Fabiola Fajardo
Strategic Consultant
Alitea Life Science Consulting
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Lilia Leon-Moreno
Regulatory Affairs and Compliance
Alitea Life Science Consulting
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Clinical Support for Successful Startup Market Positioning

By Miriam Bello | Wed, 09/01/2021 - 12:50

Q: How does Alitea Consulting contribute to the Mexican digital health ecosystem?

FF: We founded the company after recognizing the problems startups faced in escalating their products to the market, especially the lack of clinical support necessary to obtain regulatory approval. Alitea capitalizes on our team’s vast expertise in R&D and our multidisciplinary approach. We offer biostatistics services, R&D for clinical or pre-clinical projects and guidance on regulatory requirements. Our main targets are tech-based startups looking for clinical support for their developments but we also work with independent researchers who wish to shine a light on their clinical findings.

Our clinical trial management and execution services have been used in phase 3 and 4 clinical trials at hospitals in Guadalajara. We were also consultants in the validation of a medical device created by a Jalisco-based medical research center and we are working on the integration of two radiomic machines for the therapeutic evaluation of cancer patients.

LLM: From a regulatory perspective, we have mentored private laboratories, especially in the introduction of new treatments. At Alitea, we are experts on COFEPRIS’ regulatory requirements so we can help companies get their developments approved. COFEPRIS needs to expand its evaluation capacities to identify and respond to entrepreneurial projects that offer added value for the local population. One effective way to achieve this could be through the active participation of entrepreneurs and the overall industry to foment an environment of innovation and technology.

Mexico’s regulation also has gaps and ambiguities that allow the entrance of fraudulent products that are not supported by science. This creates a large barrier to the introduction of evidence-based technology and can result in Mexico losing the opportunity to incorporate valuable health solutions. Other agencies, such as the FDA, have well-defined protocols.

Q: How did the pandemic increase the appeal of new digital solutions and what challenges are these facing in terms of regulation?

FF: Tech companies saw an exponential boost during the COVID-19 pandemic, leading to investment in startup projects. The implementation and adoption of digitalization would not have happened at this speed without the pandemic. It also facilitated connectivity and allowed for collaboration among different industries. HealthX is an example of collaborative alliances that would have been difficult for us to reach before the pandemic but this group has supported our establishment and growth.

LLM: Society is also becoming more willing to adopt technology, which is changing the cultural mindset regarding the use of technology and fomenting investment in technological developments.

Q: How is Mexico situated in the medtech market compared to Latin America and the rest of the world?

FF: There are brilliant ideas in the startup ecosystem but some entrepreneurs compare their developments with those of other countries, which impacts their confidence in their projects and their potential market success. We need to raise awareness of the competitiveness of the country to carry out impactful tech projects.

Q: Alitea has placed a special focus on the Latin American population. How does this benefit clinical trials?

LL: Most clinical trials are done in the EU or the US but focusing on Mexican and Latin American populations is also important to validate their developments. Latin American countries could come together to enhance their potential as a population for clinical trials and attract investment for R&D and innovation. We want Latin America to be competitive against other global powers and, while this is a long-term vision, it is important to begin locally as soon as possible.

Q: What are Alitea’s long-term expansion goals?

FF: Our long-term goals include the promotion of personalized medicine, which we will start by integrating third-party services with our complimentary consultant offerings.

 

Alitea Life Science Consulting is a tech-based firm focused on the pharmaceutical industry and independent researchers. It offers services in clinical research and development, biostatistics and medical writing.

 

Miriam Bello Miriam Bello Journalist and Industry Analyst