Bioavailability & Bioequivalence: BA/BE Studies Summit

Biography

Biography: Marlene Teresa Llópiz-Avilés

Abstract

Investigación Farmacológica y Biofarmacéutica, SAPI de CV (IFaB) is a market-leading clinical research organization (CRO–Authorized Third Party) that focuses on bioavailability and bioequivalence testing studies in the Mexican healthcare market. The company is comprised by a group of highly qualified and renowned professionals in various areas of expertise related to the pharmaceutical industry who have worked together as a team for over ten years. IFaB is certified by the Mexican Federal Commission for the Protection against Health Risks (COFEPRIS–Ministry of Health) and the Brazilian National Health Advisory Agency (ANVISA) - the only Mexican company to have this certification. The company´s client base includes first-rate international and local pharmaceutical companies. Over the past 10 years, the bioequivalence market has witnessed a boom derived from new regulation aiming to renewal legacy drug licenses in Mexico. It is estimated that every year 300-350 bioequivalence studies are conducted, which represent a total market of $40 million dollars. With IFaB´s dual strategy, the Brazilian and Mexican regulatory requirements are fulfilled, and with this pharmaceutical companies can obtain licenses in Brazil, Mexico, Chile, Colombia, Peru, and several Central American countries–covering approximately 80% of the Latin American market with just one BE study. The pharmaceutical industry is experiencing significant changes: Biosimilar products provide cost savings, increases in patient access and innovations. The company believes that it can add value by developing new and complex products that can differentiate IFaB from competitors and increase its portfolio services with oncologicals, inhalables–combining complex drugs with sophisticate medical devices, patches–innovative alternative for controlled drug delivery through the skin, and biotechnological products including monoclonal antibodies, etc.