FDA and the Center for Research on Complex Generics (CRCG) will host a public workshop on April 20-21, 2023: Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products
Workshop Date and Time:
April 20-21, 2023; 8:30 a.m. – 5:30 p.m.
Registration:
Register now. Registration will close April 10 at 5:00 p.m. (ET) for in-person attendance and April 21 at 7:00 p.m. (ET) for virtual attendance.
About the Event:
FDA recommendations for establishing bioequivalence (BE) with local drug delivery for orally inhaled drug products (OIDPs) often involve study designs for conducting comparative clinical endpoint (CCEP) and pharmacodynamic (PD) BE studies. Considering the difficulties that these studies can present for generic drug developers, FDA product-specific guidance (PSG) recommendations for some OIDPs have included alternative BE approaches that do not involve CCEP BE studies. However, understanding what studies may be suitable as part of an alternative BE approach can be difficult when developing generics for certain inhalation products with complex formulations, such as suspension-based metered dose inhalers (MDIs) and dry powder inhalers (DPIs).
The purpose of this two-day OIDP workshop is to discuss the current scientific and regulatory perspectives for using in vitro, in vivo, and in silico studies as alternatives to CCEP and PD BE studies, and to explore potential designs for alternative BE approaches that can address the particular challenges associated with establishing local drug delivery equivalence for suspension-based MDIs and DPIs. The workshop will begin with a reflection on the successes, limitations, and challenges with BE approaches that include CCEP and PD BE studies. Next, two parallel sessions will provide focused discussion on the in vitro, in vivo, and in silico studies that may serve as alternatives to CCEP and PD BE studies, where these interactive sessions will allow for small group discussions centered on the technical and practical aspects of these studies when used across OIDPs. The workshop will conclude with panel discussions for MDIs and DPIs that will provide participants the opportunity to discuss their study designs and issues with applying alternative BE approaches in lieu of CCEP and PD BE studies, with the goal of identifying where consensus can be achieved between collaborators from government, industry, and academia on what may constitute adequate alternative BE approaches for complex OIDPs.
Hybrid Experience:
The workshop will offer both in-person and remote attendance options. The event will be held at the Universities at Shady Grove in Rockville, Maryland.
Workshop Topics:
- Reviewing successes with the use of CCEP and PD BE studies to establish BE for locally acting OIDPs, and discussing relevant challenges
- Evaluating alternative BE approaches that utilize in vitro, in vivo, and in silico studies, instead of CCEP and PD BE studies, and discussing relevant technical and practical issues when used with different OIDPs
- Discussing the integration of multiple alternative in vitro, in vivo, and in silico studies to form cohesive alternative BE approaches in lieu of CCEP or PD BE studies for MDIs and DPIs
FDA and the Center for Research on Complex Generics—which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy—are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.
Audience:
This workshop is primarily suggested for the generic drug industry and other involved collaborators, including consultants and contract research organizations that support generic drug applications.
Registration Fees:
This workshop is FREE for virtual attendees. The cost for in-person attendance is $425 and will cover event related expenses. Register for in-person or online attendance here.
Workshop Outline:
Introduction to the Workshop
The introduction to the workshop will be a brief overview of the generic landscape for OIDPs, the challenges with bringing more generics to the market, and FDA’s successes and continuing efforts to address these challenges through approaches that will be discussed in this workshop. An overview of the workshop agenda will also be provided.
- Presentations by experts from FDA
SYMPOSIUM I: Successes and Challenges Associated with the Use of Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Locally Acting Orally Inhaled Drug Products
In this symposium, FDA presenters will provide an overview on where the use of CCEP BE studies and PD BE studies have been successful for supporting locally acting generic OIDPs. This will be followed by presentations from industry on the encountered challenges with these in vivo BE studies, and potential ways for addressing them.
- Presentations by experts from FDA and the generic drug industry
- Audience Q&A with panelists from FDA and the generic drug industry
SYMPOSIUM II: Integration of Alternative In Vitro, In Vivo, and In Silico Studies to Establish Bioequivalence of Locally Acting Orally Inhaled Drug Products in Lieu of Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies
This symposium will be comprised of three sessions that facilitate in-depth discussions on the various alternative in vitro, in vivo, and in silico studies that may be used for alternative BE approaches in lieu of CCEP and PD BE studies for locally acting OIDPs. These sessions will cover the scientific and technical challenges of these approaches along with the potential ways they may be used together for more complex OIDPs. Sessions 1 and 2 will run in parallel followed by Session 3.
- Presentations by experts from FDA, academic, and generic drug industry representatives with opportunities for in-person small group and larger panel discussions
SESSION 1: In Vitro Studies that May Contribute to Alternative Bioequivalence Approaches for Locally Acting Orally Inhaled Drug Products
This session will run in parallel with Session 2 and will cover various in vitro alternative studies, including dissolution studies, realistic aerodynamic particle size distribution (APSD), particle morphology and other advanced characterization methods. The scientific and practical challenges with using these approaches for different OIDPs will be discussed.
- Presentations by experts from FDA, academic, and generic drug industry representatives with opportunities for in-person small group and larger panel discussions
SESSION 2: In Vivo and In Silico Studies that May Contribute to Alternative Bioequivalence Approaches for Locally Acting Orally Inhaled Drug Products
This session will run in parallel with Session 1 and will introduce various in vivo and in silico alternative studies, including alternative pharmacokinetic (PK) studies. The challenges with proper study design, model selection, purpose and validation will be discussed.
- Presentations by experts from FDA, academic, and generic drug industry representatives with opportunities for in-person small group and larger panel discussions
SESSION 3: Holistic Alternative Bioequivalence Approaches in Lieu of Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Metered Dose Inhalers and Dry Powder Inhalers
This session will provide an opportunity for participants to hear discussion summaries from Sessions 1 and 2 along with in-depth panel discussions on where alternative BE approaches may be possible for MDIs and DPIs with complex formulations. Session summary presentations will be presented by FDA, while the panel discussions will include representatives from FDA, academia, and industry.
- Presentations by experts from FDA
- Audience Q&A with panelists from FDA, academia, and the generic drug industry
For More Information: If you have any questions about this workshop please contact info@complexgenerics.org.
