Dr. Conrad Savoy

Senior Advisor providing expertise and advice to startup and established biopharmaceutial companies in drug development and regulatory affairs. Indepth experience in biosimilar and biobetter therapeutics development and registration.

Accomplishments: - Restructured Biopartners’ organization in line with its business requirements - Identified, built up and nurtured commercial business relationships with potential distributors for Biopartners’ products - Lead the organization to successfully submit an electronic submission (eCTD for a novel, long-acting recombinant human protein (biobetter) to EMA

As a member of the Board of Directors and as a key member of the Management Team, in charge of exploring new development opportunities and providing science strategy advice to the company. Provide advice to projects leaders on scientific issues related to ongoing projects. Oversee the overall development of biotechnology derived molecules up to marketing authorization. Define strategy and supervise development plans. Give advice on evaluation, selection and management of service partners.

Lead the development of biotechnology derived molecules up to marketing authorization. Successfully pioneered the biosimilar approval pathway with CHMP/EMA for registration of rhGH (somatropin). Create and implement a development plan, based on regulatory scientific advice, from phase I through to phase III for a long-acting recombinant human protein (biobetter). Perform evaluation, selection and management of service partners which handle the development work (CROs, CMOs, experts).

Lead the regulatory affairs team and provide regulatory strategy input into the international drug development team. Manage the planning and implementation of all the regulatory work in support of a global drug development. Preparation of a registration submission documentation for EMEA and FDA and successfully manage the regulatory review process through to approval.

Strategy; Creativity, Innovation and Change; Finance; International Enterprise