AGENDA 1st MEETING

November 4, 2105 in Washington

  •   Welcome and introduction
    Marta Sokolowska, Grünenthal, Karsten Lindhardt, Egalet
  • Final ADF Guideline in April 2015 and Current Experiences with Category 1data in submissions
    James Tolliver, CSS/FDA
  • Review of drug preparations utilized by abusers ad how these procedures could be categorized and translated into in vitro testing
    Megan J. Shram, Altreos Partners
  • Standardization of physical/mechanical manipulation studies
    Brandon Priesley, NMS Lab, Bob Bianchi,PDRC
  • Managing evolving regulatory demands to Cat 1 labs & Interpretation of manipulation results for design of extraction studies
    Anthony Constantino,DrugScan
  • Can we standardize household tools?
  • Stephen Byrn, Purdue University, Steven Hoag, Maryland University
  • Panel Discussion: How do Category 1 studies reflect real world product manipulation?
    James Tolliver, FDA, Silvia Calderon, FDA, Megan J. Shram, Altreos Partners, Bob Bianchi, PDRC, Ed Cone, PinneyAssociates, Steven Byrn, Purdue University, Steven Hoag, Maryland University
  • Product experience from Category 1 studies on Hysingla, Targiniqand OxyContin
    Richard Mannion, Purdue Pharma
  • Bridging the gap between in vitro and clinical studies: Strategic design considerations for in vitro studies to support clinical study design (Category 1 and 2)
    Beatrice Setnik, INC
  • “Level of Effort” Studies: A New Dimension to Category 1 Abuse-Deterrent Testing
    Ed Cone, PinneyAssociates, Jeffrey Dayno, Egalet
  • Practical solutions: Hammer apparatus and syringability versus viscosity
  • Sebastian Schwier, Grünenthal/Torben Elhauge, Egalet
  • Panel Discussion: How can Category 1 and “level of effort” studies be more standardized and inform interpretation of HAL studies?
    Julia Pinto, FDA, Silvia Calderon, FDA, Richard Mannion, Purdue Pharma, Beatrice Setnik, INC, Ed Cone, PinneyAssociates, Jeff Dayno, Egalet, Marta Sokolowska, Grünenthal
  • Wrap up
    Marta Sokolowska, Grünenthal, Karsten Lindhardt, Egalet

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