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 categoriesof 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
Below you can download the presentations from the meeting