Colombia- Latin America's Life Sciences Innovation Star

Colombia: Latin America's Life Sciences Innovation Star

Colombia, strategically located close to the US and on the same EST time zone, offers many strengths for medical device trials: It is the third-most populous country in Latin America, after Mexico and Brazil, and it's considered the most urbanized Latin American nation. Nearly 89% of its 50 million people live in big cities, it has good clinical practice guidance and over 120 hospitals licensed to run trials —trials in Colombia have been conducted for almost 30 years, and it receives about 120 annual trials, making it one of the leaders in the Latin America region. It has a centralized healthcare system that draws patients with particular needs to specialized or regional hospitals, which can help speed patient recruitment. A large number of experienced investigators working in certified sites means fewer concerns about generating high-quality data. Also, treatment-naive populations are plentiful. Strong doctor-patient relationships support high trial recruitment rates and low dropout rates. Furthermore, prices for hospital procedures in Colombia are considered to be about 30 lower than costs in the US and Europe. We recognized that development stage medtech and biotech startups struggle to find highly talented medical staff that will give them the focus and energy to complete, on a timely manner, quality, ethical clinical research at a very competitive cost. We recognized that clinical research sites in Colombia have had very little international exposure and have been unknown to the global medtech and biotech industry. These are highly qualified sites that receive a significant volume of trials sponsored mainly by the local Colombian subsidiaries of multinational pharmaceutical companies (e.g. Johnson & Johnson, Novartis, Roche, Pfizer, Sanofi, Merck, etc.). These sites are staffed by experienced and highly trained personnel and can be made available to the medtech and biotech industry.…

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Please watch the "Invest in Colombia" official video: https://www.youtube.com/watch?v=hXNApf5_FDE Why Colombia: http://www.investincolombia.com.co/why-colombia.html Colombia, Latin America’s New Silicon Valley: CNN Money (http://www.investincolombia.com.co/news/788-colombia-latin-america-s-new-silicon-valley-cnn-money.html) Colombia, Among the Top Foreign Investor Destinations: Fortune (http://www.investincolombia.com.co/news/778-colombia-among-the-top-foreign-investor-destinations-fortune.html) Colombia will continue to grow at a higher rate than the rest of the region in 2015: IMF (http://www.investincolombia.com.co/news/781-colombia-will-continue-to-grow-at-a-higher-rate-than-the-rest-of-the-region-in-2015-imf.html)

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Colombia Country Commercial Guide: http://www.export.gov/colombia/marketresearchoncolombia/countrycommercialguide/index.asp Market Overview The Republic of Colombia is the fourth largest economy in Latin America, after Brazil, Mexico, and Argentina, and has the third largest population with approximately 46 million inhabitants. It is the only country in South America with two coasts (Pacific and Caribbean), which provides tactical shipping advantages in today’s global economy. Aided by major security improvements, steady economic growth, and moderate inflation, Colombia has become a free market economy with major commercial and investment ties to the United States, Europe, Asia and the rest of Latin America. Since the implementation of the U.S.-Colombia Free Trade Agreement (FTA) on May 15, 2012, U.S. exports to Colombia have increased nearly twenty percent. Nevertheless, Colombia may be a far different country than many U.S. exporters expect. In fact, the past ten years have brought extraordinary change to the country in terms of economic development due to improvements in the national safety and security situation. Strong political stability, a growing middle class (35.3 percent of the population), and improved security have created an economic boom in Colombia that, coupled with the government’s conservative fiscal policies, lessened the impact of the global economic crisis. Key economic indicators demonstrating the positive long-term effect of Colombia’s political and economic policies include: GDP growth of 4.3 percent in 2013; and foreign direct investment of US$ 16.8 billion in 2013, a record for…

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Colombia Country Commercial Guide: http://www.export.gov/colombia/marketresearchoncolombia/countrycommercialguide/index.asp

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Keraderm: http://www.innpulsacolombia.com/en/portafolio-de-empresas/keraderm Jorge Reynolds Pombo: http://en.wikipedia.org/wiki/Jorge_Reynolds_Pombo Salomón Hakim: http://en.wikipedia.org/wiki/Salom%C3%B3n_Hakim Manuel Patarroyo: http://en.wikipedia.org/wiki/Manuel_Elkin_Patarroyo

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Ultrachopper: A New Way to Divide the Nucleus (http://crstodayeurope.com/2007/03/0307_08.php)

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Read more here: http://www.wsj.com/articles/in-battle-against-alzheimers-heres-ground-zero-1430127182#livefyre-comment

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The "Update" section and the Strategy Development/Clinical Strategy chapter are profiling our work to make Colombia the top choice for early-stage clinical trials. This book was inspired by the world-renowned Stanford University's Biodesign program and was written by Paul Yock, MD, director of Biodesign, and one of the most respected authorities in the industry and other collaborators.

