Opportunities and Considerations for Inhaled Biologics

Life Sciences, Clinical Trials, Drug Discovery & Development,
  • Wednesday, May 22, 2024

Development of biologics continues to increase, with a substantial portion of pipeline molecules falling under this umbrella. Although injections remain a common delivery route, inhaled biologics are growing their share of the development pipeline. These therapies have the potential to expand treatment options across a wide range of therapeutic areas, from lung infectious diseases to acute and chronic lung and systemic diseases. Inhaled vaccines also present a valuable opportunity within this space.

To take full advantage of these benefits, a thorough understanding of the unique considerations for inhaled biologic development is key. From small and large peptides and proteins to RNA and gene-based therapies and more, the inhaled biologics space presents a wealth of opportunities for growth, but there are also key considerations that must be addressed. Developing biologics that can withstand formulation and delivery via inhalation is a complex process, requiring specific capabilities and expertise.


In this webinar, the expert speakers will focus on the benefits and considerations for inhaled vs. injectable biologics. They will discuss factors such as the biologic’s dose/regimen, physical/chemical properties and patient and commercial requirements, which help determine the technologies that can be used to develop inhaled biologics. They will also speak about how inhaled biologics address important challenges in vaccine development and specific considerations for delivering vaccines via inhalation.

The participants can also expect a comprehensive overview of the inhaled biologics market as it stands today, with an eye toward future opportunities and challenges. The webinar will cover inhaled biologics from vaccines to drugs for chronic use, touching on the importance of being technology agnostic in the beginning and strategies for an optimized development process.

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Register for this webinar today to gain insights into the current and future trends, opportunities and considerations for the development of inhaled biologics.


John Patton, Kindeva Drug Delivery

John Patton, Head Kindeva SAB, Kindeva Drug Delivery

John Patton is a drug delivery scientist and entrepreneur with extensive experience in biotech and the development of new inhaled medications. He serves as Executive Chairman, Co-Chairman, Director and Advisory Board Member for multiple companies, where he uses his deep expertise in drug delivery science and engineering to build state-of-the-art drug delivery products that will make a difference to the widest possible patient groups.

After leading the drug delivery team at Genentech for five years, where he helped pioneer inhaled biologics, he founded/co-founded four inhalation companies: Inhale/Nektar Therapeutics (the recipient of the Wall Street Journal’s Medical Innovation of the Year in 2006 for Exubera, the first FDA-approved inhaled Insulin); Dance Biopharm (now Aerami Therapeutics); InCarda Therapeutics and iPharma Labs Inc. (acquired by Kindeva in 2022). John has more than 110 publications and is (co)inventor of more than 50 patents.

Message Presenter
Keith Ung, Kindeva Drug Delivery

Keith Ung, Director and Bay Area Site Head, Kindeva Drug Delivery

With over three decades of industry experience, Keith Ung is an expert on inhalation infrastructure setup and characterization of pulmonary and nasal drug delivery systems. In his role at Kindeva Drug Delivery, he oversees the Bay Area facility, leveraging extensive expertise in in vitro characterization of spray-dried peptide and small molecule powders and pulmonary delivery systems in support of proof-of-concept, preclinical and clinical studies.

Keith was previously the CEO, President, Director and Founder of iPharma Labs Inc., a pharmaceutical inhalation contract research organization providing drug discovery, product development, life cycle management and product testing from feasibility to commercial inhalation pharmaceutical product services. iPharma was acquired by Kindeva Drug Delivery in 2022. Keith’s previous experience spans a variety of positions across drug development, and he earned his PhD from the University of Sydney.

Message Presenter
Andy Clark, Aerogen Pharma Corporation

Andy Clark, President and General Manager, Aerogen Pharma Corporation

Andy Clark is a seasoned pharmaceutical executive, with over 35 years of experience in respiratory drug development. His experience includes managing the development of some of the pharmaceutical industry’s most novel inhalation products, including Pulmozyme® (the first inhaled protein), Exubera® (the first inhaled insulin) and Tobi Podhaler® (the first inhaled dry powder antibiotic).

Some of Andy’s past roles include Site Head at Novartis’ pulmonary drug development site in San Carlos, CA; CTO at Nektar Therapeutics; General Manager & Director at Bradford Particle Design and Head of the Pulmonary Product Development Group at Genentech. Over his career, Andy has received the Young Investigator Award (ISAM), the Thomas T. Mercer Award (AAAR) and the Charles G. Thiel Award (RDD) all for “outstanding contributions to aerosol science.”

Message Presenter
Jeff Weers, Cystetic Medicines, Inc.

Jeff Weers, Chief Technology Officer, Cystetic Medicines, Inc.

Jeff Weers is a physical chemist with a broad multidisciplinary scientific background and 30 years of experience in colloid-based research and development. As Chief Technology Officer at Cystetic Medicines Inc., he leads the early development of amphotericin b cystetic for inhalation (ABCI), a novel genotype independent therapeutic intended to restore anion transport in cystic fibrosis patients caused by Class I and other rare mutations for which there are currently no targeted therapies.

Jeff has published more than 100 peer-reviewed articles and is a prolific inventor with more than 70 issued US patents. His inventions (e.g., the PulmoSphere™ technology) have contributed to six approved respiratory products. He was named a Fellow of the American Association of Pharmaceutical Scientists (AAPS) and the International Society for Aerosols in Medicine (ISAM). Jeff has received numerous awards including the Charles G. Thiel Award (RDD) and Alexander Fleming Award (London Business School). Jeff earned his PhD in Physical Chemistry from the University of California, Davis.

Message Presenter

Who Should Attend?

This webinar will appeal to the following in pharma/biotech/medical device organizations:

  • Chief Scientists and Technology Officers
  • Manufacturing process and development — VP of External Manufacturing
  • Commercial Leads
  • Manufacturing and/or Process Engineering Manager (Director, Head or VP)
  • Formulation Scientists
  • Device Scientists and Engineers
  • VP/Heads/Managers of R&D

What You Will Learn

Attendees will learn about: 

  • Wide range of inhaled biologics in development (~10 percent of all biologics) and their applications across various therapeutic areas and conditions
  • Benefits and considerations for inhaled vs. injectable biologics
  • How the biologic’s dose/regimen, physical/chemical properties and patient and commercial requirements dictate the technologies that will build the best products
  • How engineered fine powders are revolutionizing dry powder inhalation products
  • Nebulizers vs. inhalers and the evolving vibrating mesh device’s applications to biologics
  • Approaches to wet and dry formulation development, whether starting with wet proof of concept and dry Phase II or conducting both together
  • How inhaled biologics address key challenges in vaccine development and specific considerations for delivering vaccines via inhalation
  • Use of connected devices for clinical trials to improve data collection

Xtalks Partner

Kindeva Drug Delivery

Kindeva Drug Delivery is a global contract development and manufacturing organization focused on drug-device combination products. We develop and manufacture products across a broad range of drug-delivery formats, including pulmonary & nasal, injectable, and transdermal. Our service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base from our state-of-the-art manufacturing, research, and development facilities located across the U.S. and U.K.

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