FDA-Regulated Clinical Trial Starts for Oncology Continue to Climb
• As measured by new commercial IND submissions to the FDA's Center for Drug Evaluation and Research (CDER), clinical trial starts for new oncology drugs grew by 13% in 2007.
We invite you to visit PAREXEL at these upcoming industry events. Events are a great way to get to know our experts, discuss your outsourcing challenges, and learn how PAREXEL’s global reach, technology and expertise can help your organization..
Denis Miller, M.D. Senior Medical Director and Oncology/Hematology Therapeutic Area Team Leader, Clinical Research Services Group, PAREXEL International
Dr. Miller joined PAREXEL International in 2006 following a long and distinguished career in oncology and hematology research and clinical development. His experience encompasses clinical care and teaching in an academic environment; clinical research for a non-profit foundation; and drug development for the pharmaceutical industry. Dr. Miller has worked on numerous research and clinical development programs related to lymphoma, leukemia, and other hematopoietic malignancies - including acute lymphoid and myeloid leukemias, non-Hodgkin lymphoma, chronic lymphocytic leukemia - as well as non-small cell lung cancer, malignant melanoma, and cancers of the esophagus, pancreas, colon/rectum, prostate, and breast. He also has consulted extensively with the US Food and Drug Administration and other regulatory bodies on registration and safety issues related to oncology therapies.
As Senior Medical Director and Oncology/Hematology Therapeutic Area Team Leader for PAREXEL, Dr. Miller oversees all of the Company's oncology-related clinical services and projects, and serves as senior medical advisor on major clinical trials in oncology and hematology. He also provides therapeutic area expertise to start-up biotechnology companies that are working with PAREXEL on clinical development plans for innovative cancer therapies. "At PAREXEL, I have a unique opportunity to stay current with the latest therapeutic agents and modalities being developed to treat cancers and blood disorders," Dr. Miller said. "I participate actively in every phase of development, from advising small companies on how to move novel therapeutics into clinical trials to designing new treatment protocols and working with investigators during pivotal cancer drug trials. At this point in my career, my work at PAREXEL is very rewarding because it offers me a broader understanding of cancer research and drug development."
Before coming to PAREXEL, Dr. Miller was Senior Director/Clinical Leader-Oncology for Johnson & Johnson Pharmaceutical Research and Development, in Raritan, NJ. He previously held positions at Hoffmann-La Roche and Aventis Pharmaceuticals (now sanofi-aventis). Prior to joining the pharmaceutical industry, Dr. Miller spent a number of years in academia. He served on the faculty at the University of Rochester (NY) Medical School and at New York Hospital-Cornell Medical Center in New York City. He was also chairman of pediatrics at Memorial Sloan Kettering Cancer Center, and served as vice chairman of the Childrens Cancer Group (now the Children's Oncology Group) - the leading pediatric oncology cooperative group worldwide. During his career, Dr. Miller has published more than 300 book chapters, peer-reviewed articles, and abstracts, and he was the senior editor and major contributor to the classic textbook, Blood Diseases of Infancy and Childhood, completing editions 4 through 7. He is also a past president of the American Society of Pediatric Hematology/Oncology. Dr. Miller received his A.B. and M.D. from Cornell University, and served his residency at Children's Hospital (Boston) Medical Center and Harvard Medical School. In addition, he was a Fulbright Scholar and Fellow at St. Mary's Hospital Medical School and the University of London. Dr. Miller is Board Certified in Pediatrics and Pediatric Hematology-Oncology.