Our next speaker is a Supervisory Special Agent with the Federal Bureau of
Investigations, Weapons of Mass Destruction, Directorate Biological Countermeasures Unit. I
found the Fed, I get a shirt. A little fun fact, he is also a big Star Trek fan and is a
molecular biologist and biochemist originally. So here to present on his talk, Biotechnology
Needs a Security Patch. Ladies and gentlemen, please welcome Ed Yu.
So good afternoon. Let me start off by saying I consider it a real privilege and an
honor to be able to speak at DEF CON and at the Biohacking Village in particular. And in the
interest of time I'll just go ahead and launch right into it in order to save some time for
questions and answers at the end. But very quickly, and this is very appropriate because a
couple of hours ago there was a talk.
There was a talk on DIY bioweapons and if there's anybody out there who's supposed to be
protecting you all against biological weapons, it's us. We're one of the bigger players. I'm
part of the WMD Directorate, the Weapons of Mass Destruction Directorate. It is one of the
newest divisions within the FBI and it was born unfortunately out of the events of the 9-11
attacks. And if you all recall, we, you know, the U.S. has a dubious honor of being the one
country that actually had a bioterrorism event. Literally one month after 9-11 we had the
anthrax mailings that not only rocked the U.S. but it rocked the FBI in particular. And it
shifted us from being not only a law enforcement investigative agency where we go in after the
fact, where a crime has been committed, we go in, collect the evidence, find the perpetrator.
That's all inherently reactive. Our priority, our number one priority now is one of prevention
and how do we stop another 9-11 from happening again. And in particular for my program is how do
you prevent that?
The life sciences from being exploited and abused for offensive criminal purposes. Key point,
there actually is a position within the FBI called WMD Coordinators. It's kind of a kick-ass
title. But these are really the cornerstone of our programs. These are special agents, men and
women that are trained in chemical, biological, radiological and nuclear matters. And the
reason why they're the strength of the program, there's at least one of these agents stationed in
each of our 56 field offices across the U.S. So their job is to set up, you know, the
linkages and partnerships with state and local law enforcement, with public health. And
ultimately their number one priority is to go out and develop partnerships with universities, with
companies in their jurisdiction, including the biohacker community. So there are a lot of
community labs across the U.S. who have heard of our message and has met. And one of the
recommendations is, hey, find out who your friendly local neighborhood WMD coordinator is and
invite them out for a beer. But that's how we've been effectively trying to make sure that we protect
the life sciences. And don't worry, I'm not going to bore you to death on this one slide, but this is
just, there actually are federal criminal statutes dealing with biology specifically. And if you
just look at the first one, it's a crime to possess a biological agent, toxin or delivery system
for use as a weapon. So if you have possession of a particularly dangerous biological agent, a
virus, a bacteria, a toxin, and you perpetrate an attack, that's the focus of the whole statute. It's
the intent.
If the intent is to perpetrate an attack, you're in violation of this crime. But the only reason why I
show this is that this is only looking at historically, for the last several decades, when we talk
about bio threats, it's always about the dangerous bugs or the toxins. And I want to spend this
afternoon to talk to you about where biotech is taking us. This is no longer sufficient. So here's
where things get a little bit interesting, where biotech is taking us. This paper came out almost
two years ago now, where in China, they used biotech as a means of protecting the environment. And
they used gene editing. It's a very powerful molecular biology tool now that is fueling synthetic
biology. It's going to be utilized by the biohacking communities. It's a very powerful beneficial tool.
