Chief Technology Officer at the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN MEdical), and advisor tot the JPM CBRN Medical USA
Although much emphasis is typically put on countering engineered Chemical, Biological, Radiological, and Nuclear (CBRN) threats, the ongoing pandemic has demonstrated that countering naturally occurring biological threats should also be prioritized, as Mother Nature can arguably be considered as the world’s worst terrorist.
Although engineered threats are oftentimes seen as exponentially greater than naturally occurring ones, the vigorous testing on the new COVID variants has shown the diabolical nature of threats engineered by Mother Nature. The lines between engineered and naturally occurring threats keep getting blurred, and differentiating between the two becomes even more complex. Pandemics are volatile and have no boundaries, and proper counter mechanisms can be hard to come by, whereas artificial “designer” biological and chemical threats are somewhat limited in scope, presumably easier to counter since we have an understanding of the imminent threat posed by these agents. Arguably, COVID-19 is by far one of the worst public health crises we have encountered. The early days were the most confusing, as the reporting out of China seemed to downplay what was headed our way. Remember back to December 2019 (nCOV19): We were asking ourselves: “Is this something like the flu?” We were being told, “most people don’t know they have it or have super mild symptoms.” But then, in what seemed like a flash, hospitals were being overrun with patients dying of what sounded like Acute Respiratory Distress Syndrome (ARDS), a life-threatening lung injury that allows fluid to leak into the lungs. ARDS is something we are acutely aware of in the CBRN space, and for many of us, the mention of ARDS was a game-changer when it came to an understanding of what was headed our way.
Nevertheless, there is light at the end of the tunnel as new policies, strategies, Artificial Intelligence (AI), and Medical tools keep improving and evolving. New institutions are also likely to emerge on the scene, replacing old, fragmented ones. It is also crucial to look into drug development and repurposing approaches, e.g., the JPM CBRN Medical RAIDR- Repurposing Framework (RF), a process facilitating the rapid delivery of a medical countermeasure to the warfighter, or the general population, as needed, in order for us to find a way out of this pandemic and to be adequately prepared for the next one.
Thank you Dr. Wingerd for taking the time to do this interview, despite your busy schedule. Firstly, would you please introduce yourself and the JPM CBRN Medical for our readers?
I am the Chief Technology Officer for the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, part of the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. The JPEO-CBRND protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological, and nuclear threats. Within the JPEO-CBRND, the JPM CBRN Medical facilitates the advanced development and acquisition of safe, effective, and innovative medical solutions and systems that combat and protect the warfighter from CBRN threats and emerging and infectious diseases. My job is to advise the Joint Project Manager and Deputy Joint Project Manager on all technical matters related to our mission space, which includes vaccines, therapeutics, and diagnostics. Our products span the continuum of medical care: from prevention, to diagnosis, to treatment. I lead an incredible team, which includes our interagency liaison, two engineering interns, and 16 contracted experts in chemistry manufacturing and controls, non-clinical development, clinical development, and assays/diagnostics. This team serves the integrated project teams as advisors that aid in progressing the programs by assessing risks and helping to find solutions. The JPM CBRN Medical mission is to deliver safe, effective, and affordable medical solutions to counter CBRN threats for the Joint Force. It’s a difficult mission, but nevertheless, we deliver.
As I understand, you have been awarded special commendations for your efforts both in the 2015 Ebola outbreak and the 2020 COVID-19 pandemic (both of which demonstrated how ill-prepared the global health and humanitarian systems are when faced with an outbreak of infectious disease)… what systems or mechanisms do you feel should be put in place for the international community to be better prepared for the next pandemic?
The international community plays a critical role in global health security, and for us it comes to identification of a threat, and the context in which the threat is found. Without this information, it would be impossible for us to look at existing programs for rapid response and enduring capability development. Additionally, the community has the knowhow related to the types of assistance they are willing to accept from the United States. One of the most important factors in the ebolavirus outbreak in 2015 were preventative measures related to physical contact and basic health care needs, which elevated the standard of care. Taking these initial steps and gaining credibility for the health care workers allowed directed therapies (like monoclonal antibodies), and ultimately vaccine prophylactics, to be accepted in the communities. Regional labs providing surveillance and specimen samples make it possible to look at the infectious agents’ mechanisms of action; we saw this in both the ebolavirus and coronavirus outbreaks. Lastly, the international community can play a larger role in making funds available for international response efforts. I do realize there are many issues here… however, a group like JPM CBRN Medical has the ability to work with international partners and share the expense of specific product development efforts. Ultimately, partnership is key. Both the ebolavirus and coronavirus outbreaks have taught us that no one can do it alone. Partnership is critical to outbreak response.
