Dr. Gottlieb is a physician and Resident Fellow at the American Enterprise Institute. He served as the Deputy Commissioner of the Food and Drug Administration between 2005 and 2007, and was a senior medical technology advisor to the FDA Commissioner and FDA’s Director of Medical Policy Development from 2003 to 2004. In the spring of 2004, he left the FDA to implement the new Medicare Drug Benefit as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services.
“We are pleased that Dr. Gottlieb has joined our board and we look forward to his advice and guidance as we initiate our Phase 3 program in ovarian cancer for our personalized cancer immunotherapy,” said the President and Chief Executive Officer of Gradalis, Joseph M. Limber. “I look forward to this exciting time in the advancement of novel immunotherapies for the treatment of patients with cancer. We are clearly on the leading edge of medicines to help even more patients with this deadly disease.”
The adjuvant treatment of patients with stage III/IV ovarian cancer after surgical debulking and six-week long chemotherapy, for which there are no approved therapies at present, will be the main focus of the Gradalis personalized immunotherapy Phase 3 program. The ovarian cancer program is the first of several development directions in which this personalized immunotherapy is applied. Other planned programs include the treatment of hepatocellular carcinoma, colorectal cancer with liver metastases, and Ewing’s sarcoma.
Dr. Gottlieb is a regular contributor to major medical journals as well as The Wall Street Journal, The New York Times, and Forbes magazine. He has held editorial positions on the British Medical Journal and the Journal of the American Medical Association, and is currently a member of the editorial board at Value Based Cancer Care journal, the Food and Drug Law Institute’s Policy Forum, and he assists the board of advisers of Cancer Commons.
Dr. Gottlieb is also an advisor to the National Comprehensive Cancer Network, and the National Coalition for Cancer Survivorship. He is a member of the policy boards of the Leukemia and Lymphoma Society and the Society of Hospitalist Medicine. Dr. Gottlieb was appointed by the Senate to serve on the Federal Health Information Technology Policy Committee in 2013.
Gradalis is a Dallas, Texas-based fully integrated biotechnology company focusing on the development, manufacturing, and commercialization of novel personalized immunotherapies to treat cancer. In addition to having its own GMP manufacturing facility, Gradalis relies on highly skilled technical leadership and staff and it holds a strategic partnership with Mary Crowley Cancer Research Centers for clinical development of Gradalis products.