And here, the Chinese actually announced that they modified human embryos. And that shocked
everybody. I mean, this caused a flurry of policy discussions around the world. And then on top of
that, just last year, you had the former director of the Institute of Biopharmaceutical and Biological
Engineering of the U.S. National Intelligence Organization classifying gene editing the
equivalent of a WMD. So here you have, he listed the top ten threats. Right there, up there, was
North Korea and their nuclear program, Iran and their nuclear program, and gene editing. And to be
honest with you, what? But that's the whole focus, is the whole focus on here, biotech is developing
some really powerful tools. And, oh, God, someone out there is going to engineer the next zombie
apocalypse-causing virus. Okay, that's a little bit of a concern. But because of those one or two
specific trees, we're missing an entire forest. And, by the way, let me back up one real quick. If
you look at that one paper, though, even the Chinese admitted that the work that they did on the
human embryos, it was crappy. The efficiency was really bad. And one of the things they realized
that to counter, to make things like gene editing work better in the future, they need to
more data. They need more genetic information to make targeting more efficient. So the takeaway
for me here is not the zombie apocalypse. The takeaway from here is, this is an indication that
it incentivizes gathering more biological data to make tools like this more effective. So what
do I mean by that? Well, this, this is you. And I don't mean this as a commentary on your
personal hygiene. But if you think about it, this is us, because you leave DNA everywhere.
Like, you throw away the plastic water bottle you just drank from. Spit out a piece of chewing gum.
Throw away a cigarette butt. Use a plastic fork you toss away. Even the seats you're sitting in.
You're leaving a bit of yourself. DNA is everywhere. And that is actually very specific biological
data. And it's getting more and more accessible, not just in what you slough off. But the first
time an entire human person, an individual's DNA was sequenced was in 2002, the Human Genome
Project. That took over ten years. And that's a lot of data. And that's a lot of data. And that's
3.5 billion dollars to sequence one person's DNA. The technology today, you can sequence
all of your DNA in one day for about 600 bucks. And I think in about a year or two it's gonna
be about $200 to sequence all of your DNA. And so right now we are generating massive
amounts of DNA, uh, genetic information. It also comprises of the data footprint you leave
when you go visit a doctor's office. It's your medical records. It's your family history.
The private sector's developing
an interesting data profile on who you are. When you download an app, this DEF CON among
any other place is painfully recognizing that, you know, what rights are you allowing these
different companies when you download an app to have access to your contact list, your
caller activity? They're using that information for some, yes, some beneficial and some profitable
ways, but do you realize what you're agreeing to when you sign on to that? Wearable tech.
You know, you have your Fitbit or your Jawbone and you upload your daily activity into their
corporate clouds. There's a reason why that's going to be intriguing, not just only for
your individual health, but I'll talk a little bit more about that later. And even social
media is looking at the potential health, the biological applications of the data, because
when you put in an entry, that's timed, date stamped, and geotagged. So that's actually
going to be kind of interesting. And a good shining example of that is the near and
present.
Precision and personalized medicine. So this is happening as we speak, that when you go
into a doctor's office pretty soon, when you need, require medical treatment, the first
thing they're probably going to do is do a data dump. They're going to look at your
genetic information. They're going to look at your family records, your medical history.
And this is happening in order to treat existing disease states. So if you go in as a cancer
patient, they'll do a DNA sequence and based on your genetic profile, that'll determine
what your chemotherapy cocktail will look like. So we're starting to see that already.
But the real brass ring, the goal is how do you stop disease from happening in the
first place? And that's where all the other data comes in. That if you identify the risk
factors, maybe you can counter it and stop it now in its tracks before the disease, before
the medical condition manifests itself. That's the whole goal of how do we get customized
specific treatment for your condition, but even better, how do we stop it from happening
in the first place? And here's a good example of data in action. This is a U.S.-based company.
It's one of those DNA diagnostic services. You pay a monthly service, subscription fee.
You submit a DNA sample. They'll sequence it. And they provide you some regular information.
So for like the women in the room, they'll identify for you what BRCA, the BRCA gene
variant you have. And that'll determine your risk of developing potentially breast cancer
or obesity or Alzheimer's disease. This is a new thing.
But here this company, they've published this paper that was really significant in two ways.
That one, they identified 15 specific regions in your DNA that are highly correlated to
severe clinical depression. And what I mean that's interesting is that it's one of the
few times where you see such a high correlation between genetic and to a clinical state. But
the other part that really makes this so powerful is how they got there. They had a cohort of
450,000 individuals. So 450,000 of these subscribers provided their genetic information and volunteered
their medical history, their family history, and using all that data is how they were able to find this correlation.
This is how precision medicine works. It's finding all the data, looking at it in the massive scale.
