Why Gene Therapy Companies like Libella Gene Therapeutics are Looking at Colombia for their Clinical Trials?
The approval of a gene therapy clinical trial in Colombia takes about 30 days or less from the date of submission to a hospital IRB. This positions Colombia as one of the countries with the fastest approval time in Latin America for gene therapy research.
“Traditional clinical trials in the US can take years and millions, or even billions, of dollars. The research and techniques that have been proven to work are ready now.”
Libella Gene Therapeutics —a US-based company— recently chose Colombia to conduct a phase I clinical trial that could represent a breakthrough in the treatment of age-related degenerative diseases using gene therapy. Gene therapy offers the ability to permanently correct a disease at its most basic level, the genome, and could offer cures for many conditions that are considered incurable. Unlike traditional drugs, which tend to be taken for months or years at a time, gene therapy interventions are intended to be one-off treatments that tackle a disease at its source, repairing faulty DNA and allowing the body to fix itself.
Colombia's clinical research regulation is friendly to gene therapy trials. Resolución 8430 de 1993 from the Colombian Ministry of Health regulates human research with advanced therapies (including gene therapy). Chapter 1 of the resolution states the following conditions for approval of a gene therapy clinical trial in Colombia,
The legal representative at the clinic must approve it
The institutional review board (IRB)/ethics committee (EC) at the clinic must approve it
Patients must sign an informed consent form
The approval of a gene therapy trial in Colombia takes about 30 days from the date of submission to an IRB/EC. This time may be shorter or longer depending on how fast the ethics committee at the chosen hospital evaluates the study documents. This positions Colombia as one of the countries with the fastest approval time in Latin America for gene therapy research.
In the US usually takes too long to get a clinical trial approved and and a gene therapy be made available. Many life science companies are realizing that the answer would be to manufacture it and have it administered in another country.
This is what a US company will typically need to provide to most IRBs in Colombia to get its clinical trial approved:
Research protocol
Investigator's brochure
Patient informed consent form
Case report form
“I’m in shock. The hospitals, the clinics, the high service level, the professional training, and the certifications. I am still surprised by what Colombia can offer in terms of specialized medical services.”
In terms of costs, there are essentially two rubrics to consider: Hospital and CRO costs. Hospital costs in Colombia are typically 30% less than in the US and services are provided at a superb level of quality. When the World Health Organization ranked the healthcare systems of 191 countries, Colombia came in at #22. That is better than Canada at #30 and the United States at #37. On top of this, when financial publication América Economía put together their latest annual list of Latin America’s top 58 hospitals, 23 of those hospitals were based in Colombia. That means that 40% of the top Latin American hospitals are located in Colombia.
Four of these hospitals are Joint Commission International accredited, the gold standard in world health. Two are located in Bogotá (Fundación Cardioinfantil – Instituto de Cardiología, and Hospital Universitario Fundacion Santa Fe de Bogotá), one is located in Medellín (Hospital Pablo Tobón Uribe), and one is located just outside of Bucaramanga (Fundación Cardiovascular de Colombia – Instituto del Corazón).
If your gene therapy clinical trial involves plasmapheresis, immunosuppressant drugs, isolation of the subject, an intravenous gene therapy treatment, and 10 days of hospitalization in the intensive care unit, then expect to pay about USD $30,000 per subject. This number will depend on the schedule of activities/events in your study protocol.
CRO costs are typically around $50,000 for every patient that you bring from the US to Colombia to be recruited in the trial. For a gene therapy trial, CRO costs include,
Selection of the hospital/site and the principal investigator
Coordination of the translations of the study documents
Preparation and submission of the dossier package for IRB evaluation and approval
Clinical project management of the study
Study monitoring
Importation of the investigational product (if applicable)
Coordination of shipping blood samples to the US or other countries
Coordination of third party vendors (e.g., interpreter, patient transportation and accommodations, etc.)
Five US airlines provide non-stop, daily flights between Colombia and the United States: Delta (from Atlanta and New York City), United Airlines (from Houston and New York), American Airlines (from Miami and Dallas), Spirit (from Fort Lauderdale), and JetBlue (from Orlando and Fort Lauderdale). Non-U.S. airlines (Copa, LATAM, Viva Colombia) also operate on some of these routes. Colombian airline Avianca provides non-stop flights to Miami, Fort Lauderdale, Orlando, New York, Washington-Dulles, and Los Angeles. If you are a US citizen, you won't need a visa to enter Colombia and visit for up to 90 days.
bioaccess™ has established a close relationship with a hospital in Zipaquirá, Colombia to conduct gene therapy clinical trials. Zipaquirá is a town outside of Bogotá reachable by car after a 45-minute drive from Bogota's El Dorado Airport. Zipaquirá is a tourist attraction famous for its underground Salt Cathedral —considered one of the most notable achievements of Colombian architecture— and its colonial Spanish architecture. There are plenty of hotel choices in the area including a five-star hotel called Clarion Sabana Park.
Colombia is a hidden gem for gene therapy clinical trials. The approval of a gene therapy clinical trial in the US can take millions of dollars and several years to get started. US companies developing gene therapies can quickly, ethically, and cost-efficiently conduct their trials in Colombia. Read more about clinical trials in Colombia in our FAQ. Contact us at info@bioaccessla.com for more information about how you could conduct your gene therapy clinical trial in Colombia.