3RD Meeting

Category 1 Focus Group
(part of CCALC)


From: January 30th 2018 - 8:00 AM

To: January 31st 2018 - 02:30 PM

 

Alexandria, Virginia 22314

 

REGISTER

 

 

 

 

Group Objectives:

 

To share experiences and best practices in in vitro (category 1) assessments of abuse deterrent formulations

 

To discuss standardization of in vitro (category 1) studies and limits associated with established standard practices

 

To provide an open forum or society enabling discussion on the FDA Guidance for Industry: Abuse Deterrent Opioids – Evaluation and Labeling

 

To provide an opportunity for presentations by academia, regulatory and industry experts focused in the Category 1 field

 

 

 

THE DAY BEFORE

MONDAY, JANUARY 29TH, 2018

 

 

05:30 - 07:30 PM

Pre-meeting come-together:

If you arrive Monday evening please join us for cocktail and snack at the hotel complimentary Evening Reception

 

 

 

DAY 1

Tuesday, January 30th, 2018

 

 

08:15 - 08:30AM
Welcomee

Karsten Lindhardt, Egalet and Sebastian Schwier, Grünenthal

 

 

08:30 - 09:30 AM
Keynote

FDA perspective (e.g. An Update on the Evolving Regulatory Requirements for Innovator and Generic Abuse Deterrent Opioids)

FDA representative tbd

 

 

09:30 - 10:00 AM

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

Inflexxion, Steve Butler

 

 

10:00 - 10:30 AM
Coffee and Networking Break

 

 

10:30 - 11:30 AM
Introduction to Working Group 1,2,3 and 4 (new Generic guideline to be considered)

 

1) Bob Bianchi / Torben Elhauge

2) Chris Altomare / Sebastian Schwier

3) TBD

4) Beatrice Setnik

 

 

11.30 AM - 01.00 PM
Working Sessions

 

Working Group 1 – Analytical considerations

 

Strategies to streamline in vitro testing based on screen testing and product knowledge.

  • Considerations for analytical standardization considering different solvents (e.g. beverages) and requirements for method validation
  • Limits of testing? Which parameters make sense to test starting with the test parameters mentioned in the guideline and how to interpret them

 

Working Group 2 – Manipulation methods

 

Examining the goals and methods of in vitro testing:

  • Should testing be as close to the “street” as possible or relevant as QC-Methods?
  • Which ADF properties could be QC tested during shelf life and how do methods and specification limits look like?

 

Working Group 3 – New Generic ADF guidance


Discuss content and collect / provide comments

 

Working Group 4 – Tampering in the Laboratory vs.Clinic

  • Selecting the best manipulation method for clinical evaluation
  • Manipulation method transfer to  Category 2/3 clinical studies and how in vitro methods can impact clinical results.
  • Strategies to ensure consistent manipulation across doses

 

 

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; Sebastian Schwier, Grünenthal

 

 

01:00 - 02:00 PM

Lunch

 

 

02:00 - 02:30 PM
Wrap up

 

 

 

 

AGENDA

REGISTRATION

 

Pricing information:

 

 

Registration rate

Industry: $600

Government employee: $300

Acedemia: $300 - including one student

Student: $150

 

Speaker rate: No Registration fee

Space is limited, registration on a first come first serve basis.

 

 

 

 

 

 

 

 

 

 

LINKS

REGISTER

 

 

Venue

 

From: January 30th 2018 - 8:00 AM

To: January 31st 2018 - 02:30 PM

 

Location:

Embassy Suites by Hilton

Alexandria, Old Town

1900 Diagonal Road

Alexandria, VA 22314

 

Reduced room rates are available

until December 18, 2017

 

 

GO TO HOTEL WEBPAGE

 

 

 

VENUE

CONTACT

If you have questions, please contact

 

Torben Elhauge

Egalet Corporation

telhauge@egalet.com

 

SPONSORS

UPCOMING event is taking place here:

Embassy Suites by Hilton

Alexandria, Old Town

1900 Diagonal Road

Alexandria, VA 22314

 

If you have questions, please contact

Torben Elhauge

Egalet CoRpOration

telhaugE@egalet.com

 

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