Category 1 Focus Group

part of CROSS COMPANY ABUSE LIABILITY COUNCIL (CCALC)


SECOND Meeting

9 March 2017, EMBASSY SUITES ALEXANDRIA

AGENDA

 

08:30 - 08:40

Welcome

Marta Sokolowska, Depomed and Karsten Lindhardt, Egalet Corp

 

08:40 - 09:00

Challenges in Standardization of Cat 1 studies – Perspectives and Discussion from Last Meeting

Karsten Lindhardt, Egalet Corp

 

09:00 - 09:40

Abuse Deterrent Product sameness with in vitro studies: Opportunities and challenges with FDA guidances

Mansoor A. Khan, Texas A&M Health Science Center (No presentation avalible)

 

09:40 - 10:10

Outcome of Hearing in Oct/Nov 2016 (How to proceed with standardization)

Alison Fleming, Collegium and Penny Levin, Teva

 

10:30 - 12:20

Audience Discussion

Areas of standardization and forming working groups for a coming standardization meeting

Panel: James Tolliver, Mansoor A. Khan, Alison Fleming, Torben Elhauge, Bob Bianchi, Sebastian Schwier, Chris Altomare

 

13:20 - 14:00

Can AD equivalence be established from Cat 1 data? Review of methods and risks

Beatrice Setnik, INC

 

14:00 - 14.40

Opportunities and limits of Cat 1 data in interpretation of Human Abuse Potential Studies

Ryan Turncliff, PRA International

 

14:40 - 15:50

Audience Discussion

Can “abuse deterrent Equivalence” be established in a meaningful way from in vitro data alone?

Panel: James Tolliver, Karsten Lindhardt, Ryan Turncliff, Beatrice Setnik, Penny Levin, Ed Cone, Marta Sokolowska

 

16:20 - 17:00

Future Development of Abuse Deterrent Products

Marta Sokolowska, Depomed (Megan Shram made a presentation in Martha’s absence)

 

 

DOWNLOAD PRESENTATIONS HERE:

Perspectives from Last Meeting

 

Karsten Lindhart, Egalet

 

FDA Open Public Hearing

 

Alison Fleming, Collegium Pharmaceutical

Penny Levin, Teva

Review of Methods and Risks

 

Beatrice Setnic, INC Research

 

Opportunities and Limit of Human Studies

 

Ryan Turncliff, PRA International

 

Future Development of Products

 

Megan J. Shram, Altreos Research Partners

 

THANKYOU TO THE SPONSORS

If you have questions, please contact

Torben Elhauge

Egalet CoRperation

telhauG@egalet.com