In this new article, Megan Palmer, a senior research scholar at the Center for International Security and Cooperation, talks about the different ways that the FBI is collaborating with the biotech community in order to be prepared to respond to an emerging biological threat. One of them is by reaching out to student bioengineers at programs like the International Genetically Engineered Machine (iGEM) Competition. The purpose of that event is to demonstrate how synthetic biology can be used to address pressing global issues.

As the article states, whether it’s an accidental outbreak or a biological attack, the FBI seeks to create a culture of trust and transparency with the biotech community. Palmer discussed this topic recently at the Biofabricate conference for synthetic biology and design in New York City.

As Palmer noted, biological attacks are a historical reality. In 1984, cult members poisoned patrons of 10 salad bars in Oregon with salmonella, sickening more than 750 people. And in 2001 shortly after the 9/11 attacks, anthrax spores that were mailed to newsrooms and government offices killed five people. While other incidents may have simply failed, it seems prudent to prepare for future attacks that could be even more deadlier.

Enter the FBI's foreay into the biotech community. Collaboartion between the public and private sectors is increasing in this area. As Palmer said, examples exist of iGEM students acting as "white hat biohackers" to help biotech companies detect weaknesses in their systems that  all in collaboration with the FBI, Palmer says. 

“There’s the overall sense that the government has acknowledged that it is not necessarily the center of influence in technological development,” Palmer told the publication. “We’re going to start seeing many more examples of partnerships between the government and the private sector where you wouldn't have necessarily expected them before. People should be willing to give them a chance.” 

To Palmer, the key to the collaboration is open communication. She reports progress with the FBI and biotech community on this front. Palmer herself asks the FBI questions about its involvement and interest in biotech dangers. So far, they have “been willing to have more of those conversations,” she said. The true test will come when the relationship is finally tested by what Palmer describes as a “triggering event,” either a situation where there is reason to believe a biotech has occurred or one in which the FBI is prying a bit too much into the lives of biologists. Palmer said that if the relationship doesn’t withstand this type of challenge, the trust between the FBI and the community would weaken, and communication would break down.

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Biosecurity leaders gathered at Stanford this week to offer new ideas and perspectives on a wide range of issues critical to societal health.

The conference, “Emerging Leaders in Biosecurity,” began Sept. 13 with a trip to Lawrence Livermore National Laboratory in the East Bay. The second day featured a series of panel discussions on the Stanford campus. The fellows, chosen by the UPMC Center for Health Security, hailed from a wide array of backgrounds, including biological science, medicine, policy, the military, law, public health and the private sector.

Biosecurity and its relationship to global health is a key issue for Stanford’s Center for International Security and Cooperation (CISAC), which hosted and helped organize the conference along with the sponsoring UPMC Center. The conference was sponsored by the Defense Threat Reduction Agency and the emerging leaders program run by the UPMC. 

With rapid advances in technology and science, biosecurity is increasingly focused on how harmful biological agents could become national security threats and risks.

‘A changing world’

David Relman, co-director of CISAC, addressed the fellows on Wednesday with remarks on the origins of CISAC’s involvement in biosecurity. Relman, a professor in the departments of medicine, and microbiology and immunology, later served as a panelist in a discussion on biosecurity and national and international policy.

Megan Palmer, a fellow and CISAC senior research scholar on biosecurity, panel moderator and organizer of the conference, described the program as one that “brings together some of the most talented and committed rising leaders from multiple organizations and disciplines critical to national and international biosecurity.”

She noted, “Stanford's biosecurity programs are focused on developing strategies for biosecurity in a changing world. Today we face complex biosecurity challenging ranging from emerging infectious diseases, intentional misuse of biotechnology, and potential accidents and unintentional consequences of our increasing ability to manipulate living systems.”

At the same time, biotechnology continues to be an important and growing part of the global economy, Palmer said. “Our scholarship and engagement work seeks to developing new ways to think about and act in this changing environment.”

Research focus

Through the “emerging leaders” program, fellows deepen their expertise in biosecurity, build leadership skills, and forge networks of lasting professional relationships, she added.

The two-day conference included talks on threat awareness, biodetection, a “viral storm” exercise, bioengineering research, computational biology and national security, biosecurity and national and international policy, the evolving biotechnology field, among other topics.

Stanford participants and speakers included CISAC’s William Perry, the former secretary of defense; Drew Endy, a Stanford associate professor of bioengineering; Tim Stearns, chair of the biology department; Milana Trounce, clinical associate professor of emergency medicine; and Manu Prakash, assistant professor of bioengineering.

