Mexican CRO Sees Future in PharmacovigilanceWed, 09/05/2018 - 16:41
Mexico would greatly benefit from the opportunities associated with clinical research, not just in terms of economic investment but by increasing access to innovative medications, says Arturo Rodríguez, CEO of Infinite Clinical Research (ICR), a 16-year-old Mexican CRO that offers a wide range of services and specializes in clinical trials for metabolic diseases, oncology and dermatology.
The global clinical-trial management market is expected to reach US$36 billion by 2020, according to Research and Markets. “If Mexico could attract even 1 percent more of the global share, investment in the country would be significant,” says Rodríguez. He sees important potential to reach this ambitious goal based on the country’s history in the segment. “Mexico was extremely attractive for clinical research. When the country had approval times of 30 days, it attracted a large number of clinical trials and CROs. The problem began when that timeline grew to over 200 days, which greatly damaged the industry. If the country could reduce the timeline once again, Mexico could have a strong position in the sector.”
Rodríguez says that if Mexico continues with no clear ethics committee’s rules and COFEPRIS long approval times, the international industry would turn to see other markets. For processes to be reflected on official documents, work tables are usually very long and in many cases do not reach a good end. Something new that we are experiencing is the synergy of authorities and the industry in the pursuit of a common goal. This makes companies and researchers wary and does not give false expectations outside of the country, as the industry requires fast approval times, certainty, predictability and transparency to operate efficiently.”
Considering the size of the problem, pharma and local CROs had greatly invested in the solution. “As ACROM, we participated in March 2017 in a group of leaders in charge of optimizing response times for the approval of clinical trials.” The group is still led by ProMéxico and includes representatives from COFEPRIS, the National Comission of Bioethics (CONBIOETICA), SAT, SHCP, the Ministry of Economy, several health institutes, IMSS, ISSSTE and a few general hospitals. The group brought together the specific needs in each sector and implemented corrective actions to streamline processes and improve approval times and it worked. “By September 2017, COFEPRIS had reduced its approval times from 120 days to 70,” says Rodríguez.
The benefits from increasing the number of clinical trials conducted in the country are not limited to the attraction of foreign investment, explains Rodríguez. “Clinical trials reduce entry barriers to innovative treatments, especially in terms of cost, which is a significant hurdle in Mexico for low-income individuals. Patients should be empowered to take control of their healthcare and, given the opportunity, to demand inclusion into clinical trials.”
The ICR’s Pharmacovigilance Unit is already working with clients and Rodriguez says the sector will be an interesting one to tackle. “There is a significant difference between a regular protocol and that for pharmacovigilance. In the first, a hypothesis is proposed and tested; in the second, results make way to approaches and situations found in the research that lead to new hypothesis on how to attack unidentified new risks. Pharmacovigilance studies are more open as they involve pregnant women, children and other vulnerable groups. This intensive methodology is a new challenge in Mexico that we are learning alongside the authorities,” he says. On Jan. 15, 2018, a new regulation version on pharmacovigilance was implemented to strengthen risk management plans: NOM-220-SSA1-2016. This NOM, according to CANIFARMA, raises Mexico’s standards for conducting pharmacovigilance studies to international levels.
ICR’s goal is to capitalize on the growth of the clinical research sector, but with a different strategy than that of larger CROs. “We are seeing a growing number of smaller biotechnology developers entering the sector that are developing one or two molecules. ICR is targeting these smaller companies and we are working alongside them through the entire process. When the molecule is sold to a larger company, we move on to another small company to avoid competing with multinational CROs.”