Participation in the working group is based upon invitation and time/resources are based upon a volunteer basis. The following list contains the membership of those individuals that volunteered time within the working group.
FDA Participants
Mat Soukup(Group Co-Lead) - CDER
Richard Forshee - CBER
Industry Participants
Brenda Crowe (Group Co-Lead) - Eili Lilly
Ken Koury (Group Co-Lead) - Merck Research Laboratories
Richard Anziano (Lead: ECG Subgroup) - Pfizer Inc.
Susan Duke (Lead: General Principles Subgroup) - GSK
Robert "Mac" Gordon (Lead: Labs/Liver Subgroup) - Janssen Research and Development
Liping Huang(Co-Lead: General AE Subgroup) - CSL Behring
Qi Jiang(Co-Lead: General AE Subgroup) - Amgen
Stephine Keeton (Co-Lead: General AE Subgroup) - PPD