About the Company’s Mission Bay Clinical R&D Services aims to assist pharmaceutical and biotechnology companies in all aspects of clinical development. The President of the company, Anastassios D. Retzios, Ph.D. has extensive experience in all areas of drug and biologics development, in regulatory strategy, in clinical study operations, in the writing and compilation of INDs, BLAs and NDAs, and in interactions with regulatory agencies. If required by the demands of the project, the company can assist by bringing in a number of top collaborators with substantial industry experience to assist in a variety of development tasks including CMC, quality, contract manufacturing, product testing and others. The company can also assist in partnering and M&A activities, performing studious and exhaustive due diligence. About Anastassios D. Retzios, Ph.D. Anastassios D. Retzios, Ph.D. the Founder and President of Bay Clinical R&D Services studied biology in the Aristotelian University of Thessaloniki, Greece; he obtained his doctorate in Molecular Biology in the University of Edinburgh, United Kingdom. In his postdoctoral work at the University of Southern California, he pursued studies in the structure -function relationship of components of the contact phase of blood coagualation. Still at USC, he worked in industry/academia collaboarations on the development of novel thrombolytic enzymes (with various patenta awarded), in the development of an HIV vaccine, and in the pharmacokinetics and pharmaco- dynamics of locoregional application of chemotherapy. He then served in a variety of leading roles in the pharmaceutical industry in large, medium-sized and smaller companies: as Associate Director of Clinical R&D at Alpha Therapeutic Corporation; as Senior Director of Clinical R&D at Questcor Pharmaceuticals; a Global Director of Clinical Development at Baxter, and as Vice President of Clinical Development at AP Pharma, Inc. Through his efforts a number of drugs and biologics were successfully registered in the US including Alphanine SD and Profilnine SD (treatments for hemophilia B); Alphanate (in both hemophilia A and von Willebrand Disease), Advate (a leading 3rd generation recombinant FVIII in hemophilia A), Ceprotin (Protein C deficiency); Sustol for the control of nausea and vomiting in emetogenic chemotherapy; and KedRab for rabies exposure. As an independent consultant, Anastassios Retzios worked with a number of US and overseas pharmaceutical companies assisting them in matters of product development, clinical operations, interactions with regulatory agencies and due diligence. Such companies included Kedrion Biopharma and Kedrion S.p.A. (Italy), Inspiration Bio, ImCure Therapeutics, Kyowa Kirin (Japan), Green Cross (Korea), JW Life Sciences (Korea), Prime Biologics (Singaporre), Sealantium (Israel), Praj Industries Ltd (India), Biosolutions, OncoNano, Decktherapeutics, Sanquin Plasma Products -BV (The Netherlands) and others. In his career, he has developed substantial expertise in: • In devising the optimal development of regulatory strategy • The authoring of effective protocols, investigator brochures, clinical study reports and all other documentation required for the filing of successful applications to regulatory authorities • The conduct of clinical trials in all phases of development (Phase 1 through 4) in the US, Europe, Asia and Latin America • Interactions with regulatory agencies in the US, Europe and Japan and other countries • The management of teams of clinical development professionals • The assessment of product portfolios for various companies • The due diligence process in partnering, company mergers and product acquisitions Anastassios’s Retzios’s CV is available upon request

Copyright© 2021 - Bay Clinical R&D Services - All Rights Reserved