Breathe Easy: Selecting analytical strategies for inhaled drug product development
Sponsored by: Malvern Panalytical
Date: 5 December
Time: 3:30PM London/10:30AM New York
In response to pressure from healthcare providers to increase access to medicines while managing their costs, global regulators have been considering the requirements for encouraging increased generic competition. Specific attention has been given to the challenge of complex drug products where, due to the nature of the formulation or route of delivery, the development of generics is more difficult. In response, regulators such as the US FDA have released product-specific guidance documents aimed at advising generics manufacturers on the methods which should be applied to establish bioequivalence.
One class of complex drug products which has received significant attention is Orally Inhaled and Nasal Drug Products (OINDPs). These products are considered complex drug products for two reasons: First, delivery of the drug often requires the use of a device, the operation of which must be understood in order to ensure effective drug delivery. Secondly, there are a paucity of data that correlate in vitro and in vivo parameters for OINDPs, which increases the difficulty to demonstrate bioequivalence. As a result, the typical standards required for the approval of a new generic complex drug products can be challenging to meet. The US FDA has therefore released a number of product-specific bioequivalence guidance documents for OINDPs, highlighting the application of novel analytical methods to enable in vitro assessment of bioequivalence. This guidance, coupled with the introduction of new, prioritized review processes, has led to a significant increase in recent generic drug approvals.
This webinar will address key questions such as, what are the novel analytical methods relevant to OINDP in vitro bioequivalence studies? Also, what supporting evidence can be generated to aid formulation optimization and therefore help speed successful product development and regulatory submission? This webinar, led by OINDP experts from Aptar Pharma companies Next Breath and Nanopharm, will examine the analytical methods and regulatory frameworks associated with ensuring and establishing bioequivalence. The presenters will discuss the multiple, sometimes interconnected, strategies for reducing cycle times for OINDP development projects and how such strategies can be implemented in a practical way. In addition, technologies such as utilization of component-specific morphological methods will be highlighted as a means to advance OINDP development.
Dr. Jag Shur,
CEO, Nanopharm (an Aptar Pharma business), and Research Fellow at the University of Bath - School of Pharmacy and Pharmacology
Dr. Jag Shur – CEO, Nanopharm, an Aptar Pharma company . Jag’s main area of research is investigation of the bioequivalence of orally inhaled and nasal drug products (OINDPs). The key theme of his research has been the development and application of novel tools to understand and quantify the microstructure of OINDPs. 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 â€˜Formulated Muco-Regulatory Agents in the Airways of Patients with Cystic Fibrosis’, at Portsmouth School of Pharmacy. 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.
Dr. Julie D. Suman, R.Ph., Ph.D.,
Founder & President, Next Breath, an Aptar Pharma business
Julie D. Suman, R.Ph., Ph.D is the Founder of Next Breath, an Aptar Pharma company , and serves as its President. 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 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. She is also a licensed Maryland pharmacist. Julie has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings at the FDA Topics in Bioequivalence Seminar Series and has been an invited speaker at ANVISA in Brazil. Julie is also a member of the Parental Drug Association Visible Particulate Taskforce.
Key Learning Objectives
- Learn how to optimize your analytical strategy to speed formulation development and regulatory submission
- Discover a combination of analytical techniques which support in vitro establishment of bioequivalence
- Understand more about the particular challenges of developing and manufacturing OINDPs
- Learn more about the regulatory guidance for the development of complex generic drug products
- Formulation Development Scientist
- Analytical R&D Scientist
- Senior Scientist
- Principal Scientist
- Formulation Scientist
- Analytical Scientist
- Analytical R&D
- Regulatory Affairs