The Frederick National Laboratory is addressing some of the most urgent problems in the biomedical sciences – in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious disease.
Some key milestones in the history of our lab include:
FDA approves immunotherapy for a cancer that affects infants and children- The Frederick National Laboratory produced an immunotheraphy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of children who are affected. The FDA approved the treatment in 2015 after a long road to clinical approval. BDP began producing the antibody for human testing in 1997.
Zika vaccine approved for clinical trial in just 90 days- In response to an urgent global health threat, our lab developed an accelerated schedule to produce, test, and release a Zika vaccine candidate. A Phase I clinical study using the vialed drug product began in August 2016. The laboratory anticipates more than 90 shipments to clinical sites in at least six countries that will support subsequent Phase II clinical trials, which are now in the planning stages.
Ebola clinical trial support- Our laboratory receives and distributes medical donations to treat survivors of Ebola in West Africa. Through The Frederick National Laboratory’s support, eleven hospitals, clinics, and health centers treating Ebola survivors in Liberia have received critical equipment and supplies. We also monitor more than 400 ongoing human clinical trials in the United States and overseas.
FDA accelerates testing and review of experimental brain cancer drug- An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Laboratory won breakthrough status from the Food and Drug Administration (FDA) in 2016 to fast-track its further refinement and clinical testing. The Biopharmaceutical Development Program (BDP) supported Duke University Medical Center by manufacturing the drug for clinical testing.