Successful Clinical Drug Development

Example (Retigabine: Wyeth)

• In-licensed retigabine into the Wyeth portfolio; championed this compound, the first K+ opener for partial seizures
• Performed phase I studies in Wyeth’s clinical pharmacology unit in downtown Philadelphia
• Executed novel phase IIA study to determine dose and adverse events (see #3-CV, p12, #78)
• Executed 399 patient phase IIB study which showed dose response and efficacy at two highest doses (#3-CV,p11,#70) 
• Consultant to every involved company through Phase III, presentation to FDA, and approval
• Post-approval emergence of unexpected adverse events unfortunately will limit use of retigabine
• Very few experts have championed and guided a single drug through Phase I, II and III, FDA review, and Approval.