CISAC activity in biosecurity includes research on:

• Risks in misusing the emerging life sciences;
• Social and political factors behind drug-resistant antibiotics, leading to an tight pipeline for new drugs;
• Examining the ethical responsibilities of scientists in this field and the needs for regulation;
• Anticipating and pre-empting the misuse of biotechnology by people with the intent to do harm.

Matthew Watson, a senior analyst for the UPMC Center, said, “It is difficult to imagine a more fitting venue for the fall Emerging Leaders in Biosecurity workshop than Stanford. Few institutions can bring together this array of world class talent, including leaders from national security, the life sciences, and the private sector.”

Back in February, the UPMC Center for Health Security chose its 2016 fellows and launched the program with a Washington, D.C. workshop in March.

The United States needs to build a better governance regime for oversight of risky biological research to reduce the likelihood of a bioengineered super virus escaping from the lab or being deliberately unleashed, according to an article from three Stanford scholars published in the journal Science today.

"We've got an increasing number of unusually risky experiments, and we need to be more thoughtful and deliberate in how we oversee this work," said co-author David Relman, a professor of infectious diseases and co-director of Stanford's Center for International Security and Cooperation (CISAC).

Relman said that cutting-edge bioscience and technology research has yielded tremendous benefits, such as cheap and effective ways of developing new drugs, vaccines, fuels and food. But he said he was concerned about the growing number of labs that are developing novel pathogens with pandemic potential.

For instance, researchers at the Memorial Sloan Kettering Cancer Center, in their quest to create a better model for studying human disease, recently deployed a gene editing technique known as CRISPR-Cas9 on a respiratory virus so that it was able to edit the mouse genome and cause cancer in infected mice.

"They ended up creating, in my mind, a very dangerous virus and showed others how they too could make similar kinds of dangerous viruses," Relman said.

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Scientists in the United States and the Netherlands, conducting so-called "gain-of-function" experiments, have also created much more contagious versions of the deadly H5N1 bird flu in the lab.

Publicly available information from published experiments like these, such as genomic sequence data, could allow scientists to reverse engineer a virus that would be difficult to contain and highly harmful were it to spread.

And a recent spate of high-profile accidents at U.S. government labs – including the mishandling of anthrax, bird flu, smallpox and Ebola samples – has raised the specter of a dangerous pathogen escaping from the lab and causing an outbreak or even a global pandemic.

"These kinds of accidents can have severe consequences," said Megan Palmer, CISAC senior research scholar and a co-author on the paper. "But we lack adequate processes and public information to assess the significance of the benefits and risks. Unless we address this fundamental issue, then we're going to continue to be reactive and make ourselves more vulnerable to mistakes and accidents in the long term."

Centralizing leadership

Leadership on risk management in biotechnology has not evolved much since the mid-1970s, when pioneering scientists gathered at the Asilomar Conference on Recombinant DNA and established guidelines that are still in use today.

Palmer said that although scientific self-governance is an essential element of oversight, left unchecked, it could lead to a "culture of invincibility over time."

"There's reliance on really a narrow set of technical experts to assess risks, and we need to broaden that leadership to be able to account for the new types of opportunities and challenges that emerging science and technology bring," she said.

Relman described the current system as "piecemeal, ad hoc and uncoordinated," and said that a more "holistic" approach that included academia, industry and all levels of government was needed to tackle the problem.

"It's time for us as a set of communities to step back and think more strategically," Relman said.

The governance of "dual use" technologies, which can be used for both peaceful and offensive purposes, poses significant challenges in the life sciences, said Stanford political scientist Francis Fukuyama, who also contributed to the paper.

"Unlike nuclear weapons, it doesn't take large-scale labs," Fukuyama said. "It doesn't take a lot of capacity to do dangerous research on biology."

The co-authors recommend appointing a top-ranking government official, such as a special assistant to the president, and a supporting committee, to oversee safety and security in the life sciences and associated technologies. They would coordinate the management of risk, including regulatory authorities needed to ensure accountability and information sharing.

"Although many agencies right now are tasked with worrying about safety, they have got conflicting interests that make them not ideal for being the single point of vigilance in this area," Fukuyama said.

"The National Institutes of Health is trying to promote research but also stop dangerous research. Sometimes those two aims run at cross-purposes.

"It's a big step to call for a new regulator, because in general we have too much regulation, but we felt there were a lot of dangers that were not being responded to in an appropriate way."

Improving cooperation

Strong cooperative international mechanisms are also needed to encourage other countries to support responsible research, Fukuyama said.

"What we want to avoid is a kind of arms race phenomenon, where countries are trying to compete with each other doing risky research in this area, and not wanting to mitigate risks because of fears that other countries are going to get ahead of them," he said.

The co-authors also recommended investing in research centers as a strategic way to build critical perspective and analysis of oversight challenges as biotechnology becomes increasing accessible.