Cecilia Moreno
Associate Director of Clinical Management, Mexico & Caribbean
José Viramontes
José Viramontes
Director of Remote Site Management & Monitoring Latin America

Strength of People, Quality of Work

Wed, 09/07/2016 - 11:59

Q: What steps should clinical research professionals in Mexico take to attract investment for clinical research?

CM: We have been working with different associations and the government, mostly involving process improvement. The Minister of Health in Mexico and the Federal Protection Commission against Sanitation Risks (COFEPRIS) are deeply interested in taking the benchmark of other countries and reviewing their regulatory processes to improve timelines. As a country, we are more predictable, which is good for clients. The pharma industry will send more studies to Mexico if they see the timeframes for regulatory approval are improving.

JV: As a country, Mexico has several characteristics that make it very attractive to conduct clinical trials, such as its population of about 128 million people, predominantly living in cities, and its wide epidemiologic profile, which includes both acute and chronic conditions. The country has a large number of highly qualified health and medical professionals and a well-established regulatory environment, especially strong intellectual property protection. While we are officially part of Latin America, our close proximity to the US has enabled our country to incorporate practices, processes and procedures that are similar to those of the US, making us familiar and comfortable with the way US companies work. In practice, for companies having their corporate offices in the US, sharing the same time zone has been a clear advantage to Mexico from a business perspective. Being a Latin American country, we also can offer the international implementation of sites that most trials desire.

PPD hopes to take advantage of these natural conditions and for economic and political stability to grow in Mexico. We have the tools and favorable characteristics to attract more clinical research investment to Mexico compared to other countries. The company has made efforts to replicate South Korean success to integrate the efforts of the main stakeholders, namely academia, the authorities and industry, in a common strategic plan known as KoNECT, Korea National Enterprise for Clinical Trials. This aims to place Korea among the first 10 countries in clinical research investment.

Q: What perception does the global arena have of Mexico in clinical studies?

CM: Evidence was published that the quality of data generated in Mexico for international trials is comparable to any other country. Over the past five years, more trials have been allocated to Asia Pacific and Eastern Europe than to Latin America. As a sector, we need to become more competitive and attract more clinical trials in tandem with companies and governments.

JV: We must become a household name among decisionmakers. Clear factors influence this: timeframes, costs, the quality of the sites and market size. We should be promoting our advantages in medical infrastructure, which is in place and supported by many professionals already prepared and interested in working in this area.

Q: As a clinical research professional, what are the areas of opportunity in terms of human capital?

JV: As with any profession, the Mexican clinical trials industry is focused on education. We want to make sure the people who are part of our industry have the correct preparation and understanding of our operations. A step was taken in that direction via collaborations with universities to start the clinical research training process even earlier.

CM: All of our industry in Mexico has been working with universities, both private and public, to raise awareness among those who are graduating with science degrees. Few students have access to information regarding clinical trials, so the burden falls on the Mexican clinical trials industry to promote the benefits of developing a career in our line of work. There are courses for clinical monitors at the National Autonomous University of Mexico (UNAM) and the National Polytechnic Institute (IPN).

JV: PPD routinely hires many graduates straight out of universities. For junior positions, we need the right talent as early as possible to teach them about clinical trials. We also need to have qualified and well-trained professionals at the sites to provide role models for graduates, not just working in the industry. Several companies in Mexico already have implemented internship programs. At PPD Mexico we have junior positions that are similar in scope and allow people to learn and grow with the company. Their daily work contributes to the development of better pharmaceutical products for those who need them. Every time a product is launched for which we conducted a clinical trial we celebrate because we are part of an important achievement.

Q: What methodology are you implementing to find new efficient ways to introduce drugs to the market, differentiating your company from competitors?

JV: PPD is one of the most innovative companies in the clinical research industry. We are recognized for the strength of our people and the quality work we do. The enterprise has several global initiatives underway that address key elements of the drug development process, helping to make the process more efficient.

CM: The use of technology is another of our strengths. We have a strong database system that is useful internally and for clients to review in real time and for sites to evaluate patients. These interfaces are one of our differentiators.

Q: What type of trials is PPD Mexico primarily conducting in Mexico?

CM: We often work with oncology, a rising trend in the industry. We also work on rare diseases, pediatric indications, diabetes and neurology, and we have some vaccine trials underway. A great advantage is a large population concentrated in big cities, such as Mexico City, Monterrey and Guadalajara. These three cities are about the size of the total population of some European countries. There are also branches of hospitals here such as national institutes or regional hospitals.

JV: With a population of about 128 million people in Mexico, we know we can participate in almost any type of trial because we have the quantity of patients. Although we have more experience in conventional therapeutic areas, we try to participate in all kinds of trials.

As a CRO, PPD has studies covering a wide spectrum of medical products. PPD works with a variety of clients, both big and small, as we are capable of responding and adapting to our clients’ particular needs. As a company, PPD has strategic relationships with some clients, frequently acting as their clinical research team.

Q: What advantages does working with governmental institutions like IMSS offer?

CM: The Mexican Social Security Institute (IMSS) is evolving to change its processes, but only a few clinical trials are underway. Usually the time needed to implement and conduct a clinical trial is short and IMSS cannot always meet those deadlines. We need to continue working with them to shorten turnaround time as this institution serves an important part of the population.

JV: Although the Mexican Association of Pharmaceutical Investigation Industries (AMIIF) works directly with IMSS to improve how it implements clinical trials, we still have progress to make with timeframes and the contract template, as some terms are not accepted by the legal departments of the companies we work for. A local legal department understands the importance of working with IMSS and is more flexible working through the terms. As a CRO, we cannot have one template that fits all, so we have a variety of plans, each tailored to different ways of doing things.

Q: What upcoming projects do you have planned at PPD Mexico?

CM: We will be taking advantage of new technology and biotechnology needs. Biotech companies are growing and the clinical studies are changing so we need to adapt to this.

JV: As a global CRO with a strong presence in Mexico, we are responding to industry needs. PPD aims to satisfy every need, big or small. A substantial number of PPD research centers are operating and we are looking to increase this number as needed. We focus on the sites with the greatest success and seek to replicate their achievements at all our sites.