Trial Master File Summit

Faculty

Patricia Brady
Patricia Brady
Senior International Clinical Trial Manager
SANOFI
Rose-Emily Calo, MBA, PMP
Rose-Emily Calo, MBA, PMP
Independent Project Management Consultant
CELGENE CORPORATION
Troy Deck
Founder, CEO
Wingspan Technology, Inc.
Jennifer Embury
Jennifer Embury
Independent Clinical Research Consultant
LUNDBECK
Ann Meeker-O’Connell, MS
Ann Meeker-O’Connell, MS
Acting Associate Director, Risk Science, Intelligence, and Prioritization, Office of Scientific Investigations
CDER, FDA
Jason Methia, MS
Jason Methia, MS
Manager, Clinical Documentation, Clinical Site Services
VERTEX PHARMACEUTICALS
JP Miceli
JP Miceli
Manager I, Clinical Business Operations
MILLENIUM PHARMACEUTICALS
Lisa Mulcahy
Lisa Mulcahy
Co-Leader, DIA Expanded TMF Reference Model Initiative
MULCAHY CONSULTING
Donald Palmer
Donald Palmer
Associate Director, Regulatory Systems
MEDIMMUNE
Susan Paul
Director, Development BT, TMF Process Owner
PFIZER
Lisa Rakebrand, MLIS
Lisa Rakebrand, MLIS
Associate Director and eTMF Business Owner, Global Clinical Operations
JOHNSON & JOHNSON
Karen Redding
Karen Redding
Global Business Development Director, Co-chair DIA TMF Reference Model
PHLEXGLOBAL
Fran Ross
Fran Ross
Continuous Process Improvement Principal Analyst, Clinical Research
GENZYME
Carol Smith
Director of Clinical Strategic Sourcing and Systems Management
CEPHALON