Emergency Preparedness and Response

Suzanne Schwartz, MD, MBA: Faces Behind MCMi


 Dr. Suzanne Schwartz 

The unfathomable tragedy of 9/11 was a life-altering moment for me. As a surgical faculty member conducting burn trauma and wound repair research, I, along with many others who witnessed the carnage that day, made an unwavering commitment to never allow our country to be vulnerable again.

Through collaborations with colleagues, I learned about MCMi and Public Health Emergency Medical Countermeasures Enterprise activities. I started reading about FDA's MCMi responsibilities to safeguard our national public health and security and knew immediately that this was my personal calling. 

Since joining FDA in October 2010, in my role as medical officer and clinical reviewer, I have been able to make an impact on furthering product development for burn victims.  

The images of destruction, horror, shock, and despair are seared in my memory, even more than a decade on.  I was working at the Weill Cornell-New York Presbyterian Hospital on September 11, 2001, when the planes hit the towers of the World Trade Center.  Stunned and unprepared,confused and afraid, my colleagues and I in the burn center rallied, clearing out the ICU and transporting the more stable patients to stepdown units and other ICUs throughout the hospital to make room for what we expected would be a massive influx of burn patients from Ground Zero.  

But those mass casualty transports never came. Those patients who were received were so severely burned and systemically injured that every staff member who worked in the William Randolph Hearst Burn Center was personally affected for months after. 

At that time, I was engaged in clinical and translational burn research to further understand burn injury and wound repair and explore new opportunities for interventions that would improve the outcomes of burn patients.  My passion has always been figuring out how we bring early stage R&D discovery through advanced development to eventual delivery at the patient's bedside. I was and am particularly drawn to the challenges industry, academia, and government face in working collaboratively to achieve this end.
As Director of Emergency Preparedness/Operations and Medical Countermeasures for the Center for Devices and Radiological Health (CDRH), I now have the opportunity to work across multiple MCMi-related projects and help guide the direction of FDA's medical countermeasures and public health emergency national preparedness efforts by identifying unmet needs and gaps in these areas.
I was fortunate to receive MCMi funding to put together FDA's September 2012 Public Workshop on Medical Countermeasures for a Burn Mass Casualty Incident, whose goals were to discuss strategies for burn MCM development, evaluation, deployment, and monitoring.  The workshop engaged subject matter experts and stakeholders across the public and private sector to define unmet needs; emphasize the issues related to burn MCM product R&D, testing, and commercialization; and address opportunities to meet those challenges, through coordination and collaboration among strategic networks.
The agenda of the two-day workshop, along with slides, webcast, transcripts, and posters are on this web page; action items and next steps that have emerged as a result of the robust discussions that took place during this meeting will be available there as well.
I particularly cherish opportunities like this workshop to foster critical dialogue across sectors. Seeking out methods to improve problem-solving strategies that build the capacity for collaboration and coordination across public and private sectors is essential to creating a unified effort in national emergency preparedness and disaster resiliency and to advance innovation in the biomedical and healthcare fields.


Suzanne Schwartz is FDA's Director of Emergency Preparedness/Operations and Medical Countermeasures in the Office of the Center Director at CDRH. Initially recruited in 2010 as a Commissioner’s Fellow, she became a Medical Officer in the Office of Device Evaluation, Division of Surgical Orthopedic and Restorative Devices, Plastic and Reconstructive Surgery Branch in August 2011. Suzanne spearheads the InterCenter Wound Healing Working Group and represents FDA in several inter-Agency working groups and integrated program teams for the Public Health Emergency Medical Countermeasures Enterprise for chemical, biological, radiological and nuclear threats.
 Before joining FDA, she was a full time surgical faculty member at Weill Cornell Medical College in New York City. Prior to that Suzanne was Medical Director & Tissue Bank Director of Ortec International, a startup biotechnology company focused on tissue engineering therapeutic approaches to burns and chronic wounds. Suzanne earned an MD from Albert Einstein College of Medicine in 1988, an MBA from NYU Stern School of Business in 2012, and currently is enrolled in the National Preparedness Leadership Initiative – Harvard School of Public Health & Harvard Kennedy School of Government, Cohort X, December 2012-June 2013.

Page Last Updated: 01/26/2015
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