What kind of challenges does the JPM CBRN Medical tackle on a daily basis?
Day-to-day, for me, it’s one meeting on the heels of another. The volume of information moving around during the COVID-19 pandemic has been like no other. Personally, my biggest challenge is making sure the right information is getting to the right people at the right time… which is easier to say than to do. We do a lot of “dividing and conquering” here at the JPM CBRN Medical, and we have a great team to do that. Second to this is the never-ending quest to find funding, as budgets for CBRN Defense are always being challenged. This requires us to always be on the lookout for solutions that not only meet our mission needs, but also fit into cost and schedule profiles that are highly constrained. To this end, we have partnered with the Biomedical Advanced Research and Development Authority’s (BARDA) TechWatch program. We also have our own JPM CBRN Medical TechWatch program, which can be found at our website under the “Work with us” tab. In 2020, we had over 2,000 TechWatch meetings. If one person were to have attended them all, it would have been a full-time job, but many hands make the work lighter. Additionally, we use the Medical CBRN Defense Consortium (MCDC) as a place where our Requests for Information (RFIs) and Requests for Proposals (RFPs) are sent to industry. During COVID, we have managed to secure ~$120 million in funding for 10 clinical trials with six products (four U.S. Food and Drug Administration (FDA)-approved products, two Investigational New Drug (IND) products). Currently, our tech team is hyper focused on seeing these trials completed and data analyzed.
How will the JPEO-CBRND JPM CBRN Medical keep striving for excellence in its mission? (i.e. developing medical diagnostic systems, vaccines?)
In the field of diagnostics, we are seeing engagement from additional industry partners with devices that are amenable to CBRN-relevant diagnostic targets due to the COVID response. We hope to leverage these new relationships to further our mission impact with field deployable diagnostics, and it is our intention to be able to push these tests as far-forward as we can. We are even looking at handheld devices that can warn us about chemical attacks before symptoms are experienced, which will allow the warfighters the ability to separate those with presumptive exposure from those who are about to become ill. For vaccines, we are looking at contracting mechanisms that will allow us to rapidly get mRNA and adenovirus vectored vaccines into manufacturing and start supplying vaccine for early clinical trials based on artificial intelligence/machine learning platforms. Our sister organization, the Joint Project Lead for Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies (JPL CBRND EB) is actively developing manufacturing and product platforms for us to leverage in the future. It’s an exciting time in vaccine development, where we can take a truly informatics approach to vaccine development. Now is the right time to leverage the successes of both of these manufacturing platforms to address emerging infectious diseases. We are now a step closer to taking a defense posture, rather than a reactive posture, as we saw with both the ebolavirus and coronavirus outbreaks.
This pandemic has taught the international community various lessons about interagency cooperation and the need for international partnerships. However, it also exposed these networks to various shortcomings and demonstrated the importance of local production. What role does industry play in the work that CBRN Medical does?
No one can do this alone, no one. Industry owns the product development solution space. Without strong industrial partners, no amount of international/interagency effort will go anywhere, as they are the life blood of the response. We depend on industry to leverage their intellectual property to provide solutions that our community can invest in and procure as an enduring solution to the problem. With the COVID response, we had a number of large companies participate in the response. During the ebolavirus outbreak we had only a handful, which makes sense given the difference in global impact. What we have noticed working with the larger companies is that we have to give up control when it comes to some aspects, but in exchange we experience fewer technical difficulties due to the amount of resources they can bring to the fight. Sometimes smaller companies have a difficult time recruiting the talent they need to be successful. We do our best to help where we can. To this end we have stood up the Advanced Development and Manufacturing (ADM) facility to be a manufacturing partner to the smaller companies. We are also looking at opportunities for on-shoring manufacturing of Active Pharmaceutical Ingredients (APIs) that are important to our mission.
Vaccine developments: Will the U.S. be able to achieve herd immunity by the end of 2021?
This is a difficult question to answer. There are a number of competing forces: vaccine efficacy, speed of vaccine roll-out, asymptomatic carriers and transmission, emerging variants, re-infection rates, kids going back to school, and compliance to social distancing plus mask wearing (just to name a few). If I were to look into my crystal ball and take a guess, I would say that variants from the U.S. and other parts of the world are going to challenge existing vaccines… most likely requiring an annual booster program to cover the dominate circulating strain(s). The key to overcoming the pandemic lies in breaking the chain of transmission, and currently the only countries that might be able to actually achieve this goal by the end of 2021 are Taiwan and New Zealand.
What would you say has been the most memorable achievement in your professional career?
