SAO PAULO, Brazil – Latin America is following the lead of other developed markets by ramping up its focus on personalized medicine, but there are challenges, including the higher costs of those medicines and a lack of regulations.

Speakers at the BIO Latin America conference that kicked off Monday came back to the topic time and again.

"Nowadays, everybody is thinking about this and how we can have better products for the patients, and there are a lot of discussions about personalized medicine, what we achieve over this digital parity and also the pharmaceutical or diagnostic parity," Eduardo Emrich, CEO of even co-organizer Biominas Brasil, told BioWorld.

"There's a lot of advances in this area, that is quite a new area, but we see that the development and the industry will grow in this direction, and here in Latin America there are a lot of companies, there are a lot of people thinking about this. It's of course a priority for the government, but also a challenge for the government and for the society," Emrich added.

Personalized medicine requires the biotech industry to adopt new approaches and to consider the impact on society and government, said Katherine Tsokas, from the department of global regulatory affairs, and head of regenerative medicine and advanced therapy at Janssen Research & Development, of Raritan, N.J.

"Traditional development pathways may not always be appropriate or optimal," Tsokas said during the opening plenary of the conference. "Some aspects of development may require completely novel approaches."

And Anvisa, the Brazilian health surveillance agency, is following closely the development of advanced therapies and personalized medicines being studied in the Latin American country.

"We understood that this was becoming concrete and real. Brazil is a country that has been a lot at the studying front of cell therapy," João Batista Jr., manager of the blood, tissues, cells and organs office at Anvisa, told the audience during a debate over the status of personalized medicine in Latin America.

The cost debate

A topic highlighted by most of the panelists was the cost of personalized medicine and how that impacted developing countries, which comprise most countries in the region.

"When you are able to reach cost decrease, regulation is very important," said Batista. "Innovation demands costs, because there is high development there."

Felipe Abdo, senior principal at Iqvia Brasil, from Sao Paulo, called on all stakeholders to join the discussion over regulation and prices for personalized medicine.

"The dialogue of all stakeholders becomes critical. Everybody has to participate in innovation," he said. "We don't know what's going to happen; we foresee production of organs in a lab, so we have a future and we have to live with that," Abdo explained.

Abdo remarked on the fact that Brazil is way behind other Latin American countries when it comes to regulations of personalized medicine.

"In Brazil, there is a long lack of regulation. There are countries that inspire us like Argentina and Costa Rica," he said.

Carlos Murillo, country manager of Pfizer Inc. in Brazil, agreed with Abdo on the fact that development of regulation for precision medicine is urgent in countries like Brazil.

"Compared to other parts of the world, we are really, really behind with what has to do with regulations," he said, also noting that Brazil, the most populous country in the region, should take advantage of opportunities such as increasing its participation in clinical trials.

While discussing pricing of precision medicine, Murillo highlighted that managing the price of those drugs is complex and will need an extensive debate over the next few years.

"Almost half of new medicines are precision medicines. There's a huge development of drugs from precision medicine. How we manage the price is a complex debate. And it is not just the price of the medicine itself, but the whole chain that needs to be part of the equation so that we understand the impact of precision medicine," he said.

The upshot is that both pricing and regulations need to be addressed to clear the path for innovation.

"Once you make this regulatory aspect abstract, all the stakeholders must be available and willing to work on that. There is space to increase our knowledge," said Abdo.

BIO Latin America brought together executives, health care leaders, entrepreneurs, academics and researchers, to discuss the state of the biotech sector in the Latin American region, as well as the challenges that the pharma sector faces in view of new developments, such as the emerging biotech, advanced therapies and personalized medicine.

"The idea here is to bring academia, startups, big companies, investors, government all together and create an environment for business, for interactions and for more network, and to really develop this sector and the health care in Brazil and in Latin America," Emrich said.

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