We also need to develop our capabilities to respond to the full range of chemical, biological, radiological, and nuclear threats. Confronting these threats is a top priority for me and HHS, but it is also a top concern for the entire Trump Administration—right up to the top.
Good morning, everyone, and welcome to BARDA Industry Day.
I want to thank everyone in attendance for joining this important event—whether you’re a researcher, industry stakeholder, government official, or involved in the biodefense and preparedness enterprise in some other way, I want to thank you for being here today.
Today’s event was designed to offer an opportunity to learn about the U.S. government’s medical countermeasure work and our requirements, to interact with BARDA staff, and to meet private sector colleagues working in this space.
This morning, I want to give you a brief perspective on how I’ve seen our biodefense work evolve over the years, and how we’ve all come to see, through BARDA’s success, the important role of public-private cooperation for developing medical countermeasures.
I was confirmed as HHS’s General Counsel, in August 2001.
One month later, 9/11 was a wake-up call for us as a country—and it was just the first of many wakeup calls for HHS about our role in national security.
On 9/11, HHS had no central command center to track the public health threats that could arise from a terrorist attack—or other significant event, natural or manmade. Our main phone system had gone down, so our only way to communicate with other agencies was on our personal cellphones.
I’m sure quite a few people in this room had that same experience here in D.C.
Shortly after 9/11, we experienced the anthrax attacks, which were the first real bioterrorism attacks on this country. HHS was responsible for coming up with countermeasures, like Cipro, and we had to procure and develop anthrax vaccine.
Parts of HHS, like the CDC, had to develop closer relationships with the FBI to investigate the attacks.
Anthrax was far from the last infectious threat we had to handle in my first tour of duty at HHS. There was pandemic flu, smallpox, SARS, MERS, and many more.
All of this was a bracing reminder that biology and health are not just an area of interest for HHS or our nation’s health systems. They can be an integral part of our national security.
Some of the threats we faced were so unexpected as to be almost comical.
I remember waking up one morning and seeing that the New York Times was talking about monkeypox getting into the United States.
How was it getting here? Through collectors importing giant Gambian rats.
And how was it being spread? It was being spread by prairie dogs, and people who collect prairie dogs.
So, we banned the importation and inter-state sale of giant Gambian rats and prairie dogs.
That is when I discovered that there is, and remains, a very active prairie dog lobby in the United States. I had no idea those little animals could generate so much hate mail.
All of these events were a reminder of a mantra many of you know well: Biological threats that are manmade, accidental, or naturally occurring are real and growing.
As the world grows more urbanized and interconnected, infectious threats can spread more rapidly and easily than ever before.
Today’s rapid technological advances have great potential to improve human health, but they also create the opportunity for new kinds of threats, and for small-scale actors or even individuals to make use of biological weapons.
We also need to develop our capabilities to respond to the full range of chemical, biological, radiological, and nuclear threats.
Confronting these threats is a top priority for me and HHS, but it is also a top concern for the entire Trump Administration—right up to the top.
Just last month, President Trump signed an executive order to support modernizing influenza vaccine manufacturing and development.
The EO was an important recognition of the work we have to do toward better, faster, more reliable flu vaccines. Asyou all know, progress on those fronts can help keep Americans safer from the threat of pandemic flu and safer from the seasonal flu each year.
HHS is working to modernize flu vaccine manufacturing across the whole department—at FDA, CDC, and NIH.
But in particular, we’re counting on BARDA and all of you to develop new technologies to advance this work.
The flu EO is just one sign of a broader commitment to biodefense under President Trump.
Earlier this year, the administration released the first-ever National Biodefense Strategy to help combat biological threats and pandemics, which names HHS as the lead agency for the strategy.
The strategy requires a coordinated effort from biomedical and public health experts, across the government and private sector, to develop medical countermeasures.
Many of the tools we have to keep us safe from CBRN threats today can be attributed to BARDA, and to Project Bioshield, both of which I was proud to play a part in creating during my first tour of duty at HHS.
Those of us who helped create these entities should be thrilled with the results they have produced.
I want to congratulate everyone in this room, and especially our team at BARDA, on the recent announcement of the 51st FDA approval, licensure or clearance for a BARDA-developed product just last week. That is an amazing accomplishment for a 12-year-old program.
