SOS-2015 Program

Our speaker list is correct as at 10/06/2015.

Download a copy of the program HERE

   Notes

FREE Pre-Conference Workshop
ASAP 101 USE and IMPLEMENTATION

MONDAY, OCTOBER 12, 2015

7:00 PM - 7:30 PMASAPprime® Review
Ken Waterman,
FreeThink Technologies, Inc.
Groton, CT USA
[bio]
7:30 PM - 9:00 PMImplementation of ASAP Workflows:
Application of ASAP in Early API and Formulation Development
Fenghe Qiu,
Boehringer Ingelheim, Ridgefield, CT, USA
[abstract & slide deck]
[bio]
Drug Product Development
Sabine Thielges,
Janssen Pharmaceuticals (J&J), Beerse, Belgium
[bio]
[Slide Deck]
Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development
Llurellyn Malcolm,
Pfizer, Pearl River, New York, USA
[bio]
[abstract and slide deck]
Panel Discussion: Q&A
Ken Waterman, Fenghe Qiu, Sabine Thielges, Llurellyn Malcom

SESSION I: Forced Degradation & Method Development

TUESDAY, OCTOBER 13, 2015

8:00 AM - 9:00 AMRegistration and Breakfast
Paragon, 24th Floor, Grand Pequot Tower
9:00 AM - 9:05 AMOpening Remarks
Ken Waterman,
FreeThink Technologies, Inc., Groton, CT, USA
[bio]
9:05 AM - 9:10 AMSession Introduction
Session Chair, Sabine Thielges,
Janssen Pharmaceuticals (J&J), Beerse, Belgium
[bio]
9:10 AM - 9:50 AMIn Silico Modeling of Degradation Chemistry
Steve Baertschi,
Baertschi Consulting, Indianapolis, IN, USA
[bio]
9:50 AM - 11:00 AMDeveloping Stability: Forced Degradation of Pharmaceuticals: What? Why? How?
Tom Sharp,
FreeThink Technologies, Inc., Groton, CT, USA
[bio]
A Systematic Approach to Developing Stability Indicating Assay Methods
Jennifer Lewis,
FreeThink Technologies, Inc., Groton, CT, USA
[bio]
[SLIDE DECK]
11:00 AM - 11:15 AMBreak
11:15 AM - 11:55 AMStress Testing Degradation Pathways: Case Studies
Peter Persich,
Janssen Pharmaceutials (J&J), Beerse, Belgium
[bio]
[abstract]

SESSION II: The Science of Acceleration

TUESDAY, OCTOBER 13, 2015

11:55 AM - 12:55 PMLunch
Paragon, 24th Floor, Grand Pequot Tower
12:55 PM - 1:35 PMOxidative Susceptibility Testing
Steve Baertschi, Baertschi Consulting, Indianapolis, IN, USA
1:35 PM - 2:15 PMModeling of Degradation Chemistry at AstraZeneca
Anders Broo,
Astra Zeneca, Sweden
[bio]
[abstract]
2:15 PM - 2:55 PMASAP Fundamentals
Garry Scrivens,
Pfizer, Sandwich, UK
[bio]
[abstract]
2:55 PM - 3:15 PMBreak and Refreshments
Paragon, 24th Floor, Grand Pequot Tower
3:15 PM - 3:55 PMTemperature and Humidity Impact and the Interactions Involved in Solids;
Why ASAP does not add Extra Cross-Terms

Ken Waterman,
FreeThink Technologies, Inc., Groton, CT, USA
[bio]
[[SLIDE DECK]]
3:55 PM - 4:15 PMPanel Discussion and Closing Remarks, Day 1

Steve Baertschi, Tom Sharp, Jennifer Lewis, Peter Persich, Anders Broo, Garry Scrivens, Ken Waterman
4:15 PM - 5:30 PMWine & Cheese Social
Paragon, 24th Floor, Grand Pequot Tower

SESSION II: The Science of Acceleration (Continued)

WEDNESDAY, OCTOBER 14, 2015
8:00 AM - 9:00 AMRegistration and Breakfast
Paragon, 24th Floor, Grand Pequot Tower
9:00 AM - 9:05 AMOpening Remarks
Steve Baertschi
Baertschi Consulting, Indianapolis, IN, USA
[bio]
9:05 AM - 9:10 AMSession Introduction
Session Chair, Steve Baertschi,
Baertschi Consulting, Indianapolis, IN, USA
[bio]
9:10 AM - 9:50 AMASAP Assumptions and the Impact on Predictions:
Case Study on Controlling Mutagenic Degradation

Brian Pack
Eli Lilly and Company, Indianapolis, IN
[bio]
[abstract]

SESSION III: Learning from Examples

WEDNESDAY, OCTOBER 14, 2015

9:50 AM - 10:30 AMExcipient Compatibility as Predicted by ASAP: A Case Study
Jerusha Thompson,
Upsher-Smith, Maple Grove, Minnesota
[bio]
[abstract]
10:30 AM - 10:45 AMBreak
10:45 AM - 11:25 PMPredicting Degradation Rate as a Function of Drug Load in Solid-State Drug Products
Allison Dill,
Lilly, Indianapolis, IN, USA
[bio]
[abstract]
11:25PM - 12:05 PMUse of ASAP in Formulation Development: Case Studies
Sabine Thielges,
Janssen Pharmaceuticals (J&J), Beerse, Belgium
[bio]
[SLIDE DECK]
12:05 PM - 1:05 PMLunch
Paragon, 24th Floor, Grand Pequot Tower
1:05 PM - 1:45 PMInteresting Degradation Chemistry
Patrick Jansen,
Eli Lilly and Company, Indianapolis, IN, USA
[bio]

SESSION IV: Let's Get Physical

WEDNESDAY, OCTOBER 14, 2015

1:45 PM - 2:25 PMCreating Tomorrow's Packaging Today:
Technology and Collaboration-Based Approaches
to Optimize Pharmaceutical Package Design

Carlos Daniel Stagnaro & Steven Warakomski
Klöckner Pentaplast, Charlottesville, VA, USA
[bio Daniel]
[bio Steven]
[abstract]
2:25 PM - 2:45 PMBreak and Refreshments
Paragon, 24th Floor, Grand Pequot Tower
2:45 PM - 3:25 PMRecent Advances in Functional Coatings for Immediate Release Dosage Forms
Jason Teckoe,
Colorcon, Harleysville, PA, USA
[bio]
[abstract]
3:25 PM - 4:05 PMAccelerated Stability for Proteins: A Peptide Case Study
Ken Waterman
FreeThink Technologies, Inc., Groton, CT, USA
4:05 PM - 4:45 PMFull System Moisture Management for Drug Preservation
Valere Logel,
Clariant, Belen, NM
[bio]
[abstract]
4:45 PM - 5:00 PMPanel Discussion and Closing Remarks, Day 2

Brian Pack, Jerusha Thompson, Allison Dill, Sabine Thielges, Patrick Jansen, Daniel Stagnaro, Steven Warakomski, Jason Teckoe, Ken Waterman, Valere Logel