Cardinal Points Consulting Site
  • About CPC
  • Our Services
  • Contact Us
  • Rx-to-OTC Switch
  • Innovation and Insights
Picture
Picture
Picture

Switch Credentials

At the forefront of Rx-to-OTC switch, Steve Neumann  has served as  a  key player in strategy and regulatory development plans
  • Claritin® …AR and Hives (New indication); Lotrimin® Ultra; MiraLAX®; Zegerid®; Oxytrol® (New indication)

Experience with switch assessment  in existing and prospective categories

Seasoned  lead on  consumer behavior studies with two Non-Prescription Drug Advisory Committee (NDAC) presentations  leading to switch approvals

Presentation of development plans at numerous FDA meetings. Proven track record of working collaboratively with FDA to shape approach, including accelerated timelines

Presenter at numerous Industry (CHPA)/FDA round tables on switch study protocols and consumer research methods

Experience with design and execution of consumer research studies to support device approvals

Critical knowledge from several aborted or unsuccessful programs

Some Notable Accomplishments

Pioneered  clinical protocol methods with market research companies unfamiliar  with GCP standards prior to FDA label study guidance.  Conducted early study regarded by FDA Consumer Behavior Scientist at the time as “the best study of its kind”

Incorporated  on-line consumer and physician survey data in a switch submission to explain that behaviors of concern already existed in the marketplace and that safety fears were unfounded. One of the first uses of internet generated survey results in a switch submission.

Innovative study design and execution including one of the early uses of “telemedicine”  to support a switch program

Conducted one of the first label discernment studies to support Phase 4 marketing  commitment regarding consumer understanding of ingredient differentiation. Approach  has become a tool for DMEPA  in  support of umbrella branding



  • About CPC
  • Our Services
  • Contact Us
  • Rx-to-OTC Switch
  • Innovation and Insights