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.

Dr. Morgan has over thirty-seven combined years of experience in the healthcare and clinical research fields including Professor of Surgery, Trauma/Critical Care/General Surgery; Private Practice Surgery/Trauma/Critical Care; with over 23 years of combined experience as Medical Director, Chief Medical Officer and Executive Vice President Global Medical Affairs in various Pharmaceutical, Contract Research Organizations and an NCI Cancer Cooperative Group with headquarters at Duke University. He has performed medical oversight of over 145 clinical trials spanning Phases 1-4. Dr. Morgan received his AB degree in Biochemistry, Magna Cum Laude, from Duke University, an MD degree from University of Illinois College of Medicine, completed a residency in General Surgery at Michigan State University, and a Critical Care Fellowship at University of Pittsburgh.