Bienvenidos a Ciencia en Canoa, una iniciativa creada por
Vanessa Restrepo Schild.

lunes, 20 de octubre de 2014

'Green' solar cell is made from plants

To make super cheap solar cells, MIT researchers look to commandeer the process of photosynthesis in plants.

In a mashup of biology and electronics, researchers said they've made progress in making low-cost solar cell from plants.

A paper published in Scientific Reports today describes an improved method for making electricity-producing "biophotovoltaics" without the sophisticated laboratory equipment previously needed. Researchers said custom-designed chemicals could be mixed with green plants, even grass clippings, to create a photovoltaic material by harnessing photosynthesis.

"Take that bag (of chemicals), mix it with anything green and paint it on the roof," said MIT researcher Andreas Mershin, who is one of the paper's co-authors, in a statement. He imagines that this sort of cheap solar cell could be used by people in developing countries who don't have the power grid to charge lamps or cell phones.

The advance represents a 10,000 percent efficiency improvement on previous plant-based solar cells, but these cells are far from being practical. Experimental solar cells made using this process only convert 0.1 percent of sunlight to electricity, which would need to improve tenfold to be practical, Mershin said.

Scientists for years have sought to make solar cells from the set of molecules within plant cells that do the work of photosynthesis, called photosystem-I. However, this material required specialized thin-film deposition and optical equipment. And the current produced was too low.

Related stories

Mershin was able to create a workable solar cell made using a combination of new materials that isolate the PS-I molecules and form an array of tiny zinc oxide nanowires, which carry the flow of current and provide a large surface area. These nanowires, which also provide structure for a multi-layered solar cell, can be grown at room temperature on a variety of flexible and inexpensive substrates, according to the paper.

"After many ears of research, we've managed to make the process of extracting this protein and stabilizing it and putting on a surface that is made in a way to allow for the photovoltaic effect to happen to be very easy," he said in a video provided by MIT.

In their paper, the researchers note a number of challenges to these "green" solar cells, including the durability and efficiency. But the initial performance tests for this new technique offers a promising route for further research, they said. "Commandeering this intricately organized photosynthetic nanocircuitry and re-wiring it to produce electricity carries the promise of inexpensive and environmentally friendly solar power," according to the paper.

February 2, 2012 7:52 AM PST

Machine-Learning Maestro Michael Jordan on the Delusions of Big Data and Other Huge Engineering Efforts

Big-data boondoggles and brain-inspired chips are just two of the things we’re really getting wrong

Photo-Illustration: Randi Klett

The overeager adoption of big data is likely to result in catastrophes of analysis comparable to a national epidemic of collapsing bridges. 
Hardware designers creating chips based on the human brain are engaged in a faith-based undertaking likely to prove a fool’s errand. 
Despite recent claims to the contrary, we are no further along with computer vision than we were with physics when Isaac Newton sat under his apple tree.

Those may sound like the Luddite ravings of a crackpot who breached security at an IEEE conference. In fact, the opinions belong to IEEE Fellow Michael I. Jordan, Pehong Chen Distinguished Professor at the University of California, Berkeley. Jordan is one of the world’s most respected authorities on machine learning and an astute observer of the field. His CV would require its own massive database, and his standing in the field is such that he was chosen to write the introduction to the 2013 National Research Council report “Frontiers in Massive Data Analysis.” San Francisco writer Lee Gomes interviewed him for IEEE Spectrum on 3 October 2014.

Michael Jordan on…

1- Why We Should Stop Using Brain Metaphors When We Talk About Computing

IEEE Spectrum: I infer from your writing that you believe there’s a lot of misinformation out there about deep learning, big data, computer vision, and the like.

