A group of authors from the International Society for Aerosols in Medicine (ISAM), including Faegre Drinker’s Svetlana Lyapustina, has published an appeal for accelerating the development and regulatory approval of therapeutic drugs for COVID-19 for delivery by inhalation.
In the recent communication titled “Urgent Appeal from International Society for Aerosols in Medicine (ISAM) During COVID-19: Clinical Decision Makers and Governmental Agencies Should Consider the Inhaled Route of Administration,” the group of clinicians and life-industry scientists outlined several proposals. The following approaches were highlighted for consideration by decision makers and regulators: expedited regulatory pathways for treatments intended for seriously ill patients; rethinking of regulatory requirements for clinical trial size and quality-control specifications; wider use of physiologically based pharmacokinetic modeling to support demonstration of efficacy and safety of new treatments; creation of an anonymized registry of COVID-19 patients, including placebo controls; and retrospective observational studies. The group further emphasized the importance of collaboration among all stakeholders. Svetlana Lyapustina, Ph.D., Senior Director for Science, Regulation & Policy at Faegre Drinker, is a member of the ISAM Regulatory and Standardization Issues Networking Group, which authored the appeal.