Melissa Rosales
Director General
RM Pharma
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View from the Top

Long-Term View Can Help Revamp Clinical Research

Mon, 03/09/2020 - 07:00

Q: Last year, RM Pharma announced the creation of an association in Mexico to promote research in the country. What are the latest developments?
A: The Associated Centers for Excellence in Clinical Research (SAIC) is up and running. RM Pharma and SAIC’s other founding members are inviting more research centers to join. The association’s goal is to help research centers develop a more holistic view of clinical research. RM Pharma’s focus will be to help companies organize their talent, their processes and other aspects related to research. SAIC is now also a member of the Research Commission of CANIFARMA.


Q: What advantages and disadvantages does RM Pharma see in ending multiplicity of lanes?
A: Authorities analyzed this concept for years. The idea was that those protocols previously approved by foreign regulatory agencies, such as the FDA or EMA, were not required to pass a COFEPRIS review. This simplification represents a reduction in approval times of up to one month, which makes the industry more competitive.
The real challenge for COFEPRIS is to ensure it has the necessary human resources to carry out this initiative since at present the team designed to review the protocols is small, which delays the process. If COFEPRIS’ idea is harmonized and implemented efficiently, attraction of projects from Europe and other markets could grow. There are many laboratories that seek to do research in Latin America but until now these companies have not found the channels that facilitate these opportunities.


Q: Why is RM Pharma’s focus on rheumatology and does it have any interest in moving into areas like oncology?
A: Oncology is a focus for the authorities because it is an industry trend but it is not the only area that requires attention in Mexico. RM Pharma specializes in rheumatology, immunology, pediatrics, respiratory and chronic degenerative diseases and we are starting with gastroenterology and urology protocols. Because of this, we have no immediate plans to participate in the oncological area. The company focuses on chronic degenerative diseases because its study will be key for future generations due to the aging population. RM Pharma has developed a clinical research group that collaborates with IMSS to accelerate administrative processes for pharmaceutical companies with processes such as CRF and also provides coordination of research services.


Q: Volunteer recruitment is key to developing a clinical research industry. What is RM Pharma’s approach and how can this area be improved in Mexico?
A: In the US, volunteers receive financial compensation for participating in clinical research, while in Mexico, pharmaceutical companies only pay for travel and food expenses. If a similar remuneration were applied in Mexico, we would run the risk of receiving more volunteers than could be accepted and they probably would not meet the necessary criteria to participate. I believe that the dynamics of not contributing economically should continue unless it is a Phase I project, which requires volunteers for a longer period of time.
Rather than monetary incentives, education is key. Volunteering for a clinical research study gives patients options to treat their illness and help eliminate from society the stigma that volunteers are guinea pigs. In the case of volunteers who collaborate with RM Pharma, word-of-mouth is used to encourage patients to become clinical research volunteers. In the near future, we plan to provide more structure to this network and carry out a program called Ambassadors for Health in which volunteers themselves promote volunteerism. In exchange, they can obtain discounts for laboratory studies, medications and medical assistance. The purpose is to promote healthcare and encourage people to participate in clinical research.

 

RM Pharma is dedicated to phase I-IV clinical research studies, medical services, services to the pharmaceutic industry and CROs. The company specializes in therapeutic areas such as cardiology, dermatology and general medicine.