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Patient Participation In R&D Still Needs to Be Encouraged

Melissa Rosales - RM Pharma
Director General

STORY INLINE POST

Miriam Bello By Miriam Bello | Senior Journalist and Industry Analyst - Tue, 06/16/2020 - 11:38

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Q: How did RM Pharma’s Associated Sites for Clinical Research Excellence (SAIC) initiative develop in 2019?

A: We are integrating more associated sites and diversifying the specialties we cover. In the beginning, we had research sites related to rheumatology, now, we also have pediatrics and asthma. We just opened a space for research into psychiatry, which has caught the attention of independent researchers with no affiliation to a society or association. We have also partnered with AMEIFAC, which provides SAIC’s associates the same benefits they would get as AMEIFAC associates. Our goal is to collaborate with other associations and attract more affiliates.

Q: In which specialties would RM Pharma like to focus to grow its operations?  

A: Gastroenterology and urology were the projects that I initially wanted to open because of their importance to the population. We started studies for gastroenterology with a national laboratory that focuses on reflux, but we faced complications to find patients with ailments like ulcerative colitis and Nonalcoholic steatohepatitis. The lack of participation led us to drop these two research areas. We are trying to focus our work on the priorities of the pharmaceutical sector. We would like to dabble into other areas but the lack of a representative population makes it difficult.

We are now looking into the area of vaccines, with three studies in the pipeline. We expect to start one in 2020. This year, we are looking at many other possibilities within the area of vaccines. In the latter demographic, PM Pharma has incorporated a study gynecology, which is a vaginosis study on 150 patients. Vaccines are an important issue in Mexico with outbreaks of measles or dengue, making these studies important to promote preventive healthcare measures. We also want to strengthen our participation in psychiatric research for illnesses like bipolar disorder and depression.

Q: How has your Queretaro office developed?

A: This office will no longer be a research facility but a place to host events for our foundation and to train entrepreneurial women who want to start their own business. Of course, the offices can serve as an extension to our research facilities but that would not be their main purpose.

Last year, we held our first workshop for patients, which led us into a different way of focusing our research rather than just using the pharmaceutical approach. These workshops allowed us to really approach the patient’s needs, which is fulfilling and helpful for our development. This experience allowed to produce a book with 20 testimonials regarding how participating in our study contributed positively to the patient’s quality of life. We would like to produce other similar volumes to boost participation in medical studies. Other initiatives include free medical check-ups and our Ambassadors for Health network of patients who promote the benefits we offer and help us grow our population sample.

Q: What were RM Pharma’s biggest achievements in 2019?

A: We were nominated for the Achievements Forum award in the Business and Economics category. We also enjoy the support of COPARMEX, CONCANACO and the Swiss Chamber. We also participated in a anticorruption program for which we released our integrity, anticorruption and ethics policies. We were assigned a mentor, Medix, that held monthly meetings with us to check on our progress until we had a final product, which in this case were our three policies.

Q: What does Mexico need to do to become a clinical research destination?

A: Regulations are just stabilizing after the change in administration, so I do not expect an improvement in the short term, nor has there been any improvement before. Healthcare companies are just thankful that our regulatory environment is stable because uncertainty is what we do not want from regulators. I do hope to see more research protocols but the government has been slow to pick up where the previous administration left off. If COFEPRIS maintains its three-month approval period, we can call it a win.

Q: How could PPPs boost Mexico’s performance as a clinical research hub?

A: Obviously, the panorama would be much different if there was more participation but I feel like the government has not allowed this to occur. This new administration has many good plans for the healthcare sector but I do not see it focusing on these projects. This will continue to be a private sector matter.

Q: How would IMSS’ proposal to offer its beneficiaries the option to participate in clinical studies benefit the industry?

A: This initiative would really boost participation and R&D in Mexico. IMSS really has everything needed to take on clinical research, which is why we provide the service of external coordinators to support the studies conducted at the IMSS incentive would also benefit the institute because the results would be theirs to work with. IMSS, INC and INCAN have all the ingredients to fuel research but regulation stops them because of the long processes and times needed to approve initiatives like that.

 

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

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