Long-Acting Injectable Generics:Navigating Hurdles in Prod Dev/Reg Assess
About this Event
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 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.
Agenda
D1 S1: Critical Aspects of LAI Development
Info: Critical Aspects of LAI Development: Formulation, Excipient Characterization, and Manufacturing Considerations (presentations and panel discussion; virtual and in-person): This session will explore the scientific and technical challenges in developing LAI products, with an emphasis on establishing formulation sameness from characterizing complex excipients and reverse engineering. Presenters will highlight analytical challenges in excipient identification and quantitation, critical formulation properties affecting drug release, and manufacturing consideration influencing performance and batch consistency. Industry and FDA speakers will provide insight into regulatory experiences, common ANDA deficiencies, and best practices to aid in facilitating successful product development and approval.
D1 S2: Drug Release Mechanism Understanding of LAI products
Info: Drug Release Mechanism Understanding of LAI products: From IVRT to Totality of Evidence Approach (presentations and panel discussion; virutal and in-person): This session will focus on the mechanistic understanding of drug release from LAI products and the development of appropriate IVRT methods to support BE assessments. Presenters will discuss the scientific principles underlying drug release from various LAI platforms, from crystalline suspensions, polymeric microspheres, in situ forming depots, to non-biodegradable matrix systems, and the challenges in developing IVRT methods designed to be discriminatory and reflective of in vivo performance. The session will also address the totality of evidence approach for establishing BE of complex LAI products, integrating understanding of formulation characterization, IVRT data, and potential in vitro-in vivo correlations (IVIVC) to support regulatory submissions and reduce reliance on clinical endpoint studies.
D1 S3: Small Group Working Session
Info: Interactive Working Session (Iin-person only): In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, and academic experts. In-Person Attendees will engage in discussions related to the challenges and opportunities presented in Day 1 sessions, including formulation characterization, excipient quality, IVRT method development, and drug release mechanisms. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable research or policy recommendations.
D2 S4: Alt BE Approaches & Alt PK Study Designs for LAI Products
Info: Alternative Bioequivalence Approaches and Alternative Pharmacokinetic Study Designs for LAI Products (presentations and panel discussion; virtual and in-person): This session will focus on alternative BE strategies and innovative PK study designs for LAI products. Presenters will discuss the practical challenges of conducting traditional PK BE studies, including extended study durations and large sample size requirements, and will explore alternative approaches that reduce these burdens while maintaining scientific rigor. The session will also address in vitro BE approaches that may support waiving PK BE studies and the totality of evidence framework for integrating in vitro and in vivo data to support regulatory submissions.
D2 S5: Small Group Working Session
Info: Interactive Working Session (in-person only): In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, and academic experts. In-Person Attendees will engage in discussions related to the challenges and opportunities presented in Day 2 sessions, including alternative BE approach, innovative PK study design, and model-integrated evidence approach. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable research or policy recommendations.
D2 S6: Open Exchange (NEW Session Format)
Info: Interactive Discussions on Focused Product Development and Assessment Areas (in-person only): This session is dedicated to interactive discussion and candid dialogue with FDA, Industry, Academic, and other subject matter experts about scientific and regulatory challenges for complex LAI generic products.
D2 S7: Accelerating LAI Generic Development Using Model-Integrated Evidence
Info: Accelerating LAI Generic Development Using Model-Integrated Evidence (presentations and panel discussion; virtual and in-person): This session will focus on the application of model-integrated evidence (MIE) approaches to accelerate generic development of LAI products. Presenters will discuss how industry is leveraging modeling approaches, including population PK and mechanistic PBPK models and release kinetics modeling, to streamline LAI generic development programs. Regulatory expectations for MIE submissions will be addressed, along with successful case examples demonstrating acceptable approaches for incorporating modeling data into regulatory packages.
Where is it happening?
Event Location & Nearby Stays:
USD 0.00 to USD 350.00
