Aug. 14, 2015


Sandra Sánchez y Oldenhage

Mexico

Sandra Sánchez y Oldenhage

Deputy General Manager, PROBIOMED

TBY talks to Sandra Sánchez y Oldenhage, Deputy General Manager of PROBIOMED, on the role of new regulations, impending developments in the pharmaceutical industry, and new innovations that are leading the way.

BIO

Sandra Sánchez y Oldenhage has 26 years of executive level experience in top ranked pharmaceutical companies such as Pfizer, Merck Sharp & Dohme, Searle and Pharmacia and recently as President and General Manager for Amgen Mexico. She has worked across multiple functional areas including general management, commercial (marketing & sales), strategic planning, business development and operations. Since 2014 she has been Deputy General Manager of Probiomed. Sandra has a degree in Business Administration from the Intercontinental University, an MBA from the Instituto Tecnológico de Estudios Superiores de Monterrey (ITESM) and a certificate from Harvard’s Executive Leadership Development Program, as well the Washington University’s School of Business “On The Board” program.

What are your thoughts about the new regulations on biotech medicines in Mexico?

Mexico has made remarkable progress from a regulatory standpoint in a very short time. COFEPRIS, led by Commissioner Mikel Arriola, was recently recognized as a regulatory agency of reference in Latin America. Today, many Latin American countries recognize Mexican regulatory approvals and supporting documentation, thus reducing time-to-entry into these markets. COFEPRIS was able to obtain PAHO certification for pharmaceuticals and biopharmaceuticals as well as the WHO certification for vaccines, thus positioning it as a strong regulatory agency worldwide. The latest biotechnology/biosimilars regulation (NOM 257) is of note. It is already a benchmark in Latin America and I would dare to say it is close to the European Medicines Agency (EMA) regulation. Companies that manage to comply with these new regulatory requirements will have met high standards for their products. With the new NOM 257, innovative biopharmaceuticals and biosimilars will coexist in the Mexican healthcare system while ensuring product efficacy and patients' safety. Prior to this new regulatory framework for biosimilars, around sixty-five products were registered as generic drugs and the quality and safety requirements were not as strict. The new norm requires characterization and biocomparability studies, as well as safety and efficacy trials that altogether will have to demonstrate their similarity to the reference products.

How do you expect the national pharmaceutical industry to perform in the coming years?

I expect that it will grow in a number of different ways. Initially because of demographics; the population is aging and chronic degenerative diseases are now more common than infectious diseases, which means that people have more comorbidities and are treated for longer periods of time, with more expensive, and complicated drugs such as biotechnology drugs, which have significant budget and cost implications. The second trend is that patients are opting for public hospitals over private hospitals because of the cost of their treatments. Many chronic diseases are treated with biotechnology products, which are more expensive. The third trend is that there will be many more biotechnology products because of the types of diseases we are looking at now. The biotechnology industry will keep on growing at double digit paces. Today this segment grows at approximately a 25% annual rate. In early 2000, 10% of NDAs submitted to the FDA were biotech drugs. Today 70% are. This rate will only increase.

To what degree is innovation a key factor in PROBIOMED's continued growth?

PROBIOMED is the only company that has the entire high-technology manufacturing process of biotechnology (biosimilars) medicines in Mexico. In contrast to traditional generics, the manufacturing of biosimilars requires significant innovative processes, such as the genetic engineering of living organisms, growing them in bioreactors for the production of proteins and antibodies, and obtaining the final product. It is essential to promote local manufacturing so that Mexico does not only rely on imported biotechnology products. At PROBIOMED, we believe that quality should be based on science, and this is the reason that since our founding, we have invested 20% of our sales in research and development, equivalent to the investment made by the major innovation labs. We have a R&D unit, formed by an interdisciplinary team of highly specialized professionals for the design and development of biotechnological processes. We always use technology that allows us to offer high quality products to satisfy global health needs. We are the only biopharmaceutical in Mexico that develops products from gene to drug—including hormones, cytokines, monoclonal antibodies, fusion proteins and vaccines for the treatment of chronic degenerative diseases, malignancies, hematological disorders, metabolic disorders and autoimmune diseases. Currently we have 16 biotech products in the market and five more in development.

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