3rd Annual Method

Development Olympics

Ken Fountain, Kevin Gauger, Bill Farrell, Wolfgang Goetzinger

©2014 CoSMoS

©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

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

Past Medalists

GOLD SILVER BRONZE

2012 Pfizer Groton Univ. of Ghent Univ. of Geneva

2013 Pfizer Groton Averica Catalent

©2014 CoSMoS

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

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

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