What makes nasal delivery systems more challenging than solid dosage forms? How safe is nasal drug delivery? Are there such things as safe excipients? How does all this fit within the regulatory environment in Europe and the USA? How difficult is it to bring all these products to market?
This seminar seeks to explore these and other questions within the field of nasal drug delivery while reviewing interesting new data, innovative technologies and the very latest scientific developments. Leading authorities in nasal drug delivery will cover relevant aspects of nasal physiology, anatomy, absorption of a variety of drugs in various phases of drug development, and new drugs entering the market. In addition, nasal delivery to the sinuses will be discussed and the programme will include interesting case histories.
This seminar will offer an excellent networking opportunity to build business relationships and discuss all these issues with an unrivalled panel of experts in this field of drug delivery.
Those already involved in nasal drug delivery will benefit from updating their knowledge and sharing experiences with some of the leading practitioners in this field. If you are involved in nasal drug delivery or are just considering the potential, this seminar is an excellent route to understanding all aspects from the basic physiology through to launching a successful product.
1. Gain an update on the very latest scientific developments and technology advances in this field.
2. Hear from an unrivalled panel of expert speakers.
3. An excellent networking opportunity to build business relationships.
Nasal drugs to treat nasal disorders: a comprehensive review
Nasal drug delivery challenges
Nasal formulation of drugs
Developing next generation powder nasal delivery using POD technology
Rethinking nasal packaging environment
Key insights for a successful device development to achieve nasal bioequivalence requirements
The unique challenges of nasal drug delivery to treat chronic rhinosinusitis (CRS); considerations before and after sinus surgery
Review of day one
Dr Julie Suman and Dr René Bommer
Review of nasal drug delivery devices
Requirements concerning bioequivalence of nasal drug products from an authority’s point of view
Regulatory science associated with BE/TE for nasal products
US/FDA regulatory guidance on combination products
Qualification of new nasal drug delivery systems for existing drugs
Investigations regarding the developability of nasal metered dose inhalers
What are chemisimilars and what’s the problem?
Close of conference and refreshments
Dr. René Bommer is a founder and an owner of pharmAccel Consulting.
He received his Ph.D. in Chemistry from the University of Constance in Germany in 1990. After research positions at the Scripps Clinic in San Diego, USA , at Altana Pharma Germany (now Takeda) and a lectureship at the University of Buenos Aires he joined the device developing and manufacturing company Ing. Erich Pfeiffer GmbH in Germany and became a Director of Business Development. In 2007 René founded a consulting company with a focus on delivery devices. pharmAccel Consulting delivers a service to support an accelerated entry into the market with consideration of technical, regulatory, marketing and pharmaeconomical aspects of the drug delivery device business.
Dr. Julie D. Suman, R.Ph., Ph.D., is a co-founder and President of Next Breath, LLC, an incubator company located at the UMBC Technology Center. Next Breath, which incorporated in April 2002, is a contract research organisation dedicated to the development of nasal and inhalation delivery systems. She directs the contract research division that supports product development for North American and European clients in the pharmaceutical, biotechnology and medical device markets.
Julie holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a licensed Maryland pharmacist and a member of the Maryland Pharmacy Volunteer Corp. Julie has also been an affiliate assistant professor in the Department of Pharmaceutics at Virginia Commonwealth University since 2009.
Dr. Michael S. Benninger has been the Chairman of the Head and Neck Institute at The Cleveland Clinic since 2008. Previously he was the Chairman of the Department of Otolaryngology-Head and Neck Surgery at Henry Ford Health System in Detroit, Michigan. He has also been involved in Regional, National and International medical organizations. He served on the Board of Directors of the American Academy of Otolaryngology-Head and Neck Surgery for 12 years, having been a former Vice President and Chairman of the Board of Governors. Dr. Benninger is on the Board of Directors of the Voice Foundation and the International Association of Phonosurgeons, and has recently been on the Executive Council of the Triological Society. In addition to his numerous professional pursuits Dr. Benninger has authored 6 books, including his most recent books, “The Performer’s Voice” and “The Singer’s Voice”. He has written over 100 scientific articles, focusing primarily on voice care and laryngology, nasal and sinus disease and health care management. Dr. Benninger has also lectured extensively across the US and throughout the world.