Michael Jordan: Well, on all academic topics there is a lot of misinformation. The media is trying to do its best to find topics that people are going to read about. Sometimes those go beyond where the achievements actually are. Specifically on the topic of deep learning, it’s largely a rebranding of neural networks, which go back to the 1980s. They actually go back to the 1960s; it seems like every 20 years there is a new wave that involves them. In the current wave, the main success story is the convolutional neural network, but that idea was already present in the previous wave. And one of the problems with both the previous wave, that has unfortunately persisted in the current wave, is that people continue to infer that something involving neuroscience is behind it, and that deep learning is taking advantage of an understanding of how the brain processes information, learns, makes decisions, or copes with large amounts of data. And that is just patently false.

Spectrum: As a member of the media, I take exception to what you just said, because it’s very often the case that academics are desperate for people to write stories about them.

Michael Jordan: Yes, it’s a partnership.

Spectrum: It’s always been my impression that when people in computer science describe how the brain works, they are making horribly reductionist statements that you would never hear from neuroscientists. You called these “cartoon models” of the brain.

Michael Jordan: I wouldn’t want to put labels on people and say that all computer scientists work one way, or all neuroscientists work another way. But it’s true that with neuroscience, it’s going to require decades or even hundreds of years to understand the deep principles. There is progress at the very lowest levels of neuroscience. But for issues of higher cognition—how we perceive, how we remember, how we act—we have no idea on
  • how neurons are storing information
  • how they are computing, 
  • what the rules are, 
  • what the algorithms are, 
  • what the representations are, and 
  • the like. 
So we are not yet in an era in which we can be using an understanding of the brain to guide us in the construction of intelligent systems.

Spectrum: In addition to criticizing cartoon models of the brain, you actually go further and criticize the whole idea of “neural realism”—the belief that just because a particular hardware or software system shares some putative characteristic of the brain, it’s going to be more intelligent. What do you think of computer scientists who say, for example, “My system is brainlike because it is massively parallel.

miércoles, 8 de octubre de 2014

Stefan Hell (Nobel Prize in Chemistry 2014): STED - Insights into the nanoworld

Ok, so do you wonder what all the fuss is about with the Chemistry Nobel Prize this year : ) -? If so, this film will do the trick & tell you all about it! A quick introduction of Max Planck researcher Stefan Hell & and his pioneering work in the field of ultra-high resolution fluorescence microscopy.

Optical microscopes cannot distinguish between objects that are closer together than about 200 nanometers – about one two hundredth of a hair's breadth. The reason for this is the wave nature of light, the half wavelength of which roughly corresponds to those 200 nanometers. The STED microscopy developed by Stefan Hell is the first optical microscope technology to go beyond this magic barrier, enabling researchers to gain fascinating insights into the nanoworld.

ORIGINAL: What's The Big Deal

lunes, 29 de septiembre de 2014

Meet Amelia: the computer that's after your job

A new artificially intelligent computer system called 'Amelia' – that can read and understand text, follow processes, solve problems and learn from experience – could replace humans in a wide range of low-level jobs

Amelia aims to answer the question, can machines think? Photo: IPsoft

In February 2011 an artificially intelligent computer system called IBM Watson astonished audiences worldwide by beating the two all-time greatest Jeopardy champions at their own game.

Thanks to its ability to apply 
  • advanced natural language processing, 
  • information retrieval, 
  • knowledge representation, 
  • automated reasoning, and 
  • machine learning technologies, Watson consistently outperformed its human opponents on the American quiz show Jeopardy.
Watson represented an important milestone in the development of artificial intelligence, but the field has been progressing rapidly – particularly with regard to natural language processing and machine learning.

In 2012, Google used 16,000 computer processors to build a simulated brain that could correctly identify cats in YouTube videos; the Kinect, which provides a 3D body-motion interface for Microsoft's Xbox, uses algorithms that emerged from artificial intelligence research, as does the iPhone's Siri virtual personal assistant.

Today a new artificial intelligence computing system has been unveiled, which promises to transform the global workforce. Named 'Amelia' after American aviator and pioneer Amelia Earhart, the system is able to shoulder the burden of often tedious and laborious tasks, allowing human co-workers to take on more creative roles.

