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Delivery of Biologics to the Nasal Cavity Training Course

The Future of Nasal Drug Delivery

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

★★★★★ "Very clear and informative!"

4 June 2024
+ 8 October 2024 »
from £299

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Format: Live online
CPD: 3 hours for your records
Certificate of completion

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Overview

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. For example, an intranasal mAb formulation is in phase 1 clinical trials for progressive Multiple Sclerosis.

This course will address the challenges associated with formulation and clinical trial manufacture of biologics for delivery to the nasal cavity. The course will also highlight barriers to cell penetration and absorption and identification of an ideal target product profile.

The pros and cons for liquid versus powder formulations will be discussed. In addition, the course will focus on strategies for maintaining stability and prolonging retention in the nasal cavity. Device selection for preclinical and clinical studies using predictive tools such as nasal casts will be presented.

Finally, the session will help prepare the audience with manufacturing strategies for clinical trials with a nasally administered biologic.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Who Should Attend

Research and Development
Formulation Development
Clinical Development
CMC Managers
Program Management
Development Engineers
Clinical Trial Manufacturing

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The Delivery of Biologics to the Nasal Cavity course will cover:

Challenges and Opportunities

Define biologics scope
Challenges to target cells and/or achieve absorption
Overcoming barriers
Identify target product profile

Jag Shur, Nanopharm

Formulation Strategies

Liquid vs powder formulations (pro/cons and formulation development techniques overview)
Stabilizing biologics
Retention and targeting strategies
Case studies

Irene Rossi, Nanopharm

Delivery to the Patient

Device selection
Bridging animal and human studies
Nasal deposition
Supporting care with training and digital health applications

Julie Suman, Aptar Pharma

How to Get Ready for a Clinical Trial with a Biologic

Drug product manufacturing
Drug product release testing
Stability studies
Regulatory considerations

Paul Shields, Enteris BioPharma, Inc

Q & A Discussion

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Julie Suman
Next Breath

Dr. Julie D. Suman is the Vice President of Scientific Affairs for Aptar Pharma. She manages strategic scientific planning and Aptar’s Scientific Advisory Board. Dr. Suman is also the co-founder of Next Breath. She holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). Dr. Suman serves on the External Advisory Committee of the New South Wales RNA Production and Research Network. In addition, she is a co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University.

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Jag Shur
Nanopharm Ltd, an Aptar Pharma Company

Dr Shur is an academic and entrepreneur having over 100 published scientific papers and was CEO of Nanopharm Ltd, which he led to a successful exit in 2019. Jag’s main area of research and commercial endeavour is in the complex topical pharmaceutical drug products area. A key theme of his research and commercial enterprises have been to develop patient-centric drug development platforms. He began his career with Profile Drug Delivery (now Philips Respironics) where he developed liquid dose drug delivery systems for cystic fibrosis patients, and later went on to work for GlaxoSmithKline. Jag holds a BSc (Hons) in Chemistry and completed his PhD, entitled ‘Formulated Muco-Regulatory Agents in the Airways of Patients with Cystic Fibrosis’. Following this, he was a post-doctoral fellow at the London School of Pharmacy, investigating the fabrication of microparticles for vaccine delivery using supercritical fluid technology.
Jag remains a part-time member of Nanopharm Ltd, an Aptar Pharma Company as Vice President of Science and Technology.

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Irene Rossi
Nanopharm, an Aptar Company (UK)

Irene Rossi is the Head of New Modalities Pharmaceutical Development at Nanopharm, an Aptar Company (UK). Irene obtained a MSc in Pharmaceutical Chemistry and Technology in 2014 and a PhD in Drugs, Biomolecules and Health Products at the Food and Drug Department, University of Parma (Italy) in 2019.
She joined Nanopharm in 2019 and she currently leads a group focused on the development of new technologies for OINDP products. Her main research area is the production, optimization and characterization of powders and liquid formulations for nasal and inhalation containing both small or large molecules.
Up to date, Irene has submitted and published 6 original papers, a patent application on the development of a dry powder for pulmonary vaccination and she presented her work at more than 20 international conferences

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Paul Shields
Enteris BioPharma, Inc

Dr. Shields holds a Ph.D. in Biochemistry from the University of Pennsylvania and a B.S. in Chemical Engineering from the University of Michigan. He has 33 years of experience in process development and manufacturing of APIs and drug products, including recombinant peptide and protein production, formulation, sterile product manufacturing, oral solid dose, nasal sprays and nasal powders. He has built and operated pharmaceutical manufacturing facilities, and has overseen development and production of commercial drugs for both the US and European markets.

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NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

4 June 2024

Live online

14:00-17:00 UK (London) (UTC+01)
15:00-18:00 Paris (UTC+02)
09:00-12:00 New York (UTC-04)
Course code 13759

GBP 299 349
EUR 429 499
USD 501 579

Until 30 Apr

3 hours of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

8 October 2024

Live online

14:00-17:00 UK (London) (UTC+01)
15:00-18:00 Paris (UTC+02)
09:00-12:00 New York (UTC-04)
Course code 13990

GBP 299 349
EUR 429 499
USD 501 579

Until 03 Sep

3 hours of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.