ClinicalRM recently expanded access protocol with ZMapp, an investigational treatment for Ebola virus disease (EVD) in Africa and the United States.
ZMapp combines three monoclonal antibodies developed by Mapp Biopharmaceutical, Inc., and LeafBio, the commercialization arm of Mapp, to fight against EVD.
ClinicalRM will perform as a subcontractor under a federally-funded contract awarded to Mapp by the Biomedical Advanced Research and Development Authority’s (BARDA) Office of the Assistant Secretary for Preparedness and Response to assist in carrying out expanded access protocol to ZMapp.
ZMapp’s protocol will take place in the regions that were most affected by EVD, including Sierra Leone, Liberia and Guinea. At least three sites in the United States will monitor the safety of study participants and manage the safe storage and shipping of the experimental product. ClinicalRM’s global infrastructure development (GID) group will ensure that each site in Africa has the necessary infrastructure, laboratories, technology and operational improvements.
“Our involvement in this study is an acknowledgement of the expertise we gained during the 2014 outbreak working with EVD and the research environment in west Africa,” Joseph Sgherza, president of ClinicalRM, said. “Our group’s motto, and goal, is ‘leave something behind.’ We didn’t simply bring in bloodmobiles and staff as a temporary fix until the crisis was over, we stayed to build a sustainable structure of labs, supply chains, communications systems and highly trained clinicians that can now support research projects from sponsors around the world.”