Michael G. Kurilla Describes Key Contributions of NIAID to US Biosecurity: Part I

Michael G. Kurilla, MD, PhD

Director Office of BioDefense Research Affairs, National Institute of Allergy and Infectious Diseases (NIAID)


Dr. Kurilla describes the key contributions of the National Institute of Allergy and Infectious Diseases to US biosecurity, including early stage research and development of drugs and vaccines, and transitioning candidate products to the most appropriate federal or industry partners for further development. Dr. Kurilla offers insight on how development timelines could be shortened, and he suggests that one way to increase the nation’s medical preparedness to biological threats could be to explore methods to enhance the host immune response, as opposed to focusing on a “one-bug-one-drug” approach.

Video produced by the Center for Biosecurity of UPMC

Posted in Uncategorized | Leave a comment

Robert Kadlec Discusses 3 Key Improvements to US Biodefense Policy

Robert Kadlec, MD

Former Special Assistant to the President for Biodefense Policy


Dr. Kadlec discusses 3 key improvements to US biodefense policy that he believes are achievable within 5 years. Dr. Kadlec has served in both the executive and legislative branches of the US government. As a former Special Assistant to the President for Biodefense Policy, Dr. Kadlec is well acquainted with a broad range of technical and policy issues relating to biosecurity.

Video produced by the Center for Biosecurity of UPMC

Posted in Uncategorized | Leave a comment

Interview with Luciana Borio

Luciana Borio, MD

Assistant Commissioner for Counterterrorism Policy and Director, Office of Counterterrorism and Emerging Threats in the Office of the Chief Scientist, US Food and Drug Administration


In this interview, Dr. Borio outlines the evolving role that the Food Drug Administration (FDA) has assumed in the development of medical countermeasures. Under Dr. Borio’s leadership, the FDA has established the Medical Countermeasure Initiative (MCMi), which is an effort to hasten the development of these products, and to improve their odds of achieving FDA approval. The MCMi has made investments in improving the regulatory science that will be necessary for government’s ability to evaluate a new generation of medical products. Here, Dr. Borio discusses some of the successes that the FDA has achieved in this arena, such as the ability to evaluate and approve multiplex diagnostic assays, as well as the challenges that remain.

Video produced by the Center for Biosecurity of UPMC

Posted in Uncategorized | Leave a comment

Interview with Phyllis Arthur

Phyllis Arthur
Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy, Biotechnology Industry Organization

The timely availability of medical countermeasures—drugs, vaccines and other medical resources needed for a robust response—is a key component of US biosecurity. Ms. Arthur discusses the role of public-private partnerships in drug and vaccine development and production and broadly outlines the roles that Congress, the Administration, and the private sector play regarding US biodefense policy.

As a senior leader at the Biotechnology Industry Organization (BIO), Ms. Arthur has a unique and critical role at the interface between the resources and requirements of the US government and the research, development, manufacturing, and production capabilities of private industry.

Video produced by the Center for Biosecurity of UPMC

Posted in Uncategorized | Leave a comment

Posted in Uncategorized | Leave a comment


I just finished reading CENTERLINE–one of the best novels I have ever read. CENTERLINE captures the incredible story of the U.S. military’s medical system–moving the wounded from the battlefield all way the back to their hometowns. However, no matter how well the “system works”, the stresses on the soldiers and their families remain: “Going to war throws people off center, so does coming home.”

The author, Dr. Dave McIntyre. taught English at West Point and later served as the Dean of Academics and Faculty at the National War College. Dave’s sons assisted in the technical editing–Roy, a third generation Army ranger, and Sam, a USAF pilot who recently returned from his 11th combat deployment.

Dave has been invited to speak about CENTERLINE at the Air Force Association Convention in DC on September 18. The official release will be on Veterans Day, but you can get an advanced copy or e-book version for your iPad, Kindle or Nook at:


“Centerline captures the passion, dedication, heartbreak and triumph of combat medicine and aeromedical evacuation in a way no reader can forget. Not every hero is at the front. Not every act of valor takes place under fire. This is an important story. I am glad to see it told right.”
—LIEUTENANT GENERAL (DR.) PAUL K. CARLTON JR., USAF (RET), Former Surgeon General of the Air Force

“Centerline is a great novel … a thrilling, high-action page-turner that also captures the story of what many Americans fail to appreciate—the post 9/11 sacrifices of our armed forces and the families who support them. The tactical flight operations and ground combat scenes are real—not Hollywood, and the stories of wounded warriors and the military medical teams that care for them are unforgettable.”
—GENERAL BILL BEGERT, USAF (RET), Former Commander, Pacific Air Forces