This last year had a number of memorable achievements. My favorite one involved a British Knight, an Australian professor, a large U.S. academic institution, a major pharmaceutical company, and us (JPM CBRN Medical). The JPM CBRN Medical team authored a whitepaper describing the host response factors observed with COVID patients who were suffering from the cytokine storm. Cytokine storm is an umbrella term encompassing several disorders of immune dysregulation characterized by constitutional symptoms, systemic inflammation, and multi-organ dysfunction that can lead to multi-organ failure if inadequately treated. The paper was shared with some of our collaborators at a university here in the U.S., who connected us with the Australian professor and the British Knight. We shared our ideas back and forth and identified a drug with an ideal mechanism of action to study; a drug that was already FDA-approved for another indication. We got into contact with the pharmaceutical drug maker, shared our collective idea, and they agreed to support the clinical trial. A Cooperative Research and Development Agreement (CRADA) is still in the works, but we went and shopped the idea around within the DOD and found a willing funding source – from there, we were off to the races. We hope to start this trial in a few months from now. Ultimately, what made this project so special to me, so memorable, is that we started with scientific data, found international partners, industrial partners, and DOD partners, and joined together to put resources to action – it was a true testament to partnership and comradery.
From your perspective, what is the major CBRN threat that we should be on the lookout for in the following years? Will it be a national or an international threat?
At the JPM CBRN Medical, we are always on the lookout for highly-infectious agents with mixed reactions in the general population. It is tempting to only consider high-consequence pathogens, but the reality is that something like COVID really highlights the impact a virus can have when the outcome of the infected individual is variable and seemingly unpredictable. In this threat space, the origin could be domestic, international, natural, or engineered, and we have to be ready to respond. If I were to lay bets on anything, it would be a respiratory virus that will be the next outbreak, because unfortunately, there are plenty of options out there, and viruses don’t pay much attention to maps. Any threat that arises nationally has the potential to be an international concern, and vice versa.
What technological or policy developments are you most looking forward to within your field?
From a technology standpoint, I really would like to see more vaccines developed on the mRNA platform. There is so much great promise here in terms of rapid response and ease of manufacturing. There are also some significant hurdles to overcome, related to storage and stability, but like all such things it’s a matter of time until that problem is solved too. I would like to see someone develop an mRNA vaccine for toxins as well, which will certainly be a challenge, but if it can be done, I am sure the smart folks in Science and Technology can figure it out.
Is there anything additional you would like to say/add that I have not touched on here today?
In many ways, the COVID response has brought the medical countermeasures community closer together than ever before. The problems we encountered went from opinions to in-your-face facts, and everyone could agree on the problem statement. We were able to accelerate a number of diagnostics projects, and gain greater buy-in from our customers on the need and use for such instruments. Same thing in the therapeutic’s area, where some of the countermeasures we were able to bring into the COVID fight would also be valuable against other threats. Because of the great need, we were able to cement interagency and international relationships, relationships that will be the bedrock of our future efforts. No one does this alone, and no single solution will be the answer. If the next threat is naturally occurring or engineered, once loose in the world natural processes take over and literally take on a life of their own. That said, I am confident we will prevail if we stick together, set any differences aside, and do the right things.
All opinions and views expressed in this interview are those of Dr. Wingerd’s and do not reflect the official policies or position of any of his current or past employer.
About the Author
Dr. Kevin Wingerd was designated as the Chief Technical Officer (CTO) for the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) on 23 January 2019. As the CTO, he is an advisor to internal and external leadership, and has supervisory responsibility for technical subject matter experts. In addition, he provides technical management and professional leadership on complex issues related to joint service CBRN defense acquisition programs. He plans, directs, manages, and coordinates with the JPEO-CBRND JPM CBRN Medical’s mission objectives, and is responsible for the development, training, hiring, and retention of highly-skilled experts in the development of medical diagnostic systems, therapeutics, and vaccines.
Prior to this designation, Dr. Wingerd was a senior scientist supporting the vaccine development group as a contractor from 2013 to 2018, and as a civilian from 2018 to 2019. Prior to joining the JPEO-CBRND team, Dr. Wingerd worked at Emergent BioSolutions, Inc., in Lansing, Michigan, from 2005 to 2013. He was the senior director of process and analytical development, and provided leadership, training, and technical direction to a large staff and four laboratories. During his time at Emergent, Dr. Wingerd worked closely with the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA), to improve and scale-up anthrax vaccine manufacturing.
Dr. Wingerd’s awards include special commendations for his efforts in the Ebola Response, 2015, and the COVID-19 response in 2020. He has received numerous performance and time-off awards since joining the JPEO-CBRND team.
