Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic

Abstract

Leveraging limited clinical and nonclinical data through modeling approaches facilitates new drug development and regulatory decision making amid the coronavirus disease 2019 (COVID‐19) pandemic. Model‐informed drug development (MIDD) is an essential tool to integrate those data and generate evidence to (i) provide support for effectiveness in repurposed or new compounds to combat COVID‐19 and dose selection when clinical data are lacking; (ii) assess efficacy under practical situations such as dose reduction to overcome supply issues or emergence of resistant variant strains; (iii) demonstrate applicability of MIDD for full extrapolation to adolescents and sometimes to young pediatric patients; and (iv) evaluate the appropriateness for prolonging a dosing interval to reduce the frequency of hospital visits during the pandemic. Ongoing research activities of MIDD reflect our continuous effort and commitment in bridging knowledge gaps that leads to the availability of effective treatments through innovation. Case examples are presented to illustrate how MIDD has been used in various stages of drug development and has the potential to inform regulatory decision making.

Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access

“…As a result, there is a growing tendency to utilize model-informed drug development approaches in the development of novel formulations and the bridging of dosing frequencies, thereby supporting lifecycle management in the post-approval phase [ 108 ]. The COVID-19 pandemic has further accelerated the adoption of model-informed drug development as a valuable tool to supplement the regulatory review process, particularly in situations where clinical studies may not have encompassed all proposed doses, indications, and populations [ 109 ].…”

Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making

“…Sotalol injection (26) popPK and exposure-response modeling and simulation Support the approval of loading doses for treatment initiation and up-titration. Remdesivir (Veklury®) Baricitinib (Olumiant ®) Bamlanivimab and etesevimab (27) popPK modeling and simulation Support the use of the drugs in pediatric patients.…”

Editorial: Model-informed drug development and evidence-based translational pharmacology

“…At least 90% of all US FDA-approved pharmacological agents have an MIDD-based research origin ( Madabushi et al, 2022 ). Most recently, its applications have been crucial for rapid vaccine and treatment development against the COVID-19 pandemic ( Xiong et al, 2022 ).…”