“I was a combat medic on the front end of the global military medical system that McIntyre describes—until an RPG made me a critical care patient. As someone who has experienced an arduous medical journey through this system—from serving in Afghanistan to treatment at Walter Reed (40 operations), and finally, back home to Mississippi, I learned a great deal of all the processes unseen to me as a casualty.”
—C. J. (DOC) STEWART, Former Medic in 101st Airborne Division, Wounded in Afghanistan, June 15, 2010

“Centerline captures not only the intensity of aeromedical evacuation but accurately depicts the tremendous advances made in keeping our wounded warriors alive. It is a fitting tribute to the dedication and expertise of the medical teams and the bravery and sacrifice of our wounded warriors. It is an inspirational story for all.”
, Former Special Forces Flight Surgeon

“As a young copilot flying in the middle of the night across the north Atlantic, I remember the feelings I had while reading Ernest Gann’s Fate is the Hunter for the first time. It was a story written by a pilot, about being a pilot. But it was much more than that. Now comes a story for this generation. Life and leadership boiled down to its essence. How the seemingly random turns out to be amazingly perfect … like it was meant to be. How your past is always preparation for your future. Ever wondered what that might be like? Read Centerline and find out how it feels.”
, Commandant of Cadets, Virginia Tech

“Centerline is the realistic and compelling story of the “battle” after the fight is over …. Military members, some injured and some not, yet all having to deal with the issues of career, family, health, recovery and frequent exposure to the trauma of combat. An excellent story highlighting aspects of sacrifice that are frequently hidden from public view.”
—GENERAL WILLIAM S. WALLACE, US Army (Ret), Former Commander, United States Army Training and Doctrine Command, Former Commander, US Army V Corps, during the ground invasion of Iraq

“Centerline is a superb, fast-paced novel that realistically captures the spirit and emotion of Americans involved in seeing that our wounded warriors are professionally cared for. The artful description of a C130 flying low level brought back many memories…of bouncing around in a darkened cargo hold, tethered to the floor by a sling rope, as we approached an unlit airfield. The story of how our wounded return to their loved ones is told in a very powerful way… Centerline is an awesome read.”
 Ranger Hall of Fame, 2010

“Not since the early works of Tom Clancy has an author so superbly captured the drama, detail, and personal experience of soldiers and airmen at war—except these scenes are real. Do you want to know what it is like to fly a four-engine airplane, in bad weather, with a serious emergency? Read Centerline.
—HOWARD PUTNAM, Former CEO Southwest Airlines

Riveting! I couldn’t put it down. I believe Centerline should be required reading for every spouse of a member of the United States Military. I gained more insight into what my husband does from reading this book than from any military spouses’ workshop I’ve attended over the last 29 years.
—KATY KANE, Air Force Spouse

“The flying scenes in Centerline are detailed, realistic and thrilling. You smell the jet fuel and sweaty flight suits. You feel the enormous strain we’ve placed on our crews and airframes during the past decade. Brilliantly written … unforgettable.”
—ROBERT F. DORR, Author of 72 books on military aviation including Mission to Berlin and Mission to Tokyo

“I read Centerline one night on an airliner flying through stormy weather. I got so engrossed in the story and narrative that when we touched down at each stop, my mind and body were in the seat of a C-130. I honestly thought we’d touched down, in a Herc, at that “air base outside Baghdad”… with all the adrenalin and reactions that might’ve entailed. It was that real!”
—GENERAL CHARLES T. (TONY) ROBERTSON, USAF (RET), Former Commander USTRANSCOM and Air Mobility Command

“As a military spouse and new mom, with a pilot husband on his second tour to a combat zone, I understand the hardships and sacrifices that go along with the constant cycle of separation that families endure. Gone to war—gone to training—gone to war. I am thankful somebody finally told this part of our story.”
—KELLI FARGASON, Army Spouse, Illesheim, Germany

“If you’ve flown over Iraq at night, cringed at incoming rockets in the Green Zone, dined with the Combat Support Hospital staff with their ears cocked for in-bound choppers, held the hands of our young soldiers, dazed and freshly admitted from an IED ambush that devastated their unit, and then participated in the honor, recognition, and rehabilitation of our returned wounded warriors–then you will recognize the scenes in this book. Centerline brings it home, often with a tear, for those who sacrificed, physically/mentally/financially, more than most Americans will ever appreciate. Dave–THANKS!”
—CHRIS NORTH, Counterinsurgency and Counterterrorism Advisor, Iraq 2007, 2009-11, Advisor to Afghan Army, 2012


Posted in Uncategorized | Leave a comment

Well it’s about time…

On Oct 20, 2010, this blog had a post titled, “Vaccine to Burn” talking about the folly of allowing anthrax vaccine to be destroyed because it had exceeded its shelf-life. There are far better alternatives:  offer it to volunteer first responders before it exceeds the shelf-life, extend the shelf-life, or keep it in the stockpile for emergency use.

