Category 1 Focus Group


FIRST Meeting

4 November 2015, Mayflower Hotel Washington DC



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)


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)


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)





Marta Sokolowska, Grunenthal

Karsten Lindhart, Egalet


Final FDA Guidance


James Tolliver, CDER/FDA


Review of drug preperations


Megan J. Shram, Altreos Research Partners


Protocol Standardization?


Bob Bianchi, PDRC


Standardization of Physical/Mechanical Manipulation Studies


Pat Haneman, NMS labs


Can we standardize household tools?


Stephen Byrn

Stephen W. Hoag

NIPT & UMB-School of Pharmacy

Hysingla, Targiniq, Oxycontin


Richard Mannion, Perdue Pharma

Bridging the Gab between In Vitro and Clinical Studies


Beatrice Setnik, INC Research

Level of Effort Studies


Edward J. Cone, Pinney Associates

Jeffrey M. Dayno, Egalet

Standardized Hammer Test


Sebastian Schweir, Grunenthal


Syringability versus Viscosity


Torben Elhauge, Egalet


Wrap Up


Marta Sokolowska, Grunenthal

Karsten Lindhart, Egalet



If you have questions, please contact

Torben Elhauge

Egalet CoRperation