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Anne Kathyrn Vallerga, M.A., Ph.D., M.B.A. has over 22 years of experience in bioproduct development, corporate strategy, mergers, acquisitions, and strategic business development, including identifying and out-licensing or in-licensing. This includes immunobiologics, small molecule pharmaceutical drugs, devices, and companion diagnostic technologies. Dr. Anne Vallerga has successfully developed and subsequently sold or strategically partnered several late pre-clinical and clinical Phase I/II/III pharmaceutical and companion diagnostic assets to private and public companies. Dr. Vallerga has also successfully managed, both scientifically, financially, and operationally, a 100-million-dollar contract, 10 million-dollar-grant, and several singles- and double-digit multi-million-dollar collaborative therapeutic drug and device product development projects in diagnostics, medical devices, cancer, immunity, infection, allergy, and regenerative medicine. Product successes have been achieved by Anne Vallerga in diagnostics/prognostics, early detection, and biomarker validation. This includes the development and commercialization of an advanced instrumented diagnostic devices and reagent kit products that received US approvals and are in use today. Dr. Vallerga also has led or been an important part of teams that developed lymphatic drug-delivery/diagnostic device systems for intratumoral or intralymphatic diagnostic and companion therapeutic products, for example, used in combination with immunotherapy, radiotherapy, and/or chemotherapy for cancer or other patients.