According to today’s Global Security Newswire, there may be progress in getting it to volunteer first responders before it expires–by far, the best use of this national resource.

That’s good news!


Posted in Uncategorized | Leave a comment

Emerging Leaders in Biosecurity Initiative

The Center for Biosecurity of UPMC has launched the Emerging Leaders in Biosecurity Initiative, a competitive program that will develop and maintain a network of promising early career professionals from multiple disciplines who are considering future careers in biosecurity.
In this first year of the program, the Initiative will select up to 25 highly talented new professionals as Fellows from academia, government, defense, private industry, science, public health, medicine, and the social sciences. Fellows selected will be sponsored during the year to attend two biosecurity meetings, engage in networking opportunities with established leaders in the field, participate in a writing competition that can lead to publication and public presentation opportunities, and participate in educational webinars. Involvement in the Initiative will enable Fellows to develop leadership skills and connections that can propel them into a career in biosecurity.
Program description and application details available at:  (www.emergingbioleaders.org).
Applications must be submitted NLT March 15, 2012.
Posted in Uncategorized | Leave a comment

The Risk of Engineering a Highly Transmissible H5N1 Virus

Editorial by Thomas V. Inglesby, Anita Cicero,
and D. A. Henderson

Thomas V. Inglesby, MD, is the Chief Executive Officer and Director; Anita Cicero, JD, is Chief Operating Officer and Deputy Director; and D. A. Henderson, MD, MPH, is a Distinguished Scholar, all at the Center for Biosecurity of UPMC, Baltimore, Maryland. Drs. Inglesby and Henderson are Coeditors-in-Chief of
 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science.

Over the past 8 years, H5N1 avian influenza has sickened 571 people, killing 59% of them. To give some perspective, the fatality rate of the virus that caused the 1918 Great Pandemic was 2%, and that pandemic killed on the order of 50 million people. Like all influenza strains, H5N1 is constantly evolving in nature. But thankfully, this deadly virus does not now spread readily through the air from person to person. If it evolves to become as transmissible as normal flu and results in a pandemic, it could cause billions of illnesses and deaths around the world—the proportion of the global population affected by past pandemics.

Scientists recently have announced that they genetically modified H5N1 in the laboratory and that this mutated strain spread through the air between ferrets that were physically separated from each other. This is ominous news. Since ferret influenza virus infection closely mirrors human infection and is similarly transmissible, these scientists appear to have created a bird flu strain with characteristics that indicate it would be readily transmissible by air between humans. In fact, the lead scientist on one of the experiments explicitly stated this.

The question is this: Should we purposefully engineer avian flu strains to become highly transmissible in humans? In our view, no. We believe the benefits of this work do not outweigh the risks. Here’s why. 

There are no guarantees that such a deadly strain of avian flu would not escape accidentally from the laboratory. This particular experiment was performed by internationally respected scientists in biosafety conditions considered top of the line. They seem to have taken the expected and necessary precautions. The risk of a person accidentally becoming infected and starting an outbreak with this new strain is low. But it is not zero.

The safety record of most labs working at high biocontainment levels is outstanding, and the historic number of accidents is very low. In almost all situations, even if a laboratory worker comes in contact with a dangerous pathogen and becomes sick, the risk of extensive wide community spread is negligible. This is because very few dangerous pathogens are as highly transmissible as influenza is. An accidental escape of an influenza strain from a lab in 1977 proves the possibility: That accident led to widespread flu epidemics. Given the potential global consequences of an accident with the newly modified strain of avian flu, we are playing with fire.

We are not opposed to research in high-containment labs using dangerous pathogens, including H5N1. Over the past decade, the Center for Biosecurity has publicly argued for the importance of such research to develop diagnostics, medicines, and vaccines for the most threatening infectious diseases. But research and development for those purposes does not require engineering lethal viruses to make them more transmissible between humans. There is no virus disease today other than influenza that has exhibited the potential attributes of global transmission such as has been documented with flu over the past 2 centuries and more. Thus, it occupies a unique position in the pantheon of microbes.

Some who defend the value of this recent experiment have argued that it is important to determine whether the present H5N1 strain could acquire genetic characteristics of a pandemic strain and, if so, what the particular characteristics might be. The thinking is that currently circulating strains of the H5N1 virus could then be screened for these characteristics, which, if found, might serve as an early warning. It is a speculative hope but not worth the potential risk.