I want to congratulate everyone involved in that enterprise, from our current BARDA director, Rick Bright, to all of our private-sector partners, on these results.
Just this month so far, we’ve seen the first anthrax diagnostic test for use in non-governmental laboratories and the first FDA-cleared Ebola diagnostic.
Relatively recently, we’ve also seen the approval of the first-ever smallpox therapeutic, as well as a number of new antibiotics.
Many of BARDA’s initiatives will keep us safe in the event of a disaster or attack, but can also be useful in keeping us healthier and safer every day.
Earlier this year, President Trump launched an initiative to advance American kidney health, the first major action by a President on kidney disease since Medicare began covering patients with end-stage renal disease.
Part of that work will involve developing new portable dialysis technologies that can be used in the event of emergency evacuations, but may also undergird new technology for kidney patients more broadly.
We also know people with kidney disease most often die of infections, including falling victim to sepsis.
They’re not alone: Almost all natural and man-made health threats can result in infections or injuries that lead to sepsis. Tackling sepsis will support our kidney initiative, save lives throughout our health system, and protect our national health security.
So sepsis is now an area of interest across HHS, and BARDA is pursuing transformative technologies that improve the predication, diagnosis, and treatment of the condition.
Some of the intersections between public health and national security may be even more surprising.
One of the top public health priorities for the Trump Administration is our country’s crisis of opioid addiction and overdose. While we are beginning to see real progress, with decreases in overall drug overdose deaths, we continue to see rising deaths from synthetic opioids like fentanyl and fentanyl analogues.
But there is also concern about potential for weaponization of these agents.
That’s why BARDA announced a project last year to develop an improved form of the drugs we use to reverse opioid overdoses, which are sometimes inadequate to counter a fentanyl overdose.
The final point of pride I want to mention is the role that BARDA and private industry have played in the response to the current Ebola outbreak in the eastern Democratic Republic of the Congo.
Security challenges have made this outbreak the most complex, challenging Ebola outbreak we have ever seen, and it shows few signs of slowing.
But the good news is that we do have tools to use that we did not have during the last major Ebola outbreak, in West Africa in 2014.
That includes an investigational vaccine developed with more than $176 million in support from BARDA.
More than 230,000 people in the outbreak area have now received this vaccine: healthcare workers, contacts of Ebola cases, and contacts of contacts.
BARDA is also supporting a second investigational vaccine that is under consideration, and Project BioShield and BARDA both helped advance the investigational therapeutics being used in the clinical trial currently being run in the eastern DRC.
I recently traveled to the DRC and neighboring countries to see the situation on the ground.
It is clear we have a long ways to go in defeating this outbreak. But there has been real progress made, the work of American biomedical innovators is being put to use by health workers on the ground, and it’s saving lives.
I want to close by noting that the Ebola outbreak, even as it’s occurring in a relatively remote part of the world, is a reminder of how infectious threats pose such a threat in the modern world.
Hundreds of thousands of people cross the borders between the DRC and countries near the outbreak area each day.
Since the outbreak began, an estimated 98 million travelers have been screened for signs of illness at health checkpoints in the outbreak area, at airports, and at land borders in the DRC.
That is just one outbreak, in one relatively remote place. You can imagine the whole panoply of threats that confront us all around the world.
That’s why it is essential for HHS to place a high priority on emergency preparedness, and we cannot do that without BARDA and the cooperation of private industry.
Central to the success of BARDA, and HHS’s role in biodefense and emergency preparedness, is the work of our Assistant Secretary for Preparedness and Response, Dr. Bob Kadlec.
He has helped oversee the transition of our Strategic National Stockpile to ASPR, and I have been delighted to have someone with such deep expertise in national security, biomedical science, and the ins-and-outs of government running ASPR.
Today, you have an important opportunity to learn a bit more about each of these areas, and better understand our current activities, our priorities, and opportunities for coordination.
So, I hope you find today’s event to be informative and productive, and Dr. Kadlec and I look forward to working with all of you to keep our country safe and healthy in the years to come.
With that, I’d now like to welcome Dr. Kadlec to kick off the rest of the day.
