Pills and Needles:  At the Forefront of Next Generation Pandemic Preparedness

by Stephen Taylor

How do you stop a pandemic?  Do you focus on rapid diagnosis and treatment of the infected?  Do you try to anticipate it and head it off at the start?  Do you vaccinate against the etiologic agent and stop it entirely?  The ‘Pills and Needles’ Panel on Monday, February 12th explored all of these options.  Distinguished speakers from the Defense Advanced Research Projects Agency (DARPA) and the Biomedical Advanced Research and Development Authority detailed prevention, planning, and response initiatives to better prepare the United States against pandemic threats.

Justin Yang, a project officer at BARDA, spoke about BARDA’s vision to shrink the gap between patients and treatment, both physically and temporally.  For instance, U.S. healthcare providers have access to a myriad of influenza diagnostics.  Using these tools in a timely manner however, is problematic.  Influenza diagnostic capabilities are not networked, meaning that there is a two-week lag in the U.S. to collect and disseminate influenza incidence data.  With the population’s view of flu outbreaks constantly stuck two weeks in the past, patients are less likely to be proactive about reporting to a healthcare provider with flu-like symptoms.  By the time most patients receive a flu diagnosis, they are well outside the window of effectiveness for antivirals like oseltamivir.  BARDA’s solution to this diagnostic lag is to empower individuals as pandemic first responders, taking a personalized approach to a global problem.  BARDA modeling shows that if individuals were equipped with either in-home or wearable diagnostics in advance of an influenza pandemic, their time to report to a health care provider would be shortened, their spread of the virus to others limited, and overall incidence of flu cases greatly reduced.  BARDA is applying this paradigm to other pathogens of pandemic potential with the aim of building an early identification ecosystem around next generation wearable diagnostic technology.

Colonel Matthew Hepburn, MD, outlined DARPA research programs aimed at increasing rapid response capacity to outbreaks of pandemic potential.  Among these were programs such as Prometheus, which will use predictive analytics to anticipate how contagious novel pathogens are and advanced ultrasound diagnostics, which will be highly automated, allowing strategically placed responders to make rapid diagnoses outside of a hospital setting in an emergency.  Complementary to these efforts is the ADEPT program which aims to recreate natural physiological processes at scale to produce to protective antibodies and nucleic acid vaccines against novel pathogens.  The centerpiece of his presentation was the P3 Pandemic Prevention Platform.  The aim of P3 is to develop pandemic prevention countermeasures in under 60 days using a platform that integrates the ADEPT development methodology, regulatory, and manufacturing stages to get therapeutics to market.  Some of the myriad challenges to this goal include manufacturing nucleic acid that effectively encodes highly potent antibody, manufacturing this nucleic acid in quality conditions, and conducting safety and toxicology studies, all within a span of eight weeks.  If the P3 Platform is successful, however, it will be revolutionary to the development of medical countermeasures.

‘Pills and Needles’ covered the full spectrum of next generation pandemic preparedness, from early detection and intervention to the creation of platforms for rapid countermeasure development in the face of novel threats.  How these innovations will change the threat landscape remains to be seen.  Will they interact with U.S. healthcare, emergency response, countermeasure production, and regulatory environments as expected?  Will they benefit the population equitably or, as is so often the case, will the most vulnerable people lack access to them?  If they are successful in the United States, will their effectiveness translate to other parts of the world?  Many unknowns remain to be tested with these innovative ideas.

 

 

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