LAI Generics: Advancing Innovation in Product Dev. & Regulatory Assessment

Purpose is to facilitate an in-depth examination of current challenges & emerging solutions relating to LAI prod. dev. and reg. assessment. This two-day workshop will address the most pressing scientific and regulatory challenges in the development and assessment of long-acting injectable (LAI) generic products. The program will explore the technical hurdles associated with LAI formulation development, including complex excipient characterization, reverse engineering, and manufacturing considerations that influence product performance and batch consistency. Sessions will cover drug release mechanisms across diverse LAI platforms and the development of discriminatory in vitro release testing (IVRT) methods. The workshop will also address alternative bioequivalence strategies and innovative pharmacokinetic (PK) study designs that reduce the burden of traditional BE studies while maintaining scientific rigor. Model-integrated evidence (MIE) approaches, including population PK modeling and mechanistic physiologically-based pharmacokinetic (PBPK) modeling, will be discussed as tools to accelerate generic LAI development and support regulatory submissions. Common deficiencies identified during ANDA assessment for LAI products will be highlighted, with an emphasis on best practices and actionable solutions. Sessions will feature expert presentations, case studies, and interactive panel discussions. In-person attendees will have an additional opportunity to participate in the open exchange and small-group working sessions focused on real-world challenges, best practices, and actionable solutions, offering direct engagement with regulators and thought leaders from industry and academia.