Mounting uncertainty threatens research and innovation in medicines

March 27, 2017 ctheodoropulos

 

On top of the usual financial and biological risks of drug development, new layers of uncertainty have emerged over the past six months that are disrupting the work of pharma and biotech companies.

It is easy to symbolize this added risk in one name, but according to Alex Lash, the National Biotechnology Editor for Xconomy, it goes well beyond the new American President as there are rapid changes underway across the globe.

BIO-Europe Spring opening plenaryAs he opened the plenary panel discussion at BIO-Europe Spring® in Barcelona, Lash offered a whirlwind tour of these turbulent times. There is regulation reform that may or may not happen in the European Union, in China, in the United States. There is the hanging doubt over the exit of the United Kingdom from the EU. There is a proposed cut of up to 20 percent of the funding for the US National Institutes of Health, that he called the “engine of biomedical research.” There is the executive order from the Trump Administration that bans travel and restricts immigration that threatens to blunt scientific dialogue and stymie research.

One member of the audience asked how the scientific community can hope to counter the broadcasting of alternative facts and the “loud noises coming out of Washington that have created this crisis of ignorance.”

Kevin Sin, VP for Oncology Business Development with Genentech Partnering, suggested that you can get an idea of the potential impact of the proposed travel and immigration ban for the US “if you look at the startup community in America, 27 percent of new US companies across all sectors were founded by immigrants.

Kevin Sin, Genentech

“Great ideas are multi-disciplinary and need a free exchange. Scientific discovery needs to be a live engagement that is diverse, inclusive and collaborative. The concern is that these proposed changes will chill that effort,” he said.

The Executive VP and Global Head of Business Development for BeiGene, Ji Li presented himself as being someone who personally benefited from the visa policies in the US.

“If you look at academic labs or biotech and pharmaceutical companies, I would say 50 percent of the employed scientists were not born in the US, and that is likely an understatement.”

Annie De Groot, CEO and CSO at EpiVax, said her company has several scientists from Europe, “and there is a concern that these type H-1b visas may be reduced by the Trump administration. We are a small company, so the impact will be greater in larger companies.”

Regarding the cuts to the NIH budget, Kevin Sin said that for the moment it is only a proposal, that it is meeting with resistance, “yet the impact could be tremendous. Many academic scientists would lose their jobs, projects will slow or stop, there would be a contraction of new hires. It also raises the question of what this could mean for the next generation.

“It is not good for anyone,” he added, saying, “Private funding by industry is only a fraction of what the government spends.”

Ji Li noted, “This is the first time a reduction to the NIH funding would not be due to economic conditions. If a fraction of what is proposed comes through, we have to ask who can fill the gap?”

He contrasted the situation with China where the government “is throwing money at people to bring them back. And so far 800 scientists have returned.”

Building on this perspective, he suggested that “we are in such a well-connected global ecosystem now that when there are problems in one part of the world, the opportunity will redistribute to other parts of the world.”

China has undertaken what he called a “tremendous reform in the regulatory framework, truly surprising.  They got rid of the backlog of generic and me-too submissions that were blocking the review pipeline. They are favoring innovative developments, equally for international as well as domestic pharma and biotechs. This creates an great time to consider cross-border collaborations.

“In what is the world’s second-largest economy there are a lot of opportunities to get a drug approved in China without a multi-year lag, and perhaps simultaneously, or even slightly ahead of the US and Europe. It is an opportunity to leverage a humongous patient population to speed up global development programs.”

Annie De Groot said that many in the audience have been through uncertainty with the NIH before.

“What happened in the recession some years back gives us guidance. Funding was cut, people’s jobs were threatened.  But the biotech sector continued on. Even though there was a lot of turmoil, we continued to do business, and our businesses did well, did not experience a significant decrease.

“What we need to do is stay focused on really good science, on the business we have at hand,” she said. But in terms of opportunities, we should keep our heads down and stay steady as we go.”

She also suggested, “We should become politically active, we should voice our discontent. There is an opportunity to advocate for science in the current context. It is unifying the scientific world, the opposition is getting organized. Resistance by raising voices stimulates the discussion of the importance of science to the economy, its role in improving people’s health.”

Ji Li agreed, saying, “This is the moment when we need to better educate people, to educate politicians about just how hard is the job we are doing to change human healthcare.”

According to Kevin Sin there is a populist view of the industry that is skeptical, “which is not all bad if it stimulates a healthy discussion and a motivation to produce results in order to show that the value society places on healthcare is attainable. Better drugs delivering on the promise of personalized healthcare will go a long way toward that.”

Yet he also said he is concerned about the magnitude of uncertainty, the number of potential changes, that “create a distraction that has a cost to us as an industry. If you are constantly agonizing over scenario plans around uncertainty it becomes overwhelming to the point where you are putting all your time and energy in trying to navigate these ambiguities instead of giving the focus and commitment you need for research and development.

“We are in the business of risk, but when you layer on additional regulatory risk and jurisdictional differences, this can easily become a distraction that steers us off the course of what we are really trying to do which is discover and develop next-generation medicines. There is a huge cost to us for that,” he said.

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