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Read more about Colombia as a top destination for clinical trials here: http://interventionalconcepts.net/colombia/

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Colombia offers generous incentives for life sciences startups to conduct R&D and clinical trials: A tax deduction of 175% of the invested amount, over $150 million available for grants and more. Read more here: http://goo.gl/gWZAdi

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The National Institute of Drugs and Food Vigilance, or INVIMA, has instilled requirements to ensure patient protection and data quality. Colombian research sites must be audited and certified by INVIMA, and that requires GCP certification. Colombia’s regulators are quick as well. Even with its stringent requirements, the country still manages to generate some of the shortest regulatory approval and importation times in the region, averaging 30 days for medical devices —and 90 days for pharma.

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Interventional Concepts, Inc. is a clinical development and consulting firm; we focus on helping highly innovative biopharmaceutical and medical device companies bring their life-changing developments from initial strategy through clinical development to market. We help innovative Medtech startups reach their clinical development and research goals by providing clinical consulting services and by partnering them with clinical research sites in Colombia, South America. We have partnered with the Colombian government to bring to Colombia early-stage innovative medical device and biopharma companies in US, Europe, and Asia to conduct their trials at the over 120 government-CGP-certified centers in Colombia (please read the official press release: http://www.colombia.co/en/exports/colombia-promotes-destination-clinical-research.html). Our services include protocol design, first-in-man or early stage trial strategy, site selection, regulatory submission, importation & logistical material storage and distribution to sites, trial management, post-trial national sanitary registration and local commercialization assistance, etc. Please download our detailed slidedoc at http://interventionalconcepts.net/s/Interventional-Concepts_slidedoc_Jan-9-2015.pdf. Why we do it: We believe that Colombia represents an untapped opportunity for startup medical device and biopharma companies to conduct cost-effective, quality and ethical early-stage clinical trials —with the same quality standards that they would find in the U.S. or Europe — and to market their innovations to a population of almost 50 million.

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Pedro Martinez-Clark is a world-renowned interventional cardiologist based out of Miami, Florida. Having earned his medical degree at Colombia’s acclaimed Universidad del Norte in the city of Barranquilla, Pedro travelled to Ohio’s Case Western Reserve University to begin his post-graduate medical training in Internal Medicine. Having excelled and made a name for himself in the northeast, Dr. Martinez-Clark placed into one of the United States’ most competitive Clinical Fellowships in Cardiovascular Disease (Cardiology), at Beth Israel Deaconess Medical Center, Harvard Medical School. At Harvard, Pedro further subspecialized with one year of training in Interventional Cardiology, adding a second year in Endovascular Therapies and Vascular Medicine. It would be no surprise that Pedro would become recognized, globally for his research in structural heart valve disease, his true passion. During Dr. Martinez-Clark’s final years at Harvard, he earned the respect and admiration of his colleagues for his passion for interventional cardiology and clinical research. Having succeeded in both private practice and large academic institutions, Pedro began authoring and acting as co-investigator on numerous clinical trials. His experiences culminated on the salient PARTNER Trial (Placement of Aortic Transcatheter Valves Therapies) with supervision by leading interventional cardiologist Dr. William O’Neill. Pedro has also worked on the PROTECT (drug eluting stent) and PROTECT II (mechanical support device) trials among many others. These clinical trials have led to the approval of two of the most important technological breakthroughs currently used in the United States. Furthermore, Dr. Martinez-Clark has authored numerous juried and indexed journal publications, furthering his colleagues’ understanding of structural and valvular heart disease around the world. He has also co-authored a Hurst medical textbook…

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Dr. Pedro Martinez-Clark recently worked with Dr. Antonio Dager’s team in Cali to develop a novel retrograde caval-aortic approach in a subgroup of inoperable patients with severe aortic stenosis (please see here: https://goo.gl/pZ9yRi). This abstract won the "Best of the Best Abstract Award" of 2014 at the annual event for the Society of Cardiovascular Angiography and Interventions (SCAI). Dr. Martinez-Clark is currently working on developing a special closure device through a medical device incubator that he has created (www.miamimedtech.com.

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Interventional Concepts, Inc. is well positioned to lead you through your clinical path to ensure successful clinical trials for your innovation. We pride ourselves on providing Medtech companies with a comprehensive portfolio of services. 1. Pre-clinical animal research, cadaver and animal medical device training 2. First-in-human studies, medical device and biopharmaceutical feasibility trials, phase I-IV trials 3. Regulatory submissions 4. Project feasibility assessments 5. Protocol design and review 6. Study management 7. Study monitoring 8. Pharmacovigilance…

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Clients such as the University of Miami (DirectFlow Medical, NeuroTronik), Mitralign, Roxwood Medical, InterValve, Avinger, CeloNova BioSciences, Syntheon Medical, MitraSpan, Kona Medical, among others, have trusted us with their clinical trials in Colombia.

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Avinger, Inc. customer testimonial: https://vimeo.com/77175820 Dr. John B. Simpson, CEO of Avinger, Inc., speaks about Avinger's satisfactory experience while conducting OCT guided atherectomy clinical research at Interventional Concepts, Inc.'s affiliated research site in Cali, Colombia.

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Colombia's vision for 2025 is to become the third most innovative country in Latin America. Read more: http://goo.gl/gWZAdi

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Colombia- Latin America's Life Sciences Innovation Star

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