An interview with Jorge Estrella,M.D., President and Medical Director by Senior Editor of Centerwatch Sarah Gambril

An interview with Jorge Estrella, MD, president and medical director

Profile: Contract Research Organization ESTERN Medical, Cambridge, Mass.

How and why was ESTERN Medical founded?

When I was working as the director of clinical development for a sponsor company here in Cambridge, I would think about where drug development could expand. I wanted to start a company that could provide full contract research organization services to pharma, biotech and device companies in regions that had the regulatory framework to allow clinical research to grow. The main focus of ESTERN Medical is emerging regions. I put a senior management team together from pharma, biotech and device companies who have experience not only at the operations level but also in the regulatory arena both in the U.S. and in emerging markets. We established a company based in the U.S. and at the same time we incorporated in Mexico. We started growing into Mexico with the U.S. office providing business development and company strategy. Mexico was the platform on which we grew in Latin America.We now have offices also in Colombia and Chile, and we provide services in 21 Latin American countries. The main countries we focus on are Mexico, Colombia, Chile, Venezuela, Brazil, Peru and Argentina. We have worked with physicians in diverse therapeutic specialties, including cardiovascular, central nervous system, gastroenterology, oncology, ophthalmology and respiratory and many others, for both drugs and devices.We have a database of 535 clinical centers across Latin America.We can provide services to clients that are tailored to the needs of their clinical trial.When we have an oncology clinical trial, we can specify the clinical centers of excellence, meaning those centers that have had successful audits, can execute clinical trials promptly and where the key opinion leaders are.

What differentiates ESTERN Medical from other CROs operating in Latin America?

What differentiates ESTERN Medical is that our management team has a strong track record of successful clinical trial conduct on a global basis. We have worked in the U.S., Europe, Latin America and Asia, so we understand the various aspects of the regulatory requirements in all those regions, what the clients’ needs will be and also the resources required for any given clinical trial.All the people we hire have a similar strong knowledge with a proven track record.

What are the challenges that you face?

One of the main challenges is often the client company’s lack of experience in emerging regions. For example, in Latin America, the regulatory timelines vary, depending on the country. I had a client who didn’t understand that Latin America has one regulatory agency per country, independent of each other and with their own laws. I had to explain that some Latin American countries’ regulatory approval timelines were faster than others’. Regulatory timelines can be an advantage or a disadvantage, depending on which Latin American country you want to conduct a clinical trial in. For example, many clients want to conduct clinical research in Brazil, but I have to tell them first that it will take six to eight months to get regulatory approval. If that’s okay with them, then we can do it.

What are your plans for growth?

We are beginning a collaboration that allows us to offer services in Eastern European countries as well as a partnership in India.We do not plan to open any offices in those regions because our partnerships will be sufficient. In Latin America, we plan to open one office each in Argentina, Venezuela and Peru within the next one or two years. In the next three years, we plan to open an office in Brazil. In all the countries we work in, we are able to offer all our clients services that are tailored to their needs.We grow with our clients, and they grow with us.

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