It's straight-up statistics, right? The bigger the data set you have, the more reliability
or fidelity you're going to have in your results. So bottom line if I go in as a patient, you can have
every single piece of data about who I am. It means nothing in isolation. How this works is now you
compare me to a population data set. And now I can look at these data sets and measure in what the
So look at how many other people are like Asian, male, my age range, my lifestyle.
Look at the similarities.
Look at the differences.
And that will dictate what the treatment is going to be.
And by the way, all those companies out there that you are now seeing advertising a lot,
saying, hey, look at your genealogy.
What ethnicity are you?
And all these type of diagnostic services.
When you subscribe, they don't make money off of that.
In fact, they lose money.
It's not profitable for them.
How they're going to make their return on investment is just this.
Pharmaceutics, that when they find those correlations, they can sell this information
to pharmaceutical, to biotech companies, and come up with the specific treatments and the drugs.
And by the way, if you're a subscriber, you sign on.
You sign on any rights, any claim to any products that come out of this.
So bear that in mind.
But the important aspect of this is that the name of the game as we speak today is
whoever has the largest, most diverse data sets wins the day.
Unfortunately, that means that.
The bad guys know that, too.
And what I'm proposing here, and this is somewhat theoretical,
is that this is one of the reasons why you're seeing a targeting of the health care sector.
That this is not ransomware.
This is not want to cry.
This is looking at getting access to biological data.
So if you look at historically, the very, very large and significant health insurance company hacks.
I don't care about the PII, the private information.
I don't care about the insurance.
I don't care about the credit card information.
It's the biological data that's really important.
Because here you have a senior level person at a university who suffered from a breach of 4.5 million patients.
And this is a direct quote.
Say, hey, don't worry, folks.
It doesn't look like your credit card or financial information was impacted.
So don't sweat it.
But in the same breath said, but those parts of the network that contains names of birth,
names, dates of birth, social security numbers, Medicare health identification,
and patient diagnoses and procedures.
Well, yeah, that was hacked.
That was accessed.
Forget about credit card information.
If you get the patient diagnoses and procedures, that's to the tune of millions of people,
their medical condition, what drugs are being provided, what treatments are being provided,
what the schedule is.
And oh, by the way, all these significant hacks, these companies hired their own private cybersecurity firms.
They were Mandiant, CrowdStrike, FireEye.
And those companies attributed all these health insurance hacks to a hacker group based in China.
So somewhere sitting in China is all this.
This biologically relevant data to the tune of millions of patients out there.
But it doesn't mean that, you know, I classify that as criminal or covert acquisition of data.
It doesn't help that we're giving it away, too.
That as of today, we are also in the midst of an information space race, whether you knew it or not.
And we don't, and for the most part, we don't recognize that.
And so what I mean by giving it away, this is a snapshot of a company called BGI.
BGI.
BGI was formerly known as the Beijing Genomics Institute.
They are now based in Shenzhen.
And through the government and private support over the years, they are one of the world's largest DNA sequencing companies out there.
So they sequence DNA fast.
They do it scale.
And most importantly, they do it cheap.
And so a lot of our universities and companies have partnered or contracted BGI to do DNA sequencing.
So for cancer research, for diabetes research, for autism research, we're sending over blood samples, tissue samples.
And, yes, the DNA gets sequenced.
And our scientists.
And our doctors are getting that information.
But at the end of the day, they have it, too.
And I don't care, really, whatever privacy, you know, contracts or statements they have signed.
I don't know.
But the point being is that the data is being made.
And the key question is who actually has access to that?
And it's not just the U.S.
BGI rolled out a prenatal test kit in the European Union into 16 member countries.
So if you're an expectant mother and you're worried about the health of your child,
currently you go through.
And a very invasive, somewhat risky amnio where they jam a large-bore needle into your abdomen and pull out some amnio fluid.
Well, this test kit is you just do a blood draw from the mother.
And they'll isolate the circulating maternal and fetal DNA and sequence the DNA.
And you get just as good a result as you would get from an amnio.
So very cheap, very easy to do.
And BGI, when they rolled this out in 2014, they wanted to get 400,000 pregnant women into the program.
As of last year, they had more than 1 million.
