Melissa Rosales
Director General
RM Pharma
View from the Top

Local Rheumatology Studies Expert Sees Steady Growth

Wed, 09/09/2015 - 11:43

Q: What is the story behind the creation of RM Pharma Specialists?

A: RM Pharma was established in 2009 to provide consulting services to the pharmaceutical industry and to conduct clinical studies as an independent monitor. Entrepreneurship has been at the core of RM Pharma since its creation. My experience in the pharmaceutical industry compelled me to take the risk of creating my own company, and it started as a clinical research site specialized in rheumatology in 2010. That same year we were selected to conduct two studies, and by 2013 we had 12 studies to conduct that year.

Q: What is the impact of autoimmune diseases in Mexico?

A: The field of autoimmune disease in Mexico is similar to other countries in the region. It is important to point out that autoimmune diseases cover a wide spectrum of clinical entities, affecting joints, connective tissue, skin, liver, lungs, and thyroid gland, among others. We are working mostly on rheumatic autoimmune diseases; of these, rheumatoid arthritis is the most pertinent. It affects 1-2% of the population and is one of the main causes of disability in Mexico. The coverage of social security has increased in recent years and several efforts have been made to inform the general population about this rheumatic disease.

Q: Being certified by ISO 9001, what are the advantages of implementing a quality management system in the organization?

A: With this system we have an overview of the tasks that need to be done, not only one particular task at a time. Moreover, the quality management system ensures the whole process is recorded so it can be reviewed and discussed at any time, which is convenient for all participants at the center. The ISO 9001 would also be helpful to promote our site by implementing new protocols so that any CRO can be confident about the quality provided by our site knowing it has an external and international certification. To date, few Mexican centers have achieved this qualification.

Q: As an FDA audits candidate, how does this influence RM Pharma and Mexico’s global reputation?

A: RM Pharma was the top patient recruiter around the world for a particular study. This achievement was important for us, as well as becoming the site with the largest number of patients worldwide in one study in rheumatoid arthritis, in 2013. The audit of the sponsor produced zero findings, which positioned the site and Mexico as a country where studies are conducted with high quality and meet international standards. However, if we were to have an inspection by the FDA this would allow us to continue learning from observations or findings generated to improve our current quality management system. In addition, this should be replicated in other clinical research sites in the country to improve the image of Mexico as a partner of choice in which to conduct future clinical studies.

Q: What other activities does RM Pharma have besides clinical trials to promote health in Mexico?

A: At RM Pharma we have an annual plan for disseminating health information. For example, we generate quarterly conferences for patients and the general public on autoimmune diseases and we approach patient’s associations and provide workshops on nutrition and stress management.

Q: Only 1.2% of multi-national clinical trials are conducted in Mexico – what needs to be done to attract more studies?

A: In the past, there was no legal certainty for the authorization of trials, with rules and requirements varying with each new head of the COFEPRIS. Today this situation is changing with new proposals from COFEPRIS to reduce protocols approval time and the generation of a national database of clinical research sites and a database of Principal Investigators operating clinical research in Mexico. Both databases will be elaborated by the pharmaceutical companies and CROs in order to reduce approval timelines to 20 days. Nevertheless, there is not yet enough clarity as to how and when this process will start. In addition, in the majority of the cases, research sites and pharmaceuticals or CROs meet all of COFEPRIS’ requirements, but because of the lack of legal certainty, a large number of late starting protocols remain in Mexico due to long official approval timelines. Since most clinical research studies are international with a competitive recruitment approach, expected delays prevent some pharmaceutical companies from conducting studies in Mexico