Q: What added value does Parque Pharma provide?

AV: Parque Pharma is a life sciences real estate and financial platform, dedicated to improving access to new pharma-grade facilities in Mexico. The company was born to offer innovative solutions to the traditional alternatives that have been around for decades: building a new facility or purchasing an existing one. These solutions have represented a significant bottleneck for the life sciences industry, due to extremely long timelines, regulatory uncertainty, and capital intensiveness. We identified a key ​​opportunity to optimize and streamline the real estate process. The result? Fastrack delivery times, regulatory compliance guarantees, and no capital investment required by our clients. It’s a full end-to-end process, from design to GMP’s: we are responsible for each project’s execution, regulatory compliance and CapEx requirements, and deliver the plants inside a one-of-a-kind multi-tenant facility.

Our multi-tenant life sciences infrastructure, allows us to deliver turnkey facilities in four months’ time, guaranteeing regulatory compliance and doing so with zero-capital investment from our clients. We offer tailor-made solutions and have created a new model for independent life sciences manufacturing plants, under a condominium model, including for: medical devices, veterinary, supplements, cosmetics, medical cannabis, pharmaceutical and biotech.

EV: We seek to help our customers to significantly reduce the time needed to enter the market, allowing them to quickly generate cash-flow. An additional advantage to our long-term lease model, is rent payments are fully tax deductible. If a customer chooses to build and own a facility, they will have to depreciate it at a 5% annual rate, meaning a total of 20 years to achieve a full depreciation and equipment for about 10 years. With Parque Pharma, rent is 100% tax deductible.

Q: How common is it for pharmaceutical and medical device companies in Mexico to outsource services rather than build their own facilities?

AV: A critical question companies in Mexico must answer is whether to manufacture in-house or through a third-party manufacturer. It is a tough situation because both decisions come with great risks and disadvantages. On one side, there are no institutional third-party manufacturers in Mexico. CMOs have built a negative reputation in part due to missed delivery times, high prices and low quality. It is very risky to be fully dependent on a third-party. Also, CMOs have their client’s formulas and could easily begin manufacturing it without a tangible IP legal risk. 

On the other hand, to build your own facility, companies must be prepared for long lead times of several years, regulatory uncertainty, long-term ROI and taking on a highly complex project by nature. If the survival of companies in the life sciences space greatly depends on constant innovation, then how come there has been absolutely no innovation in the available alternatives to gain access to new compliant facilities? 

There are also currently many pharmaceutical companies that started operations around 50 years ago in the Mexico City metro area, and have slowly become victims of the rapid urbanization of our country. These companies now face serious problems putting their operations at risk: land use, logistics, angry neighbors, regulatory compliance and have run out of space to grow. These companies desperately need to be relocated to a proper industrial location.

This is where Parque Pharma comes in. We offer a complete solution that mitigates risks and removes the real estate obstacles that companies face. By leveraging our quick delivery times and removing capital investment needs, clients can quickly access spaces at premium locations. We also guarantee our facility’s regulatory compliance, something that no one else on the market is able to deliver.

Q: How do you ensure that tenants within the pharmaceutical plant complex maintain the confidentiality of their proprietary information and intellectual property?

EV: Each plant within our condominium is completely private and independent from one another. We sign bilateral confidentiality agreements, committing to keep all processes secret. While it is important to understand how they make their products, we do not get involved in their chemical processes and formulation. The information provided to us is kept strictly confidential and given only to those who need it to design and adapt processes. 

Q: What added advantages do your clients get regarding regulatory compliance?

AV: Our capabilities go beyond facilities and infrastructure. We have the capability to accompany clients all the way to cGMP. Our scope can include the development of the quality management system and our clients’ operational and documentation processes. We seek to shield our clients through offering an end-to-end compliance focused process. If COFEPRIS issues non-compliance warnings related to the plant, we are capable of extending our rent grace period, in order for us to solve any issues. The grace period does not start until we deliver a fully equipped plant, which is a unique and valued differentiator. In addition, we complement our services with our consulting arm, Parque Pharma Consulting. 

Q: What are the main obstacles for Mexico to evolve its production practices to manufacture biotechnology medicines and eventually personalized therapies?

AV: Talent drain is a real issue Mexico suffers from due to the lack of infrastructure, available capital, and the proper incentives. There are limited available facilities for entrepreneurs and scientists for the R&D stage but the scaling stage is where most projects fail. We are trying to generate interest among certain institutions to build infrastructure with fully equipped spaces or laboratories that are leased through memberships or short-term rentals. This would be like the WeWork model, allowing entrepreneurs, university students and researchers to gain easy access to the correct infrastructure needed to scale their projects. We are in talks with different companies, such as Sartorius and Thermo Fisher Scientific, to jointly create this ecosystem.

EV: Regulation also slows down new products from entering the market, as it is necessary to guarantee their efficacy and safety. We want COFEPRIS to be confident about how Parque Pharma designs and builds these spaces to speed up the introduction of biotechnology products to the Mexican market.

Q: How does Parque Pharma support the attraction of foreign direct investment in Mexico?

AV: Parque Pharma Consulting serves as an end-to-end platform for soft-landing services, ranging from regulatory consulting to the development of a strategy to enter the market. We also develop communication channels with chambers of commerce, embassies, and health science associations in other countries. Mexico has a unique opportunity in nearshoring. The country could also benefit from reintroducing the requirement to have a plant in Mexico to sell products, as this requirement would give the country the opportunity to become a manufacturing and R&D hub. 

Q: How necessary is it for Mexico to continue pushing for the homologation of regulatory standards across countries?

EV: Homologation is key and significant progress has been made, as COFEPRIS is already recognized by other regulatory agencies. COFEPRIS has taken many steps forward but what worries the private sector is the lack of transparency. By strengthening transparency and trust between businesses, regulatory agencies, and academia, it will be possible to offer the best therapies and guarantee universal access to healthcare. Mexico also has a large opportunity in clinical trials thanks to its large population and talent to carry out these clinical therapies. But COFEPRIS needs to step up and establish the rules that allow more clinical trials to be based in Mexico to facilitate timely access to cutting-edge therapies. 

Q: What are Parque Pharma’s main objectives for 2023?

AV: We want to reach 100% occupancy in our facility located inside of Toluca 2000 and start planning our next developments. Parque Pharma is a valuable company for the life sciences industries because no other company is working to create solutions that improve access to new pharma-grade infrastructure.

Parque Pharma is the only real estate and financial life sciences platform in Mexico, focused on improving access to pharmaceutical-grade facilities through innovative end-to-end solutions.The Company currently operates the only life sciences condominium in Mexico, where it delivers turnkey, compliant, modular facilities, in record times and under long-term lease agreements, with common areas and shared services. Parque Pharma is the only real estate and financial life sciences platform in Mexico, focused on improving access to pharmaceutical-grade facilities through innovative end-to-end solutions.The Company currently operates the only life sciences condominium in Mexico, where it delivers turnkey, compliant, modular facilities, in record times and under long-term lease agreements, with common areas and shared services.