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The Complex Roadmap to Infectious Disease Innovation: The Intersection of Bugs, Drugs, and Special Populations

The importance of clinical pharmacology and the need for precise dosing strategies in populations targeted by highly resistant, hardtotreat pathogens has never been more in the spotlight than it has over the past year. With the onset of coronavirus disease 2019 (COVID19) and the unprecedented number of people affected by it, the longterm consequences, as well as the impact on other infectious processes remain largely unknown at the present time. The theme of this issue of Clinical Pharmacology and Therapeutics features the “complex roadmap” of the current state of antiinfectives to combat a range of pathogens from antivirals (e.g., severe acute respiratory syndromecoronavirus 2 (SARSCoV2), HIV, hepatitis B virus) to antibacterials (e.g., multidrugresistant organisms and tuberculosis) to antifungals and antimalarials. This issue has articles covering topics that touch on leveraging realworld evidence for assessing pharmaceutical treatments in the context of COVID19, tutorial on vaccines, and the US Food and Drug Administration (FDA) perspective on streamlined regulatory pathways providing knowledge and insights that can be leverage by those working outside the realm of infectious diseases. Several articles in this issue describe how the clinical pharmacology community have used its collective knowledge and expertise to address the ongoing global crisis. A stateoftheart review by Franklin et al. summarize how realworld evidence can be leveraged to address clinical questions in the absence of randomized clinical trials. Choi et al. provide a regulatory perspective on the development of COVID19 therapeutics and discuss the need to maintain balance between speed and agility with scientific rigor. Aliu et al. offer an industry perspective on the use of managed access programs for unapproved or repurposed medications— ending with a call to action for more data on these programs to inform progress. Lessons learned and applied from other viral pathogens are also included. Another stateoftheart review by Perelson and Ke describes the application of HIV and hepatitis C virus mechanistic models to understand viral dynamics and interactions between SARSCOV2 and the host immune response for optimizing nonpharmaceutical and pharmaceutical interventions. In contrast to the novelty of SARSCoV2, this issue also features clinical pharmacology approaches to a virus we have been fighting for over 40 years. A stateoftheart review by