SPDS 09052014

PDE5 Inhibitors Working Group: Members

 Katerina Mastovska, Covance (Chair)  Anton Bzhelyansky, USP  Teresa Cain, FDA  Jana Hildreth, Blaze Science Industries  David Kennedy, Phenomenex  James Neal‐Kababick, Flora Research 

 Joe Betz, NIH  Anatoly Chlenov, PerkinElmer  John Edwards, Process NMR  Todd Koch, Pfizer  Alexander Krynitsky, FDA  Stephen Lock, AB SCIEX  Elisa Nickum, FDA  Catherine Rimmer, NIST  Brian Schaneberg, Starbucks  Olga Shimelis, Supelco  Garrett Zielinski, Covance

 Melissa Phillips, NIST  Steve Royce, Agilent

 John Travis, NSF International  Lukas Vaclavik, FDA  Jerry Zweigenbaum, Agilent

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