Many believe that Mexico is in the right place at the right time when it comes to biopharma and the BioPharma 2014 event, held on 4 and 5 November brought experts from around the globe together to discuss the best ways to propel the country’s potential. Innovation, research and development, regulatory improvement, market trends, universal healthcare, biosimilars, stem cells, and vaccines, were some of the topics covered by the event BioPharma 2014, which took place at the St Regis Hotel on Reforma in Mexico City. Leaders from both multinational and local companies, research institutes, academia, students, and public sector experts shared their views and perspectives for the field in a variety of conferences and roundtables. Attendees had the opportunity to exchange ideas for projects and business prospects with experts, colleagues, suppliers and potential customers.

Globally the pharmaceutical and biotechnological field is extremely competitive, and Mexico’s industry is no exception. Emerging pharmaceutical markets are growing at a fast pace, and eyes are now firmly on Mexico . Being the second largest market in Latin America after Brazil, the Mexican market presents many opportunities and challenges. In the last three years the regulatory agency, COFEPRIS, has improved many of its processes and has become a recognized reference agency by the PAHO and WHO. Ricardo Cavazos, International Affairs Director of COFEPRIS, speaking at BioPharma 2014 pointed out that Mexican pharmaceutical industry costs are 50% lower than other Latin American countries’ due to efficiency of regulatory processes. Moreover, the emission of new regulatory dispositions has evolved with the leadership of COFEMER, which is responsible for regulatory improvement and quality. Companies are betting big on generics and biopharmaceuticals, and research centers are striving to developing novel treatments such as stem cells therapies.

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In a total of 21 roundtables, attendees and specialists were invited to interact and share knowledge and experiences on biocomparability, stem cell research and regulation, personalized and genomic medicine, awareness of orphan diseases, and competitiveness in the vaccine business. Researchers made it clear that they are at the forefront of innovation, with extensive knowledge and technical expertise. It became clear that in terms of biocomparables, many research groups are focusing on this due to the reduced economic impact they have for complex diseases. A clear regulatory framework for such products was recently developed in Mexico, yet the extent of different techniques and studies for testing biocomparability are still a controversial topic. Contrastingly, regulation for stem cell therapy is still under development. Several experts from the National Center for Blood Transfusions (CNTS) are participating in a Committee for designing the Norm, which is expected to be officially published next year. Also, Mexico is already treating cancer patients at the Cancerology National Institute (INCAN) with a personalized genomic medicine approach, in which patients’ tumors are screened for genetic mutations, and effective treatments are delivered to them.

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Not everything is straightforward in Mexico however. Health expenditure is only 6.1% of the GDP, far below the OECD average. The same is true for R&D funding. As explained by Ajay Gautam, Executive Director and Emergent Market Leader for AstraZeneca, while R&D ecosystems are still evolving around the world, Mexican innovation levels are still low. Also, although the generics sector is increasing, the biosimilars industry remains uncertain in the country after Rituximab, the only biocomparable on the market, was removed by legal disposition. According to Francisco Kuri, Director of New Development of Landsteiner Scientific, price reduction of biopharmaceuticals after biosimilars introduction can be up to 82%, which represents a huge benefit for patients and insurance companies. However, companies are cautious when it comes to product development and entry to this market. Furthermore, although INCAN provides patients with novel treatments, hospital’s processes are still lagging; for instance, they have to wait up to 8 months to start receiving therapies, which is dissatisfying for cancer patients. For stem cells regulation, more experts should be included so as to establish a comprehensive Norm that covers mesenchymal cells and not only stem cells from umbilical cord and bone marrow. Regarding vaccines, big companies are not willing to invest in vaccination of vulnerable communities, so public-private partnerships have emerged to properly distribute them. Angelica Lopez, QA & QC Director of Birmex explained an effective model for the vaccination of zoster virus.

BioPharma 2014 addressed such challenges through experts’ lenses. Mexico is doing very well from the scientific arena; however, better allocation of both human and financial resources, teamwork, and further improvement of regulatory agency and institutions’ processes are still needed. Raising awareness of Mexico’s opportunities and challenges is necessary to improve performance of the whole pharmaceutical sector. Not only is it important to openly discuss them, but to act on them to push forward Mexico’s development. The next 10 years are essential for Mexico’s competitiveness and progress. Failing to succeed in this field would have a detrimental effect in people’s quality of life, so joined efforts and ventures are needed to accomplish goals on the healthcare agenda. BioPharma 2014 was the right platform to create a straight dialogue and to open new channels to come up with innovative solutions.


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