CoSMoS 2014 MDO Intro

1. 3rd Annual Method
Development Olympics
Ken Fountain, Kevin Gauger, Bill
Farrell, Wolfgang Goetzinger
©2014 CoSMoS

2. ©2014 CoSMoS
Objectives
• Stimulate discussion on different approaches
to method development
• Encourage HEALTHY competition
• Potentially leads to novel and creative ways of
analyzing small molecules

3. How Does It Work?
• CoSMoS committee designs challenge in
January planning meeting
• Sign up open until April/May
• Challenge finalized and samples sent
• Submissions due back in July
• CoSMoS committee selects three finalists
• Finalists present at CoSMoS and medalists
decided by conference attendees
©2014 CoSMoS

4. Past Medalists
GOLD SILVER BRONZE
2012 Pfizer Groton Univ. of Ghent Univ. of Geneva
2013 Pfizer Groton Averica Catalent
©2014 CoSMoS

5. 5
Nasal Formulation with 1 main component and 3
structurally similar, low level compounds (BONUS)
Component Concentration
(mg/mL)
Hydrocortisone 1.316
Cortisone 0.047
Prednisone 0.032
Prednisolone 0.086
Measured Sample Density = 1.007 g/cm3 at ~21 °C
2014 Challenge
©2014 CoSMoS

6. 6
Formulation Components
Component Concentration
(weight %)
Ethanol 7
MPEG
(Methoxy Polyethylene Glycol)
49
Proplylene Glycol 6
Peg 400
(Polyethylene Glycol MW 380-420 Da)
17
Water 21
2014 Challenge
©2014 CoSMoS

7. What’s next?
• Each presenter gets 15 minutes
• 5 minutes for questions and discussion
• Finalists
• Amy McCusker - Takeda Pharmaceuticals
• Ruchi Mehta - Pfizer Global R&D
• Jeff Kiplinger - Averica Discovery Services
• Audience will vote via ballot for medal placement
• Medals and ballot box on display at registration table
• Score sheet provided to assist in assessing whose approach
was best
• Medals given at dinner reception on Tuesday evening
©2014 CoSMoS