Cecilia Moreno
Associate Director of Clinical Management
José Viramontes
José Viramontes
Director of Remote Site Management and Monitoring
View from the Top

Expanding to Reach Public and Private Entities

Wed, 09/06/2017 - 09:56

Q: In 2016, you told MHR you had plans to open more centers in Mexico. To what extent have you fulfilled these plans?

CM: We are opening an increasing number of centers in Mexico to work with the private and public sectors and in new therapeutic areas, such as vaccines. Additionally, IMSS is modifying its internal processes to allow more interaction with pharmaceutical companies and has changed its contract template to better support the industry. We already have started working with the agency in oncology, allowing patients with less prevalent diseases to be enrolled in clinical trials. We are also working with IMSS on vaccines for infectious diseases.

Q: What are the specific challenges in working with vaccines?

CM: One of the main challenges of working with vaccines is the number of patients who have to be recruited. Studies can include hundreds or thousands of patients, so centers have to have the necessary infrastructure and personnel to support those needs. Also, vaccines are often for endemic diseases, many of which are tropical like zika and dengue and occur in Mexico, so there is an area of opportunity for these studies

JV: Another challenge is finding healthy volunteers and conducting the follow-up to ensure the vaccine is effective. The informed consent applied to healthy volunteers is different than that used to invite patients who are conscious of their disease. An additional factor to be considered is that in many cases vaccine clinical trials include children.

Q: What impact has NOM-220 had on your Mexican operations and what changes do you expect from future modifications?

CM: We have not seen much impact but we are waiting to see what new follow-up activities result from the vigilance plans. The reporting of adverse events in clinical trials is still very similar to what it was before. Also, we will probably participate in more risk-management studies or observational studies going forward.

JV: Although the section of the NOM that deals with the reporting of adverse events in clinical trials has seen a few slight modifications, it has not had a substantial impact. It has more of an impact on the spontaneous adverse events for medicine already commercially available. Most of the industry is working on how to implement these changes in their internal processes. There is a Mexican association of pharmacovigilance that holds regular meetings in which the details of the new NOM are discussed. They are in contact with the authorities.

Q: Looking to the future, what are PPD’s goals for Mexico?

CM: Our goal is to continue growing. National regulation has been beneficial to our industry and over the past few years we have seen an improvement in approval times and greater willingness to strengthen and improve regulatory processes, which has made Mexico more competitive when compared to the rest of the world. COFEPRIS continues to improve its processing time frames and research sites continue to operate at increasingly higher standards, which improves overall recruitment times.

JV: 2016 was an excellent year for Mexico in many ways. The regulatory authorities have brought much greater consistency to their internal processes and they have greatly expanded their interactions with companies. The year closed with a meeting between the authorities and associations, during which a few changes to the law were proposed. For example, Mexican law requires the involvement of three committees: ethics, research and biosafety. One proposal seeks to include only one committee, which is an approach comparable to the rest of the world. Another consideration is to run processes in parallel rather than sequentially, which can help shorten approval times. The purpose of these changes is to support the industry’s ongoing efforts to curb the cost and time curve of drug development.