Conference Day 1

Wednesday 21st June 2023

8:00 am Registration

8:50 am
Chair’s Opening Remarks

  • Joshua Ziel VP, Program Development, Aerami Therapeutics

Exploring the Inhalation Landscape for Next Generation Development

9:00 am Panel Discussion: Setting Up Context: Capitalizing on the Current Wave of Inhaled Delivery

  • Jian Liu Chief Scientist, Nitto BioPharma Inc.
  • Vivek Gupta Assistant Professor & Dean for Graduate Education & Research, Industrial Pharmacy, Saint Johns University
  • Joshua Ziel VP, Program Development, Aerami Therapeutics

Synopsis

With renewed interest sparked by COVID-19, unmet clinical needs and better formulation technologies, inhaled

delivery offers key advantages over other routes of administration for targeted local delivery. In this panel

discussion, experts will explore:

  • Reflecting on COVID-19, renewed interest and novel technologies
  • Formulating biologics for inhaled delivery such as mRNA
  • Discussing advantages of inhalation to overcome systemic toxicity issues with bypass of the liver

9:45 am Challenges & Considerations for the Transition to Low Global Warming Potential (LGWP) Propellants with Metered Dose Inhalers

  • Bryan Newman Lead Pharmacologist, US Food & Drug Administration (FDA)

Synopsis

  • Discussing the scientific understanding of propellants and their impact on MDI performance
  • Overview of the previous PFC to HFA propellant transition and lessons learned
  • Understanding the current LGWP propellant transition and the potential challenges and considerations this may present for MDI developers

10:15 am Inspired Products: Putting the Patient at the Center of Inhaled Therapeutic Development

  • Joshua Ziel VP, Program Development, Aerami Therapeutics

Synopsis

  • Understanding opportunities to enhance outcomes via the inhaled route of administration
  • Considering patient needs and context to optimize drug delivery
  • Case studies illustrating key principles for the development of inhaled therapeutics

Optimizing Inhalation Administration for Targeted Delivery to the Lung

10:45 am
Morning Break & Speed Networking

Synopsis

Enjoy a morning coffee while networking with industry experts

11:45 am Stably Aerosolized Lipid-mRNA Nanoparticles Towards Targeted Pulmonary Delivery

Synopsis

  • Understand the current work and identify challenges in delivery with lipid nanoparticles for nucleic acid delivery to extrahepatic tissues, in particular the lungs
  • Analyze and assess composition of formulations and methods of delivery to achieve effective nucleic acid delivery throughout airways
  • Identify targeting moieties and compositions that target airway epithelia

12:15 pm Roundtable Discussion: Specific Targeted Delivery for Deep Lung Tissue & Improving Bioavailability

Synopsis

  • Understanding how to target specific cell types in the lung depending on your disease indication – CF, COPD, IPF
  • How to promote target engagement with specific receptors and cell types for optimized therapeutic effects
  • Exploring how your disease can impact the deposition in the lung

1:00 pm
Networking Lunch

2:00 pm Anticalin Platform for Development of Inhaled Therapies in Chronic Airway Disease

Synopsis

  • Bullet points: inhaled Anticalin antagonists for respiratory disease
  • Benefits of local intervention via inhalation versus systemic administration
  • Development of PRS-060, a potential first-in-class, inhaled IL-4Ra inhibitor for the treatment of asthma

2:30 pm Overcoming Development Challenges of Inhaled Liposomal Formulations

Synopsis

  • Discussing the advantages of use liposomal formulations
  • Assessing challenges with developing liposomal formulations
  • Outlining a case study of ALIS (Amikacin Liposome Inhalation Suspension)

3:00 pm
Afternoon Break

3:45 pm Using Polymeric Nanoparticles for Delivery of Biologics

Synopsis

  • Delving into the use of polymer formulations for RNA delivery to the lungs and their advantage of temperature resistance, and rigidity
  • Outlining how polymers are best suited to navigate through the mucus
  • How do polymeric nanoparticles help in overcoming chemical and biological barriers to deliver to the lung?

4:15 pm Fireside Chat: Exploring Modalities & Innovations: Delivering Biologics vs Small Molecules vs Nanoparticles

Synopsis

With a historic prevalence of delivering small molecules via the inhalation route, what are the key differences

and considerations when delivering biologics such as mRNA, DNA, peptides and nanoparticle-mediated delivery compared with small molecules.

Join this panel discussion to understand:

  • Formulation considerations of small molecules vs biologics
  • Specific target engagement: small molecules are not that specific resulting in unwanted side effects
  • Shear force and bioactivity: understanding that macromolecules are more susceptible to shear force and their solid / chemical stability needs to be protects
  • Using nanoparticles for delivery: particle aggregation and immune response

4:45 pm
Chair’s Closing Remarks

  • Joshua Ziel VP, Program Development, Aerami Therapeutics