Northeast US based drug sponsor in need of specialized expertise-

• • Not clinical DDI
  • Looking for someone who can advise on transporter studies (e.g., Cytochrome interactions)
  • In EU, requirements are different; FDA has recently updated their requirements; there is gray areas regarding what goes in their labels versus our labels
  • Looking for someone who can advise on those types of studies; currently studies going on in Europe and they get the data, so need to interpret what’s clinically relevant
  • CMO played this role in the past, but recently left
  • Project-based involvement, as needed (effort TBD) for at least 6 months