Read the Conversation
Meeting highlights:
- Mexico's Pharma Potential: Strong pharmaceutical clusters in Guadalajara and Baja California.
- Proximity to the U.S. supports supply chain resilience and reduces dependency on China and India.
- 2025 Priorities: Strengthening COFEPRIS and international regulatory links (e.g., FDA, USP).
- Expanding exports to Latin America and U.S. markets. Advancing biotechnology, biosimilars, and API production.
- AI Integration: Streamlining supply chains, regulatory processes, and documentation.The urgency to adopt AI to remain competitive and drive innovation.
- Workforce Development: Collaborating with universities for specialized training programs.
- Recognizing and empowering women dominating regulatory roles in labs.
- Collaborative Leadership: Transparent dialogue with government fostering industry growth.
EF: If you were attending the JP Morgan Healthcare Conference as an ambassador for Amelaf, what message would you deliver? Why would investing $1 in Mexico's local pharmaceutical companies offer greater value than anywhere else?
JV: Mexico has a strong foundation in the pharmaceutical industry. While the concept of local pharma as a competitive player may seem new, many companies here boast a tradition spanning over 70 years. This growth has occurred organically, particularly in Guadalajara, which is home to the largest pharmaceutical cluster in Latin America and one of the largest globally. Additionally, there is another promising cluster in Baja California near Tijuana, offering unique opportunities for collaboration with the United States, especially California.
On one side, Mexico benefits from a well-qualified workforce and a robust local market, which ranks as the 12th largest in the world. On the other, it shares a border with the United States, the largest pharmaceutical market globally, accounting for 48% of the world market. Europe represents about 25%, but the U.S. increasingly seeks to reduce dependence on China and India, particularly China.
This creates an exciting opportunity for Mexico to complement the U.S. market rather than compete with it. Mexico is well-positioned to focus on both finished products and expanding its capabilities in API production for North America. This shift can help address supply chain vulnerabilities and reduce dependency on Asia, a lesson emphasized by recent challenges in global supply chain resilience.
With strong leadership under Dr. Kershenobich as the Secretary of Health and a skilled, technically focused Commissioner at COFEPRIS, Mexico is moving in a positive direction. The conditions are aligned for Mexico to solidify its role as a key player in the pharmaceutical industry, complementing North American needs while leveraging its unique strengths.
The pharmaceutical industry moves at a slow and steady pace; progress does not happen overnight. However, the current trajectory is undeniably positive. There is significant potential not only for growth but also for building stronger alliances with established Mexican companies that have been part of the industry for decades. Rather than focusing solely on standalone investments, forming partnerships with local players can enhance the supply chain in Mexico.
Dr. Kershenobich stands out not only for his strong expertise in his field but also for his willingness to listen. He has opened a dialogue with the industry, something we lacked in the past. This open communication has already been evident; we had a productive meeting with him a couple of weeks ago, and we have established a plan for regular discussions every six weeks to address various issues. Dr. Kershenobich is committed to promoting the Mexican pharmaceutical industry, recognizing its importance. For example, within AMELAF alone, there are approximately 60,000 direct employees, the majority of whom are women. His openness fosters a positive and transparent atmosphere that is invaluable for the industry’s growth.
Similarly, our discussions with COFEPRIS are becoming more technical and focused, further enhancing collaboration. This environment of constructive communication and dialogue with the government is highly encouraging and sets the stage for meaningful progress.
EF: What are your top priorities for 2025?
JV: The top priority on our agenda is strengthening Mexico's regulatory framework, particularly through improvements to COFEPRIS. There are numerous opportunities in this area, and we are eager to collaborate and provide meaningful input. For AMELAF, expanding the international presence of Mexican pharmaceutical products is equally important. Our focus is on potential export markets, starting with neighboring countries USA, Guatemala and El Salvador, as well as larger markets like Colombia, which has 50 million people.
We are also working on commercial and regulatory connections in the United States, a process we began two years ago. This includes dialogue with agencies like the FDA and other government departments. AMELAF has joined the United States Pharmacopeia (USP), and I will serve on its board starting this May. We have initiated workshops with USP to guide Mexican laboratories in obtaining FDA approvals, an essential step for entering the U.S. market.
A few Mexican laboratories are already dedicated exclusively to API manufacturing. We are identifying strategic APIs needed for the North American market, with plans to expand these efforts to South America. AMELAF has fostered strong ties with ALIFAR, the Latin American Association of Pharmaceutical Manufacturers, which represents local companies in the region. We see exciting opportunities for collaboration with countries like Argentina, Colombia, and Brazil, especially in reducing reliance on APIs from India and China to enhance supply chain resilience.
Improving the local supply chain in Mexico is another significant challenge. We have created a platform within AMELAF to identify and strengthen local suppliers. Additionally, biotechnology and biosimilars are growing areas of focus, with 8 or 9 Mexican laboratories already involved in biosimilar production.
Artificial intelligence (AI) presents a unique opportunity for the Mexican pharmaceutical sector. While distinct from its applications in Big Pharma, we are working with leading AI firms to identify specific areas where AI can provide value to local laboratories. This includes improving regulatory processes, streamlining government medicine supply, and enhancing payment systems. Digitalization is another priority, especially in addressing paper-based inefficiencies within regulatory and administrative workflows.
