The Business Year

Melissa Rosales

MEXICO - Health & Education

Continuous Improvement

Director General, RM Pharma


Before founding and directing RM Pharma, Melissa Rosales worked at Pfizer for over eight years as manager of clinical investigation. She studied chemical pharmacology at UNAM and has a master’s degree in organizational psychology.

“Our main areas are rheumatology, pediatrics, immune respiratory diseases, urology, and dermatology.“

What major challenges regarding clinical trials do companies face when bringing medicine to Mexico?

The biggest challenge is definitely regulatory affairs. We are not sure yet about the Federal Commission for the Protection against Sanitary Risks’ (COFEPRIS) impact on review process under the new government, but I hope there will not be a significant impact in this field. We are doing fine regarding quality and patient recruitment because companies know that we will produce the results. Throughout Latin America, Brazil, Argentina, and Mexico are the top three countries in terms of medicinal products. For us, it helps that we are next to a country like the US that has a large pharmaceutical industry. But they still have molecules that we don’t have access to. Usually, the development of new molecules takes place in the US, the EU, China, and India.

What clinical trials are you working on?

Our main areas are rheumatology, pediatrics, immune respiratory diseases, urology, and dermatology. We are working with a stage-two and stage-three rheumatoid arthritis clinical trial and medical monitoring. This trial is focused on small molecules since it is part of a biological therapy. The medicine was launched in 2018 but we still have 41 patients who have been taking the medicine for the last five years. Mexico has many types of medicine, including those that are considered new drugs. There might be a medicine against orphan diseases that is available around the world but not in Mexico because of low demand, and these are most likely to be the ones that you cannot find in the country. COFEPRIS has the power to authorize medicines in Mexico, and this facilitates the process. Once it’s in Mexico, it can be easily found in Latin America, even if the US doesn’t approve it. COFEPRIS and Latin American audits have gained this recognition.

How do you use alliances to improve your clinical trials?

Bioclinica is a global research network that works with all kinds of pharmaceutical companies. It offers projects to us since it has the quality they are looking for. The main advantage is that we have direct contact with them and not through an intermediary. Therefore, they offer feedback on things like our recruitment system. We also work with big laboratories, such as AbbVie, that have partner research sites and are looking for sites that guarantee quick regulatory affairs, patients, and quality.



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