018 in Alexandria

  •   Welcome
    Karsten Lindhardt, Egalet and Sebastian Schwier, Grünenthal
  • Keynote: FDA perspective (TBD)
    FDA representative Dr. Jim Tolliver
  • Keynote: FDA perspective (Generic Abuse Deterrent Opioids guideline)
    FDA representative Dr. Dajun Sun
  • Warm up for Working Sessions – Tampering with Prescription Opioids – Methods and Recipes from the Real-World
    Inflexxion, Steve Butler
  • Introduction to Working Group 1 – Working Group 4
    (new Generic guideline to be considered)
  • 1) Bob Bianchi / Torben Elhauge
    2) Chris Altomare / Sebastian Schwier
    3) Karsten Lindhart/Dr. Dajun Sun
    4) Beatrice Setnik
  • Working Sessions
    Working Group 1 – Analytical considerations:
    Strategies to streamline in vitro testing based on screen testing and product knowledge.
    Considerations for analytical standardization considering different solvents (e.g. beverages) and requirements for method validation
    --Limits of testing?
    --Which parameters make sense to test starting with the test parameters mentioned in the guideline and how to interpret them
    Working Group 2 – Manipulation methods:
    Examining the goals and methods of in vitro testing:
    --Should testing be as close to the “street” as possible or relevant as QC-Methods?
    --Which ADF properties could be QC tested during shelf life and how do methods and specification limits look like?
    Working Group 3 – New Generic ADF guidance
    Discuss content and collect / provide comments
    Working Group 4 – Tampering in the Laboratory vs Clinic:
    Selecting the best manipulation method for clinical evaluation
    - -Manipulation method transfer to Category 2/3 clinical studies and how in vitro methods can impact clinical results.
    --Strategies to ensure consistent manipulation across doses
  • New methods and technologies in ADT – academia perspective
    Stephen Hoag, University of Maryland 
  • New methods and technologies in ADT (e.g. chewing, syringing, smoking).
    Chris Altomare, Drugscan
  • Link between Category One and Real Word Data – Establishing a link between different categories of abusers and tests
    Janetta Iwanicki, RADARS
  • Category I Evaluations for Abuse Deterrent Opioids – Lessons Learned from Recent Advisory Committee Meetings
    Chris Miller, 3D Communications 
  • Reporting/ Presentation - Working Groups 1 and 2
    (15min presentation per group plus 15min panel discussion / Q&A)
    Chair: Working Group 1: Bob Bianchi / Torben Elhauge,
     Working Group 2: Chris Altomare / Sebastian Schwier 
  • Reporting/ Presentation - Working Group 3 and 4
    (15min presentation per group plus 15min panel discussion / Q&A)
    Chair: Working Group 3: Karsten Lindhart/Dr. Dajun Sun
     Working Group 4: Beatrice Setnik
  • Case Study: Apply Design of Experiments (DoE) on Category One Tests
    Chris Altomare, DrugScan; Sebastian Schwier, Grünenthal

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