"Watson is perhaps the best data analytics engine that exists on the planet; it is the best search engine that exists on the planet; but IBM did not set out to create a cognitive agent. It wanted to build a program that would win Jeopardy, and it did that," said Chetan Dube, chief executive Officer of IPsoft, the company behind Amelia.

"Amelia, on the other hand, started out not with the intention of winning Jeopardy, but with the pure intention of answering the question posed by Alan Turing in 1950 – can machines think?"

Amelia learns by following the same written instructions as her human colleagues, but is able to absorb information in a matter of seconds.
She understands the full meaning of what she reads rather than simply recognising individual words. This involves 
  • understanding context, 
  • applying logic and 
  • inferring implications.
When exposed to the same information as any new employee in a company, Amelia can quickly apply her knowledge to solve queries in a wide range of business processes. Just like any smart worker she learns from her colleagues and, by observing their work, she continually builds her knowledge.

While most ‘smart machines’ require humans to adapt their behaviour in order to interact with them, Amelia is intelligent enough to interact like a human herself. She speaks more than 20 languages, and her core knowledge of a process needs only to be learned once for her to be able to communicate with customers in their language.

Independently, rather than through time-intensive programming, Amelia creates her own 'process map' of the information she is given so that she can work out for herself what actions to take depending on the problem she is solving.

"Intelligence is the ability to acquire and apply knowledge. If a system claims to be intelligent, it must be able to read and understand documents, and answer questions on the basis of that. It must be able to understand processes that it observes. It must be able to solve problems based on the knowledge it has acquired. And when it cannot solve a problem, it must be capable of learning the solution through noticing how a human did it," said Dube.

IPsoft has been working on this technology for 15 years with the aim of developing a platform that does not simply mimic human thought processes but can comprehend the underlying meaning of what is communicated – just like a human.

Just as machines transformed agriculture and manufacturing, IPsoft believes that cognitive technologies will drive the next evolution of the global workforce, so that in the future companies will have digital workforces that comprise a mixture of human and virtual employees.

Amelia has already been trialled within a number of Fortune 1000 companies, in areas such as manning technology help desks, procurement processing, financial trading operations support and providing expert advice for field engineers.

In each of these environments, she has learnt not only from reading existing manuals and situational context but also by observing and working with her human colleagues and discerning for herself a map of the business processes being followed.

In a help desk situation, for example, Amelia can understand what a caller is looking for, ask questions to clarify the issue, find and access the required information and determine which steps to follow in order to solve the problem.

As a knowledge management advisor, she can help engineers working in remote locations who are unable to carry detailed manuals, by diagnosing the cause of failed machinery and guiding them towards the best steps to rectifying the problem.

During these trials, Amelia was able to go from solving very few queries independently to 42 per cent of the most common queries within one month. By the second month she could answer 64 per cent of those queries independently.

"That’s a true learning cognitive agent. Learning is the key to the kingdom, because humans learn from experience. A child may need to be told five times before they learn something, but Amelia needs to be told only once," said Dube.

"Amelia is that Mensa kid, who personifies a major breakthrough in cognitive technologies."

Analysts at Gartner predict that, by 2017, managed services offerings that make use of autonomics and cognitive platforms like Amelia will drive a 60 per cent reduction in the cost of services, enabling organisations to apply human talent to higher level tasks requiring creativity, curiosity and innovation.

IPsoft even has plans to start embedding Amelia into humanoid robots such as Softbank's Pepper, Honda's Asimo or Rethink Robotics' Baxter, allowing her to take advantage of their mechanical functions.

"The robots have got a fair degree of sophistication in all the mechanical functions – the ability to climb up stairs, the ability to run, the ability to play ping pong. What they don’t have is the brain, and we’ll be supplementing that brain part with Amelia," said Dube.

"I am convinced that in the next decade you’ll pass someone in the corridor and not be able to discern if it’s a human or an android."

Given the premise of IPsoft's artificial intelligence system, it seems logical that the ultimate measure of Amelia's success would be passing the Turing Test – which sets out to see whether humans can discern whether they are interacting with a human or a machine.

