Key insights for a successful device development to achieve bioequivalence requirements
The most common use of multi-dose nasal sprays is for allergy related symptoms, such as allergic rhinitis. This market is dominated by nasal preparations for the administration of locally acting drugs such as steroids, where the delivery system is a critical element for therapeutic efficacy.
Moreover, majority of big pharmaceutical drugs came or are coming off patent. We observe new trends for regulatory strategy and commercialization of nasal sprays:
1. Generic companies enquire for an equivalent delivery system to the Reference Listed Drug,
2. Innovator companies switch to Over-The-Counter status to protect from market erosion due to generics.
Speakers will cover several subjects related to the nasal spray development from different perspectives.
A detailed review of the device influence in terms of nasal spray characteristics and performances will be presented.
The bioequivalence requirements as well as region-specific regulatory strategies will be discussed.
Also, we will demonstrate how fundamental the control of the testing methods and statistical computation are to ensure reliable bioequivalence assessment.
Recognized as a world leader in design development and manufacturing, Nemera will provide useful advice for a successful development with respect to bioequivalence requirements.
Sign-up today to learn about the device perspectives in the changing landscape of the nasal drug delivery!
Presented by
Pascale Farjas,
Global Category Manager
Pascale Farjas is the Global Category Manager for the ENT (ear, nose, and throat) segment at Nemera, a leading developer and manufacturer of healthcare packaging and devices.
Her role encompasses understanding patients' needs and regulatory requirements to develop and market packaging solutions that improve the patient experience. She is in charge of the market introduction of new pump platforms for nasal sprays.
Pascale joined Nemera in 2011 and holds a chemical engineer degree from the National Institute of Applied Sciences of Rouen in France, completed with a marketing-focused Master Degree from the Business Administration Institute (France).
Prior to joining Nemera, Pascale held various positions in strategic (market intelligence and market studies) and operational marketing in the pharmaceutical industry for international markets.
Alain REGARD,
Technology Product Manager
Alain REGARD graduated as a Polymer Engineering and Processing from ESP in Oyonnax, France.
After a long experience in design and development in the automotive industry, he joined the company in 2010 as a Product development Leader. Alain, today one of the key technical experts of Nemera's Innovation Centre for Devices (ICD), leads the nasal and dermal developments.
He drives some Nemera own IP projects as well as working on several customer product developments in the field of nasal and dermal applications.
Céline Petitcolas,
Customer Technical Support
Céline Petitcolas holds Materials engineer degree from the National School of Chemic and Physic of Bordeaux (France).
Her current position is Customer Technical Support for nasal range at Nemera. Following a first R&D experience in automotive industry, Céline joined Nemera in 2012 to develop pharmaceutical device and especially for nasal spray area. Her new role consists in helping and assisting customers from a technical point of view in their development for nasal spray and more specifically on Bioequivalence topics.
Celine is the preferred technical contact for customers as she is interfacing with Nemera teams (marketing, sales, technical) to bring the support they need.
