Speakers: Guenther Hochhaus (University of Florida); Qi (Tony) Zhou (Purdue University); Wenlei Jiang (CDER, FDA); Reinhard Vehring (University of Alberta); Yoen-Ju Son (Genentech); Ram Mahato (University of Nebraska); Hugh Smyth (University of Texas, Austin); Jennifer Wylie (Merck)
Organizers: Edward Yost (Genentech), Nivedita Shetty (Genentech) and Peter Staehr (ChemoCentryx)
Date: 2021-07-29- 7/30/2021
Time: 8:30-12:30 Pacific Time
Registration fee: (USD): Regular: $0
Location: Online via Zoom
Major Sponsor: (1)MilliporeSigma;(Major Sponsorship - Day 2 still open)
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2021-07-28  (it will close sooner if the seating cap is reached)

About the Topic

The event times 8:30 am - 12:30pm are in Pacific Time.

Objectives:

1. Advancement of lung therapeutics at the interface of discovery and development.
2. Cross-functional exposure, thinking, and seeding innovation. 

Symposium Description:

The lung therapeutic symposium is aimed at bringing together scientists from the inhalation world for 2 days of networking and knowledge sharing taking place completely virtually on July 29th and 30th. The symposium will feature in-depth presentations covering a broad range of specific topics, from particles on cell culture to spray drying caveats to discussing potential alternative approaches for the development of generic inhalation drugs. In addition, current regulatory recommendations and guidelines for bioequivalence approaches of orally inhaled drug products will be highlighted. These data driven presentations and case studies focusing on advanced particle engineering techniques should be considered for the design of robust inhaled dosage forms.

Agenda:

Day one: Challenges, Prospects and Advancements in Inhalation

8:30 AM – 8:40 AM.    Welcome & General Introduction - Organizers and Chairs

8:40 AM – 9:30 AM.    The journey of inhaled product development: Key considerations in pharmaceutical development - Yoen-Ju Son, Genentech

9:30 AM – 10:20 AM    Challenges and potential alternatives for a more streamlined approval process for generic inhalation drugs - Guenther Hochhaus, University of Florida

10:20 AM – 10:30 AM.   Sponsor presentation - MilliporeSigma

10:30 AM – 10:35 AM.   Break

10:35 AM – 11:25 AM.   Particles on cell culture - Ram Mahato, University of Nebraska

11:25 AM - 12:15 PM          Global Bioequivalence Requirements for Orally Inhaled Drug Products - Wenlei Jiang, CDER, FDA

12:15 PM - 12:40 PM.    Panel discussion

Day two: Advanced Particle Engineering for Inhaled dosage development

8:30 AM – 8:40 AM.    General Introduction - Organizers and Chairs

8:40 AM – 9:30 AM.    General Introduction: Successful transitions from discovery to FIH for inhaled products: Understanding the role of API physchem properties and device, delivery and analytical technologies - Jennifer Wylie, Merck

9:30 AM – 10:20 AM.    Why engineered particles? - Qi (Tony) Zhou, Purdue University 

10:20 AM – 10:30 AM.    Break

10:30 AM – 11:20 AM.    Encapsulation of Respiratory Dosage Forms by Spray Drying - Reinhard Vehring, University of Alberta

11:20 AM - 12:10 PM.    Formulation and Delivery of mRNA to the Lungs - Hugh Smyth, University of Texas - Austin

12:10 PM - 12:35 PM.    Panel discussion