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In the last century, hundreds of new emerging infectious diseases (EIDs) have arisen in human populations most of which originate from wild animals as zoonoses [1]. The recent surge of zoonotic EIDs in human populations is driven by a constellation of socioeconomic factors including human population growth, eroding public health infrastructures, changes in land use and agriculture and ease of global travel. HIV, Ebola virus, avian influenza (H5N1, H7N9, etc.), severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) are but a few recent examples of highly virulent, zoonotic viral EIDs that have catastrophically affected global economies and public health [2]. Geopolitical flux since the 1990s and the potential for weaponizing EIDs provoked the creation of myriad policies aimed at protecting the USA from bioterrorist threats and the accidental release of potential pandemic pathogens from laboratories. Are these policies effective? Are they impacting countermeasure development for current and future EIDs? How are they shaping the direction of individual research programs, the recruitment of new investigators and the stability of impacted fields? Below, we discuss our experiences in developing therapeutics against SARS-, MERSand zoonotic CoV in an ever changing regulatory environment. Gain of function (GOF) research is critical for microbiological research in determining causal relationships between a mutation and its phenotype. In 2012, two studies describing GOF mutations facilitating the transmission of highly pathogenic avian influenza in ferrets set off a firestorm of debate ultimately resulting in a ‘pause’ of active GOF research and its future funding [3]. While influenza research was primarily targeted, GOF policies were also extended to studies that could enhance the pathogenicity and/or transmissibility of SARSand MERS-CoV in mammals, requiring regulatory approval of each experiment by NIH or its equivalent. Since the types of mammals were not specified and the assessment of mutant virus in humans or all the other approximately 5400 mammals was obviously not possible, the GOF policies by nature of their vagueness could never be adequately satisfied. During the ‘pause,’ a risk and benefit analysis conducted by the National Science Advisory Board for Biosecurity (NSABB) helped guide the creation of ‘Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO)’ released in January 2017 [4,5]. Almost a year later, US Department of Health and Human Services (HHS) lifted the pause and released policy intended to guide funding decisions of new grant applications involving potential pandemic pathogens that have been ‘enhanced’ for pathogenicity or transmissibility [6]. While the policies for new grant applications are now clear and in place, the triage process of amendments to currently funded grant applications remains unknown, as oftentimes a new recombinant must be made to address an evolving research question. For CoV researchers, regulatory complexity increased in 2012 when SARS-CoV was designated as a ‘select agent’ by the HHS and the Centers for Disease Control and Prevention (CDC) [7]. The Federal Select Agent Program (FSAP) requires those working with pathogens or toxins that pose a severe threat to public health to register and meet certain safety and security standards. Many of the 66 pathogens and toxins accompanying SARS-CoV on the select agent list are infamous including Ebola virus, smallpox and anthrax. As such, the FSAP has many positive

Is regulation preventing the development of therapeutics that may prevent future coronavirus pandemics?