Project Advisory Throughout the Healthcare Value ChainBy Miriam Bello | Fri, 01/29/2021 - 13:05
Q: How does Kiyeon Law help biopharma companies succeed in scaling research projects to reach the market?
A: We have been in the market for more than 20 years and our group is a perfect mix between executives, scientists, lawyers and engineers. This allows us to offer an integral view of the business. Our team has expertise in helping clients minimize risk, making us their one-stop shop for the different problems that they face as they grow.
Q: What is the difference between scaling projects in this country and in the US, for instance?
A: Mexico has a different environment and the needs of companies can vary depending on the industry. We have the potential to help clients create their pitch deck, one pager, interview and material needed, depending on their ticket, maturity stage or end strategy. We can also help them approach angel investors, venture capitalists, banks or private equity, either in their country of origin or around the world.
We have professionals who can locally provide services related to marketing, advertising, patents, registers, dossier filings, clinical trials, new molecules, supplements and mentoring for both health and business operations.
Q: How can Mexico’s regulatory authorities improve approval processes to boost innovation in the country?
A: Mexico has all the facilities and infrastructure needed to perform clinical trials and to grant approvals for medical devices. It is having a leading profile for performing clinical trials due to the diversity of its population. COFEPRIS is also a Rank 4 regulatory agency, which is the highest rank. This enables the country to homologate certifications to grant equivalence for imported products.
Q: How does Kiyeon Law guide clients through IP processes?
A: Mexico lacks a strong IP culture. Our firm helps our clients to understand the value of IP and its importance for their business. Companies must have the mindset of going global to scale up their business and to enter the big leagues, especially if they want to sell to pharma.
Q: What main opportunities have you identified in the cannabis market?
A: It has been said that Mexico is the biggest market for cannabis products and we believe it offers a great opportunity for business development. Legislation is different from one region to another so a crucial part of the game will be the final regulation. We have experience in filing applications in different countries for all links of the chain, from harvesting to production, delivery, storage and distribution. We are one of the few firms that has achieved this without failure in most US states.
The success of this promising market will only be possible with the right regulatory framework for recreational and medicinal use. Mexico has infrastructure and enough international interest to exploit this market but success will not materialize until our legislation is clear and logical.
A key component of the regulation is licensing to trace cannabis. Many countries have around three to five types of licenses, the most common being for planting, distributing and selling. Mexico is considering four: planting, preparation or transformation, selling and exporting.
Both startups and large companies have shown an interest in participating in this market and Kiyeon Law does can match these companies with others according to their needs. For instance, if a company wants to plant cannabis but there is a startup that does that and wants to grow, we can introduce them to each other and help both develop their interest.
Overall, Mexico is an attractive market for the health sector. However, regulatory processes can take months, which is a negative compared to other countries in Central America.
Q: How is Kiyeon Law involved in the process for clinical trials?
A: This is an area of expertise for Kiyeon Law. We manage the entire process, from CRO trials and their link to other institutions to the final result and its delivery to the sponsor company. Central and Latin America are also attractive markers for clinical trials as they have fewer barriers than Mexico.
Kiyeon Law is an investment, market and licensing firm that supports companies in developing their IP portfolio, attract investment, complete clinical trials, receive product approvals, sell products and increase market share.