SPDS 09052014 - page 133

PDE5 Inhibitors Working Group: Members
 Katerina Mastovska, Covance (Chair)
 Anton Bzhelyansky, USP
 Joe Betz, NIH
 Anatoly Chlenov, PerkinElmer
 Teresa Cain, FDA
 Jana Hildreth, Blaze Science Industries
 David Kennedy, Phenomenex
 James Neal‐Kababick, Flora Research
 Melissa Phillips, NIST
 Steve Royce, Agilent
 John Edwards, Process NMR
 Todd Koch, Pfizer
 Alexander Krynitsky, FDA
 Stephen Lock, AB SCIEX
 Elisa Nickum, FDA
 Catherine Rimmer, NIST
 John Travis, NSF International
 Lukas Vaclavik, FDA
 Jerry Zweigenbaum, Agilent
 Brian Schaneberg, Starbucks
 Olga Shimelis, Supelco
 Garrett Zielinski, Covance
PDE5 Inhibitors Working Group: Work to Date
• 8 teleconferences (May 2014 – July 2014)
3 SMPR D ft d • s ra e
• Screening Method for PDE5 Inhibitors
• Identification of PDE5 Inhibitors
• Determination of PDE5 Inhibitors
• 30 day public comment period
(July 25 2014 – August 25 2014), ,
• SMPRs made ready for SPDS review and approval