Navigating the Transition to Low Global Warming Potential Propellants
Date and Time: Dec. 4, 8:30 a.m. to 5:30 p.m., Dec. 5, 8:30 a.m. to 5:00 p.m.
Co-Hosts: Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG)
Format: In-Person (Universities at Shady Grove; Rockville, Md.) and Virtual Workshop
Current hydrofluoroalkane (HFA)-based propellants, like HFA-134a and HFA-227, play several roles for metered dose inhalers (MDIs), such as serving as the primary driving force for dose aerosolization and drug delivery. However, concerns around their contribution to climate change have driven global efforts to transition to newer low global warming potential (LGWP) propellants for use in MDIs and other commercial products. While the previous chlorofluorocarbon (CFC) to HFA-based propellant transition provides a historical reference for navigating such a transition, the current LGWP propellant transition presents potential scientific and regulatory challenges for both brand name and generic MDIs that require consideration.
The purpose of this two-day workshop is to engage subject matter experts from academia, brand name and generic drug industries, and health and regulatory agencies to discuss the current scientific understanding of LGWP propellants and the challenges encountered by the drug industry as they advance their transition development programs. This workshop will also cover the scientific and regulatory considerations regarding the data requirements to support an MDI transition program for both brand name and generic drugs. In-person attendees at the workshop will also be able to participate in small group working sessions on regulatory considerations and development strategy.
During Day 1, the workshop focus will be on the considerations around developing a brand name MDI utilizing a LGWP propellant. Presentations will cover what was learned during the previous propellant transition, what is currently understood about LGWP propellants and their impacts on product performance, and the scientific and regulatory considerations regarding a brand name LGWP propellant MDI development program. These talks will be followed by presentations from the industry’s perspective, as brand name companies discuss their experiences and current challenges with developing LGWP propellant MDIs. At the end of Day 1, in-person attendees will be able to participate in small group working sessions, collaborating with scientific experts and health regulators regarding different scenarios an applicant may encounter during LGWP propellant product development and submission, and engaging in dialogue to consider practical approaches that can address the scientific and regulatory challenges of this transition as efficiently as possible. The presentations on Day 2 will focus on developing a generic LGWP propellant MDI from both a regulatory agency and industry perspective. Presentations will cover the scientific and regulatory considerations for generic LGWP propellant development programs along with industry’s experience and challenges. The second part of Day 2 will then examine the propellant transition from a global perspective, with presentations to understand how similarities and differences between regulatory agencies may affect the transition process for drug developers. Day 2 will end with a panel discussion covering the critical points learned from the Day 1 and 2 presentations and discussions.
Through this workshop, attendees will obtain a better understanding for the basis of the current regulatory thinking regarding LGWP propellant transition programs, along with instances where challenges may still be present that could influence a drug developer’s LGWP propellant MDI development and marketing strategy.
Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person) working sessions. Virtual attendees will be able to:
- Attend all presentations and panel discussions
- Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
- Enjoy free access to workshop recordings of presentations and panel discussion (not including the working sessions)
In-Person Attendees will enjoy all the benefits of virtual attendees, and will also have an opportunity to engage in dynamic, small group working sessions to discuss the scientific and regulatory challenges associated with transitioning to LGWP propellants for MDI. In-person attendees will be able to:
- Collaborate in person with FDA, industry, and academic experts throughout the workshop, and particularly during small group working sessions
- Engage in dialogue with attendees and faculty
- Converse with panelists during discussion panel Q&As
- Network with colleagues and other industry professionals during breaks