Category 1 Focus Group Meeting


08:30 - 08:40       Welcome and introduction - (Marta Sokolowska, Grünenthal; Karsten Lindhardt, Egalet)

08:40 - 09:10       Final ADF Guideline in April 2015 and Current Experiences with Category 1 data in submissions (James Tolliver, CSS/FDA)

09:10 – 09:40      Review of drug preparations utilized by abusers ad how these  procedures could be categorized and translated into in vitro testing”   (Kerri Schoedel, Altreos Partners)

09:40 - 10:00       AM Break

10:00 - 10:30       Standardization of physical/mechanical manipulation studies - (Patricia Haneman, NMS Lab./Bob Bianchi PDRC)

10:30 - 11:00       Managing evolving regulatory demands to Cat 1 labs & Interpretation of manipulation results for design of extraction studies (Anthony Constantino, DrugScan)

11:00 - 11.30       Can we standardize household tools? – (Stephen Byrn/Steven Hoag, Purdue/Maryland Universities)

11.30 - 12.30       Panel Discussion: How does Category 1 studies reflect real world product manipulation? (James Tolliver, FDA; Silvia Calderon FDA; Kerri Schoedel, Altereos; Bob Bianchi, PDRC; Ed Cone, Pinney Associates; Steven Byrn, Purdue University; Steven Hoag, Maryland University)

12:30 - 13:30       Lunch Break

13:30 - 14:00       Laboratory Category 1 Assessments of Products? (TBD)

14:00 - 14:30       Product experience from Category 1 studies on Hysingla, Targiniq and Oxycontin OP  (Richard Mannion, Purdue Pharma)

14:30 - 15:00        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)

15:00 - 15:30       How to perform “level of effort” studies and use outcome to guide Interpretation of HAL study - (Ed Cone, Pinney Associates/Jeffrey Dayno, Egalet)

15:30 - 16:00       Practical solutions: Hammer apparatus and analytical challenges (Sebastian Schwier, Grünenthal/Torben Elhauge, Egalet)

16.00 - 17:00       Panel Discussion: How can Category 1 and “level of effort” studies studies be more standardized and inform interpretation of HAL studies? (Silvia Calderon, FDA; Richard Mannion, Purdue Pharma; Beatrice Setnik, INC; Ed Cone, Pinney Associates; Jeff Dayno, Egalet; Marta Sokolowska, Grünenthal)    

17:00 - 17:10       Wrap up (Marta Sokolowska, Grünenthal; Karsten Lindhardt, Egalet)