Others have argued that the benefit of this experiment and its findings will be to motivate more work on H5N1 flu vaccines. Scientists have already developed bird flu vaccines, and research and development work continues. Should there be more money and effort devoted to improving our vaccine and medical defenses against H5N1 and other flu strains? Absolutely. But should we undertake experiments that engineer a transmissible strain of deadly flu in hopes that the frightening results invigorate R&D for vaccine development?

Still others have argued that this experiment may help directly in the vaccine development process. That argument is that now that we have this new transmissible strain, we should use it to test whether our current vaccines are effective against it. But it is unclear that vaccine protection against this engineered strain would correlate with vaccine protection against an H5N1 pandemic strain that evolves naturally in the world. Again, we would argue that the risk of accidental release outweighs the potential and uncertain benefits of engineering a pandemic strain.

An eminent scientific journal is considering whether to publish this work. A critical tenet of the advancement of science is the publication of new research in a form that allows other scientists to reproduce the work. This principle should be followed in almost all conceivable circumstances. But in this circumstance, it shouldn’t.

Publishing the methods for transforming the H5N1 virus into a highly transmissible strain would show other scientists around the world how to do it in their own labs. One concern is the possibility that the strain would be recreated for malevolent purposes. Even disregarding this risk (which we shouldn’t), scientific publication would encourage others that this is a research initiative worthy of additional exploration.

There are already checks in the research review process that include scientists’ consideration of these issues at project conception, deliberation at the time of funding decisions, institutional biosafety committee approvals, and the scientific publication review process. In principle, these elements should provide the necessary checks and balances. In this case, it will be important to understand the reasoning and decision making that led to the execution of this work. In the future, when an experimental plan calls for engineering a lethal virus into a highly transmissible one, then the rationale for funding and approval should be made explicit publicly.

Whether this experiment is published or not, it is a reminder of the power of biology and its potential. We need new approaches for the rapid development of large quantities of medicines or vaccines to protect us against new emerging viruses. But engineering highly transmissible strains of avian flu is not the way to get us there. 



Posted on by biosecureblog | Leave a comment

Response to Dr. Salzberg’s Commentary in Forbes

A few comments on Dr. Steven Salzberg’s  posting in Forbes on October 30:    Link

Testing the Anthrax Vaccine on Children:
Getting the Facts Right

I cannot comment on the wide range of opinions within the biodefense, public health, and medical communities regarding the testing of the anthrax vaccine on children, but I will comment on my recent conversations with senior FDA personnel regarding this subject.

My understanding is that FDA wants to ensure a program would be in place to collect data on children if there was a national emergency and parents were offered the opportunity for children to receive the vaccine. This is a far different issue than what Dr. Salzberg discussed.

Furthermore, Dr. Salzberg states, “…anthrax is not infectious.”  Unfortunately it is.  Anthrax is not contagious, it does not pass from human to human, but that fact does not mean that a vaccine is therefore not required.  Tetanus is not contagious, yet the vaccine is critically important to public health.  That is because the bacterium, Clostridium tetani.  Is ubiquitous in nature.  That is why CDC recommends a tetanus shot every ten years, or more often after a potential exposure.

Bacillus anthrasis (the causative agent of anthrax) exists in nature, which is why Ted Turner lost nearly 300 buffaloes on his Montana ranch in the summer of 2008. The good news is that currently we are not experiencing a public health emergency from anthrax exposure. That could, however, change quickly since anthrax remains the top bioterrorism threat.  An act of bioterrorism in major city would put millions at risk—a certain number from the initial release, and a far larger number from the potential of secondary aerosolization.

This secondary risk was demonstrated on the island of Gruinard off the coast of Scotland where the British tested anthrax weapons during World War II.  Anthrax is the one potential bioweapon that is persistent. It took the British four decades to adequately “clean” the environment on Gruinard. (Virtually all other pathogens would be rendered harmless by environmental conditions within hours/days.)

The recent WMD Center’s Bio-Response Report Card (www.wmdcenter.org) gave failing grades for America‘s capability to properly cleanup after an aerosol release of anthrax.  This means there would only be two courses of action following a large-scale outdoor release in an urban area:  evacuate for months, possibly years, or vaccinate the population.

I commend FDA for considering the implications and taking actions in preparation for what the bipartisan Congressional Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism stated was the top WMD threat—an anthrax attack.

Whether or not we do studies on children prior to a national emergency is highly controversial issue. However, if an attack occurred, I would want the vaccine to be an option for all parents, and I would expect FDA to have a plan for collecting information.

This is an important debate, and even more important that the debaters get the facts right.

Posted in Uncategorized | Leave a comment