SOS-2016 Conference Program

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The SOS-2016 Program is currently being finalized

and is therefore subject to change.

Below you will also find the 2015 Program which you might find helpful if you are considering SOS for the first time.

Registration options include a delegate rate for all three days, or you may purchase tickets for individual days.  We are using feedback from last year’s SOS to help us put together the program.  If you have specific requests, please feel free to contact us.

 

2016 Program

Download 2016 presentations Here

Download a copy of the Conference Program

Download a copy of the Flyer 7.21.16.  Please note that the program is subject to change

Sunday Sept 25th

5:30 – 6:30pm

Registration

6:30 – 9:00pm

ASAP Workshop

6:30 – 6:45pm

Welcome & Opening Remarks

Dr. Ken Waterman, President
FreeThink Technologies
Branford, CT, USA

6:45 – 7:15pm

ASAP Prime 5.0: Introduction to Latest Version Release

Dr. Ken Waterman
FreeThink Technologies
Branford, CT, USA

Bio

Abstract

7:15 – 7:45pm

ASAP Case Study: Peptide Stability

Dr. Alisa Waterman
FreeThink Technologies
Branford, CT, USA

Bio

Abstract

7:45 – 8:15pm

ASAP Case Study

TBA

Abstract

8:15 – 9:00pm

Panel Discussion: Use and Implementation of ASAP

Moderator: Dr. Steve Baertschi
Panelists:
Dr. Ken Waterman
Dr. Sabine Thielges
Dr. Alisa Waterman

Monday Sept 26th

8:00 – 9:00am

Continental Breakfast and Registration

9:00 – 10:30am

Session I: The Science OF ASAP & Its Application in Drug Development

Chair: Dr. Steve Baertschi
Baertschi Consulting
Indianapolis, IN

Part A
(9:00 – 9:45am)

ASAP Theory and Fundamentals

Dr. Sabine Thielges
Novartis
Basel, Switzerland

Bio

Abstract

Part B
(9:45-10:30 am)

Integration of ASAP in Early Drug Development using the FAST Approach

Dr. Chandan Bhugra
Boehringer Ingelheim
Ridgefield, CT, USA

Bio

Abstract

10:30 – 11:00am

Morning Coffee / Tea Break

11:00 – 12:30pm

Session II: ASAP Applications in Drug Development & Its Use as Part of a Lean Stability Regulatory Strategy

Chair: Dr. Isamir Martinez
FreeThink Technologies
Branford, CT, USA

Part A
(11:00-11:45am)

The Use of ASAP from Early to Late Drug Development

Dr. Eduard Luss
Vertex Pharmaceuticals
Boston, MA

BIO

Abstract

Part B
(11:45-12:30pm)

ASAP Regulatory Strategy, Acceptance and Feedback

Dr. Elke Debie
Janssen Pharmaceuticals, (J&J)
Beerse, Belgium

Bio

Abstract

12:30 – 2:00pm

Lunch

2:00 – 3:30pm

Session III: ASAP Applications in the Generic & OTC Industries

Chair: Dr. Jennifer Lewis
FreeThink Technologies
Branford, CT, USA

Part A
(2:00-2:45pm)

ASAP Applications in Generic Products

Dr. Bryan Wicks
Boehringer Ingelheim (Roxane)
Columbus, OH, USA

Bio

Abstract

Part B
(2:45-3:30pm)

ASAP Applications in OTC Products

Dr. Jonathan E. Clark
Procter & Gamble
Cincinnati, Ohio, USA

Bio

Abstract

3:30 – 4:00pm

Afternoon Coffee Break

4:00 – 5:30pm

Session IV: Amorphous Drug Stability

Chair: Dr. Peter Persich
Jannsen Pharmaceuticals (J & J)
Beerse, Belgium

Part A
(4:00-4:45pm)

Modeling the Physical Stability of Amorphous Solid Dispersions

Dr. Rodney Ketner
Bend Research, a division of Capsugel
Bend, OR, USA

Bio

Abstract

Part B
(4:45-5:30pm)

In Silico, Thermodynamic and Kinetic Stability of Amorphous Solid Dispersions

Dr. Jeffrey Tan
Eli Lilly and Company
Indianapolis, IN, USA

Bio

Abstract

5:30 – 5:55pm

Discussion, Q & A, and Closing Remarks

6:00 – 7:30pm

Wine & Cheese Social

Tuesday, Sept 27th

8:00 – 8:45am

Continental Breakfast and Registration

8:45 – 10:45am

Session V: Drug Degradation Chemistry

Chair: Dr. Kenneth Waterman
FreeThink Technologies
Branford, CT, USA

Part A
(8:45-9:25am)

Drug Degradation Mechanisms

Dr. Steve Baertschi
Baertschi Consulting
Indianapolis, IN, USA

Bio

Abstract

Part B
(9:25-10:05am)

Analysis of Unstable Degradation Impurities and their Quantification without Isolation Using Multiple Linear Regression

Dr. John Campbell
GlaxoSmithKline
Philadelphia, PA, USA 

Bio

Abstract

Part C
(10:05-10:45am)

Stress Testing in Solid State: Towards a Realistic Degradation Profile

Dr. Peter Persich
Janssen Pharmaceuticals (J&J)
Beerse, Belgium

Bio

Abstract

10:45 – 11:00am

Morning Coffee / Tea Break

11:00 – 12:30pm

Session VI: Moisture and it’s Impact on Stability

Chair: Dr. Steve Baertschi
Baertschi Consulting
Indianapolis, IN, USA

Part A
(11:00-11:45am)

Understanding Importance of Water Sorption Isotherm Shape, Hysteresis, and Models on Pharmaceutical Materials

Dr. Daniel Burnett
Surface Measurements Systems
Allentown, PA, USA

Bio

Abstract

Part B
(11:45-12:30pm)

Case studies in Drug Packaging: Supporting Stability by Addressing Specific Preservation Challenges

Valère Logel
Clariant Healthcare Packaging
Paris, France

Bio

Abstract

12:30 – 2:00pm

Lunch

2:00 – 3:30pm

Session VII: Additional Stability Topics

Chair: Dr. Peter Persich
Janssen Pharmaceuticals (J&J)
Beerse, Belgium

Part A
(2:00-2:45pm)

Solution-Phase Stability

TBA

Abstract

Part B
(2:45-3:30pm)

ASAP for Non-Traditional Factors: Dissolution, Disintegration & Color

Dr. Kenneth Waterman
FreeThink Technologies
Branford, CT, USA

Bio

Abstract

3:30 – 4:00 pm

Afternoon Coffee / Tea Break

4:00 – 5:15pm

Session VIII: In-Use Stability

Chair: Dr. Garry Scrivens,
Pfizer, Inc.,
Sandwich, UK

Part A
(4:00-4:45pm)

In-Use and Excursions: Stability Beyond ICH

Dr. Kenneth Waterman
FreeThink Technologies
Branford, CT, USA

Bio

Abstract

Part B
(4:45-5:15pm)

Discussion Q & A Closing Remarks Day 2

2015 Program

Download a copy of the 2015 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