MELISSA ROSALES

Mexico 2020 | HEALTH & EDUCATION | INTERVIEW

Having been nominated for an international business award for reliability, RM Pharma is planning to go one step further and focus its efforts on internal restructuring and quality control.

Melissa Rosales
BIOGRAPHY

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.

In what ways did the company strengthen its portfolio in 2019?
In 2019, we entered new therapeutic areas. For example, we are set to start a new psychiatric protocol. We are close to starting with vaccines as well. The vaccine protocols are different from what we usually do. Normally, there is phase one with volunteers, phase two with a small number of ill patients with low doses, phase three with more patients to measure security and efficacy, and phase four for pharmacovigilance; however, vaccines have different phases, and you need a high number of patients to apply the vaccine because you usually only apply it once. We are working on a vaccine for the syncytial virus in the elderly and children. We also working with gyneco, a vaccine for pregnant women, where we have to store a piece of the umbilical cord.

How would you compare the company's results in 2019 to those of 2018?
2019 was full of uncertainty. Our performance in 2019 was slower than in 2018. The new administration changed many things. It now takes a three-month period to issue medicine permits, whereas the previous administration did it in half that time. In fact, in 2019, some pharmaceutical companies decided to work abroad given the approval time in Mexico.

What is your perspective on the decision of the administration to modify the public healthcare system?
The issue is implementation. It looks great on paper, but in reality, you do not know how it will work. The public health system was already chaotic and problematic. It is a great proposal, but we have to see if it will work in practice. There is a shortage of specialist physicians as it is, and doctors do not want to work in the public system.

We have heard of many changes in the government's process of selecting medicines for the public health system. What is your opinion on this?
It is good that the government seeks to reduce monopolies in the healthcare industry, although it should not use generic medicines brought from India and China. We know within the industry that these medicines do not undergo the same quality processes as in Mexico. This is an ongoing issue that is yet to be solved. I agree that costs should fall, but definitely not at the cost of quality, efficacy, and safety.

In terms of clinical research, what is your perspectives on the growth of the industry in Mexico?
There are great opportunities, but these have always stalled due to regulatory obstacles. Our situation is similar to Brazil, where it takes around three to six months to start a project. Yet, when we need to recruit patients, we do better than other countries, thereby mitigating this with high turnout rates; however, companies would prefer a more stable regulatory setting. The government is also changing the customs regime, and we have to import medicines and supplies, which today requires a different process. In terms of global rankings, Mexico has not advanced.

How do other regional countries compete with Mexico?
Permit approval times are rather similar. Colombia is undergoing some reforms in terms of clinical research, but not everyone there wants to undertake research. The main players are Mexico, Brazil, and Argentina. Chile and Peru are also strong players, but not as notable.

What are your goals for 2020?
Growth will be at around 20% for most projects, and the number of specialists will also increase. We are undergoing an internal restructuring, and will focus on quality control. 2020 looks like a promising year, where we have been nominated for an international business award for reliability. We have plans to use telemedicine in conjunction with actual patient visits. We will also open for business in Querétaro around June and focus on training and patient consultation.