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Paul F. Manley, has accumulated over 31 years of business and senior management experience in regulatory affairs, compliance and overall drug development, across a range of therapeutic areas within the pharmaceutical, biologic and consumer products industries. Mr. Manley’s corporate career encompassed senior management and highly technical leadership positions within the US and Europe in both large corporations and start-up like entities, with his last role being Vice President, Global Regulatory Affairs – Oncology within the Johnson & Johnson group of companies. In 2007 Mr. Manley established Orvieto Consulting, LLC, providing high-level strategic advice to numerous companies across a wide range of scientific disciplines and through all phases of development through to post-marketing.