Dr. Breitfeld has more than 30 years of experience in oncology and was most recently Global Vice President at IQVIA, responsible for the Therapeutic Centers of Excellence. Prior to that, he led the Oncology Center of Excellence at IQVIA where he worked with many large, mid-size and emerging biopharmaceutical firms. He held senior clinical development positions at Merck KGaA (EMD Serono in the US), where he led oncology development in the US, and at BioCryst, where he led oncology development and was Associate Chief Medical Officer. Philip Breitfeld, MD, also currently serves as the Chief Strategy & Innovation Officer at Champions Oncology.
Prior to his career in industry, he held academic positions at Harvard, University of Massachusetts, Indiana University, and Duke. He has approximately 50 publications in the literature dealing with basic cell and molecular biology, and translational and clinical oncology. He was trained in Pediatric Hematology/Oncology at the Dana-Farber Cancer Institute, was a visiting scientist at the Whitehead Institute at MIT, received his medical degree (MD) from the University of Rochester, and his undergraduate degree (AB in chemistry) from Princeton.
Dr. Cavagnaro is a graduate of the University of North Carolina at Chapel Hill, where she earned her PhD in biochemistry. She has had a prestigious career at a variety of scientific entities, including the US Food and Drug Administration (US FDA) and Covance Inc. (previously Hazelton Laboratories America, Inc.). In the 1990s, when existing International Conference on Harmonization (ICH) Safety Guidelines proved insufficient to apply to biotechnology-derived therapeutics, Dr. Cavagnaro’s work was instrumental in the development of the ICH S6 guidance, “Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.” Currently, Dr. Cavagnaro is the president of Access BIO, L.C., a consultancy she founded that focuses on product development via science-based approaches.
Dr. Patrick Gearing has an established track record of working with client companies to manufacture of protein (MAbs, Mab conjugates, PEGylated proteins) and small molecule therapeutics appropriate for clinical development. Dr. Gearing routinely works with world-leading contract manufacturing organizations (CMOs), using industrial experience to help clients overcome development and manufacturing challenges unique to product. Dr. Gearing has product development experience in several regulatory jurisdictions including the US, Europe, Japan, Canada and Australia. Prior to founding Ridge Biotechnology Consulting, LLC (in 2004), Dr. Gearing was Director of Pharmaceutical Development and Quality Systems at Seattle Genetics, Inc. Additional industry experience has also included positions at Coulter Pharmaceutical, Inc., PDL BioPharma, Inc., and Immunex Corp.