MELISSA ROSALES

Mexico 2021 | HEALTH | INTERVIEW

Despite the slowdown in authorizations and development of certain medication, RM Pharma is proceeding with its important trials and studies to help those suffering from diseases such as lupus and arthritis.

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.

Can you elaborate on your latest challenges in 2020 and your achievements last year?

The pandemic modified the way in which we conduct our research protocols. We had to develop a project in stages during April, May, and June depending on how the pandemic evolved. We also started a process to deliver medication directly to the homes of patients in partnership with our sponsors. We used the couriers that we used to send tests to the US to provide these delivery services for patients instead. We implemented a home office working scheme for our employees and offered some online courses on vaccines, for example. It was a huge challenge. We are heavily focused on recruiting patients as soon as we receive the green light for clinical trials. We have recruited 70 patients, and 57 remain for one obesity treatment. That was done in one and a half months. There were also some modifications in terms of how doctor visits were conducted. Telehealth is a service that will only continue to grow, though it will not replace traditional in-person medicine.

What do you expect for the next year?

We expect to receive authorization from the regulator COFEPRIS and are waiting for it to authorize the protocols. We have a protocol for a study on asthma in adults, another in asthma for children, another one on lupus, another in rheumatoid arthritis, and many others. We do not have an estimate on when these studies could be reopened. Currently, COFEPRIS prioritizes COVID-19 protocols, and pharma companies are reorganizing their priorities, though not all of them can focus on COVID-19. Otherwise, we will neglect other diseases such as cancer.

Will there is going to be a delay in the development of medicine in 2021?

Yes, there were some timelines for the development of new drugs, but that has been delayed currently. Meanwhile, there are some amendments to protocols because COVID-19 has to be included in them. However, there are many people suffering from diseases that will experience a delay in the development of their medication. There will be an impact in the middle term. The amendments of the protocols bring changes that have to be approved by the regulator, COFEPRIS. In January 2021, we received the first patient for a trial of a product that is being sponsored by Regeneron for COVID-19. This was a month in which the number of infected people increased in the country, but we experienced some issues with customs to receive the medicine we will be conducting trials for. Our goal is to have 40 people for this trial. In Mexico, we want to have around 200 patients for the study.

What is your strategy for the first half of the year?

We want to work on COVID-19 trials and vaccines and also start our second trial in obesity. We also have a study for ophthalmology. We received an award in 2020 in healthcare, and we conducted an in-person event in Querétaro.

Are you planning to add new services?

Yes, we are considering diversifying and would like to add a part of academia. We would like to train other researchers, so we want to develop some alliances with universities. We want to offer courses focused on clinical investigation for doctors, patients, and others. In addition, we are working on a book to share some of the experiences of the participants in different studies. We have several written success stories, so we would like to share them in a book. We have some patients who have lost 17kg through an injection that we provide in a clinical trial. It interacts with the insulin system, and the drug helps them lose weight. We have many programs, but we have to define our priorities. In that regard, the academia part is key.