So all across Europe, there are more than a million mothers.
And their children and their genetic information.
So, yes, they find out about the health of their future child.
But, again, somewhere sitting in China is probably that genetic information.
And it's not just BGI.
This is another company called Wuxi.
Well, that fantastic story I showed you of a U.S. company utilizing that information to find a correlation between data and depression.
Well, less than a year before they rolled out that finding,
Wuxi, this big, giant pharma company in China, became an investor, was an investor in that company.
So why steal it?
Just outright invest or merge with these companies and potentially have access to that data?
The bottom part really bothers me a lot.
That Wuxi got their own DNA sequencing company called Nextcode.
They were based in Shanghai.
And this company got CLIA-CAP accredited.
What does that mean?
They got accredited by the College of American Pathologists and got CLIA certification,
which means that they are HIPAA or privacy-compliant.
So on paper, they are good to go.
So the entire state of California is looking at outsourcing genetic testing to China.
So think about that for a second.
You might be a patient in California, you walk into a health clinic or a hospital seeking medical care,
and unbeknownst to you, your samples might be being tested in either a Chinese or a Chinese-affiliated firm.
And you don't know that.
But, at least on paper,
they are privacy-compliant, according to our existing policies.
This is another company that acquired, I guess you would say, older generation DNA sequencing.
They acquired a company in the U.S. that had next-generation sequencing capabilities.
And the only reason why I highlight this is that if a foreign company comes in and, say,
wants to buy an arm of Raytheon, Northrop Grumman, or Boeing,
that immediately raises the question, why is that?
Well, the reason it raises is a lot of red flags, right?
Because that's sensitive aerospace technology, and there's a lot of oversight and review that happens.
But if a foreign company like this company in China comes in and takes over a biological company,
or somebody has access to DNA sequencing data, it doesn't get flagged for the same kind of oversight and review.
It's just bio, it's just medical data. What's the big deal?
And here's yet another company called Novigene.
They literally only have 20 years.
couple of years old, they bought some of the latest generation DNA sequencers and now they
are actually one of the largest DNA sequencing companies in the world. So, and the thing
is, those three companies I just mentioned, Novagene, WooC, and BGI, as of two months
ago, all three are CLIA CAP accredited. All three are HIPAA compliant. And so they can
outbid everybody out there. So my guess is that if we're not careful, the entire U.S.
and the rest of the world might outsource genetic testing to one of these three companies.
So it doesn't matter that if you're familiar with data sciences, you can sit on all the
data in the world. It doesn't matter. You have to get the tools to make that data useful.
And China shows some tells here, too, that the head of BGI suddenly announced that he
was quitting, which shocked the entire world, because he was sitting on top of everything.
But why? He's starting a whole new artificial intelligence and machine learning company
to make the data useful. And here's yet another interesting tell.
That BGI partnered with Huawei. And if you're not familiar, Huawei is the world's largest
telecom out there. Think of Amazon Web Services and AT&T and Verizon combined, and that's
Huawei. And yet you have a DNA sequencing company partnering with them. And it's not
just BGI. WooC also partnered with Huawei just last year. So pretty soon, a company that's
trying to dominate the networks and put smartphones out there that you may download, you may install
a health kit or Fitbit app onto, they're going to be tapping into those networks, and they're
having access to those very large genetic data streams, as well.
So bottom line. Do we really recognize what the security implications are? And nowhere
do I want to say that we need to come full stop on this. There's just too much progress.
If you can cure cancer, if you can treat disease, absolutely we need that to happen. But we
do need to see that we need to go into this with our eyes wide open, that there are some
consequences that we need to deal with.