We have a strong ally in Undersecretary Eduardo Clark, a forward-thinking young leader with expertise in digital transformation. His vision aligns with our goals for modernizing the sector, from digitalizing government processes to integrating AI into regulatory and supply chain systems. The potential is immense, and while we remain pragmatic, the path forward is promising.
We have assembled a small group of five laboratories to explore opportunities in artificial intelligence (AI). From this foundation, we plan to develop a program to leverage the new possibilities AI offers. When combined with biosimilars, AI creates a synergy akin to mixing milk with cocoa—it is a perfect blend that holds immense potential. We are not merely addressing current challenges but are also thinking ahead, focusing on innovation and preparation for the future.
A critical part of this forward-thinking approach is strengthening human resources. We are collaborating with universities to ensure a steady pipeline of qualified professionals ready to contribute to the pharmaceutical sector. Currently, graduates, such as those in biochemical or pharmaceutical sciences, often take up to eight years to become fully productive in the field.
To address this, we are proposing specialized courses in areas like regulatory affairs. These programs would prepare students to enter the workforce with practical skills, allowing them to contribute immediately. By bridging the gap between academia and industry, we aim to build a highly skilled workforce that can meet the sector's evolving needs.
This focus on human resources, coupled with our efforts in AI and biosimilars, sets the stage for a stronger and more innovative pharmaceutical industry in Mexico. We see tremendous potential and are committed to ensuring that all aspects of the ecosystem are aligned for success. Artificial intelligence (AI) is extremely important and holds significant potential for the pharmaceutical sector. At AMELAF, our goal is to identify areas where AI can provide the most value, starting with solutions that are universally beneficial across laboratories.
For instance, one critical area we have identified is improving documentation processes. AI can streamline the generation of production reports, manage inventories, and optimize the supply chain. Additionally, integrating AI with COFEPRIS systems can enhance regulatory compliance and documentation security, minimizing risks associated with errors or delays.
While there are common challenges and opportunities shared by all labs, each laboratory will eventually need its own tailored program to meet specific needs. However, it is critical to demonstrate the return on investment for these initiatives. Laboratories that do not adopt AI will face significant setbacks in terms of competitiveness.
The pace of change in the industry is accelerating. Within three years, the landscape will look entirely different, and those who fail to embrace AI will struggle to keep up. Linking AI adoption to long-term industry trends like biosimilars is essential to future-proof the sector and maintain global competitiveness.
I attended a conference by a specialist who compared the current state of biotechnology to where electronics was in 1975. He emphasized that we are on the brink of a transformative era, akin to the pre-Walkman period for consumer electronics.
To illustrate the scale of progress, I gave a presentation highlighting this point. For example, back then, the best personal computers could handle memory equivalent to about one liter of water. In contrast, today’s iPhones, with one terabyte of storage, can handle the equivalent of eight swimming pools of memory—without even considering the incredible advancements in processing speed. This comparison underscores how dramatically the field is poised to evolve, and it is clear that the impact of biotechnology will be nothing short of revolutionary.
EF: If artificial intelligence democratizes access to intelligence, providing everyone with the equivalent of eight swimming pools of knowledge through a device like an iPhone, what will define individual value? Where will value lie in a world where intelligence becomes universally accessible?
JV: The key factor in this AI-driven world will be the integrity and quality of the data fueling these systems. If those eight swimming pools are filled with contaminated water, the entire system's output is compromised. Ensuring the accuracy, reliability, and trustworthiness of data will be a monumental challenge. Beyond that, the sheer volume of information will demand sophisticated methods to process and analyze it effectively. It mirrors today's media landscape, where discerning trustworthy sources amid an overload of information is an ongoing struggle.
Artificial intelligence will undoubtedly be transformative, but it’s no panacea. It demands strategic and responsible application, as misuse could lead to significant risks. We’re already witnessing rapid advancements, and by 2025, the landscape will look entirely different, requiring us to act decisively now.
On a personal note, I’ve always been passionate about technology, even as a lawyer. Back in 1998, as Mexico’s Commissioner of Patents and Trademarks, I led the implementation of the country’s first internet-based system for checking trademarks. In collaboration with the United Nations, we introduced a program that, while primitive by today’s standards, was groundbreaking for leveraging the Internet in official procedures. Progress takes time, but we must continually think ahead to harness the potential of technology effectively.
EF: Could you elaborate on why you consider “MujerFarma” important and relevant for AMELAF, and what priorities are currently on the group's agenda?
JV: The agenda we are currently building focuses on several key priorities. Firstly, it is about recognition. Among our team, we have eight lab owners who are also CEOs, along with an overwhelming majority—around 90%—of the regulatory and quality control staff being women.
When I presented this to the board about a year and a half or two years ago, one member commented, "Do you know why we have so many women in these roles?" The answer was simple: it is not about quotas; they excel at what they do. Many of these women come from modest family backgrounds, attended public universities, and are now the stars of their families.
For instance, while some of their siblings might earn a fraction of their income—perhaps driving taxis—these women are earning around $1,500 a month and serving as role models in their families. We aim to honor their contributions by giving them recognition and awards. Beyond recognition, we are focusing on providing ongoing training and addressing critical workplace issues. For example, laboratories operate 24/7 so we need to prioritize safety, respect, and other aspects of workplace culture.
The goal is to encourage these women to continue growing and preparing themselves professionally, creating a win-win scenario for everyone involved. This recognition will not only empower them within their families and social circles but also foster greater commitment and motivation to excel.
