SESSION 9: The MDI at 70:
Evolving Science and Regulation
Thursday • May 14, 2026 • 8:30–12:00 Noon • Trailblazer’s Ballroom
Moderator: Stephen W. Stein, M.Sc.
New Perspectives on Metering Valve Filling and Emptying Using Synchrotron X-Ray Techniques
Tom Daly
Bespak
Bespak
Beyond One-Size-Fits-All: Expanding the Design Space for Next Generation Propellant Formulations
Lucas Silva
Nanopharm, an Aptar Pharma Company
Nanopharm, an Aptar Pharma Company
Regulatory Science in Action: U.S. FDA Updates on In Vitro Bioequivalence Assessments for Metered Dose Inhalers (MDIs)
Elizabeth Bielski
U.S. Food & Drug Administration
U.S. Food & Drug Administration
An Evolving Regulatory Landscape: U.S. FDA’s Evidence Based Perspectives on Next Generation Propellant Product Transitions [Invited]
Bryan Newman and Markham Luke
U.S. Food & Drug Administration
U.S. Food & Drug Administration
The Winds of Change: Have We Finally Reached the Nirvana of a More Sustainable pMDI?
Nick Smalley
Kindeva
Kindeva
Discover More
Towards the Ultimate High Performance, Low Carbon pMDI: The Role of Valves in the Net Zero Journey
Richard Turner, Tony Mallett and Shaun Williams
Bespak
Bespak
Are You Being Left Behind? Why Partnership is Critical in Achieving a Successful Low-GWP Propellant Transition
James Ellis and Darren Bromley-Davenport
Orbia Fluor & Energy Materials
Orbia Fluor & Energy Materials
Building Regulatory Confidence in LGWP Propellant, HFO-1234ze(E), through Science and Collaboration
Rahul Parakhia and Nilesh Wagh
Solstice Advanced Materials
Solstice Advanced Materials
Simulating In Vitro Aerosolization Performance: A Tool to Support Valve Selection for Suspension Pressurized Metered Dose Inhaler Products
Benjamin Thorne
Bespak
Bespak
Decarbonizing the Pressurized Metered Dose Inhaler Valve: Designing a Low-Carbon Valve for the Next Generation of Pressurized Metered Dose Inhalers
Shaun Williams
Bespak
Bespak
Seventy Years of Metered Dose Inhalers
Stephen Stein
CGT Pharma Consulting
CGT Pharma Consulting
A Simple Calculation to Provide Insight into Impact of Propellant on Spray Pattern
Stephen Stein
CGT Pharma Consulting
CGT Pharma Consulting
Evaluation of Albuterol Sulfate Formulations with Low Global Warming Propellants using a Non-PFAS-Coated MDI Can
Loy Britto
Healthy Airways
Healthy Airways
Managing Supply Continuity During the Pressurized Metered Dose Inhaler Transition to Next Generation Propellants
Svetlana Lyapustina and Sheryl Johnson
IPAC-RS
IPAC-RS
Assessment of Dissolution Profiles for Mometasone Furoate Inhalers Using a Paddle-Over-Disk Dissolution Apparatus
Katherine Polzin
Kindeva
Kindeva
Defining a Reproducible Reference Condition for 'Immediate' Actuation in Low-Global Warming Potential HFA-152a Albuterol Sulphate Suspension Pressurized Metered Dose Inhalers
David Lewis
Oz-UK Limited
Oz-UK Limited
Minimizing Variability in Shot Weight of HFO-1234ze(E) Metered Dose Inhalers Using Automated Systems Compared with Manual Handling
Erik Boldt
Solstice Advanced Materials
Solstice Advanced Materials
Antimicrobial Effectiveness Testing of HFO-1234ze(E) with and without Ethanol
Erik Boldt
Solstice Advanced Materials
Solstice Advanced Materials
Performance Comparison of Fluticasone Propionate Suspension Formulations in HFO-1234ze(E) to a Reference Listed Drug
Gregory Smith
Solstice Advanced Materials
Solstice Advanced Materials
Budesonide Solution Formulations in HFO-1234ze(E): Novel Alternatives to Suspensions
Gregory Smith
Solstice Advanced Materials
Solstice Advanced Materials
Computational Modeling of Actuation Timing Effects on Regional Lung Drug Delivery from Pressurized Metered Dose Inhalers
Bora Sul
U.S. Food & Drug Administration
U.S. Food & Drug Administration
Engineering Budesonide Microparticles to Improve Suspension Stability in Low-Global Warming Potential Pressurized Metered Dose Inhalers
Francesca Buttini
University of Parma
University of Parma
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