Conference Day 2

Thursday 22nd June 2023

8:50 am
Chair’s Opening Remarks

  • Stephen Pham Senior Vice President - Product Development, Avalyn Pharma

Enhancing Formulation for Improved Stability, Optimized Efficacy & Longer Shelf-Lives

9:00 am Stabilization of Vaccines for Inhaled Delivery

  • Pavan Muttil Associate Professor and Vice-Chair, University of New Mexico

Synopsis

  • Importance of temperature-stable vaccines for universal vaccination
  • Formulation and characterization of vaccines for pulmonary delivery
  • Evaluating the protective efficacy of inhaled vaccines in a preclinical model

9:30 am Physical Stability of Nucleic Acids in Inhalable Dry Powder Formulations

Synopsis

  • Formulation of inhalable RNA powders via a combination of microfluidics and spray drying
  • Methodology to asses stability of RNA containing dry powder formulations
  • Understanding key factors that determine the solid state stability of dry powder formulations

10:00 am
Morning Break & Speed Networking

Synopsis

Enjoy a morning coffee while networking with industry experts

11:00 am Spray Drying Techniques to Enable Inhalation
Virtual

  • Sune Andersen Principal Scientist - Spray Drying, Janssen Global Services, LLC

Synopsis

  • Enabling particle homogeneity and control over particle size
  • Spray trying as a technique to enable deep lung delivery
  • How can we make formulation more stable?

11:30 am Exploring the Impact of Lipid & Phospholipid Excipients on Aerosol Performance of High Drug Load Spray Dried Particles for Inhalation

Synopsis

  • Employing particle engineering such as spray drying to formulate high drug load inhalable formulations
  • Understanding the effect of small amounts of lipid excipients during spray drying on solid-state, surface characteristics, and aerodynamic performance of co-spray dried formulations

12:00 pm Selection of an Aerosol Delivery System for an Inhalation Product

  • Stephen Pham Senior Vice President - Product Development, Avalyn Pharma

Synopsis

  • The aerosol delivery system to administer an active ingredient to the lung is of paramount importance in the development of an inhalation product
  • Understanding that the selection of the right aerosol delivery system, is largely dependent on the required drug dose
  • Evaluating strategy for selecting an appropriate aerosol delivery system for an inhalation product, with a special emphasis on inhalation products that require high drug loading

12:30 pm
Networking Lunch

Capitalizing on Innovation in the Device Landscape & Patient Centricity

1:30 pm Improving Our Formulation-Device Compatibility

  • Cees van rijn Professor - Nanotechnology & Microfluidics, University of Amsterdam

Synopsis

  • Understanding the impact of shear force on the integrity of your formulation
  • How to protect large molecules and delivery vehicles during nebulization
  • Design of optimized inhalation devices to protect fragile formulations

2:00 pm Inhalable Bifunctional sEH/COX-2 Inhibitors for Treatment of Asthma

Synopsis

  • Developing inhalable bifunctional sEH/COX-2 small molecule inhibitors with novel mechanisms of action to treat Asthma
  • Asthma affects over 300 million people worldwide and up to 55% of these patients experience recurrent episodes of bronchospasm despite long-acting beta-agonists plus high-dose inhaled or oral corticosteroids
  • Chronic use of corticosteroids can lead to immune suppression, CVD risk, glaucoma, bone loss and myopathy, while alternative new therapies including biologics are expensive and cause adverse side effects

2:30 pm
Afternoon Break

3:00 pm Novel & Innovative Patient-Centric High-Dose DPI for Respiratory & Systemic Indication, Cyclops

Synopsis

  • New concept for dry powder inhalation with great patient benefits and high-dose capabilities
  • Currently one product marketed for CF, and in-house pipeline in development for pulmonary and systemic indications, including rescue therapies
  • Co-development of products with NCE/NBE partners, including new modalities

3:30 pm Roundtable Discussion: Addressing Key Questions of Formulating in Dry Powder Inhalers (DPI) vs Liquid / Nebulizers vs Metered Dose Inhalers (MDIs)

  • Stephen Pham Senior Vice President - Product Development, Avalyn Pharma

Synopsis

Weighing up the pros and cons of each administration formulation is multifactorial and complex. There are many considerations across modalities, patients and disease that need to be evaluated.

Discuss these points to help guide you in your formulation decision:

  • Identifying administration times and ease of use
  • Which ones are suitable for which modalities? How can you formulate and what is achievable for your API
  • Drug loading and disease indication considerations – whether you’re delivering mgs or more and penetration to areas of the lung

4:00 pm Challenges in Development of a Dry Powder Inhaler Product

  • Lakshmi Sunku Associate Director- Combination Product Development, Insmed

Synopsis

  • Understanding the patient population, optimizing the formulation and choice of the right device
  • Understanding the resistance and flow rate requirements of dry powder inhalers for targeted lung delivery
  • Overcoming process challenges during development of the combination product

4:30 pm
Chair’s Closing Remarks

  • Stephen Pham Senior Vice President - Product Development, Avalyn Pharma