Earlier this year, a chatbot named Eugene Goostman became the first machine to pass the Turing Test by convincingly imitating a 13-year-old boy. In a five-minute keyboard conversation with a panel of human judges, Eugene managed to convince 33 per cent that it was human.

Interestingly, however, IPsoft believes that the Turing Test needs reframing, to redefine what it means to 'think'. While Eugene was able to immitate natural language, he was only mimicking understanding. He did not learn from the interaction, nor did he demonstrate problem solving skills.

"Natural language understanding is a big step up from parsing. Parsing is syntactic, understanding is semantic, and there’s a big cavern between the two," said Dube.

"The aim of Amelia is not just to get an accolade for managing to fool one in three people on a panel. The assertion is to create something that can answer to the fundamental need of human beings – particularly after a certain age – of companionship. That is our intent."

ORIGINAL: Telegraph
By Sophie Curtis
29 Sep 2014

jueves, 25 de septiembre de 2014

Beijing Hosts Debut of Formula E as Engines Whir Rather Than Roar

The first carbon free, fully-electric racing championship is held in Beijing. Video Credit 
By Jonah M. Kessel on Publish DateSeptember 13, 2014. Image CreditAdam Dean for The New York Times

BEIJING — The world’s first fully electric motor racing series, featuring battery-powered racecars that can accelerate from 0 to 60 miles per hour in three seconds, opened here Saturday.

Known as Formula E, this 10-stop international circuit is approved by the International Automobile Federation and aims to inspire developments in electric car technology and attract a new generation of fans.

The inaugural race, the Beijing ePrix, was unexpectedly dramatic. A crash at the last turn of the final lap involving the leading cars allowed the Brazilian driver Lucas di Grassi of the Audi Sport ABT team to win.

Nicolas Prost had long been in the lead when his car touched Nick Heidfeld’s. Heidfeld’s vehicle flew end over end and landed upside down in pieces. He emerged unscathed.

The Beijing ePrix took place in Olympic Park, site of the 2008 Olympics. The cars made 25 laps on the 3.44-kilometer course (about two miles), weaving between the Water Cube and Bird’s Nest.

Among the 75,000 people reportedly on site were a large number of local residents who were pleasantly surprised to find an international sporting event to attend as long as they paid the park entrance fee. 
Lucas Di Grassi of Audi Sport ABT won the first Formula E electric motor race on Saturday at the Olympic Park in Beijing.CreditAdam Dean for The New York Times

The series was the brainchild of the federation’s president, Jean Todt, and a Spanish businessman, Alejandro Agag, who came up with the idea in 2011.

We expect this championship to become the framework for research and development around the electric car, a key element for the future of our cities,” Agag told the event’s website.

The championship has strong backing — it took $100 million to get the project off the ground — and a number of Formula One veterans like Jarno Trulli strapped into racecars. Sir Richard Branson, the four-time Formula One champion Alain Prost and the actor Leonardo DiCaprio are among the team owners.

Unlike other racing series, Formula E schedules practice rounds, qualifying and races into a single day’s program instead of three, making it less disruptive to the host cities where the street circuits have been built.

To engage spectators, a gimmick called the FanBoost allows fans to vote for their favorite drivers; the top three get a chance to bump their car’s power for two and a half seconds.

We have 1.4 billion people,” said Steven Lu, chief executive of the China Racing team. “If even .0001 percent of them vote, that’d be enough to win.

The fan favorites proved to be di Grassi, Bruno Senna and Katherine Legge, one of two women in the 20-car race.

For the series, Michelin designed an 18-inch all-weather tire intended to last an entire race. Each Formula One car receives 52 tires per race weekend; Formula E cars receive 10.

All drivers drove a version of the Spark-Renault SRT_01E, equipped with a battery weighing nearly 800 pounds. It has enough power for 20 to 30 minutes of hard racing, so drivers switched cars midway through, substituting the poetry of Formula One pit stop tire changes for a hop into another vehicle.

