Institutional Affiliation: QLS Advisors
|Financing Vaccines for Global Health Security|
with Jonathan T. Vu, Benjamin K. Kaplan, Monique K. Mansoura, Andrew W. Lo: w27212
Recent outbreaks of infectious pathogens such as Zika, Ebola, and COVID-19 have underscored the need for the dependable availability of vaccines against emerging infectious diseases (EIDs). The cost and risk of R&D programs and uniquely unpredictable demand for EID vaccines have discouraged vaccine developers, and government and nonprofit agencies have been unable to provide timely or sufficient incentives for their development and sustained supply. We analyze the economic returns of a portfolio of EID vaccine assets, and find that under realistic financing assumptions, the expected returns are significantly negative, implying that the private sector is unlikely to address this need without public-sector intervention. We have sized the financing deficit for this portfolio and analyze sever...
|Bayesian Adaptive Clinical Trials for Anti‐Infective Therapeutics during Epidemic Outbreaks|
with Andrew W. Lo, Danying Xiao, Qingyang Xu: w27175
In the midst of epidemics such as COVID-19, therapeutic candidates are unlikely to be able to complete the usual multiyear clinical trial and regulatory approval process within the course of an outbreak. We apply a Bayesian adaptive patient-centered model—which minimizes the expected harm of false positives and false negatives—to optimize the clinical trial development path during such outbreaks. When the epidemic is more infectious and fatal, the Bayesian-optimal sample size in the clinical trial is lower and the optimal statistical significance level is higher. For COVID-19 (assuming a static R0 – 2 and initial infection percentage of 0.1%), the optimal significance level is 7.1% for a clinical trial of a nonvaccine anti-infective therapeutic and 13.6% for that of a vac...