We need to be taking into consideration. My program, we partner with the National Academies
of Sciences, and we hosted a series of workshops over the last couple of years looking at this
future bio-based economy and recognize that we're doing a lot on data security when it
comes to privacy, not a whole heck of a lot when it comes to security. And that becomes a
little bit of a problem. But because of this, though, it's a challenge. We have a window of
opportunity to understand, hey, one, this is an issue. This is not, like I said, viruses,
bacteria, or toxins. But sort of the meme that I'm trying to get started is, for our lack of
foresight, if we're not careful, they corner the global pharmaceutical market based on our data
and everybody else's, then the U.S. might become health care crack addicts and China might
become our pusher. And if that happens, is that okay from a security standpoint? And I don't
mean to be completely China-bashing all the time. It's just that they are the most blatant
players. But I guarantee you that as data becomes more and more important, we're going to have to
make sure that it becomes more a commodity that everybody's going to go out and try to grab as
much data as they can to see how they can monetize it. And once it becomes a commodity, you're
going to have all kinds of security considerations to think about. So with that, you know, I'm
an FBI agent. I deal with biological WMDs. And yet here I am speaking at DEF CON, which,
again, hats off to Nina and the invitation. This is really, truly a privilege. And even a few
months back to South by Southwest where you're seeing the cutting edge of innovation and the
investment. This is where the economy, not only in the U.S., but globally is going. And do we
really, really understand what the security implications are? So with that, I just wanted to
tell you that there's so much promise in this field in biotech that all of you are going to be a
part of this, either willingly or not. But at the same time, how can we potentially recognize this
as an issue and then how can we be part of the solution to address these new challenges? So with
that, thank you. And I think I have a little bit of time for questions.
Right? All right. Thank you very much.
Hello? Is this work? Shout? Oh. Hello? Oh, okay. To sort of combine the whole WMD
with the data is a commodity and hacking, do you guys look at, what if say, some foreign entity
hacks this vast store of data, gets access to this data and then uses it to either one, target a
specific population based on their genetic data? Or conversely, target a vast area of the
the population based on the genetic data.
Yes, thank you, I appreciate that.
That always comes up, and that actually was brought up
two talks ago about the DIY biological weapons.
And again, it goes back to somebody making the engineering
the zombie apocalypse of virus
and targeting a specific ethnic group.
Yeah, you're always gonna have a discussion that includes
that, but I'm gonna turn that around a little bit.
So, look at where the incentives are going to be,
like I mentioned before.
So, it's in their best interest.
So, if you look at China or the Southeast Asian region
just in general, they are faced with a clear
and present danger of emerging
and re-emerging infectious disease.
Influenza, it's percolating in their background.
It's not a matter of if, it's when.
We had a 2009 H1N1 pandemic, right?
It's gonna happen again, I guarantee you that.
But theoretically speaking, though,
theoretically speaking, you could potentially,
if you have enough population data all around,
next time you get hit by a virus,
if you get hit with a pandemic,
you can probably engineer, manufacture a vaccine
that may be more specific for your own population
and just sit back and let the rest of the world get sick.
That's almost as good as an offensive capability,
but it's far more an incentive
to want to do that for yourself.
Either, or sell it to the rest of the world
at an incredible markup.
Either way, they hold all the levers.
And again, it comes back to this is not privacy,
this is not germ warfare per se,
although it has an aspect of it,
it's a whole spectrum of risk that we're not thinking about.
What does it mean that if some are out there,
they can figure out what your future medical fate
or those of your family members
or those of your children, what it might be?
Can you imagine right now that when you buy stuff
from Google or Amazon, you get bombarded with emails saying,
hey, based on your purchase history,
you might be interested in this.
That's all machine learning based on your pattern of activity.
Well, what happens if someone out there
has that type of information about you biologically?
And say, hey, you might be vulnerable
to this particular disease.
We're the only ones that can provide this to you.
That becomes an incredible hook.
And again, this goes so much beyond the individual,
looking at what's the impact on our economy or economies,
and then looking at what does this do for our biodefense
or also destabilization on our current foreign trade
agreements.
If you promise I won't target your finished IP, data today,
it may not mean that much because you don't have the tools
to make it useful.
And if someone out there will take it, but two years,
five years, 10 years from now, as soon as we develop this,
all of a sudden, that data becomes incredibly valuable.
But we're not thinking about it that way.
We're looking at the finished product.
And I think that's too short-sighted on our part.
And because of that, we're leaving our size
wide open to be blindsided.
So sorry, long-winded answer to your question, but it is true.
You bring up at one point, that's one aspect, but there's
a whole other range of issues that we haven't taken
into consideration yet.
All right, thank you, everyone.