Ho-Pin Tung, a Dutch driver of Chinese descent on the China Racing team, said that the best drivers in this series would be those who mastered the ability to manage the battery’s energy.

In race mode, we will be playing around with the power all the time,” he said. “We have six different engine mappings on the steering wheel, which we have to adjust while driving.

The local fans were disappointed by China Racing’s finish, as Tung placed placing 16th and his teammate Nelson Piquet Jr. placed eighth. What caught Tung by surprise the first time he drove the SRT_01E was the sound of the wind in his helmet.

It’s always there of course, but normally there’s a screaming loud engine behind you,” he said.

The electric car’s motor emits an 80-decibel whir, about the same as a garbage disposal, compared with Formula One cars that sound like jet engines.

I had no idea electric cars could be so fast,” said Wang Zhigang, 60, a Beijing native who had seen racing only on television. He added, however, that he would not buy one soon.

The government gives subsidies for them,” he said, “but there are just too few charging stations. What would you do if you ran out of battery here?

But China is seeking to put five million electric cars on the road by 2020 in an effort to cut pollution. Indeed, Lu, whose team played a crucial role in bringing the race to Beijing, said that the Chinese government was willing to host because it wanted to promote electric cars.

Speaking of government officials, Lu said: “They said: ‘Wow, this is really new. It’s a golden opportunity. Let’s do that.’

Stops on the Formula E circuit include Miami and Long Beach, Calif. The final race is in London in June.

A few years ago, few believed this series could come to fruition. Standing on a hastily built viewing platform, Lu was optimistic, saying, “It’s real, it’s fast, and it’s the future.

SEPT. 13, 2014

DNA: The Software of Life

J. Craig Venter

J. Craig Venter, Ph.D., is a biologist renowned for his contributions in sequencing the first draft human genome in 2001, the first complete diploid human genome in 2007 and construction of the first synthetic bacterial cell in 2010. He is founder, chairman and CEO of the J. Craig Venter Institute (JCVI). He is also a co-founder and CEO of Synthetic Genomics Inc (SGI), a privately held company focused on developing products and solutions using synthetic genomic technologies; and a co-founder and CEO of Human Longevity Inc (HLI), a privately held genomics and cell therapy-based diagnostic and therapeutic company focused on extending the healthy, high performance human life span. He and his teams are focused on a variety of projects and programs including: 
  • synthetic genomic research and the application of these advances to develop new vaccines and food and nutritional products, new biofuels and biochemicals; 
  • continued analysis of the human genome including the human microbiome, and discovering and understanding genetic diversity in the world's oceans. 
Dr. Venter is a recipient of the 2008 National Medal of Science and is a member of the National Academy of Sciences. He is the author of "Life at the Speed of Light: From the Double Helix to the Dawn of Digital Life" (Viking, 2013) and "A Life Decoded: My Genome: My Life" (Viking, 2007).

ORIGINAL: Zeitgeist Minds

miércoles, 24 de septiembre de 2014

Made With Code

We started Made with Code because even though technology runs more and more of our lives, women aren't represented in the companies, labs, research, creative arts, design, organizations, and boardrooms that make technology happen

If girls are inspired to see that Computer Science can make the world more beautiful, more usable, more safe, more kind, more innovative, more healthy, and more funny then hopefully they will begin to contribute their essential voices. 

As parents, teachers, organizations, and companies we're making it our mission to creatively engage girls with code. Today, less than 1% of girls are interested in CS. Tomorrow, we can make that number go up.

India makes history with successful maiden voyage to Mars

Indian space agency's low-cost mission to Mars has successfully entered the red planet's orbit, crowning India as first country to execute such a project in its maiden attempt

India has triumphed in its first interplanetary attempt by successfully putting a satellite into orbit around Mars.

Scientists broke into wild cheers on Wednesday morning as the orbiter's engines completed 24 minutes of burn time and maneuvered into its designated place around the red planet.

