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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
Overcoming barriers
Device selection
Targeted delivery in the nose
Liquid vs powder formulations

Julie Suman, Aptar Pharma

Formulation Strategies

Stabilizing biologics
Formulation strategies
Identify CQA and TPP
Case studies

David Farrow, Aptar Pharma

Analytical Considerations for Nasally Delivery Biologics

Considerations with compendial analysis for nasal products
Secondary structure and aggregate analysis
Modeling of deposition using nasal casts
Device impact on the formulation

Lucas Silva, Nanopharm

How to Get Ready for a Clinical Trial with a Biologic

Specification setting
Drug product manufacturing
Drug product release testing and stability studies
Regulatory considerations

Gemma Budd, Nanopharm

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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David Farrow
Nanopharm

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Gemma Budd
Nanopharm

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Lucas Silva
Nanopharm

Lucas Silva is a Molecular and Cellular Biologist by academic training from the University of Lisbon and currently is working as a Senior Specialist leading the Analytical services at Nanopharm, an Aptar Pharma company.

Prior to his experience in Nanopharm, Lucas did a research internship at University College London focused on the development of particle engineered Dry Powder Inhalers (DPIs) for pulmonary infections.

With over 8 years of immersion in the pharmaceutical industry, Lucas has cultivated expertise spanning analytical services, formulation technology, and drug delivery devices, predominantly within the realm of research and development, particularly in orally inhaled and nasal drug products.

His key research areas are the development of more realistic respiratory and nasal analytical methods, the application of specialized in vitro performance data to de-risk and accelerate drug product development.

Lucas has showcased his research findings at numerous international conferences through both poster presentations and podium talks. Additionally, he has contributed as a co-author to a peer-reviewed paper centred on enhancing impactor testing for assessing the bioequivalence of DPIs.

Currently, Lucas actively engages in discussions within the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), contributing valuable insights to navigate the evolving landscape of inhaled and nasal drug products.

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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.