Biomedicine Stealing the Spotlight

As technology evolves so do the options for treating disease. While the world waits on the next big cure or treatment in medicine, pioneers in the field are working to deliver just that. To do so, they are increasingly turning to advanced technology and innovations to find solutions for complicated puzzles.

This is the world of biological medicine, where cuttingedge treatments are on the market or in development for everything from infertility to cancer. Instead of chemically synthesizing drugs, these researchers and innovators are looking into stem cells, gene therapy, blood components and tissues, among others. It is an area that is growing and for companies big and small, Mexico is increasingly on the radar

Amgen, among the world’s leading biotech companies with an array of products on the market, came to Mexico in 2006 and invests 19 percent of its global revenue in R&D. It sees a growing trend for biological drugs, citing a COFEPRIS report that said 35 percent of the drugs approved in Mexico are biologics

“We assume this to be a sustainable trend,” says Elvin Penn, Director General of Amgen. “Biologics account for around 30 percent of the products undergoing clinical development.”

This growth has come rapidly, as technology overtakes more traditional methods of drug development. Mauricio Vidales, Director General of Croda, points out that “in 2004, just one of the leading global drugs was a socalled big molecule or biologic with nine others being developed through more traditional means. Ten years later, seven of the top 10 new drugs approved in 2014 were biologics.”

The US is the traditional leader in biomedical research funding but it appears to be slowing as others climb into the arena. A 2015 study led by The Boston Consulting Group and published in The Journal of the American Medical association showed US government research funding from 2004-2012 fell to 50 percent of the global total from 57 percent. US companies also spent less, posting a drop to 41 percent from 50 percent in the same period, according to the study. At the same time industry accounted for 58 percent of US research funding in 2012, compared with 46 percent in 1994. 

As the US slowed its spending, Asia picked up the slack. The study showed China tripling its research funding to US$4.9 billion from US$1.6 billion. The total for Asia jumped to a whopping US$14.6 billion from $1.6 billion in the period.

A GROWING NICHE

Biosimilars, or drugs that are similar to already approved biological products, are an area that companies like Croda view favorably. “Over the next few years we will be looking into biosimilars, a growing niche believed to be the future of the pharmaceutical industry,” Croda’s Commercial Manager Christian Escandón says.

Penn, at Amgen, agrees. “Amgen is committed to developing and launching biosimilars since they can cover a wider population, hence helping the healthcare system,” Penn says. “These medicines require a significant effort to be developed because their comparability and effect has to be demonstrated through clinical studies, not only through physicochemical characterization methods.”

Edna Álvarez, the Latin America Manager of Malvern Instruments, a leading provider of scientific instrumentation, says the sector is actively growing. “Three technologies are seeing the highest demand,” she says. “These are laser diffraction for particle size characterization and distribution, dynamic light scattering and nanoparticle tracking analysis focused on nanoparticles, and image analysis solutions for characterizing the shape of particles.”

Mexico has a number of advantages that help it attract investment, including its close proximity to the US and involvement in a number of free-trade agreements like NAFTA that make it easier to do business here for foreign companies.

Equivalency agreements signed by COFEPRIS with agencies like the US FDA and Europe’s EMA are also important because they can quicken the process of getting drugs to market

“Regulatory recognition among countries is evolving and will certainly play a much more relevant role in upcoming years,” Penn says. But there are problems and hurdles that need to be overcome, among them is local expertise. To overcome these, many industry players are looking at partnering with academic institutions

“A key problem is the expertise in the industry regarding state-of-the-art biotechnology,” says Octavio Ramírez, Director of UNAM’s Instituto de Biotecnología (IBt). “Lack of expertise and knowledge results in foreigners often selling suboptimal or outdated technology to the Mexican industry, which, in general, is not capable of differentiating them from true valuable state-of-theart technology. The industry is gaining more and more knowledge, but they need to trust the academy as allies on technology assessment.”

But it’s a two-way street, he says. “Academics need to make a better work in collaborating with the productive sector and gaining their confidence.”

PERCEPTION PLAYS A ROLE

Perception also plays a big role as foreign companies look to Mexico. Thanks in part to medical tourism, the country is seeing an improvement in how it is viewed from abroad.

“It is slowly changing, and medical tourism has influenced this,” says Ernesto Gutiérrez, President of World Stem Cells Clinic. “World trends, especially regarding US and European patients, have made healthcare systems almost unaffordable for big population segments, giving way to insurance companies. The social gap between those using Medicaid and Medicare, and others that can afford private health services in the US is quite sizeable. As such, Mexico offers them an affordable solution to their needs.”

Gutiérrez adds that understanding of the possibilities for biologics such as stem cell therapies is another factor to consider. “There is still a long way to go in terms of understanding everything we can achieve with stem cell technology and how to do it.”

THE NEXT FIVE YEARS

As the industry develops and grows to the extent of the that of the US and Europe, it is possible to imagine what lies ahead. UNAM’s Ramírez looked five years out to give an idea of what biopharma applications might be on the horizon.

“Biopharmaceuticals aimed at attending the particular needs of the Mexican population, would be the ideal niche for the industry segment to be able to compete with translational companies. I believe that personalized and genetic medicine is a key field that the Mexican biopharmaceutical industry could focus on. Diagnostics is also a field of particular importance for Mexico, and again, particular niches can be exploited by the pharmaceutical industry.”

To create a healthy biopharmaceutical market that can thrive in the short term, Ramírez sees an important role for COFEPRIS in bringing new opportunities.

“The increased strength of COFEPRIS is an important area of opportunity. Mexico has become a leading country by approving state-of-the-art treatments in an expeditious manner, with a strict scientific review,” he says.

“An example is the approval of the dengue vaccine. I believe this is an important area of opportunity, as the table is set for the evaluation of new approaches to improve health. Mexico needs to stop being a follower and continue down a leadership track, with strong support from the scientific community in the country.”