Karen Hahn
Director of Global Program Management at ICON

Clinical Trials Bloom Through Public-Private Collaboration

Tue, 01/15/2019 - 14:09

The high investment needed to develop new medicines is leading pharmaceuticals into emerging economies like Mexico. Thanks to its lower costs for clinical trials and excellent physicians and researchers, the country will become an even more attractive investment destination, according to Karen Hahn, Director of Global Program Management at ICON, fueled as well by collaboration between the private sector and public healthcare institutions.  “Pharmaceutical companies are looking for ways to offset costs,” says Hahn. “Mexico’s lower costs for clinical trials outweigh the attractive conditions offered by other countries.”
Medicines must follow a long and costly road from molecule discovery to commercialization. A 2018 study by the Tufts Center for the Study of Drug Development calculated the cost for drug development at US$1.2 billion. Headquartered in Ireland, ICON is a multinational CRO whose goal is to accelerate the development of medicines and medical devices, thus reducing this cost. The company employs over 13,250 people in 38 countries and specializes in oncology, CNS, internal medicine, infectious diseases, gastrointestinal, women’s health and rare diseases.
Hahn says ICON is betting on Mexico as a key part of its development strategy for Latin America. “At this point, Mexico and Brazil are the most important countries in Latin America for the company. Studies that would previously go to Colombia, Peru and Chile are now going to Mexico, Brazil and Argentina,” she says. Beyond the low cost for clinical trials, Hahn explains that interest in Mexico also is increasing because of the country’s excellent physician pool and large prospective patient population. Moreover, companies are seeing potential for increasingly specialized tests. “We see a growing interest in more specialized areas, such as PVSS and project management,” says Hahn.  
Collaboration between CROs and public healthcare institutions will be the key to untap the country’s clinical trial potential. CROs have targeted the public sector due to the latter’s large patient population. Although there have been efforts from the private sector to align to the needs of public institutions, the challenge, according to Hahn, has been finalizing and signing contracts between both parties. “We were aware that public institutions had good doctors but we had no access to them due to the many barriers we faced to sign public-private contracts,” she says. “Now that contracts are finalized, everything else will fall in line.”
ICON has signed contracts with IMSS and other healthcare institutions to perform clinical trials. Although doctors from public institutions often have no experience in these studies, Hahn points out that institutions are often open to provide as much training as necessary to their physicians. The expectation is for these collaborations to strengthen, thanks in part to renewed interest from the federal government under President López Obrador.
The one possible hurdle is regulatory delays that could set the sector back. “CROs need continuity in regulatory processes to avoid a slowdown in approval times,” says Hahn. ICON is opening new business areas at its offices in Mexico City to prepare for increased demand for its services, one of which is focused on data management, which it expects will bring an added value to clients. “Our goal in the short term will be to continue strengthening our business areas and prove to our headquarters that they were worthy investments.” The company is also partnering with ACROM in offering courses to keep clients updated on the latest changes in regulation. During 2018, ICON participated as a lecturer during a pharmacovigilance training program for CROs and pharmaceutical companies organized by ACROM. “While the sector is already knowledgeable regarding pharmacovigilance procedures, these change continuously so companies must remain updated at all times,” says Hahn. “We will push to make this an annual course and keep CRO employees up to date.”