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.
Good to know
Highlights
- 1 day 9 hours
- In person
- Paid parking
- Doors at 7:15 AM
Refund Policy
Location
The Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20850
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Agenda
D1 S1: Critical Aspects of LAI Development
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
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
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.