The rocket launch (DD)

The success of India's Mars Orbiter Mission, affectionately nicknamed MOM, brings India into an elite club of Martian explorers that includes United States, the European Space Agency and the former Soviet Union.

The success of the Mars Orbiter Mission, lauded for its low price tag of $74 million, will boost India's five-decade-old space programme that newly-elected Prime Minister Narendra Modi aims to expand with better infrastructure and technology.


Hacked photosynthesis could boost crop yields

Algal enzyme can speed up rate at which plants make food.


Rice is one of the crops that could increase their yields by converting solar energy more efficiently.

It is difficult to find fault with a process that can create food from sunlight, water and air, but for many plants, there is room for improvement. Researchers have taken an important step towards enhancing photosynthesis by engineering plants with enzymes from blue-green algae that speed up the process of converting carbon dioxide into sugars.

The results, published today in Nature1, surmount a daunting hurdle on the path to boosting plant yields — a goal that is taking on increasing importance as the world’s population grows.

With the limited ability to increase land use for agriculture, there’s a huge interest in trying to improve yield across all the major crops,” says Steven Gutteridge, a research fellow at chemical firm DuPont’s crop-protection division in Newark, Delaware.

Researchers have long wanted to increase yields by targeting Rubisco, the enzyme responsible for converting carbon dioxide into sugar. Rubisco is possibly the most abundant protein on Earth, and can account for up to half of all the soluble protein found in a leaf.

But one reason for its abundance is its inefficiency: plants produce so much Rubisco in part to compensate for its slow catalysis. Some have estimated that tinkering with Rubisco and ways to boost the concentration of carbon dioxide around it could generate up to a 60% increase2 in the yields of crops such as rice and wheat.

Light speed
Plant geneticist Maureen Hanson of Cornell University in Ithaca, New York, and her colleagues decided to borrow a faster Rubisco from the cyanobacterium Synechococcus elongatus.

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Experiment aims to steep rainforest in carbon dioxide
Life found deep under the sea

More related stories

A team including Hanson and plant physiologist Martin Parry of Rothamsted Research in Harpenden, UK, shuttled bacterial Rubisco genes into the genome of the chloroplast — the cellular organelle where photosynthesis takes place — in the tobacco plant (Nicotiana tabacum), a common model organism for genetic-engineering research. In some of the plants the researchers also added a bacterial protein that is thought to help Rubisco to fold properly. In others, they added a bacterial protein that structurally supports Rubisco.

Both lines of tobacco were able to use the bacterial Rubisco for photosynthesis, and both converted CO2 to sugar faster than normal tobacco1.

The work provides an important foundation for testing the hypothesis that a faster Rubisco can yield a more productive plant, says Donald Ort, a plant biologist at the University of Illinois at Urbana–Champaign. But Hanson is quick to note that her team will need to do more before that hypothesis has been proven.

Although the bacterial Rubisco works faster than the tobacco enzyme, it is also more prone to wasting energy by reacting with oxygen rather than CO2. Photosynthetic bacteria overcome this problem by creating specialized structures called carboxysomes, which enclose the enzyme and create a CO2-rich environment, discouraging wasteful reactions.

Without carboxysomes, Hanson’s engineered plants — which also express much less Rubisco than normal plants — must be grown in chambers that can maintain artificially high CO2 concentrations.

There is hope, however, that they may soon be weaned off this requirement. In June, Hanson’s team reported3 the creation of tobacco that could generate structures resembling bacterial carboxysomes. The next step, says Hanson, will be to try this experiment in plants that express the turbocharged bacterial Rubisco.

Ort says that it may be possible to generate tobacco plants with functional carboxysomes in the next five years. Naturedoi:10.1038/nature.2014.15949
Read the related Editorial and News & Views.


