Category 1 Focus Group

part of CROSS COMPANY ABUSE LIABILITY COUNCIL (CCALC)


THIRD Meeting

30-31 JANUARY 2018, EMBASSY SUITES ALEXANDRIA

DAY 1

Tuesday, January 30th, 2018

 

 

08:15 - 08:30AM
Welcome

Karsten Lindhardt, Egalet and Sebastian Schwier, Grünenthal

 

 

08:30 - 09:00 AM
Keynote

FDA perspective

FDA representative, Dr. Jim Tolliver

 

09:00 - 09:15 AM
FDA perspective - Generic Abuse Deterrent Opioids guideline

FDA representative Dajun Sun

 

 

09:15 - 09:45 AM

Warm up for Working Sessions –  Tampering with Prescription Opioids – Methods and Recipes from the Real-World

Inflexxion, Steve Butler

 

 

09:45 - 10:30 AM
Coffee and Networking Break

 

 

10:30 - 11:30 AM
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. Dajun Sun / Karsten Lindhardt
  4. Beatrice Setnik

 

11.30 AM - 01.00 PM
Working Sessions

 

Working Group 1 – Analytical considerations

Working Group 2 – Manipulation methods

Working Group 3 – New Generic ADF guidance

Working Group 4 – Tampering in the Laboratory vs.Clinic

 

01.00 - 02.00 PM
Lunch

 

 

02:00 - 03:00 PM
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

 

 

03:00 - 03.30 PM
Coffee and Networking Break

 

 

03:30 - 04:30 PM
Link between Category One and Real Word Data – Establishing a link between different categories of abusers and tests

Janetta Iwanicki, RADARS

 

 

04:30 - 05:00 PM
Wrap up Day 1

 

06:00 - 08:00 PM

Networking event

Thiesmann’s, 1800 Diagonal Rd. Alexandria, VA 22314

 

 

 

DAY 2
WEDENSDAY, JANUARY 31TH, 2018

 

 

08:00 - 08:15 AM
Short Welcome

 

 

08:15 - 09:30 AM
Category I Evaluations for Abuse Deterrent Opioids – Lessons Learned from Recent Advisory Committee Meetings

Chris Miller, 3D Communications

 

 

09:30 - 10:30 AM

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

Chair Working Group 2: Chris Altomare / Sebastian Schwier

 

 

10:30 - 11:00 AM

Coffee and Networking Break

 

 

11:00 - 12:00 AM

Reporting/ Presentation - Working Group 3 and 4

(15 minuttes presentation per group plus 15min panel discussion / Q&A)

Chair Working Group 3: TBD

Chair Working Group 4: BeatriceSetnik

 

12:00 - 01:00 PM

Case Study: Apply Design of Experiments (DoE) on Category One Tests

Chris Altomare, DrugScan
Peter Persich, Sebastian Schwier, Grünenthal

 

 

01:00 - 02:00 PM

Lunch

 

 

02:00 - 02:30 PM
Wrap up

 

 

DOWNLOAD PRESENTATIONS HERE:

Welcome

 

Karsten Lindhardt, Egalet


Sebastian Schwier, Grünenthal

 

 

 

FDA perspective
Generic Abuse Deterrent Opioids guideline

 

FDA representative Dajun Sun

 

 

Tampering with Prescription Opioids

Methods and Recipes from the Real-World

 

Steve Butler, Inflexxion

Working Group Topics and Rules

 

 

Sebastian Schwier, Grünenthal

 

Introduction to Working Group 1

 

 

Bob Bianchi
Torben Elhauge

 

 

 

Introduction to Working Group 2

 

 

Chris Altomare

Sebastian Schwier

 

 

Introduction to Working Group 3

 

 

Dajun Sun

Karsten Lindhardt

 

 

 

New methods and technologies in ADT

Academia perspective

 

Stephen Hoag, University of Maryland

New methods and technologies in ADT
Chewing, syringing, smoking

 

Chris Altomare, Drugscan

 

Link between Category One and Real Word Data

 

 

Janetta Iwanicki, RADARS

 

Lessons Learned from Recent Advisory Committee Meetings

 

 

Chris Miller, 3D Communications

Working Group 1 - Results

 

 

Bob Bianchi
Torben Elhauge

Working Group 2 - Results

 

Chris Altomare

Sebastian Schwier

 

Working Group 3 - Results

 

Karsten Lindhardt

Dajun Sun

Working Group 4 - Results

 

Beatrice Setnik

 

 

 

 

Case Study:

Apply Design of Experiments (DoE) on Category One Tests

 

Chris Altomare, DrugScan

Peter Persich, Sebastian Schwier, Grünenthal

THANK YOU TO THE SPONSORS

If you have questions, please contact

Torben Elhauge

Egalet CoRperation

telhauGE@egalet.com