Prices of dermal application drugs (topical products) exploded in the USA between 2009 and 2015 (rise of between 2 and 10 times!) due to weak competition. Furthermore, faced with exorbitant expenses and inconclusive clinical study results, allowing the launch of topical generics, Food and Drug Administration (FDA) has collaborated with research centers to develop new tests. These tests have made it possible to more effectively and quickly demonstrate bioequivalence of a generic product with its brand name product.
These assays were developed and validated with acyclovir (Zovirax). Five years later, there are five times more acyclovir generics approved on the market. Consequently, this led to a decrease in the median price of this product.
Based on these findings, European Medicines Agency (EMA) has completed consultation on a draft guideline that should be published in 2021.
In contrast, nanotechnology, which makes use of nanometre-sized particles (10-9 m) and has new physical properties, does not yet have established guidelines. This creates new challenges in the development of pharmaceutical products.
Everyone will be able to benefit from our Workshop by discovering these new in vitro and in vivo tests and the new challenges arising from nanotechnology as well as expanding knowledges into the current political context of generic medicines applied to the skin.
New concepts, new technology, and a workshop to talk about it !
This guideline will be promulgated in few months by the EMA to positively overturn the pharmaceutical industry and the poles concerned, notably production and R&D functions such as galenical, regulatory affairs, quality assurance, or preclinical. The regulatory challenge of novel nanotechnology in this arena will be addressed.
To accompany them and help them face the new challenges that are opening up to them, Dr. Nathalie Hasler-Nguyen from Labhnn has decided to set up this Workshop.
With twenty years of experience in the management of a preclinical laboratory in the pharmaceutical industry, Dr. Nathalie Hasler-Nguyen has decided to collaborate with confirmed experts in the field of topical product development. Their objective? To inform and guide any actor in the development/production of topical products through the meanders of this new directive and nanotechnology challenges in this arena.
In addition, this event, which will take place on 6 April in Geneva, will feature presentations by international experts in the development/production of topical products and nanotechnology.
Among which, Prof. Richard Guy (Expert in topical product regulation/development at the University of Bath – UK), Prof. Yogeshvar Kalia (Expert development at the University of Geneva-CH), Prof. Stefan Muehlebach (Expert in nanotechnology, University of Basel-CH) and Dr Vinod Shah (author of several FDA guidelines – 30 years at the FDA),
In other words, this Workshop will be an opportunity to demonstrate the new technical concepts that can be correlated with bioequivalence in vivo and to highlight the new challenges of nanotechnology.