Lin, M. T., Occhialini, A., Andralojc, P. J., Parry, M. A. J. & Hanson, M. R. Nature (2014).
PubMed Show context

McGrath, J. M. & Long, S. P. Plant Physiol. 164, 2247–2261 (2014).
ChemPort Show context

Lin, M. T. et al. Plant J. 79, 1–12 (2014).
ChemPort Show context

By Heidi Ledford
17 September 2014

domingo, 14 de septiembre de 2014

Colombia: Minsalud ya firmó el decreto sobre medicamentos biotecnológicos

Si el Presidente lo suscribe, contenido de la controvertida norma se daría a conocer este miércoles.

Foto: Archivo / el tiempo

Biotecnológicos son aquellos que resultan de la manipulación de organismos vivos (células, bacterias y tejidos).

El ministro de Salud, Alejandro Gaviria, le aseguró a EL TIEMPO que el decreto de regulación de medicamentos biotecnológicos ya tiene su firma y está a la espera de la del presidente Juan Manuel Santos para ser expedido. Si supera este requisito, el contenido de la controvertida norma se daría a conocer este miércoles. (Lea también: Estados Unidos, preocupado por biotecnológicos, camiones y etanol)

El texto es fruto de varios años de debate y cinco borradores que han sido debatidos ampliamente por las partes interesadas; pese a eso, las multinacionales farmacéuticas siguen inconformes con algunos puntos, fundamentalmente con la llamada ‘ruta abreviada’.

Para entenderlo hay que decir que los biotecnológicos son aquellos que resultan de la manipulación de organismos vivos (células, bacterias y tejidos), mediante tecnologías muy avanzadas, y que se usan para tratar enfermedades como cáncer, artritis y otros males degenerativos. (Lea también: Proponen que bloqueo a genéricos sea delito de lesa humanidad).

Se trata de fármacos innovadores y costosos, cuyo mercado durante el primer semestre del 2014 representó el 20 por ciento del gasto farmacéutico nacional, aun cuando solo representan el 1 por ciento de todos los registros de fármacos vigentes en Colombia.

Quienes los crean aseguran que por sus características (derivados de organismos vivos) es imposible obtener medicamentos exactamente iguales, razón por la cual no podrían copiarse, sino obtener, a lo sumo, biosimilares.

Al no ser idénticos a los de la referencia, los biosimilares deben demostrar, con estudios clínicos comparativos, que tienen perfiles parecidos –en eficacia, potencia y seguridad– a los innovadores. Y esos no son procedimientos sencillos.

Para todos los biotecnológicos, el Ministerio de Salud propone en el decreto tres vías de registro: 
  • la del innovador, que debe presentar evidencia clínica completa sobre sus beneficios, eficacia y seguridad; 
  • la de los medicamentos altamente parecidos al fármaco de la referencia, cuyos fabricantes deben probar su biosimilitud, y 
  • la ‘ruta abreviada’.
Esta ruta permite caracterizar moléculas al punto que se puede decir si una es similar a la otra mediante un proceso técnico, sin tener que hacer estudios clínicos en humanos. Se parte del hecho de que la molécula ya está estudiada.

Las multinacionales son contrarias a esta vía, porque consideran que por ella pueden colarse fármacos que no ofrecen la misma eficacia y seguridad. En el extremo opuesto están quienes aseguran que este argumento solo busca mantener el monopolio sobre los biotecnológicos y los precios altos.

Las dudas sobre la ‘ruta abreviada’ o ‘tercera vía’, y otros aspectos del decreto, fueron resaltadas por la Administración de Medicamentos y Alimentos de Estados Unidos (FDA), en una carta al Ministerio de Salud a la cual respondió Alejandro Gaviria, con otra misiva, dirigida a Margaret A. Hamburg, comisionada de la FDA.

En ella, el Ministro aclara las dudas de la agencia reguladora de ese país y acepta hacer algunos ajustes. No obstante, hace énfasis en que la ‘ruta abreviada’ responde a procesos que se ajustan al rigor técnico científico –de manera que evitan cualquier riesgo para la población– y en que, en términos generales, el decreto coincide con las perspectivas que sobre el tema tiene la propia FDA.

14 de septiembre de 2014