Read the Conversation
EF: In the post-Covid times, executives must deal with a complex world. How do you visualize 2023; do you see it as a challenge or an opportunity?
GS: It is both. The post-pandemic has brought important political and social challenges, and companies must overcome them by taking certain risks regarding the current government's position within Latin America. Legal and governmental stability and uncertainty also need to be taken into account. The other side of the coin is that there has been a significant trend in nearshoring industries post-pandemic, particularly in healthcare: in medical devices and pharma. The United States is the largest health market in the world and generates important opportunities for companies in the region as potential suppliers to that market.
EF: According to the Mexican Minister of Economy, nearshoring is an important economic driver. How do you see the nearshoring trend, what will it bring to Mexico, and how will you contribute?
GS: Nearshoring will bring strategic attention and regulatory accompaniment normally necessary for companies entering highly regulated markets such as the United States. There have been two big changes for Mexico:
- The interest comes directly from the source –the US. The aligned entities (the FDA, COFEPRIS, USDA, the Secretaria de Economia, and Secretaria de Relaciones Exteriores) prepare the road for Mexican companies to achieve access to the market successfully.
- A market change; specific incentives within the Trade Agreement make it easier for Mexican companies to supply health inputs to the US than Asian companies.
EF: Last time we spoke, you were opening new avenues for the company in vaccines and establishing Carnot as a leader in CNS and neuropsychiatrists. How has this progressed and evolved?
GS: We are delighted with our results in both new therapeutic areas. Regarding vaccines, we have set up and organized the infrastructure through the CanSino partnership to fill and finish the Covid vaccine locally. We have submitted it for approval and hope to receive a positive response whenever the government deems it appropriate. Once this happens, we will be well positioned as one of the few Mexican companies with locally manufactured, domestically consumed vaccines. Our platform will allow us to export vaccines throughout Latin America. We have signed agreements that will soon be made public with an additional vaccine developer to give us access to other products currently supplied only by very few multinational companies. We are happy to bring a locally manufactured vaccine to the market. Our portfolio strengthens as we seek alliances with good vaccine developers and become their regional industrial and commercial arms.
EF: Do you think Mexico has the potential to become an innovation hub at a Latin American level?
GS: Regarding CNS, we have developed a pipeline of innovative products, developed in-house and patented, launched at the beginning of 2022. We were delighted by the great reception from psychiatrists and neurologists to innovation generated in Mexico. Our innovation makes the treatments more accurate and effective and has better compliance. Since launching this line, we have had incredible results and an over-performance of our sales expectations. It is confirmation that innovative, patented products developed in Mexico can be extremely successful and is a platform for growth for the companies participating in this market. We will soon roll out the central nervous system line to Latin America and other markets while looking for partners interested in licensing these technologies and taking them to other markets. An example of these technologies is our micro orodispersible tablets of Clonazepam that behave effectively as a solution but have the solid´s precision, avoiding overdosages in patients.
EF: When we last spoke, you mentioned the need for collaboration and trust between sectors. How can greater cooperation and trust be promoted within the healthcare sector to advance the industry?
GS: The regulatory environment for innovative products has higher standards as regulations evolve, meaning the products take longer to develop and be more expensive when they finally access the market. We have to capitalize on multiple markets for a significant return on investment in innovative products. The most efficient way of capitalizing is through small bilateral agreements. The agreements between government agencies, particularly health regulatory agencies, are critical for the multilateral approach. The work done in one country can be homologated with another country's approval standards, streamlining the development process for it to be approved in more than one place in a shorter time. Homologizing the requirements, standards, and plants to specific world norms, the WHO norms, for instance, can be very helpful. Mexico and everywhere to the South look to this sort of homologation with WHO. The FDA has always been reticent to homologate with other regulatory agencies, they are their reference, but I still think there is a lot of opportunity and desire in the FDA for companies in different markets to understand and meet FDA requirements. There is an openness to help companies and supply them with the requirements to reach the FDA standards. The help might be, in some cases, government to companies and government to government in others. It is a matter of having similar standards everywhere to allow for quicker development of products.
EF: Regarding women's health, is there anything new and exciting in your portfolio for 2023?
GS: Women's health has historically been an underserved market; it has significant unmet needs that are not yet filled. Considering this, we have a drug diagnosis combo development program for endometriosis, an important unmet need in women's health. There is no good way to diagnose endometriosis un-invasively, so we are working on an earlier, more accurate, and less invasive method. The hormonal treatment also tends to be quite aggressive and not optimal for the woman obliged to take it, so we are developing non-hormonal endometriosis targets to give women and physicians a more amenable treatment alternative. Gastroenterology is the other therapeutic area where interesting things are happening. We are launching KI-CAB, the first potassium-competitive acid blocker for the Latin American market. It will be available in pharmacies all over Latin America in the next couple of months. We expect it to quickly become one of the larger products in the Gastro category and are delighted to bring it to patients and physicians in Latin America.
EF: If you had to create a startup in the health sector in Mexico tomorrow, what would you generate and why? Where do the opportunities lie?
GS: I would create a bridge between academia and the industry. I would create the infrastructure that would encourage small startups, the National Institute of Health, the Mexican universities, or the CONACIT centers to bring forward their great developments early to partner with commercial companies. I am unsure what shape it would take; it could be a CDMO (contract development manufacturing organization), a wet lab, or something along those lines. There is much value currently lost, and this would be a project I would like to do.
EF: What would be your three base pillars if you had to create a "Road Map to the Future" for the Latin American healthcare industry?
GS: I would first take a step back to lessons learned, take in the Covid experience, and figure out what infrastructure is essential for each country. My main pillar would be to ensure the necessary infrastructure is central, strategic, and protected because basics must be covered -they are not necessarily covered in Latin America. For example, we are just restarting in the vaccine field, which should be the pillar for necessary infrastructure. My second pillar would be international connections (multilateralism), having the appropriate international trade and regulatory links for trade. For Mexico, this would mean continue consolidating what has been happening in Latin America and significantly expanding at a NAFTA level. The third pillar would be innovation for the next twenty years, not for today. We don't want Mexico to become a contract manufacturer for foreign technology but to have the necessary innovation platforms allowing Mexican innovation to be brought forward. Foreign innovation should be brought into the country, adopted, assimilated, and improved. These three road map pillars would ensure the current requirements and safety be met, take advantage of opportunities and possibilities to expand, and prepare to succeed.